IL MPJE

Can you get in trouble for possession and use of cannabis?

A criminal statute, designed to remove cannabis from the criminal penalty scheme applicable to other controlled substances. Possession and use is still subject to criminal sanctions, but penalties are less severe, and courts have greater latitude in deciding the appropriate penalty and sentencing.

What is Carisoprodol used for?

A muscle relaxant

What are requirements to become a pharmacy investigator?

Each pharmacy investigator shall be a licensed pharmacist unless employed as a pharmacy investigator on or before 8/27/15.

Misbranded or adulterated: it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health

Adulterated

Misbranded or adulterated: it is a drug, and the methods used in, or the facilities or controls used for manufacturing, packaging, etc. are in violation of current good manufacturing practices

Adulterated

Misbranded or adulterated: strength or quality or purity falls below compendium standards

Adulterated

Misbranded or adulterated: An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper-resistant package

Adulterated under section 501 or misbranded under section 502, or both

Are controlled substances regulated by federal or state laws?

Both federal and state

What are delivery requirements of pharmacies preparing sterile parenteral products?

Assure environmental control and temperature controlled

What does protected health information not include?

Education records covered by the federal family educational right and privacy act or employment records held by a licensee in its role as an employer

How long are DEA 222 forms filed for?

2 years

How long do PSE and EPH records have to be maintained?

2 years

Under Illinois law, what is the age requirement for exempt narcotics?

21 years old

How often is the renewal of pharmacy registration?

3 years

How much ethylmorphine is considered schedule 3?

300mg ethylmorphine/100mL (15 mg/dosage unit)

How many hours does a pharmacist have to work to earn one 30 minute meal break and one 15 minute break?

6 continuous hours

How long is the authorization be maintained for?

6 years

If the controlled schedule 2 drug is not received, how long does the form remain active?

60 days (must be voided and use new form if not received in that time)

When do nonresident special pharmacy registrations have to be renewed?

60 days preceding the expiration date by paying the fee

How many days a PIC is on leave that a new PIC must be designated?

90 days

Under IL law, how long is a CII prescription good for?

90 days after the date of issuance

What alcohol is obtained by pharmacies?

95% ethanol (190 proof grain alcohol)

If a patient is on methadone for detoxification, can a doctor that works in a narcotic treatment program prescribe methadone for analgesic purposes?

No

If the patient declines to sign the authorization form, can the pharmacy refuse treatment?

No

Does the practitioner's state registration have to appear on the RX?

No, just the DEA number. However, the practitioner, as well as the pharmacy, must have both a DEA registration number, and a state controlled substance license.

Can a defective DEA form 222 be corrected?

No, must be replaced by a new DEA form 222 for the order to be filled.

Can prescriber fax a CII if dispensing solid or liquid oral dosage form or an IV form to be injected by the patient?

No, original written RX is required because it is not infused

What does HIPAA require?

HIPAA requires that PHI be maintained and used by a CE or BA only for certain purposes ("TPO"), unless patient authorization is obtained

What are the remote consultation sites requirements?

No prescription inventory, but staffed by pharmacy technicians and filled prescriptions filled at the home pharmacy are given to patient and consulted via audio/video

Under federal law, what is the quantity limitation for CIIs?

No quantity limitation

When is the hard copy of the prescription drug not required?

If a pharmacy's computer system can capture an unalterable electronic visual image of the prescription drug order, the electronic image shall constitute the original prescription

Can compounded products be considered as exempt narcotics?

No, always will require a prescription

Are after hour cabinets the same as automated dispensing units?

No, automated dispensing units are accessed when the pharmacy is open

What does P/R mean in the first letter of the DEA number?

Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program

Who should the pharmacy contact for controlled substance theft or loss?

Nearest DEA office and local police

What happens if there are lost or stolen forms?

New form should be submitted with a written statement

Are partial fills treated as full refills?

No

Are patients required to bring collected substances to an authorized collector or to law enforcement for destruction?

No

Are pharmacies required to dispense a drug without payment of their usual and customary or contracted charge?

No

Are pharmacies required to physically transfer prescriptions or information for dispensing purposes?

No

Are poisons drugs?

No

Are prescriptions issues in foreign countries such as mexico and canada valid in Illinois?

No

Are products found not to be bioequivalent approved?

No

Can chiropractors prescribe in IL?

No

Can licensed practical nurses prescribe in IL?

No

Can naprapaths prescribe in IL?

No

Do employee pharmacists need to obtain a separate registration?

No

Doe the DEA 224 applicant have to be a pharmacist?

No

Does IL have a ratio or a limit on the number of technicians that a pharmacist is permitted to supervise?

No

What schedule is Xyrem?

Schedule 3 (Gamma Hydroxybutyric Acid preparations is the generic)

What schedule is gamma hydroxybutyrate?

Schedule 3 (Gamma Hydroxybutyric Acid preparations is the generic)

What schedule is Butisol?

Schedule 3 (butalbital is the generic)

What schedule is Fioricet with Esgic?

Schedule 3 (butalbital with APAP are the generic)

What schedule is Dihydrocodeine?

Schedule 3 (synalgos-DC is the brand)

What schedule are anabolic steroids?

Schedule 3 (testoderm and winstrol are brand names)

What schedule is Pentothal?

Schedule 3 (thiopental is generic)

What schedule are pentazocine products under federal law?

Schedule 4

What schedule is Meprobamate?

Schedule 4 (equanil, miltown is brand)

What schedule is Dalmane?

Schedule 4 (flurazepam is generic)

What schedule is Clonazepam?

Schedule 4 (klonopin is brand)

What schedule is Temazepam?

Schedule 4 (restoril is brand)

What schedule is Oxazepam?

Schedule 4 (serax is brand)

What schedule is Carisoprodol?

Schedule 4 (soma, soprodal, vanadom is brand)

What schedule is Zaleplon?

Schedule 4 (sonata is brand)

What schedule is Restoril?

Schedule 4 (temazepam is generic)

What schedule is Ultram?

Schedule 4 (tramadol is generic)

What schedule is pseudoephedrine under IL law?

Schedule 5

What schedule is Gamma hydroxybutyric acid (GHB)?

Schedule I (GHB, gamma hydroxybutyrate, sodium oxybate, non- pharmaceutical is the generic)

What schedule is GHB, gamma hydroxybutyrate, sodium oxybate, non- pharmaceutical?

Schedule I (Gamma Hydroxybutyric Acid (GHB) is the brand)

What schedule are products containing just pentazocine under IL law?

Schedule II

What drugs need to be reported theft of significant loss?

Scheduled drugs under federal law

What is the format of a DEA registration number?

Series of two letters, followed by seven numerical digits

What does a BN mean in the orange book?

Not equivalent

What does a BP rating mean in the orange book?

Not equivalent

What does a BT rating mean in the orange book?

Not equivalent

What does a BB rating mean in the orange book?

Not equivalent and not substitutable

Under federal law, how much dihydrocodeine is considered schedule 5?

Not more than 100 mg. of dihydrocodeine per 100 milliliters or per 100 grams.

Under Illinois law, what are the possession limits on exempt narcotics?

Not more than 4.5 liters per drug product plus amount of product needed for dispensing during busiest week

Policy on out of state prescriptions?

may fill or refill valid prescription on file in a licensed pharmacy in another state or prescription sent by an out of state prescriber, just determine validity

What if you eventually find the lost or stolen forms?

Supplier is required to void it and return it to ordering pharmacy for filing

Who is responsible for ordering, securing, and dispensing controlled substances?

The PIC even if they are/aren't the registrant or are/aren't the POA

Who can pharmacy investigators investigate?

The actions of any applicant or of any person or persons holding or claiming to hold a license or registration

Are inspectors ever not allowed into the pharmacy?

The answer is no, provided that they are inspecting pharmacy issues, and the inspection is during normal business hours.

When must you report to the PMP?

The information required to be transmitted under this Section must be transmitted not later than the end of the next business day after the date on which the controlled substance is dispensed.

What are requirements for maintaining recordkeeping for dispensing of orders for offsite institutional pharmacy services?

Which shall be readily retrievable and in a format that provides enforcement agents a concise, accurate and comprehensive method of monitoring drug distribution via an audit trail. This system may require two or more documents that, when read together, will provide all required information.

Can a pharamcist be a PIC for more than one pharmacy?

Yes but the PIC must work an average of at least 8 hours per week at each location where they are the PIC

Can Illinois and DEA registration limit schedule to practitioners?

Yes i.e. a practitioner can have a DEA registration for just CIII, IV, and V substances. It can also be limited by drug class (narcotic vs. non-narcotic)

What is cytotoxic?

a pharmaceutical that has the capability of killing living cells

How long should invoices be maintained?

1 year from the date of the invoice

What does AB stand for?

Substitutable Solid dosage form

What schedule is Numorphan?

Schedule 2 (generic is oxymorphone)

What schedule is sufenta?

Schedule 2 (generic is sufentanil)

When do non-controlled prescriptions expire?

15 months regardless of number of refills remaining or prn instructions

What schedule is Norco?

Schedule 2 (hydrocodone/apap is the generic)

What schedule is Vicodin?

Schedule 2 (hydrocodone/apap is the generic)

What schedule is Vicoprofen?

Schedule 2 (hydrocodone/ibuprofen is the generic)

Under federal law, what is the age requirement for exempt narcotics?

18 years old

What schedule is Tapentadol?

Schedule 2 (nucynta is the brand)

What schedule is Oxycontin?

Schedule 2 (oxycodone hcl is generic)

What schedule is Oxycodone HCl?

Schedule 2 (oxycontin, percodan is brand name)

What are the ID requirements on PSE and EPH products?

18 years old with valid drivers license or photo ID

What year was the Food and Drug Act enacted?

1906

What year was the Kefauver-Harris Amendment enacted?

1962

What year was the Orphan Drug Act enacted?

1983

What year was the PDMA amended?

1992

What year was the Dietary Supplement Health and Education Act enacted?

1994

What year was the Food and Drug Modernization Act enacted?

1997

What schedule is Sufentanil?

Schedule 2 (sufenta is brand name)

What schedule is Pentazocine?

Schedule 2 (talwin is the brand)

How many pharmacy investigators can the DFPR employ?

As many as deemed necessary

What schedule is Lisdexamfetamine?

Schedule 2 (vyvanse is brand)

What schedule are suppository forms of short acting barbiturates?

Schedule 3

What schedule is Butalbital w ASA?

Schedule 3

What schedule is Paregoric?

Schedule 3

Misbranded or adulterated: if not packaged and labeled in accordance with USP/NF specifications

Misbranded

What is included in written statement of lost or stolen forms?

(1) drugs were not received (2) order form is presumed lost.

What must you include in the DEA 222 form?

-Name of drug -NDC number of drug (if available) -Strength, package size and number of packages -Number of lines completed -Signature of purchaser or agent -DEA number of pharmacy -Date form issued

What is counted in inventory requirements?

- Drugs "in inventory"; - "Wasted" drugs awaiting disposal

How much ethylmorphine is considered schedule 5?

100 mg/100 mL ethylmorphine

How much dihydrocodeinone/hydrocodone is considered schedule 2?

ANY amounts

What is Ezogabine (Potiga) used for?

Adjunctive treatment for partial-onset seizures

What is the New Drug Application process?

All data concerning drug efficacy, safety, stability, production methods, packaging and data from the clinical trials are submitted to FDA for review. FDA undertakes an exhaustive review, and if approved, the NDA is placed on file with the FDA, and the drug can be marketed.

What is the Nutrition Labeling and Education Act?

Allowed the use of FDA-approved health claims on food labels and required a uniform format for labels that includes serving size, contents, calories, nutrients, and the recommended daily allowance of nutrients for which such daily values have been established; lists of ingredients, and the number of servings per container. Certain foods such as those served in restaurants are exempt from these requirements. Because of the NLEA, dietary supplement manufacturers now can make health claims without being considered drugs.

Who can apply for a DEA registration?

An owner, active partner, or any corporate officer. May assign power of attorney

When should an inventory of CII and approximate inventory of CII-V drugs be done?

Annually and maintained for a period of not less than 5 years

Alcohol sales are regulated through what organization in the US?

Bureau of Alcohol, Tobacco and Firearms (not by FDA or DEA)

Registration covers what controlled substances?

CII-V

What labeling requirements must be met for drugs dispensed from the ER?

Community pharmacy labeling requirements

Who is regulated by HIPAA?

Covered entities Business associates' of CE's

Who always gets copy 2 of the DEA form?

DEA!

The DEA is part of what US department?

Department of Justice

What is email address of record?

Designated email address recorded by the Department in the applicant's application file or the licensee's license file, as maintained by the Department's licensure maintenance unit.

How does pharmacy register for controlled substances?

Dispenser

What is required before an ANDA can be approved?

FDA requires a demonstration of bioequivalence

Under federal law, can a pharmacist change the date of a CII prescription?

Federal law is silent

Controlled substance registration is divided into what categories?

II narcotic II non-narcotic III narcotic III non-narcotic IV V

What is a B rating in the orange book?

Inequivalent, not substitutable

Tax free alcohol is used for what kind of use?

Inpatient use only

When do pharmacy licenses expire?

March 31 of even numbered years

Are faxed prescriptions electronic prescriptions?

NO

Can hospital residents who practice outside of the hospital prescribe under the authority of the hospital?

No. must have state medical registration number

Are C-II refillable?

Not refillable! Expires 90 days after issuance.

Where should invoices be maintained?

On site for at least 1 year from the date of the invoice

When is an offer to counsel permitted?

Only for refills

What are the benefits of CSOS?

Ordering freedom, faster transaction, accurate orders, decreased cost

Who is responsible for proper handling and disposition of all drugs when pharmacy ceases operations?

PIC

What can be changed to a CII prescription after consultation with the prescribing practitioner?

Patient's address, drug strength, drug quantity, dosage form, and directions for use

What is a community pharmacy?

Pharmacies that engage in general or specialty community pharmacy practice and are open to, or offer pharmacy service to, the general public

What is Tramadol (Ultram) used for?

Synthetic Opioid Agonist

Does the DEA accept triplicate DEA form 222?

They will not be accepted after October 30, 2021

Ocular pharmaceutical agents administered by injection can only be used for what?

Treatment of anaphylaxis

What does TPO stand for?

Treatment, Payment, Health care Operations

When do Schedule III, IV, or V controlled substances expire?

"A written prescription for Schedule III, IV or V controlled substances shall not be filled or refilled more than 6 months after the date thereof or refilled more than 5 times unless renewed, in writing, by the prescriber."

What are the requirements of the anti-tampering regulations?

"Cosmetic liquid oral hygiene products" and vaginal products, contact lens solutions, and most over-the-counter drugs to be packaged in tamper-resistant packages. Products' packaging must be "distinctive by design," and the package labeling must indicate to consumers what tamper-resistant measures are being used. The Federal Anti-Tampering Act makes tampering with consumer products a felony punishable by up to 10 years in jail.

How does hospitals register for controlled substances?

"Institutional practitioners". This registration is issued to the entire hospital, allowing controlled substances to be stored anywhere in the registered location, and to give employee practitioners, nurses, pharmacists the authority to possess, prescribe, dispense, and administer controlled substances.

What are illegal kick backs?

"It is unlawful for a pharmacist or pharmacy to pay or promise to pay to any person who owns, operates, manages or is an employee of a hospital, nursing home or other health care facility or to any person authorized by law to prescribe drugs or to any entity in which a person authorized by law to prescribe drugs holds an interest, any rebate, refund, discount, commission or other valuable consideration for, on account of, or based upon income received or resulting from the sale or furnishing by any such pharmacy of drugs or devices, prescriptions or any other service to patients of the above specified persons, organizations or facilities."

Can you post date Controlled prescriptions?

"Post-dating" of prescriptions is strictly PROHIBITED; state and federal regulations have always required that all prescriptions for controlled substances "be dated as of, and signed on, the day when issued. This means a pharmacy CANNOT accept a prescription with a date in the future, and hold the Rx until the date of fill, even if it was accidentally post-dated (i.e., MD wrote tomorrows date instead of today).

What statements dietary supplements labels say?

"Regular use of this product will help maintain healthy cholesterol levels", but cannot say" "Regular use of this product will help prevent heart disease"

What are the labeling requirements for orally or rectally administered OTC products containing aspirin or nonaspirin salicylates as active ingredients?

"Reye's syndrome [subheading in bold type]: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness." This warning statement shall appear on the immediate container labeling. In cases where the immediate container is not the retail package, the retail package also must bear the warning statement. In addition, the warning statement shall appear on any labeling that contains warnings and, in such cases, the warning statement shall be the first warning statement under the heading "Warnings.'' Shall not recommend the product for use in treating flu or chicken pox

If a prescription is not in stock or unavailable, or have a clinical issue, what can a pharmacist do?

(1) Contact the prescriber to address concerns such as those identified in subsection (e)(1); (2) If requested by the patient or his or her agent, return unfilled lawful prescriptions to the patient or agent; or (3) If requested by the patient or his or her agent, communicate or transmit, as permitted by law, the original prescription information to a pharmacy of the patient's choice that will fill the prescription in a timely manner.

What are two requirements of good faith dispensing?

(1) Diagnosis that supports the prescribing of the CS. This is the "legitimate medical purpose prong. (2) Prescriber acting in the "usual course" of practice. Look for odd fact patterns, such as internet prescribing, lack of a physical exam, "bad" medical practice, etc. Also consider "scope of practice".

What are the exceptions to returning to the closed network?

(1) Dispensing error (2) Drug recall (3) Pharmacy is an authorized collector

When do you need multiple registrations for controlled substances?

(1) Multiple Locations (2) Different Activities

What is a narcotic?

(1) Opium, opiates, derivatives of opium and opiates, etc. (2) Poppy straw and concentrate of poppy straw. (3) Coca leaves (4) Cocaine, etc. (5) Ecgonine, etc. (6) Any compound of the above

What are ways the entry should be access by the prescriber through?

(1) an interoperable electronic medical records system; (2) an electronic prescribing technology; (3) a pharmacy benefit management system; or (4) a pharmacy record

What are the digital imaging system requirements?

(1) contain all info required for manual records; (2) capability to produce hard copy when requested; and (3) system most not allow image to be altered, revised, or replaced after image is made.

When can a CE requirement be waived?

(1) full-time service in armed service; or (2) extreme hardship, as determined on individual basis by the Board and limited to documented incapacitating illness, physical inability to travel to sites of approved programs, or other similar extenuating circumstances (e.g., illness of family member). Application for waiver must pre-date renewal date. If interview before Board is desired, applicant must make request at time he applies for waiver. Applicant is considered to be in good standing until DPR reaches a decision.

When is the pharmacy exempt from FDA registration?

(1) in conformance with local law (2) are regularly engaged in dispensing prescription drugs or devices, upon prescription of practitioners licensed to administer such drugs and devices to patients under their care in the course of professional practice, and do not manufacture, prepare, propagate, "compound", or process drugs or devices for resale other than in the regular course of their business of dispensing or selling at retail.

What are the two ways for an authorized collector to take back controlled substances?

(1) maintaining collection receptacles (2) administering mail-back programs. In addition, the regulations allow authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities.

Who must be registered with federal DEA?

(1) manufacturer (2) distributor (3) dispenser (C-II thru C-V) (4) narcotic treatment program (5) detox compounder

What are the label requirements for controlled substance prescriptions?

(1) name and address of pharmacy; (2) patient name; (3) prescription number; (4) date of initial dispensing; (5) name of prescriber; (6) directions for use; and (7) cautionary statements, if any. Federal law requires all C-II, III and IV prescriptions to contain the following "transfer warning statement": "CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED."

What are conditions that allow a pharmacist may substitute an interchangeable biological product for a prescribed biological product?

(1) the substituted product has been determined by the United States Food and Drug Administration to be interchangeable, as defined in subsection (a) of this Section, with the prescribed biological product; (2) the prescribing physician does not designate orally, in writing, or electronically that substitution is prohibited in a manner consistent with Section 25 of this Act; and (3) the pharmacy informs the patient of the substitution.

When are pharmacies impacted by the FDCA?

(1) when a pharmacy's compounding activities crosses the line, and they are viewed as manufacturing a new drug, as opposed to compounding and dispensing pursuant to a prescription, and (2) when a pharmacy violates the FDCA prohibition against marketing/selling a drug product that is "misbranded" or "adulterated".

When can you dispense a partial quantity of CSII drugs?

(A) it is not prohibited by State law (B)the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law; C)the partial fill is requested by the patient or the practitioner that wrote the prescription (D)the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

When is the communication not required?

(A) there is no FDA-approved interchangeable biological product for the product prescribed; or (B) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.

In emergency situations, what can you do with the remaining portions of a partial fill of schedule II controlled substances?

(i) may be filled (ii) must be filled within 72 hours

What are conditions of partial dispensing CII if unable to supply?

- Pharmacist must note the quantity supplied on the front of the written prescription, on a written record of the emergency oral prescription, or in the electronic prescription record. -The remaining portion may be filled within 72 hours of the first partial dispensing. -However, if the remaining portion is not or cannot be filled within the 72 hour period, the pharmacist must notify the prescribing practitioner, and no further quantity may be supplied beyond 72 hours without a new prescription.

What is the practice of pharmacy?

- The interpretation and the provision of assistance in the monitoring, evaluation and implementation of prescription drug orders - the dispensing of prescription drug orders - participation in drug and device selection - drug administration of vaccinations, long acting medications -drug regimen review -drug or drug related research - the provision of patient counseling - the practice of telepharmacy - the provision of those acts or services necessary to provide pharmacist care - mtm - compounding and labeling of drugs and devices

What are requirements for a pharmacist to dispense and deliver a reasonable quantity of a non sterile compounded drug to a practitioner for office use by the practitioner?

- The quantity of compounded drug appropriate -The pharmacy maintains readily retrievable records -label that states for office use - maintain, at a minimum, standards and equipment - "Plumb's Veterinary Drug Handbook" available - Consumable materials - drug distribution and control of patient profile or medication record system and labeling, aux labels, records maintained for 5 years - Delivery service - Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or manufacturers, other than as provided in subsection (d), are not allowed, except for sales provided by pharmacies contracted to provide centralized prescription filling services pursuant to Section 25.5 of the Act, including compounding in anticipation of receiving a prescription or order based on routine, readily observed dispensing patterns.

What are additional requirements for sterile compounding?

- current resource materials and texts shall be maintained in the pharmacy and may be in electronic format - A pharmacist shall be accessible at all times to enable each licensed facility to respond to patients' and health professionals' questions and needs. A 24-hour telephone number shall be included on the prescription label of compounded drugs and medication infusion devices if used off site. - Pharmacies that dispense compounded sterile drugs to patients in facilities off site or for administration in the patient's residence shall stock supplies and medications appropriate for treatment of allergic or other common adverse effects, to be dispensed upon the prescription or order of an authorized prescriber.

What information must repackaged OTC labels have?

- established name of the product, and its pharmacological category - name and address of the manufacturer, packer, or distributor - net contents of product, by weight or numerical count - the established name of all active ingredients and quantity of certain other ingredients, whether active or not - name of any habit forming drugs in the product - instructions for safe storage - cautions and warnings needed to protect the consumer - adequate directions for safe and effective use

What are the requirements for a supplier for procedure for filling DEA forms 222?

- fill the order - record DEA number, number of containers, date shipped - if cannot fill in its entirety, fill out what you can and then ship the rest within 60 days - keep the original DEA 222 form. If not required to do so, make a copy to send to DEA

What is required in a prescription?

- name of patient - date when prescription was issued - name and strength of drug or description of the medical device prescribed - quantity -direction for use -prescriber's name, address and signature -DEA where required for controlled substances (except for inpatient drug orders)

What are ways that the department will not renew a pharmacy technician license?

- student pharmacy drops out of pharmacy program, did not complete rotations, or failed boards 3 times - must then register as certified pharmacy technician

What are duties and responsibilities of the PIC for automated dispensing and storage system?

-Assuring that ADS is in good working order accurate -Establishment of a quality assurance program -Providing the DPR with written notice 30 days prior to the installation of or at the time of removal of an automated storage and dispensing system. -Determining and monitoring access to and the limits on access (e.g., security levels) to the automated storage and dispensing system -Authorizing access -Ensuring that access to the medications complies with State and federal regulations as applicable -Ensuring that the automated dispensing and storage system is stocked/restocked accurately and in accordance with established, written pharmacy policies and procedures.

What is the application process?

-Complete application on forms provided by DFPR -an inspection of physical requirements -may have interview with the Board. -For name change or change in PIC, pharmacy owner must complete application on DPR form, pay fee, and submit present license. If satisfactory, DPR will issue a new license. -Prior complaints against owner/applicant will delay or prevent licensure -The Department shall render no final administrative decision relative to any application for a license under this Act if the applicant for such license is the subject of a pending disciplinary proceeding under this Act or another Act administered by the Department. For purposes of this Section "applicant" means an individual or sole proprietor, or an individual who is an officer, director or owner of a 5 percent or more beneficial interest of the applicant. -Pharmacy must open within thirty (30) days of issuance of the pharmacy license.

What should be done on the day the pharmacy closes?

-Conduct an inventory of the pharmacy's controlled substances and maintain the inventory record for inspection by the Division for 5 years. -Return the pharmacy license to the Division's drug compliance investigator or other authorized Division personnel. -Notify the Division in writing as to where the controlled substances inventory and records will be kept and how the controlled substances were transferred or destroyed. Records involving controlled substances must be kept available for 5 years for inspection by the Division. -Notify the Division in writing of the name of the person responsible for and the location where the closing pharmacy's prescription files and patient profiles will be maintained. These records shall be kept for a minimum of 5 years from the date the last original or refill prescription was dispensed. -Cover all signage indicating "drug store" or "pharmacy" as soon as practicable. The signage shall be removed in a timely manner. A sign shall be prominently posted that the pharmacy is closed

What are medication therapy management services that are provided in retail or other non-hospital pharmacies?

-Evaluation of prescription drug orders and patient medication records -known allergies; -drug or potential therapy contraindications; -reasonable dose, duration of use, and route of administration, taking into consideration factors such as age, gender, and contraindications; -reasonable directions for use; potential or actual adverse drug reactions; -drug-drug interactions / drug-food interactions / drug-disease contraindications; -identification of therapeutic duplication; -patient laboratory values when authorized and available; proper utilization (including over or under-utilization) and optimum therapeutic outcomes; and -drug abuse and misuse.

When can the DEA 222 form be refused by the seller/distributor?

-If improperly completed -Appears altered

How is a pharmacy considered a manufacturer?

-It purchases controlled substances for purposes of repackaging for sale within the pharmacy without a prescription or to other registrants requires registration as a manufacturer -It compounds for office use, if permitted under state law. (Note: Office use compounding is considered to be manufacturing, and is NOT permitted, so this "exception" no longer has validity.)

What are reasons that DEA can revoke registration?

-Materially falsified information in application -Been convicted of a drug-related felony -Committed such acts as to make registration inconsistent with the public interest -Has had its state license suspended, revoked or denied. -AND where applicant has been subject to mandatory exclusion from participation in the Medicare or any state health care program.

What is requirement contents of inventory record?

-Name of drug -Dosage form and unit strength -Number of units or the volume in the container -Number of containers

What are the requirements for Illinois CII duplicate order requirement?

-Name, address and DEA number of ordering registrant -name, address and DEA number of selling or transferring registrant -name of drug ordered -finished bulk form and strength of substance (e.g. 50 mg. tablet) -number of units or volume in each container (e.g. 100 tablet bottle/10 ml. vial); -number of containers ordered -name and quantity per unit of the controlled substance contained in the order if not in pure form. -Form to be signed and dated by person authorized to execute federal order form.

What are three activities that trigger multiple registrations?

-Pharmacy as a distributor or manufacturer -Pharmacy as manufacturer -Pharmacy as a detox compounder

What is the requirement for Illinois CS registration?

-Proof of federal registration -Payment of registration fee

What are the requirements for foreign graduates?

-Register as pharmacy technician and considered a student pharmacist - Complete 1,200 clinical hours and no more than 18 months after completion of these hours -Must become licensed as a pharmacist or become a certified pharmacy technician before the second pharmacy technician registration renewal following completion of the Board approved clinical training.

What are the requirements of non-resident pharmacies?

-Registration required -It is licensed in the state where the dispensing facility is located -The location, names and titles of all principal corporate officers and all pharmacists who are dispensing drugs to residents of this State; -That it complies with all lawful directions and requests for information from the board of pharmacy of each state in which it is licensed or registered -That it maintains its records -That it cooperates with the Board in providing information to the board of pharmacy of the state in which it is licensed concerning matters related to the dispensing of drugs to residents of this State; and -That during its regular hours of operation, but not less than 6 days per week, for a minimum of 40 hours per week, a toll free telephone service is provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records. The toll free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this state

What are the requirements for computerized record keeping?

-Retrieve original prescription, -retrieve current prescription orders -supply documentation of refill information entered by the pharmacist using the system through a hard copy printout of each day's refill data -All refill data shall be maintained by the pharmacy on the premises for 5 years, -A hard copy printout shall be provided to the Division, upon request, within 48 hours.

What are the requirements of student pharmacists?

-Same requirements as technician except the requirement of certification -Pay the required pharmacy technician registration fees.

What was the amendment of Prescription Drug Amendments Act?

-Samples or donated pharmaceutical products cannot be sold to consumers. If a company becomes aware that a product has been stolen or significant loss, you have to conduct an investigation and report the situation to the FDA within 5 days - ensures that drugs are stored securely and that wholesalers provide the name and lot number of the drug to purchases - wholesalers who serve as middlemen between the drug manufacturers and prescription drug dispensers need to be licensed by the states - Prescription drug wholesalers that do not quality as an "authorized distributor of record" are required to provide a "pedigree" with each wholesale distribution of drug .

What is required in a prescription?

-Sign and dated on the date of issuance -Full name and address of patient -Name, address, and DEA number of prescriber -Drug name, strength, dosage form and quantity Directions for use -If written, must be in ink

What is an owner for applying for a DEA registration?

-Sole proprietor -Partnership -Corporation - Any Officer or Director of the corporation can complete the form -The person who completes the form is referred to as the "registrant". The entity that receives the registration is also called the "registrant"

What are the responsibilities of a PIC?

-Supervision of all activities of all pharmacy employees -Establishment and supervision of the method and manner for storage and safekeeping of pharmaceuticals -Establishment and supervision of the record keeping system for the purchase, sale, delivery, possession, storage and safekeeping of drugs. -procedure of recalled drugs -procedure of dispensing drugs -Establishment and supervision of a method of documenting an oral prescription from a licensed physician to a pharmacist and for transmission of that information to the appropriate members of the nursing staff of the institution or facility.

What Illinois organizations are responsible for monitoring and enforcement of the Illinois act?

-The Department of Human Services -Office of Alcoholism and Substance Abuse -Department of Financial and Professional Regulation

What are the regulations for mailing of controlled substances?

-The controlled substances are not outwardly dangerous and are not likely to cause injury to a person's life or health. -The inner container of a parcel containing controlled substances must be marked and sealed and be placed in a plain outer container or securely wrapped in plain paper. -If the controlled substances consist of prescription medicines, the inner container must be labeled to show the name and address of the pharmacy or practitioner dispensing the prescription. -The outside wrapper or container must be free of markings that would indicate the nature of the contents.

What is information about the drug produce and patient package insert that should be included for OC products?

-The name and place of business of the manufacturer, packer, or distributor, or the name and place of business of the dispenser of the product -The date, identified as such, of the most recent revision of the patient package insert placed prominently immediately after the last section of the labeling.

What should the patient med pak information include?

-The name of the patient -A serial number for the patient med pak and serial number for each order and each drug -name, strength, physical description,and total quantity of drug -The directions for use and cautionary statement -Any storage instructions -prescriber - date -The name, address and telephone number of the pharmacist and any other registrant involved in dispensing.

What are ocular pharmaceutical agents?

-Topical: anesthetics, mydriatics, cycloplegics, miotics - Mydriatic reversing agents (topical or oral) - Anti-infective agents(topical or oral) - Anti-allergy agents (topical, oral, or injectable*) - Anti-glaucoma agents (except oral carbonic anhydrase inhibitors, which may be prescribed only in a quantity sufficient to provide treatment for up to 72 hours - Anti-inflammatory agents (except oral steroids) (topical or oral) - OTCs - Analgesic agents.

How long can applicant for registration as a pharmacy technician may work for before the issuance of a certificate of registration?

-Up to 60 days when application and payment was submitted -Keep copy of the submitted application in the pharmacy -If application is not processed and license is not issued within 60 days, MUST STOP WORKING AS A TECHNICIAN.

When Schedule I and II drugs are received, what must the registrant, POA, or any person designated by the registrant or POA do?

-Verify all drugs ordered have been received. -Indicate receipt on the form. -Date and sign the form to confirm receipt of the order.

What are medication therapy management services include?

-documenting the services delivered and communicating the information provided to patients' prescribers within an appropriate time frame, not to exceed 48 hours -providing patient counseling designed to enhance a patient's understanding and the appropriate use of his or her medications - providing information, support services, and resources designed to enhance a patient's adherence with his or her prescribed therapeutic regimens. - may also include patient care functions authorized by a physician licensed to practice medicine in all its branches for his or her identified patient or groups of from the physician.

Under federal law, what are the record requirements for exempt narcotics?

-initials of purchaser -date of sale -initials of RPh

How is a pharmacy considered a distributor?

-it participates in joint buying activities, and is the location from which drugs are stored and shipped to other pharmacies -its annual distribution of controlled substances to other pharmacies or practitioners exceeds five percent (5%) of the total number of dosage units dispensed.

What are the requirements for a purchaser for procedure for filling DEA forms 222?

-make a copy of the original DEA Form 222 for its records, paper or electronic -submit the original to the supplier -record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.

Under IL law, what are the emergency medication kits requirements?

-obtained from a DEA registered hospital, pharmacy or practitioner -safeguarded per DPH standards -authorized access to the CS -no more than 10 different controlled substances per kit, and no more than 3 single, injectable doses of each controlled substance -administered only under emergency conditions only by an RN, LPN or practitioner. -"proof of use" filled out by the nursing staff or practitioner when any CS is used from the kit. The consultant pharmacist shall receive and file for TWO years a copy of all completed proof of use sheets. -Whenever the kit is opened, the consultant pharmacist is to be notified within 24 hours. During any shift that the kit is opened, a shift count shall be done each shift until the kit is closed or locked by the consultant pharmacist. Shift counts are not required when the kit is sealed. -The consultant pharmacist shall check inventory least monthly -Failure to comply could result in the loss of kits

How can prescription drugs be dispensed?

-only upon written RX of practitioner licensed by law to administer such drugs; -upon the practitioner's oral RX, which is promptly reduced to writing and filed by RPh; -by refilling where authorized by the prescriber; -by administration directly by the prescriber.

Who must be involved in order to execute the POA?

-person who signed the most recent application for DEA registration or reregistration -person to whom the POA is being granted -two witnesses

Who must be involved in order to revoke the POA?

-person who signed the most recent application for DEA registration or reregistration -two witnesses

What is the Prescription Drug Marketing Act (PDMA)?

-requires states of license wholesale distributors of prescription drugs -ban the re-importation of prescription drugs, except by the manufacturer or for emergency use -mandate storage, handling, and recordkeeping requirements for drug samples -ban the trafficking in or counterfeiting of drug coupons -prohibit the resale of prescription drugs purchased by hospitals or health care facilities, with certain exceptions

What does medication therapy management services in a licensed hospital include?

-reviewing assessments of the patient's health status -following protocols of a hospital pharmacy and therapeutics committee with respect to the fulfillment of medication orders.

Under Illinois law, what are the record requirements for exempt narcotics?

-signature of purchaser -certification of no purchases within 96 hours -time of sale -signature of pharmacist

How much difenoxin and atropine sulfate is considered schedule 5?

0.5 mg difenoxin/25 mcg atropine

What is the usual dosage of ipecac syrup?

1 tablespoon (15 ml) in persons over 1 year of age

Prescriptions cannot be dispensed after how long from the date of the original issuance of the prescription by the prescriber?

1 year

What are standard and equipments that all pharmacies that compound drugs must maintain?

1) A separate storage area for materials used in compounding; 2) Scales or measuring devices with sufficient accuracy for the products to be compounded; 3) An area of the pharmacy used exclusively for compounding; 4) A logbook or record keeping system to track each compounded drug, which must include the lot number, expiration date of components used, and beyond-use date of compounded drug. This applies to each nonsterile compounded drug and each sterile compounded drug with a beyond-use date greater than 24 hours; 5) The current edition of the USP Compounding Compendium. This publication may be in electronic format and/or available via the internet;

What should you patient counsel on new mediations?

1) Name and description of medication 2) Dosage form and dosage 3) Route of administration 4) Duration of therapy; 5) Techniques for self-monitoring; 6) Proper storage; 7) Refill information; 8) Actions to be taken in cases of missed doses; 9) Special directions and precautions for preparation, administration and use; 10) Common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur

What should be included in counseling?

1) Name and description of medication 2) Dosage form and dosage 3) Route of administration 4) Duration of therapy; 5) Techniques for self-monitoring; 6) Proper storage; 7) Refill information; 8) Actions to be taken in cases of missed doses; 9) Special directions and precautions for preparation, administration and use; 10) Common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur.

What is the pharmacist responsible to maintain what part of the patient profile?

1) Name, date of birth (age), gender, address and telephone number; 2) Individual history, when significant, including disease state, known allergies, drug interactions, and a comprehensive list of medications and relevant devices; and 3) Pharmacist's comments relevant to the individual's therapy.

What licenses must a pharmacy in Illinois have in order to dispense all prescription drugs?

1) Pharmacy license 2) Federal DEA registration 3) State controlled substance license or registration

What are the three options for disposal of controlled substances?

1) Return to supplier (use 222) 2) Send to reverse distributor (use form 41) 3) disposal or destruction by pharmacy (use form 41)

What are accepted patient ID for proper filling?

1) The sex field is a verifying element of a patient ID. The patient's gender shall be entered in the sexfield. 2) The birth date is a verifying element of a patient ID and needs to be entered in the birth date field (yyyymmdd).

How much codeine is considered a schedule 3?

1.8g/100 mL codeine (90 mg/dosage unit)

How much dihydrocodeine is considered a schedule 3?

1.8g/100mL dihydrocodeine (90 mg/dosage unit)

Under Illinois law, how much dihydrocodeine is considered schedule 5?

10 mg/100 mL dihydrocodeine

What age does the patient have to be for the pharmacist to administer the Tdap?

10 years and up

What age does the patient have to be for the pharmacist to administer the flu shot?

10 years and up

When should a new pharmacy application must be filed?

10% or more of the ownership of the business, other than a publicly traded business, to which the pharmacy licensee was issued is sold or otherwise transferred to a person or entity that does not hold any interest in the business issued the pharmacy license prior to the sale or transfer;or More than half the board of directors or executive officers of a business issued a pharmacy license change.

How much opium is considered schedule 5?

100 mg/100 mL opium

What is longest a pharmacy, student pharmacist, or pharmacy technician can work per day?

12 continuous hours per day, inclusive of the breaks

What the NDC code identify? i.e. 1234-5678-90

1234: manufacturer 5678: ID of drug 90: ID of package

What age does the patient have to be for the pharmacist to administer all other vaccinations?

14 and up

If DEA does not respond to the contrary within how many days, the central record keeping request is deemed to be approved?

14 days

How soon do you have to notify department of change of address or email?

14 days through department website or contacting department's licensure maintenance unit

What year was the Virus-Toxin Law enacted?

1902

What year was the Federal Food, Drug, and Cosmetic Act enacted?

1938

What year is the Durham-Humphrey Amendment enacted?

1951

What year was the Medical Device Amendments enacted?

1976

What year was the Prescription Drug Marketing Act (PDMA) enacted?

1987

What year was the Nutrition Labeling and Education Act enacted?

1990

What year was the Prescription Drug User Act enacted?

1992

How long does the pharmacy staff review the cancellation transaction for deactivation or provide that deactivation occurs automatically?

2 business days of receipt of a prescription cancellation transaction

Under Illinois law, what identification is required for exempt narcotics?

2 positive forms of identification

When does the DEA diversion field office have to receive the documents of disposal or destruction by pharmacy?

2 weeks prior to the proposed destruction date

How long should the original and transferred rx must be maintained under federal law?

2 years

How long should you file control substances schedule I and II?

2 years

How long should you maintain IL CII Duplicate orders?

2 years

Under federal law, how long should all inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business be maintained for?

2 years

Under federal law, how long should biennial inventory records, including records of newly scheduled substances since last inventory be maintained for?

2 years

Under federal law, how long should dispensing records be maintained for?

2 years

Under federal law, how long should executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent, must be maintained separately from all other records of the registrant be maintained for?

2 years

Under federal law, how long should inventory of Drugs Surrendered for Disposal (DEA Form 41) be maintained for?

2 years

Under federal law, how long should receipts and/or invoices for schedules III, IV, and V controlled substances be maintained for?

2 years

Under federal law, how long should records of amounts of CS used in compounding or discarded during the process of administration be maintained for?

2 years

Under federal law, how long should records of controlled substances dispensed (i.e., prescriptions, schedule V logbook) be maintained for?

2 years

Under federal law, how long should records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors) be maintained for?

2 years

Under federal law, how long should records of receipt of controlled substances (for CII, the DEA 222, for all others, business invoices) be maintained for?

2 years

Under federal law, how long should records of return or disposal be maintained for?

2 years

Under federal law, how long should records of transfers of controlled substances between pharmacies be maintained for?

2 years

Under federal law, how long should reports and estimates of controlled substances thefts (DEA 106) be maintained for?

2 years

Under federal law, how long should reports of Theft or Significant Loss (DEA Form 106) be maintained for?

2 years

How much diphenoxylate is considered schedule 5?

2.5 mg diphenoxylate/25 mcg atropine

What are the continuing education requirements of a registered certified pharmacy technician?

20 hours of continuing pharmacy education during 24 months preceding the expiration date of the certificate. One hour of continuing pharmacy education must be in the subject of pharmacy law. One hour of continuing pharmacy education must be in the subject of patient safety. One hour of sexual harassment prevention training. The continuing education shall be approved by the accreditation council on pharmacy education

How much codeine is considered schedule 5?

200 mg/100 mL codeine

Under IL law, what are the quantity limits on CII prescriptions?

30 day supply written numerically and in word form

How soon do you have to notify DPR that they are no longer PIC?

30 days

How soon do you have to notify the new PIC?

30 days

How soon does the PIC have to report to the DPR about an error of use of the automated dispensing and storage systems?

30 days

Pharmacy licenses expire how many days after the PIC ceases to be a PIC, unless a new PIC is named?

30 days

When does a pharmacy license expire after the PIC dies, no longer employed by the pharmacy, or has licensed suspended or revoked?

30 days

Within how many days does the pharmacist have to report vaccination administration to their primary healthcare provider?

30 days

When does controlled scheduling "automatically" made uniform with federal law?

30 days after federal scheduling unless dept of human services objects and holds hearing to place in different schedule

How soon does the pharmacy have to notify the division in writing of the closing date?

30 days in advance

What are convenience packages?

360 mg or less of EPH or PSE or their salts in liquid or liquid-filled capsule

How many time do you have to fail the boards to furnish proof of remedial education on the subjects failed?

3rd exam

Under federal law, how much can a patient obtain for a CV controlled substance without a prescription?

4 ounces (120 grams)

Under state law, how much can a patient obtain for a CV controlled substance without a prescription?

4 ounces (120 grams)

What must be completed in order for a PA to obtain a mid-level practitioner controlled substances license?

45 contact hours in pharmacology from any physician assistant program accredited by the Accreditation Review Commission on Education for the Physician Assistant (ARC-PA), or its predecessor agency, for any new license issued with Schedule II authority after the effective date of this amendatory Act The physician assistant must annually complete at least 5 hours of continuing education in pharmacology

By electing to centralize records, registrant agrees to provide DEA with records within how many hours of a request, or to allow DEA to inspect the records at the centralized location without a warrant of any kind?

48 hours

How many members of the BOP meets quorum for transaction of business?

5 members

How long do vaccinations must be maintained?

5 years

How long should are record keeping requirements for dispensing prescriptions or orders maintained for offsite institutional pharmacy services?

5 years

How long should records of all legend drugs be maintained for?

5 years

How long should records of preparing sterile parenteral products be maintained for?

5 years

How long should refill data be maintained?

5 years

How long should the original and transferred rx must be maintained under IL law?

5 years

How long should the pharmacy retain record of the biological product dispensed?

5 years

How long should you maintain documentation of self inspection of the pharmacy?

5 years

In IL, inventory shall be maintained for how many years?

5 years

The inventory record should be preserved in the pharmacy for how long?

5 years

Under IL law, all prescription records (dispensing and purchase records) must be maintained for how many years?

5 years

How long is the board of pharmacy term?

5 years No member can serve for more than 2 full terms in their lifetime Governor may remove any member for misconduct, incapacity, or neglect of duty, and is the sole judge of the sufficiency of the cause for removal

How long does the book or file have to be maintained at the pharmacy?

5 years after the date of dispensing the appropriately authorized refill

Under IL law, how long do you maintain purchase records/invoices of control substances?

5 years in total, at least 1 year onsite (all legend drugs)

Under IL law, how long do you maintain purchase records/invoices of non-control substances?

5 years in total, at least 1 year onsite (all legend drugs)

Under IL law, how long should Illinois annual inventory of controlled substances be maintained?

5 years in total, at least 1 year onsite (all legend drugs)

How much morphine is considered schedule 3?

50 mg morphine/100 mL

How much opium is considered schedule 3?

500 mg opium/100 mL (25 mg/dosage unit)

Under federal law, is there a limit as to the amount of multiple CII prescriptions?

90 day supply

Pharmacies can purchase what kind of alcohol for what purpose?

95% ethanol (which is 190 proof grain alcohol) for routine compounding using Form ATF-11

What are the requirements to be a registered pharmacy technician?

> 16 years old Has not engaged in conduct or behavior determined to be grounds for discipline under this act Attending/graduated high school/received GED

What is a drug?

A Drug is a substance which is: recognized in USP/NF or Homeopathic Pharmacopoeia, intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, non-food article intended to affect structure or function of the body, or intended to be used as a component of an item an item falling within any of these categories

How does consultation occur at remote consultation occur?

A computer audio/video link for dispensing and consultation to occur. The facility shall have a room for patient consultation exclusive of any waiting area.

What is an authorized distributor of record?

A distributor that has an "ongoing relationship" with a manufacturer to distribute that manufacturer's drug products.

What is an opioid antagonist?

A drug that binds to opioid receptors and blocks or inhibits the effect of opioids acting on those receptors, including, but not limited to, naloxone hydrochloride or any other similarly acting and equally safe drug approved by the U.S. Food and Drug Administration for the treatment of drug overdose.

What is the prescriptive authority for advanced practice registered nurses?

A licensed collaborating physician or collaborating podiatrist may delegate prescriptive authority to an advanced practice registered nurse ("APRN") in accordance with a written collaborative agreement; may but is not required to include the prescription of Schedule II, III, IV, or V controlled substances. The collaborating physician shall file with the DPR notice of delegation of prescriptive authority and termination of such delegation. APRN must have a written collaborative agreement with the collaborating physician or podiatrist.

What are after hour cabinets?

A locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it is sufficiently secure to deny access to unauthorized persons

What is the exception of using tax free alcohol?

A nonprofit clinic can dispense medicines made using tax free alcohol, but only if the patient is not charged for the medication

What are the requirements for sale of syringes or needles without a prescription?

A person 18 years or older may purchase up to 100 sterile hypodermic syringes daily without a prescription from a pharmacist in the pharmacy department of the pharmacy

What is medication shopping?

A person who intentionally or fraudulently seeks or obtains any controlled substance or prescription for a controlled substance while being supplied any controlled substance by another prescriber or pharmacy without disclosing the fact of the existing controlled substance to the subsequent prescriber or pharmacy

Can pharmacists dispense emergency supply of medications?

A pharmacist may exercise professional judgment to dispense an emergency supply of medication for a chronic disease or condition if the pharmacist is unable to obtain refill authorization from the prescriber when: (1) in the pharmacist's professional judgment (2) the pharmacy previously dispensed or refilled a prescription from the prescriber for the same patient and medication; (3) the prescription is not for a controlled substance; (4) the pharmacist informs that refill request must be made (5) the emergency dispensing is documented (b) The emergency supply must be limited to the amount needed for the emergency period as determined by the pharmacist within his or her professional judgment. However, the total amount dispensed shall not exceed a 30-day supply.

Who can counsel patients?

A pharmacist or student pharmacist acting under the direct supervision of the pharmacist can counsel. If the question is who can make the offer to counsel, the answer is different. The pharmacist, student pharmacist, or pharmacy technician can make the offer. Cashiers and other unlicensed personnel working in the pharmacy can no longer make the offer to counsel.

What are the staffing requirements of Pharmacies Preparing Sterile Parenteral Products?

A pharmacist shall be accessible at all times at each licensed facility to respond to patients' and health professionals' questions and needs. A 24-hour telephone number will be included on all labeling of compounded medication and medication infusion devices if off site.

When electronic data processing equipment is employed by a pharmacist, input of drug information shall be performed by who?

A pharmacist, or by a pharmacy technician or a certified pharmacy technician under the supervision of a pharmacist.

Who can give vaccinations?

A pharmacist, or student pharmacist under the direct supervision of a pharmacist

What is a pharmacy distributor?

A pharmacy engaged in the distribution of prescription drugs either to any other pharmacy, or to any other person or entity, including but not limited to a wholesale drug distributor engaged in the delivery or distribution of prescription drugs to other than the ultimate consumer.

What is computerization of prescription information?

A pharmacy is permitted to use a data processing system as an alternative to the manual method for the storage and retrieval of prescription order refill information for Schedules III, IV and V controlled substances. (there are a lot of regulations, just read on page 41)

What are the requirements for centralized prescription filling?

A pharmacy licensed under this Act may perform centralized prescription filling for another pharmacy, provided that both pharmacies have the same owner or have a written contract specifying (i) the services to be provided by each pharmacy, (ii) the responsibilities of each pharmacy, and (iii) the manner in which the pharmacies shall comply with federal and State laws, rules, and regulations.

What is a nonresident pharmacist or mail order pharmacy?

A pharmacy located outside the state (but within a state, commonwealth or territory of the United States other than Illinois) that ships, delivers, dispenses or distributes any prescription substance into Illinois.

Can pharmacy and practitioner have an agreement regarding the provision of the electronic transmission of prescription?

A pharmacy or pharmacist shall not enter into an agreement with a practitioner or healthcare facility concerning the provision of any means for the electronic transmission of prescriptions that would adversely affect a patient's freedom to select the pharmacy or pharmacy department of his or her choice.

What are non-resident pharmacies?

A pharmacy that is physically located outside the state, but which delivers drugs to patients located in the state.

What is multiple/sequential CII prescriptions for same drug on same date?

A practitioner may provide individual patients with up to three (3) 30-day supply prescriptions for the same schedule II controlled substance, written all on the same day, to be filled sequentially over the course of 90 days. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.

How can a prescription be transferred?

A prescription shall only be transferred upon the request or authorization of the person for whom the prescription was issued, except upon closure of a pharmacy, in which case notice shall be made to that person, orally or in writing, of the closure and location where the prescription is transferred.

What is an electronically transmitted prescription?

A prescription that is created, recorded, or stored by electronic means; issued and validated with an electronic signature; and transmitted by electronic means directly from the prescriber to a pharmacy. An electronic prescription is not an image of a physical prescription that is transferred by electronic means from computer to computer, facsimile to facsimile, or facsimile to computer.

What must occur upon receipt of a new or refilled prescription?

A prospective drug regimen review or drug utilization evaluation shall be performed

What is delegation of pharmacy technicians?

A registered pharmacy technician may be delegated to perform any task within the practice of pharmacy if specifically trained for that task, except for patient counseling, drug regimen review, or clinical conflict resolution.

What is a zero report?

A report that indicates the dispenser has not dispensed a monitored prescription drug since the last submission of dispensing or zero report to the PDMP

What if a facility, company, or organization operates multiple pharmacies from multiple physical addresses?

A separate pharmacy license is required for each different physical address

What if the pharmacy utilizes a drug distribution system which resissues the same label?

A separate record must be maintained which identifies the RPh approving each dispensing.

What is a significant loss?

A significant loss depends, in large part, on the business of the registrant and the likelihood of a rational explanation for a particular loss.

What is a standing order?

A specific order for a patient or group of patients issued by a physician licensed to practice medicine in all its branches in Illinois. This is what gives pharmacists a form of "prescriptive authority". However, RX that is issued is still in the name of the doctor as the prescriber. Note also need to comply with "MTM" requirements.

What if estrogen drug products are in bulk packages intended for multiple dispensing?

A sufficient number of patient labeling pieces shall be included in or with each package to assure that one piece can be included with each package or dose dispensed or administered to every patient. Each bulk package shall be labeled with instructions to the dispenser to include one patient labeling piece with each package dispensed or, in the case of injectables, with each dose administered to the patient. This section does not preclude the manufacturer or labeler from distributing additional patient labeling pieces to the dispenser.

What resources should be maintained in the pharmacy for sterile compounding?

A) Copies of the Act and this Part, the Illinois Controlled Substances Act [720 ILCS 570] and 77 Ill. Adm. Code 3100, 21 CFR (Food and Drugs), and the Illinois Hypodermic Syringes and Needles Act [720 ILCS 635]; B) One compatibility reference, such as: i) ASHP's Handbook on Injectable Drugs; ii) King's Guide to Parenteral Admixtures; or iii) Any other Division-approved publication; and C) A file or reference on extended (more than 24 hours) stability data given to finished preparations.

Under IL law, what can you not change in a CII prescription?

A) Date written, or add the date; B) Name of the patient; C) Name of the prescriber, or add a signature; and D) Name of the drug.

What should be included in labels for any compounded drug that is provided for office use?

A) The name, address and phone number of the compounding pharmacy; B) The name, strength and dosage form of the compounded drug and a list of active ingredients and strengths. If the number of active ingredients would prohibit proper labeling, then the pharmacist shall provide to the practitioner a complete list of the active ingredients and strengths (including those on the label); C) The pharmacy's lot number and beyond-use date; D) The quantity or amount in the container; E) The appropriate ancillary instructions, such as storage instructions, cautionary statements, or hazardous drug warning labels when appropriate; and F) The statement "For Office Use Only - Not for Resale".

What should be included in records of compounded drugs ordered by practitioners for office use?

A) The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order; B) The name, strength, quantity and dosage form of the compounded drug provided, including the number of containers and quantity in each; C) The date the drug was compounded; D) The date the compounded drug was provided to the practitioner; and E) The lot number and beyond-use date

IL has no limits regarding the quantity a doctor can write on controlled substance RXs. Is that true for mid-level practitioners as well?

A: Yes, for CIII - CV. Professional judgment and good faith are the keys. Remember, however, that for CIIs, only a 30 day supply is permitted.

What is the Virus-Toxin Law?

AKA Biologics Control Act. Required licensing of biologics establishments, inspections of vaccine manufacturers, and premarket approval of vaccine and other products

Who can write the standing order?

ANY physician;need not be the patient's own physician. Must include a protocol for administration written by the physician.

What are other names for an advanced practice registered nurse?

APRNs, advanced practice nurse, nurse practitioners

What form can institutions fill out to have a greater need for alcohol can purchase tax free alcohol?

ATF-1447

When can after hour cabinets be used?

Absence of a pharmacist

What is a closed system of distribution of controlled substances (CS)?

Access to controlled substances are restricted through REGISTRATION and SCHEDULING Once a scheduled substance leaves the closed system of distribution, and can only re-enter the closed system under limited circumstances

What is an address of record?

Address recorded by the Department in the applicant's or licensee's application file or license file, as maintained by the Department's licensure maintenance unit.

What is the drug quality and security act part 503B?

Addresses outsourcing facilities. - Large scale compounders can elect to register with FDA as an outsourcing facility, strictly voluntary - Often, but not always sterile compounding - Key- no identifiable patient; customer is the doctor, hospital or clinic - If operate in compliance with 503b, exempt from NDA and labeling requirements, but must still adhere of cGMP requirements ( cGMP are very different from USP <797>, very onerous requirements)

What are requirements for automated pharmacy systems or remote dispensing?

Adequate security and procedures Dispensing and access shall be limited to pharmacists or authorized personnel Drugs are stored in compliance Automated pharmacy system operated from a remote site shall be under continuous supervision of a home pharmacy pharmacist Drugs may only be dispensed at a remote site through an automated pharmacy system after receipt of an original prescription drug order by a pharmacist at the home pharmacy. A pharmacist at the home pharmacy must control all operations of the automated pharmacy system and approve the release of the initial dose of a prescription drug order. Refills from an approved prescription drug order may be removed from the automated medication system after this initial approval. Any change made in the prescription drug order shall require a new approval by a pharmacist to release the drug.

What is a pregnancy category A drug?

Adequate, well controlled studies reveal no risk to fetus during 1st, 2nd and 3rd trimesters of pregnancy.

What is office use?

Administration of a non-patient specific compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting. "Office use" does not include a pharmacy's delivery of a compounded drug to a prescribing practitioner's office pursuant to a valid patient-specific prescription.

Misbranded or adulterated: Fire in pharmacy

Adulterated

Misbranded or adulterated: any substance has been mixed with the drug to reduce the drug's strength, or any substance has been substituted for the drug

Adulterated

Misbranded or adulterated: drug is labeled as if recognized in an official compendium, but differs in strength, quality or purity from that represented

Adulterated

Misbranded or adulterated: drug is not listed in an official compendium, and its strength differs from, or its quality and purity falls below what is represented on label

Adulterated

Misbranded or adulterated: it bears an unsafe color additive for purposes of coloring only

Adulterated

Misbranded or adulterated: it consists in whole or in part of any filthy, putrid, or decomposed substance

Adulterated

Misbranded or adulterated: its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health

Adulterated

Misbranded or adulterated: Pharmacist drops tablet on floor, or sneezes on counting tray, and proceeds to put the drug in a vial and dispense it to a patient

Adulterated- The drugs either are contaminated, or could have become contaminated

What is the difference between adulteration and misbranding?

Adulteration- issues with condition (unsanitary) Misbranding- issues with labeling (false or misleading)

Misbranding or adulteration: drug is labeled as if recognized in an official compendium, but strength differs from, or quality or purity falls below compendium standards.

Adulteration- this is the exception

What should be advised when using alternative forms of patient information?

Advise the patient or agent that the pharmacist may be contacted for consultation in person at the pharmacy or by toll-free or collect telephone service.

The DEA issue triplicate forms now?

After October 30, 2019, the DEA will no longer issue triplicate forms

What are exceptions to having a pharmacist review the prescription before immediate patient administration?

After hours cabinet for medication dispensing in the absence of a pharmacist emergency kit The system is being used to provide access to medication required to treat the immediate needs of a patient

What are product registration requirements?

All drug manufacturers and repackagers are required to register with FDA. If they fail to register, their products are deemed to be "misbranded."

What are record and electronic data requirements?

All events involving access to the contents of the automated dispensing and storage systems must be recorded electronically; Records must be maintained by the pharmacy and must be readily available to the DPR

What are the conditions that meet a telepharmacy?

All events involving the contents of an automated pharmacy system must be stored in a secure location and may be recorded electronically Automated pharmacy or prescription dispensing machine system may be used in conjunction with the pharmacy's practice of telepharmacy after inspection and approval by the department

Under IL law, what are the requirements for oral prescriptions of CII?

All information required on a written prescription must be taken and written at the time of the emergency order Within 7 days after issuing an emergency prescription,the prescriber shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.

Where should copies of pharmacy policies and procedures related to the use of automated dispensing and storage be maintained?

All locations where the system is being used

What are the dispensing requirements for an onsite institutional pharmacy service?

All medication dispensed to a specific patient in the institution shall be dispensed in a container identified with the name of the patient and the patient's location.

What prescriptions have to have a safety cap?

All new and refilled prescriptions

When is counseling mandatory?

All new prescriptions

What are the requirements of notifying the DEA about arranging financial and shipping records (such as invoices and packing slips but not executed 222 order forms) maintained at a central location?

All notifications must include the following: o The nature of the records to be kept centrally. o The exact location where the records will be kept. o The name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally. o Whether central records will be maintained in a manual, or computer readable, form.

What are sanitary standards in a pharmacy?

All waste material shall be immediately deposited in an appropriate waste receptacle. There shall be a sink with hot and cold running water for the purposes of hand washing and drug dispensing. No sink shall be required for pharmacies that do not maintain drug inventory. Free and dry from vermin Food and drink and personal items placed in designated area away from dispensing activities

What is registration of closed system of distribution?

All who come in contact with controlled substances must be registered (or in some cases employed by a registered entity)

What are the labeling requirements of dietary supplements that were established from DSHA?

Allowed "nutritional support statements" describing the effect of a supplement, and provided for the FDA to issue good manufacturing practice regulations for the dietary supplement industry. Before DSHEA, supplements were regulated in the same way as foods, food ingredients, or food additives.

What are customized medication packaging?

Allows a daily regimen of medication to be combined into blisters or other types of containers according to time of day, to enhance patient compliance A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing 2 or more prescribed solid oral dosage forms. The patient med pak is designed, or each container is labeled, to indicate the day and time or period of time when the contents within each container are to be taken.

What is the controlled substance ordering system (CSOS)?

Allows pharmacies to order C-I and C-II controlled substances electronically

What is the Prescription Drug User Fee Act?

Allows the FDA to accept user fees from drug and biologic companies in return for committing to review new drug and biologic products within certain time frames. PDUFA has been credited with speeding the approval of new products.

Must the customer make the choice for conventional packaging in writing?

Although many pharmacists do require a written waiver, the law and regulations do not require a written request. The CPSC staff recommends, however, that the pharmacist get a request in writing particularly when a blanket waiver is being requested. This will assist the pharmacist during inspections of the pharmacy by regulatory agencies.

When a prescription drug is dispensed in a special package, would the pharmacist be in violation of the regulations if he or she included a separate non-complying closure with the package?

Although this practice is not prohibited, the CPSC staff discourages the practice in that it is likely to result in the use of noncomplying packaging by those who are able to use special packaging without difficulty.

May a pharmacist legally use reversible or other types of dual-purpose packaging for dispensing prescription drugs?

Although this type of packaging is not prohibited, the CPSC staff discourages its use because it is likely to result in the use of non-special packaging. The potential for children being poisoned thus increases.

What are requirements for directions of aspirin products?

Always bear dosage directions for each age group down to 3 years of age, with a statement such as "For children under 3 years of age, consult your physician.''

What resource materials can licensed pharmacy preparing sterile parenteral products have?

American hospital formulary service Illinois Pharmacy Practice Act and Rules, the Illinois Controlled Substances Act and 77 Ill. Adm. Code 3100, 21 CFR and the Illinois Hypodermic Syringes and Needles Act Compatibility reference (trissels, kings, etc.) A file on extended stability data given to finished products

What an advanced practice registered nurse with full practice authority?

An APRN who meets certain educational and clinical experience requirements are given full practice authority, and can practice without a collaborative practice agreement.

How many breaks does a pharmacist get for working 12 continuous hours per day?

An additional 15 minute break

What should be submitted to the division regarding inventory of the departing PIC?

An affidavit attesting to the completion of the inventory and preservation of the inventory record, bearing the date of the inventory and the name and signatures of the departing and the incoming pharmacist-in-charge, shall be submitted to the Division at its principal office within 30 days after the change in the pharmacist-in-charge.

What is whistleblower protection?

An individual or organization acting in good faith, and not in a willful and wanton manner, in complying with this Section by providing a report or other information to the Board, by assisting in the investigation or preparation of a report or information, by participating in proceedings of the Board, or by serving as a member of the Board shall not, as a result of such actions, be subject to criminal prosecution or civil damages. Any person who reports a violation of this Section to the Department is protected under subsection (b) of Section 15 of the Whistleblower Act.

What does inpatient drug order mean?

An order issued by an authorized prescriber for a resident or patient of a nursing home (long term care facility), hospital, U of I Hospital, or a facility operated by the Department of Human Services or the Department of Corrections.

What is prescribing for a legitimate purpose (good faith)?

An order issued to an individual not in the regular course of treatment nor part of an authorized methadone maintenance program, or legitimate research, and which is intended to provide the individual with controlled substances sufficient to maintain that person's physical or psychological addiction, habitual or customary use, dependence, or diversion, is not a prescription, and person issuing it shall be subject to penalties provided for violations of the CSA.

How often are pharmacy self inspections?

Annually during the same month as determined by the pharmacy

What is Lacosamide (Vimpat) used for?

Anti-seizure medication, neuropathic pain

What is Pregabalin (Lyrica) used for?

Anti-seizure; neuropathic pain

What is limitations to prescriptive authority on scheduled controlled drugs for clinical psychologists?

Any delegation of Schedule III through V controlled substances shall identify the specific controlled substance by brand name or generic name. No controlled substance to be delivered by injection may be delegated. No Schedule II controlled substance shall be delegated. Also, a prescribing psychologist shall not prescribe narcotic drugs.

What are requirements for remote prescription/medication order processing services?

Any nonresident pharmacy shall be registered in its resident state. There shall be a secure, HIPAA compliant, electronic communication system that shall include but not be limited to computer, telephone and facsimile connections. The communication system shall give remote access to all relevant patient information to allow the pharmacist of the remote pharmacy to perform remote medication order processing that shall include all laboratory results and every patient's or resident's medication profile, if appropriate. The secure electronic communication system shall be maintained on a daily basis. If this system malfunctions, the remote processing pharmacy shall cease operations related to the institution affected.

What the scope of optometrist prescriptive authority?

Any optometrist shall be authorized to purchase diagnostic and therapeutic ocular pharmaceutical agents and to utilize and to prescribe such drugs in the regular course of practicing optometry.

When would you need written authorization of the patient?

Any other use or disclosure of PHI (e.g., other than for TPO) requires the specific written authorization of the patient

Is unit dose packaging considered to be child-resistant?

Any package that contains a substance regulated under the PPPA must meet the special packaging standards regardless of the package type. This includes unit dose packaging such as blisters or pouches. Unit dose packaging is popular for many drugs, especially OTC drugs. The package is evaluated using the same test methods; however, the definition of a package failure is different than that of a bottle/closure package. If a child opens or gains access to a bottle/closure package, it is counted as a failure for that package. However, a failure for unit dose packaging is defined as occurring when a child opens or gains access to more than eight individual units or the number of units representing a toxic amount, whichever is less. The level of child-resistance required of the unit packaging depends on the toxicity of the product in it. A unit package that is compliant for one drug may not be able to be used to package another more toxic drug.

What are targeted packages?

Any package,including convenience packages, containing any amount of a methamphetamine precursor.

What is a "wholesale drug distributor"?

Any person or entity engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own label distributors; jobbers; private label distributors; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions, including, but not limited to, any pharmacy distributor as defined in this Section. A wholesale drug distributor shall not include any for hire carrier or person or entity hired solely to transport prescription drugs.

What is a student pharmacist?

Any person registered as a pharmacy technician who is also enrolled in a first professional degree program in pharmacy in a school or college of pharmacy or a department of pharmacy of a university approved by the Department or has graduated from such a program within the last 18 months

What are foreign graduates?

Any person seeking licensure as a pharmacist who has graduated from a pharmacy program outside the United States

What are exemptions from registration for non-resident non-traditional pharmD students?

Any person who is enrolled in a non-traditional Pharm.D. program at an ACPE accredited college of pharmacy and is a licensed pharmacist under the laws of another United States jurisdiction shall be permitted to engage in the program of practice experience required in the academic program by virtue of such license. Such person shall be exempt from the requirement of registration as a registered pharmacy technician while engaged in the program of practice experience required in the academic program.

What is criminal sanctions based on violation of act?

Any person who is found to have violated any provision of this Act is guilty of a Class A misdemeanor. On conviction of a second or subsequent offense, the violator shall be guilty of a Class 4 felony. All criminal fines, monies, or other property collected or received by the Department under this Section or any other State or federal statute, including, but not limited to, property forfeited to the Department under Section 505 of The Illinois Controlled Substances Act,1 shall be deposited into the Illinois State Pharmacy Disciplinary Fund.

What are penalties for unlicensed practice?

Any person who practices, offers to practice, attempts to practice, or holds oneself out to practice pharmacy without being licensed under this Act shall, in addition to any other penalty provided by law, pay a civil penalty to the Department in an amount not to exceed $5,000 for each offense as determined by the Department. The civil penalty shall be assessed by the Department after a hearing is held in accordance with the provisions set forth in this Act regarding the provision of a hearing for the discipline of a licensee. The Department has the authority and power to investigate any and all unlicensed activity.

What is temporary suspension based on impairment or mental illness?

Any pharmacist or pharmacy technician whose license was granted, continued, reinstated, renewed, disciplined, or supervised, subject to such terms, conditions, or restrictions, and who fails to comply with such terms, conditions, or restrictions or to complete a required program of care, counseling, or treatment, as determined by the chief pharmacy coordinator or a deputy pharmacy coordinator, shall be referred to the Secretary for a determination as to whether the licensee shall have his or her license suspended immediately, pending a hearing by the Board. In instances in which the Secretary immediately suspends a license a hearing upon such person's license must be convened by the Board within 15 days after such suspension and completed without appreciable delay. The Board shall have the authority to review the subject pharmacist's or pharmacy technician's record of treatment and counseling regarding the impairment.

What are examples of online pharmacies?

Any website that sells, or offers to sell, any controlled substance or a prescription therefor to a person in the United States. Any person who operates such a website. Any person who pays a practitioner to write prescriptions for controlled substances for customers of such a website. Any person who pays a pharmacy to fill prescriptions for controlled substances that were issued to customers of such a website. Any pharmacy that knowingly or intentionally fills prescriptions for controlled substances that were issued to customers of such a website. Any person who sends an e-mail that offers to sell a controlled substance or a prescription for a controlled substance in a manner not authorized by the Act; directs buyers to a website operating in violation of the Act; or otherwise causes or facilitates the delivery, distribution, or dispensing of a controlled substance in a manner not authorized by the Act.

Who is authorized to order Schedule I and II controlled substances?

Anyone with active DEA registration

How many blank forms can applicants filling out the DEA form 222 receive?

Applicants receive a maximum of 6 order form books, each containing 7 numbered blank forms. Each form contains 10 lines. (only 1 item per line, no alterations or erasures)

When do you have to apply to have your CE waived if you apply?

Application for waiver must pre-date renewal date. If interview before board is desired, applicant must make request at time he applies for waiver. Applicant is considered to be in good standing until DPR reaches a decision

What is the appointment process of the board of pharmacy?

Appointed by Governor, with due consideration given to recommendations by members of the profession and pharmacy professional organizations. Shall give consideration to individuals in all types and settings of pharmacy practice.

What are drugs?

Articles recognized in the official USP/NF, or any supplement thereto and being intended for and having for their main use the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as approved by the FDA All other articles intended for and having for their main use the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as approved by the FDA; Articles (other than food) having for their main use and intended to affect the structure or any function of the body of man or other animals Articles having for their main use and intended for use as a component or any articles specified in (1), (2) or (3) Does not include devices or their components, parts or accessories.

In the case of refills, can prescription bottles and vials be reused?

As a general rule, no. This prohibition is based on the wear associated with a plastic vial, which could compromise the package's effectiveness. Since such wear or undetected damage with a glass container is negligible, the CPSC staff has indicated that it would have no objection to the reuse of a glass container, provided a new closure is used. This same consideration would be given to any other package type that is not prone to wear.

What changes may a pharmacist make to a schedule II prescription?

As long as it is not the patient's identity, the drug prescribed (other than generic substitution), the date on the prescription or add a date or identity of the prescriber or the prescriber's signature. Any other components of a prescription for a Schedule II controlled substance may be changed after consultation with the prescriber

What do pharmacy technicians do?

Assist in the practice of pharmacy and perform such functions as assisting in the dispensing process, offering counseling, receiving new verbal prescription orders, and having prescriber contact concerning prescription drug order clarification.

Under federal law, what is the time limitation for exempt narcotics?

At least 48 hours

How long should all written RXs and original transcript or copy of verbal prescriptions to be maintained at pharmacy?

At least 5 years

Under Illinois law, what is the time limitation for exempt narcotics?

At least 96 hours

When does the supplier have to forward the copy to the DEA?

At the close of the month during which the drug is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60 day validity period expires

When should the supplier forward copy 2 if an order is filled by partial shipments?

At the close of the month during which the final shipment is made or the 60 day validity period expires

What is the Drug Quality and Security Act?

Attempts to strike balance between "traditional" compounding and non-patient specific compounding. There are two parts: 503A and 503B

What is described in the authorization form?

Authorization form must describe specific use for the PHI, who will receive it, and whether the CE will be paid in connection with disclosing it.

Electronic prescriptions should be transmitted through who?

Authorized licensed prescriber to the pharmacy of the patient's choice. No intermediary shall alter the prescription information or content of the prescription.

What are the requirements for remote automated pharmacy systems?

Automated dispensing devices that will dispense prescription drugs directly to a patient and counsel via audio/visual

How are controlled substances scheduled?

Based on medical utility of the substances, compared to its abused potential and addictive properties

What should the manual of remote prescription/medication order processing entail?

Be accessible to the remote prescription/medication order processing pharmacy staff and the staff at the dispensing pharmacy; Be available for inspection by the Division; Outline the responsibilities of the remote prescription/medication order processing pharmacy staff and the staff at the dispensing pharmacy; Include a current list of the name, address, telephone number and license number of each pharmacist involved in remote prescription/medication order processing;

What are requirements of a pharmacy using national council for prescription drug program's SCRIPT?

Beginning January 1, 2021, when receiving electronic prescriptions must enable, activate, and maintain the ability to receive transmissions of electronic prescription cancellation and to transmit cancellation response transactions.

Where can convenience packages sold by retail distributors be displayed?

Behind store counters or in locked case so that customers must request store employee assistance to access the products

Which of these is not needed in a pharmacy that makes a parenteral product: Good lighting, Biological Safety cabinet, Laminar bench, and running water?

Biological safety cabinet is not needed. What is needed is a laminar airflow hood, sink with hot and cold running water, refrigerator, temperature controlled container, disposal containers

What are requirements for refilling a prescription with both parts of plastic containers?

Both must be replaced

Misbranding or adulterated: when a medication error occurs (wrong drug strength but right drug in bottle)

Both. if it is just wrong drug then it is considered misbranded only

What are the labeling requirements of sterile solutions to which drugs have been added that are for immediate dispensing to a specific patient use at an onsite institutional pharmacy service?

Brand and/or generic name Strength

What are the labeling requirements of non-parenterals repackaged for future for offsite institutional pharmacy services?

Brand and/or generic name Strength Beyond use date Reference code to identify source and lot number

What are the labeling requirements single dose or multi dose drugs, except sterile solutions to which a drug has been added for medications for future use inside the institution or facility and not intended for immediate dispensing to a specific patient?

Brand and/or generic name Strength Beyond use date Reference code to identify source and lot number

Where should all data be maintained?

By the pharmacy. The pharmacy shall have the appropriate equipment on the premises to provide readily retrievable information in the course of an on-site inspection

How many times can CIII- CV drugs be transferred?

C-III through C-V drugs may only be transferred one time. However, per DEA (federal law) and Board Regulation, a pharmacist who is electronically sharing real-time on line computerized systems may transfer up to the maximum refills permitted by law and the prescriber's authorization

What is Current Good Manufacturing Practices (CGMPS)?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards

How should controlled substances be counted in inventory?

CII - actual count is required CIII, IV, and V - quantities in containers of 1,000 tablets or less may be estimated, while containers of more than 1,000 units or larger must be physically counted

Are CII prescriptions refillable?

CIIs are not refillable; may dispense a partial fill, and provide remaining quantity later

What are faster transactions benefits with CSOS?

CSOS certificates contain the same identification information as DEA Form 222, which allows for timely and accurate validation by the supplier. Faster transactions allow for just-in- time ordering and smaller inventories.

What are ordering freedom benefits with CSOS?

CSOS transactions are the only allowance for electronic ordering of Schedule I and II controlled substances, but may also be used for Schedule III-V substances. Additionally, CSOS has no line item limit for a single order.

What schedule are single entity and combination ephedrine (EPH) and pseudoephedrine (PSE) products in all forms?

CV controlled substances

If the package by the manufacturer came without a safety cap, should it be dispensed with a safety cap?

Can be dispensed without a safety cap

What is the illinois cannibis control act?

Cannabis is not treated as a Schedule I controlled substance under Illinois state law.

Under IL law, can a pharmacist change the date of a CII prescription?

Cannot add missing date to prescription

What are appointment requirements of the chief pharmacy coordinator?

Cannot be a member of the board Must be a registered pharmacist in good standing, and a graduate of an accredited college of pharmacy or have a BS in pharmacy > 5 years experience in practice of pharmacy immediately prior to his appointment Shall be the executive administrator and the chief enforcement officer of this act

What are the requirements of the two non-pharmacist public members?

Cannot be engaged in any way, directly or indirectly as providers of healthcare

What are prescription drugs?

Cannot be made safe by including adequate directions for use (and is therefore exempt from requirement that it contain adequate directions for use or be considered misbranded), medical experts agree that adequate directions for consumer self-medication cannot be provided, is limited to dispensing by a prescription because it is habit forming, toxic, has a potential for harm, or its NDA limits it to use under a doctor's supervision, label must contain "legend" stating: "Caution: Federal law prohibits dispensing without a prescription." (Hence the name "legend drugs".) (Now: "Rx Only")

What is the limit to administer narcotic substances to an addicted individual to relieve the individual acute withdrawal symptoms while the practitioner makes arrangements to refer the individual to a narcotic treatment program?

Cannot last more than 3 days and may not be renewed or extended

What are requirements of the computer system?

Capable of maintaining, printing, and providing, upon a request by the Department, the Department's compliance officers, and other authorized agents, all of the prescription information required by State law and regulations of the Department within 72 hours of the request.

Dietary supplement labels **MUST** have what statements?

Carry a disclaimer stating that the claims made on the label "have not been evaluated or approved by the Food and Drug Administration".

What is a red flag?

Cash paying customers

What is the consequence for failure to report a CS dispensing to the PMP?

Civil fine up to $100 per day from the time the report was required to resolution

What are the clinical psychologists with special training?

Clinical psychologists with special training who pass a national certifying exam approved by the state can obtain a prescribing psychologist license.

What are institutional practitioner registration available to?

Clinics that are licensed

When does the supplier forward copy 2?

Close of the month during which the order is filled

What is patient counseling?

Communication between a pharmacist or a student pharmacist under the supervision of a pharmacist and a patient or the patient's representative about the patient's medication or device for the purpose of optimizing proper use of prescription medications or devices.

What is the Federal food, drug and cosmetic act?

Compelled manufacturers to demonstrate to the FDA the safety of new drugs prior to marketing, allowed the FDA to inspect manufacturing facilities, allowed the FDA to seek injections from courts, and provided detailed legal definitions of drug, devices, cosmetics, and labeling

What are the requirements for the application process of a pharmacy?

Completion of application Inspection of physical requirement Interview with the board If name change or change in PIC, must complete application, pay fee, and submit present license Pharmacy must open within 30 days of issuance of the pharmacy license.

How do pharmacies obtain alcohol?

Compounding using form ATF-11

What prescriptions must be manually signed?

Computer generated prescriptions or faxed

What are computerized system requirements to transfer prescriptions?

Computerized systems must satisfy all information requirements of this Section, including invalidation of the original prescription when transferred between pharmacies accessing the same prescription records or between pharmacies of the same ownership

If the disposition or alternative plan is not completed within 30 days, what can the DPR do?

Confiscate all legend drugs

What should a pharmacist or physician do if they know or suspect that PPPA regulations are being violated?

Contact CPSC Headquarters either by phone, letter, or e-mail. The CPSC operates a toll-free hotline at (800) 638- 2772. However, we recommend that you contact the Office of Compliance directly by phone at 301-504-7913, via fax at 301-504- 0359, or via e-mail at [email protected]. CPSC staff will review the complaint and take appropriate action as warranted.

Where do you get DEA form 106?

Contact nearest DEA diversion field office

What is the investigational new drug application?

Contains preclinical data, proposed use and safety data, and proposed plan for study in humans. Data reviewed by FDA, and decision is made whether to allow sponsor to begin human trials.

What drugs must be reported in the PMP?

Control 2-5

What is a transfer warning?

Controlled substances require transfer warnings- "Federal Law prohibits transfer of this drug to any person other than the patient for whom it was prescribed."

At the time of filling, what must be signed and date on the face of the prescription by the pharmacist?

Controlled substances- initial or a unique identifier are not sufficient

What are exemptions of PSE and EPH laws?

Convenience packages sold by non-pharmacy retailers so long as the requirements of the law (ID, log books, quantity limitations, etc.) are complied with dispensing pursuant to a valid prescription for PSE or EPH

Which color copy of the DEA 222 form goes to which person?

Copy 1 - Brown (goes to the supplier) Copy 2 - Green (goes to supplier and is forwarded to DEA) Copy 3 - Blue (stays with the recipient) Exam Tip: brown dirt, green grass, blue sky

What copy number go to the supplier, pharmacy, and DEA?

Copy 1 and 2 go to supplier and 3 is maintained at the pharmacy. Supplier retains copy 1 and forwards copy 2 to DEA

Who gets what copy of the DEA 222 form: The pharmacy in example #1 discovers that it does not need the OxyContin. The OxyContin has not yet arrived - it is in transit. The pharmacist calls the delivery person and tells him to go back to the neighboring pharmacy and return the Oxy. Is it necessary to use the 222 form, or can the order be canceled? If a 222 is required, where do the copies go:

Copy 1: ABC pharmacy Copy 2: DEA Copy 3: Neighboring pharmacy

Who gets what copy of the DEA 222 form: ABC pharmacy "borrows" a supply of OxyContin from a neighboring pharmacy

Copy 1: neighboring pharmacy Copy 2: DEA Copy 3: ABC pharmacy

Who gets what copy of the DEA 222 form: A pharmacy returns a bottle of unused morphine to the manufacturer?

Copy 1: pharmacy Copy 2: DEA Copy 3: Manufacturer

How should counseling be achieved in a remote pharmacy?

Counseling in those circumstances shall be done by both video and audio means

How is counseling done in a remote dispensing site?

Counseling must be done by a pharmacist (not just an) via video link and audio link before the medication is released to a patient. The pharmacist must counsel the patient or the patient's agent on all new prescriptions and refills.

What is the primary objective of self-inspection?

Create an opportunity for a pharmacy to identify and correct areas of noncompliance with State and federal law. This includes, but is not limited to, recordkeeping, inventory, labeling and sanitation requirements.

What are schedule 5 drugs?

Current accepted medical use and low abuse potential. Limited physical and psychological dependence compared to C-IV substances ("Exempt" Narcotics). Limited quantities may be purchased without a prescription

What are schedule 4 drugs?

Currently acceptable medical use and lesser abuse potential than drugs in C-III category. Abuse may lead to only a limited physical or psychological dependence.

What are schedule 3 drugs?

Currently acceptable medical use. Abuse potential less than C-I and C-II, but abuse may be dangerous, or lead to moderate or low physical dependence or high psychological dependence.

What are schedule 2 drugs?

Currently accepted medical use and high abuse potential, with severe psychological or physical dependence.

What form should the pharmacy complete for a controlled substance theft or loss?

DEA Form-106 (Report of Theft or Loss of Controlled Substances)

What DEA form must pharmacies or other registrants fill out to order controlled substances (schedule I and II)?

DEA form 222

What DEA form do pharmacies and other dispensers register for initial registration?

DEA form 224

What DEA form do pharmacists and other dispensers register for renewal?

DEA form 224a

What DEA form do manufacturers / wholesalers / importers / exporters / researchers use for initial registration?

DEA form 225

What DEA form do manufacturers / wholesalers / importers / exporters / researchers use for renewal registration?

DEA form 225a

What form must a reverse distributor complete?

DEA form 41

What form must be completed for disposal of CS through disposal or destruction of pharmacy?

DEA form 41

What does the X mean in the first letter of the DEA number?

DEA number is for use by a practitioner in the treatment of addictions on an outpatient basis. It is issued and used in addition to the A, B, F, or G DEA number.

Where can a person holding a registration authorizing the person to obtain DEA form 22 requisition forms to?

DEA secured network connection or by contacting any division office or the registration section of the administration through the customer service center

What are DEA take back programs?

DEA sponsors "National Prescription Take Back Days" where they partner with local law enforcement to encourage patients to bring unused controlled substances to law enforcement for proper disposal

What is temporary suspension of license?

DFPR may temporarily suspend the license of a pharmacist, pharmacy, registered pharmacy technician, or registered certified pharmacy technician, without a hearing, simultaneously with the institution of proceedings for a hearing, if it finds evidence that indicates that a continuation in practice would constitute an imminent danger to the public. In the event that the Secretary suspends, temporarily, this license without a hearing, a hearing by the Department must be held within 15 days after such suspension has occurred, and be concluded without appreciable delay.

What is the drug control law that is most likely violated by the pharmacist?

DHA

What law prohibits unauthorized refills?

DHA

If a PIC files a DEA form 106, a copy must be sent to where?

DPR

What is the Medical Device Amendments Amendment?

Defined medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose."

What is the Dietary Supplement Health and Education Act?

Dietary supplements defined as vitamins, herbs, and minerals are exempt from food additive provisions. This means that the FDA must prove the supplements are unsafe as opposed to manufacturers' having to demonstrate the safety of these products.

How does one obtain nonresident special pharmacy registration in IL?

Disclosure and certification of information required and The fee required

What is disposal or destruction by pharmacy?

Disfavored by DEA but permitted by law. Registrant must request DEA authorization to destroy damaged, outdated, or otherwise unwanted controlled substances

What are limits of drugs dispensed in the ER?

Dispensed should be limited to no more than a 72 hour supply, except: antimicrobials; unit of use packages (inhalers, ophthalmics, otics, etc.); drugs dispensed via a Remote Automated Pharmacy System.

What are exempt narcotics?

Dispensing Schedule V Controlled Substances without prescription. Includes schedule V cough and cold preparations containing codeine and antidiarrheal products

How is counseling achieved for RAPS?

Dispensing and counseling are performed by a pharmacist employed by the home pharmacy via audio link and video link or by the prescriber when the RAPS is located on the same premises as the prescriber.

What are medication therapy management services?

Distinct service or group of services offered by licensed pharmacists, physicians licensed to practice medicine in all its branches, advanced practice nurses authorized in a written agreement with a physician licensed to practice medicine in all its branches, or physician assistants authorized in guidelines by a supervising physician that optimize therapeutic outcomes for individual patients through improved medication use.

What is the Durham-Humphrey Amendment?

Distinguishes prescription vs. OTC. Prescription drugs can be dispensed only with valid prescription

What is a wholesale drug distributor?

Distribution of prescription drugs to persons other than a consumer or patient,

What is "dispenser" registration?

Doctor or mid-level practitioner who "prescribes" a controlled substance. There is no such thing as a "prescriber" registration

Can you return and reuse drugs in institutional healthcare facilities?

Does not apply to a drug dispensed to a patient of institutional healthcare facility(even if dispensed by a retail pharmacy) where a licensed healthcare professional administers the drug and the pharmacist ensures that: - the drugs were stores in compliance with applicable laws - the drugs are not contaminated, deteriorated or beyond their use date - the returns are properly documented - obtaining payment twice for the same drug is prohibited

What are the exemptions of package insert requirements for estrogen products?

Does not apply to estrogen-progestogen oral contraceptives

What type of repackaged OTC label doesn't have to contain the same information as required for commercial product?

Does not apply to hospital repackaging for "own use"

Under federal law, is self prescribing of CS allowed?

Does not prohibit self prescribing or have a limit on quantity that can be written or dispensed

What are DESI drugs?

Drug Efficacy Study Implementation is a process whereby the FDA is reviewing all old drugs- drugs that were approved before the FDA approval standards required proof of efficacy. Proof of efficacy was first required in 1962 by the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act. All drugs approved before 1962 were required to undergo DESI review. There are still many drugs that are on the market, but which have not yet been reviewed. Those drugs are referred to as "DESI" drugs. Another fact about DESI drugs is that they are not listed in the FDA orange book for equivalency purposes. In other words they are not "A" rated and cannot be substituted.

What is phase 3 of the clinical trials?

Drug given to large groups of patients (sometimes thousands) in several geographical locations as part of controlled clinical trials; obtain data concerning drugs effectiveness compared to placebo; most studies are double blinded.

What is treatment IND?

Drug in phase 2 or 3 with some evidence of safety and effectiveness can be given to patients that have not been enrolled in the drug's clinical trials, and who are in imminent life-threatening stages of an illness that has no cure, and for which presently used drugs are not effective.

What is phase 2 of clinical trials?

Drug is given to a larger group (100 or more) of patients with the disease or symptoms of the condition claimed to be treated by the drug; determine effectiveness and obtain information about dosing, relative safety and adverse effects.

What else does the FDA have authority to regulate?

Drug wholesalers

What is the Orphan Drug Act?

Drugs intended for the treatment of "rare diseases and conditions" may be designated orphan drugs

What are non-prescription drugs (OTC, over the counter)?

Drugs which are recognized by experts to be safe and effective. Not considered to be "misbranded" if manufactured in accordance with GMPs and labeled with instructions for layman that indicate their safe and effective use.

What are misbranded drugs?

Drugs which are sold, dispensed or distributed in violation of the labeling requirements of FDCA are misbranded.

Who's responsible for the operations and the establishment and maintenance of security provisions?

Dual responsibility of PIC and owner of the pharmacy

What is the pedigree requirement?

Each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug.

What should the pharmacy have available where vaccinations are administered?

Each pharmacy or pharmacist functioning outside of a pharmacy shall have available a current copy or electronic version of the CDC reference "Epidemiology and Prevention of Vaccine - Preventable Diseases" at the location where vaccinations are administered.

Whose responsibility is it to notify the division of any change of address?

Each registrant. Failure to receive a renewal form from the Division shall not constitute an excuse for failure to pay the renewal fee.

What are exempt products for labeling requirements of OTC products containing salicylates?

Effervescent preparations and preparations containing para-aminosalicylate as the only salicylate ingredient are exempted from this labeling requirement.

Where should records of all legend drugs be maintained for a period of 5 years?

Either on site or at a central location where records are readily retrievable

When should a technician be certified?

Either when the license is issued or on or before the second license renewal.If the registrant has not yet attained the age of 18, then upon the next renewal as a registered pharmacy technician, the registrant must meet the requirements for certification and register as a registered certified pharmacy technician. This requirement does not apply to pharmacy technicians registered prior to January 1, 2008

What is a unique identifier?

Electronic signature, handwritten signature or initials, thumb print, or other acceptable individual biometric or electronic identification process as approved by the DPR.

What are the requirements for emergency kits?

Emergency kits shall be sealed in some manner which will indicate when the kit has been opened. A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit

Which one of these medications is not a controlled substance: Hydrocodone, Empirin, Fiorinal, or Empirin w/codeine?

Empirin. MEMORIZE BRAND NAMES OF DRUGS

What is the Drug Enforcement Administration (DEA) responsible for?

Enforcing federal controlled substances laws

What does an AP rating mean in the orange book?

Equivalent injectable aqueous solutions and, in certain instances, intravenous non- aqueous solutions

What does an AO mean in the orange book?

Equivalent injectable oil solutions

What does an AB rating in the orange book mean?

Equivalent solid dosage form

What does an AN rating mean in an orange book?

Equivalent solutions and powders for aerosolization

What does an AT rating mean in the orange book?

Equivalent topical products

What is a drug regimen review?

Evaluation of prescription drug orders and patient records for known allergies, drug or potential therapy contraindications, reasonable dose, duration of use, and route of administration, taking into consideration factors such as age, gender, and contraindication, reasonable directions for use, potential or actual adverse drug reactions, drug-drug interactions, drug-food interactions, drug-disease contraindications, therapeutic duplication, patient laboratory values when authorized and available, proper utilization (including over and under-utilization) and optimum therapeutic outcomes and abuse and misuse

If there is a fire in the front of the pharmacy, but the flames do not reach the pharmacy area, where the medications are stored, can you use them? Only if they are sealed? Who needs to be notified that the fire occurred?

Even if the flames do not reach the pharmacy, the heat and smoke generated by the fire could adversely affect the drugs. They are therefore considered to be adulterated. It does not matter if the package is sealed or unsealed. There is no requirement that any state or federal agency be notified of the fire.

How often do manufacturers / wholesalers / importers / exporters / researchers have to renew registration?

Every 3 years

What are requirements for a sign to state that the patient has the right to counsel?

Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign provided by the Division containing a statement that the patient has the right to counseling, the Division's consumer hotline number, information on how to file a complaint for failure to counsel, and any other information the Division deems appropriate. The sign must be printed in color ink or displayed electronically in color, measure at least 8 1⁄2 x 11 inches in size, and be posted at either a cashier counter or waiting area clearly visible to patients. Licensed pharmacies that do not maintain a physical location directly serving patients must include a copy of the sign within any dispensed prescriptions. The sign will be available to download on the Division's website

What are requirements for recordkeeping for onsite institutional pharmacy services?

Every prescription or medication order filled or refilled shall contain the name, initials or other unique identifier of the pharmacist (and pharmacy technician if one is used) who fills or refills the prescription or medication order, or the name, initials or other unique identifier may be recorded on another appropriate, uniformly maintained and readily retrievable record that indicates, at least, the following information: The name and dosage form of the drug; The date of filling or refilling; and The quantity dispensed.

What should be documented with every prescription or order dispensed for offsite institutional pharmacy services?

Every prescription or order dispensed shall be documented with the name, initials or other unique identifies of the pharmacist (and pharmacy technician if one is used)

In Illinois, how often do you have to do an inventory?

Every year

What are precautions the patient should observe while taking OC?

Excretion of the drug in human milk and associated risks to the nursing infant Laboratory tests which may be affected by oral contraceptives Identifies activities and drugs, foods, or other substances the patient should avoid because of their interactions with OC How to take OC properly, including information if missed dose, information about becoming pregnant after d/c drug, drug has been prescribed for the use of the patient and should not be used for other conditions or given to others Possible benefits associated with OC use

What certain records must still be maintained locally?

Executed federal order forms Prescriptions Inventories

Can the pharmacist combine or consilidate refills?

Exercise professional judgment, and combine or consolidate refills without calling the doctor in order to provide the patient with a greater quantity, up to the total number of dosage units authorized on the original RX, plus any refills. Be careful with controlled substances, mental health drugs, or fact patterns that suggest there is a risk of an adverse outcome if a larger quantity is dispensed. Although it is still legal to combine the refills without calling the prescriber, professional judgment would likely dictate that the pharmacist should call the doctor before doing so.

What is required for compounding?

Existence of a valid doctor, patient and pharmacist relationship. A doctor must prescribe or order the compounded product for a patient in order for the pharmacist to compound. Always look for this "triad" relationship on the MPJE. Compounding requires a patient specific prescription, or reasonable anticipation of a patient specific prescription.

What is the policy on interchanging of biosimilars/biologics?

FDA approves it Physicians says you can substitute on prescription Pharmacy notifies patient Within 5 business days, provide entry of product provided to the patient and keep record for 5 years

What is required in the PPI for estrogen products?

FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section, each estrogen drug product restricted to prescription distribution, including products containing estrogens in fixed combinations with other drugs, shall be dispensed to patients with a patient package insert containing information concerning the drug`s benefits and risks. An estrogen drug product that does not comply with the requirements of this section is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act.

What is seizure of drugs from market?

FDA may "seize" drugs which are "misbranded" or "adulterated." The physical isolation of drug while FDA or state agency files a civil lawsuit.

What does FDA require before an ANDA can be approved?

FDA now requires a demonstration of bioequivalence before an ANDA can be approved. Products found not to be bioequivalent are no longer being approved.

What is the Food and Drug Modernization Act (FDAMA)?

FDAMA established fast-track approval for certain new drugs and accelerated approval for innovative devices by exempting certain devices from premarket notification requirements. The Act also allowed the FDA to use expert panels in the drug approval process, regulated health claims in food, reauthorized the Prescription Drug User Fee Act, and provided federal requirements governing compounding. However, the compounding part of this law is not being enforced by FDA because of ambiguity created by certain federal court decisions.

T/F: Drugs that are not dispense but held for sale in the pharmacy cannot be considered misbranded or adulterated

False, they still can be.

(T/F) All CIIs are narcotics

False. Narcotics are a limited subgroup of controlled substances

What is pharmacist's corresponding responsibility?

Federal law imposes responsibility for proper prescribing and dispensing on the physician, and a corresponding responsibility on the pharmacist who fills the prescription.

Can issuance of coupons to try to persuade them to fill prescriptions or obtain other federally reimbursable health care services allowed?

Federal law prohibits offering inducements to federal beneficiaries to try to persuade them to fill prescriptions or obtain other federally reimbursable health care services. This is why most pharmacy chains that issue coupons exclude participation of patients who have their prescriptions paid for by any state or federal payment program.

What the package insert requirements for estrogen products?

Federal law requires that estrogen products be dispensed with a FDA approved patient information insert.

What is the process for reinstatement of an inactive or expired status for more than 5 years?

File an application, proof of 30 hours of continuing education - certification of active practice in another jurisdiction - affidavit attesting to military service - or complection of 600 hours of clinical practice under the supervision of a licensed pharmacist completed within 2 years prior to restoration or successful completion of PARE examination - course work or clinical training - any clarification of documentation by providing such information or interview

What should you do with the copies of old (lost forms)?

File them

How does one report theft/loss of controlled substances?

Fill out form 106 with DEA and Illinois DPR Notify the local DEA field office of the suspected loss of theft within one business day After notice is provided, conduct a thorough investigation, and submit the DEA 106 form after the investigation has been completed. There is no deadline for completing the investigation

What is centralized prescription filling?

Filling of a prescription by one pharmacy upon request by another pharmacy to fill or refill the prescription. must have written contract includes the performance by one pharmacy for another pharmacy of other pharmacy duties such as drug utilization review, therapeutic drug utilization review, claims adjudication, and the obtaining of refill authorizations.

What is the Notice of Intent to confiscate?

Final administrative decision of the DPR for appeal purposes

Under IL law, how many schedules of drugs are there?

Five

Under federal law, how many schedules of drugs are there?

Five

What vaccinations are pharmacists limited to give in patients age 10-13?

Flu and Tdap

What is the orange book?

Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations.

What are dietary supplements?

Food products. Dietary supplement makers can promote their products using "structure function" claims, but still cannot use "drug" claims.

What are substances regulated by the FDA?

Foods, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products, and tobacco products

What forms of CIIs can be delegated to MLP?

For CIIs, only oral, topical or transdermal dosage forms may be delegated. "Oral" dosage form is defined as "a tablet, capsule, elixir, or solution or other liquid form of medication intended for administration by mouth, but the term DOES NOT include a form of medication intended for buccal, sublingual, or transmucosal administration."

What are distribution requirements for estrogen products?

For estrogen drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient.

What are examples of health care regulations?

For legal or auditing services, accreditation, formulary development, disclosures to law enforcement, adverse event reporting, compliance with prescription drug monitoring program requirements

What are reasons are selection of product cannot constitute evidence of negligence?

For legend products, it is listed in formulary; For non-legend product, product was in same dosage form and active ingredients did not vary by more than 1% Physician's failure to prohibit DPS does not constitute evidence of negligence unless prescriber has reasonable cause to believe that patient's health condition warrants use of brand name.

What is the distribution requirements of patient package inserts of OC?

For oral contraceptive drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient.

What is the 1970 Controlled Substance Act/Comprehensive Drug Abuse Prevention and Control Act of 1970?

Gave FDA authority to determine the scheduling of controlled substances, created a comprehensive approach to preventing drug abuse

What are the qualifications of a pharmacist member in the board of pharmacy?

Good standing Graduate of accredited college of pharmacy or BS in pharmacy > 5 years of post-licensure experience as a licensed pharmacist in IL

What are variances?

Grant variances from rules promulgated under the Act where there is a finding (1) that the provision from which a variance is requested is not statutorily mandated, (2) that no party may be injured by granting of the variance, and (3) the rule from which the variance is granted would be unreasonable or unnecessarily burdensome as applied.

What happens when a pharmacist is impaired?

Grounds for discipline. If a pharmacist is addicted to drugs or alcohol, and not caught, voluntarily seeks treatment with Illinois Impaired Practitioners Health Program (IPHP) into a five-year agreement, that includes requirements for periodic, random drug and/or alcohol screens, regular attendance at recovery meetings (AA or NA), and a referral to a substance abuse professional for treatment and aftercare. If compliant- no discipline. If a pharmacist is caught and determined to be addicted to drugs or alcohol, the Department will refer the patient to IPHP, but will also enter a disciplinary order against the pharmacist. The discipline will typically include a suspension for a period of time to be determined based on the facts and circumstances presented, followed by probation for 3 to 5 years. The typical suspension is 2 years, and the typical probation is 5 years. The disciplinary order will require all the same things that are required when a pharmacist seeks self-help, and in addition, the employer will be notified, the employer will be required to provide periodic (usually quarterly) reports to IDFPR of the pharmacists standing as an employee.

What is the HITECH act of 2010?

Health Information Technology for Economic and Clinical Health Act ("HITECH Act") is part of the American Recovery and Reinvestment Act of 2009 (ARRA). Amendments to HIPAA • Provides for enhanced penalties for using PHI for marketing purposes without authorization • Breach notification requirements

What are schedule I drugs?

High potential for abuse, no currently acceptable medical use, and lack of accepted safety for use under medical supervision. If used medically, must be approved by FDA and DEA under investigational protocol.

What is the difference between tamper-resistant and tamper-evident?

Historically, the term tamper-resistant was used to describe methods used to prevent tampering. The focus is now shifted to "tamper-evident," to heighten consumer awareness to any evidence of tampering, rather than implying that a particular product is difficult to breach or is tamper-proof.

What does A/B/F/G mean in the first letter of the DEA number?

Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy ("G" has been added for Department of Defense practitioners).

Which insulin are available OTC?

Humulin R, Humulin N, and Humulin Ultra Lente are available without a prescription. There may be others, so please check available references.

What is the reason for partial dispensing CII if unable to supply?

If at the time the RX is presented, the pharmacy is unable to supply the full quantity, the pharmacist may dispense a partial quantity, and supply the remainder of the prescription balance if filled within 72 hours.

Can pharmacies compound sterile and non sterile drug products for office use by a veterinarian?

If it is a reasonable quantity

What is the procedure for endorsing DEA forms 222?

If original supplier cannot fill all or part of order, they can endorse another supplier for filling. Endorsement made only by the OG supplier and must state the DEA of the 2nd supplier and sign and date by a person authorized to obtain and execute DEA forms 222 on behalf of the first supplier

Who gets what copy of the DEA 222 form if there is a transfer between registrant?

If returning for credit, supplier prepares form and provides copies 1 and 2 to pharmacy. Pharmacy forwards copy 2 to DEA, and retains copy 1.

Can a hospital that has no narcotic treatment program on the premises may administer narcotics to a drug dependent individual for either detoxification or maintenance purposes?

If the individual is being treated for a medical condition other than narcotic addiction

What is the responsibility of manufacturers of prescription drugs subject to the PPPA?

If the manufacturer intends that the package of a particular oral prescription drug is to be dispensed directly to the patient by the pharmacist, the CPSC interprets the PPPA to require the manufacturer to market that drug in special packaging. Such packages are readily recognizable for the most part and often only require relabeling by the pharmacists prior to dispensing. The pharmacist, however, bears the ultimate responsibility for repackaging the drug into special packaging if a manufacturer has failed to comply

Where can a pharmacist have their break?

If the pharmacy has a private break room available, or if there is a private break room in the establishment or business in which the pharmacy is located, a pharmacist who is entitled to breaks must be given access to that private break room and allowed to spend his or her break time in that room. The pharmacist shall either remain within the licensed pharmacy or within the establishment in which the licensed pharmacy is located in order to be available for emergencies

In the case of an antibiotic drug provided by the manufacturer in a granular form to be reconstituted by the pharmacist, who is responsible for providing the special package the pharmacist or the manufacturer?

If the product is in the same container intended to be given to the purchaser, the manufacturer and the pharmacist are both responsible.

When would you return unused DEA forms 222?

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked

When is it lawful for the pharmacy to compound?

If there is a patient specific prescription, or facts that support anticipatory compounding

When are pharmacy exempt from the requirements of transferred prescriptions?

If those systems that access the same prescription records have the capability of cancelling the original prescription, pharmacies using such a system are exempt from the requirements of this subsection if the transferred prescription can always be tracked to the original prescription order from the prescribing practitioner and the original prescription can be produced

What should I advise a consumer who calls for information when there is a suspected poisoning or childhood ingestion emergency?

If you are unable to provide the necessary emergency information for the caller or advise him or her as to the proper course of action, refer the caller to the Poison Control Center or nearest hospital emergency room. The national Poison Control Center phone number is 1-800-222-1222. This number should be on or near your telephone, along with those of the fire and police departments. It also would be prudent to suggest that the caller follow up with his/her physician.

If, as a pharmacist, your license expires (you forget to renew it in time), can you still work?

If your license is expired, you are unlicensed, and cannot practice until it is reinstated

What act must be in compliance with disposing of controlled substances?

Illinois Controlled substances

What are the differences in strictness for maintenance of controlled substances on federal vs. illinois law?

Illinois is stricter, you have to maintain for a longer time

Under IL law, Is prescribing controls to immediate family members allowed?

Illinois law allows prescribing for family members only if a "bona fide practitioner- patient relationship" exists and appropriate records are maintained for all treatment of family members.

What are additional labeling requirements of controlled substances under IL law?

Illinois law also requires the drug name, dosage and quantity.

Under IL law, how long should DEA 222 forms be maintained?

Illinois law considers DEA 222s to be an "invoice," and therefore requires that they be maintained for 5 years.

Who are authorized to issue controlled substance prescriptions?

Illinois law identifies physicians, dentists, podiatrists, and veterinarians as authorized to prescribe controlled substances. Also allows: o PAs, Nurse practitioners o Optometrist o Clinical Psychologists

When does Controlled Substance dispensing information need to be reported to the PDMP?

Illinois requires reporting of all controlled substances dispensed pursuant to a prescription by a pharmacy, including controlled substances scheduled under Illinois law, but not federal law. Dispensing information must be turned to DHHS by the end of the next business day. The laws in other states may be different, so be careful if taking the exam in multiple states.

Under federal law, when is an exception made and oral prescriptions of CIIs permitted?

Immediate administration of the CS is necessary for proper treatment No appropriate alternative is available It is not reasonably possible for prescriber to provide a written prescription. Written prescription for the emergency quantity is to be provided within one week.

What are exemptions to reporting to the PMP?

Impatient drug orders Medications dispensed from the ER or discharged with quantity less than 72 hour supply Controlled substances administered in narcotic treatment, via infusion in the home, hospital, LTC facility, or hospice

No prescription may be dispensed for a period of how long from the date of the original issuance of the prescription by the prescriber?

In excess of one year

When can a pharmacy provide a customized patient medication package?

In lieu of dispensing or more prescribed drug products in separate containers,a pharmacist may,with the consent of the patient, the patient's caregiver, or a prescriber

If both boxes (substituted and daw) are checked for a Coumadin RX, can the generic be dispensed without talking to the doctor?

In that case, if both boxes are checked, I would answer that you must call the Doctor. By checking "May Not Substitute" the prescriber is prohibiting substitution, even if he also checked "May Substitute"

When can a prescriber issue a lawful CS oral prescription?

In the case of an emergency, a prescriber may issue a lawful oral prescription, when failure to issue might result in loss of life or intense suffering.

Where should fax of the electronically transmitted prescription be stored?

In the pharmacy as required by state and federal laws or rules and may serve as the record of the prescription

How are CIIs accounted for if a pharmacy closes or is sold?

In the transaction by the completion of official order form by the buyer, and issued to the selling pharmacy.

How will the DEA notify the registrant of its decision of disposal or destruction by pharmacy?

In writing

What is labeling?

Includes the actual label, any written, printed, or graphic material upon any container (not just immediate container), any wrapper, or written, printed or graphic matter accompanything the product, including the package insert, drug advertisements, information in publications such as PDR, and promotional materials, including newsletters and literature used in promotion

What is prescriptive authority of an advanced practice registered nurse with full practice authority?

Independent prescriptive authority to prescribe both legend drugs and Schedule II through V controlled substances; this authority includes prescription of, selection of, orders for, administration of, storage of, acceptance of samples of, and dispensing over the counter medications, legend drugs, and controlled substances categorized as any Schedule II through V controlled substances.

The label affixed to the drug container must indicate what?

Indicate the initials of the RPh who approves dispensing.

What does a pharmacist mean?

Individual health care professional and provider currently licensed by this State to engage in the practice of pharmacy.

When can pharmacists compound a drug that differs slightly from a commercially available product?

Individual patient's medical, pharmacist must document after consulting with the patient's physician. This may also be permitted in the case of a drug shortage, when the commercially available product is not available.

What is protected health information?

Individually identifiable health information that, except as otherwise provided, is transmitted by electronic media, maintained in any medium set forth in the definition of "electronic media" in the federal health insurance portability and accountability act or transmitted or maintained in any other form of medium.

What is a vaccination information statement?

Information about the vaccination that should be given to patient

What if the information on the DEA form is incorrect?

Information cannot be altered or changed by the registrant. The registrant must report any errors to the local division office or the registration section of the administration to modify the registration

What are exceptions of unit of use requirements?

Injectable medications stored in their original multi-dose vial (e.g., insulin, heparin) where the medication may be withdrawn into a syringe or other delivery device for single patient use; or Over-the-Counter (OTC) products stored in their original multi-dose container (e.g., antacids, analgesics) where the medication may be withdrawn and placed into an appropriate container for single patient use. For medication removed from the system for on-site patient administration

When can inspectors come into pharmacy and what kind of information can they seek?

Inspectors have broad powers to inspect pharmacists and pharmacies in order to ensure compliance with the PPA and rules. They can enter pharmacies during regular business hours, and can seek any information that has anything to do with the practice of pharmacy including prescriptions, invoices, various forms (including federal forms), licenses, applications, etc.; any record a pharmacy is required to maintain. They seek record retention, unlicensed practice, violations, civil penalties

What are violations of the regulation?

Intentionally destroying unfilled lawful prescriptions; Refusing To Return Unfilled Lawful Prescriptions;Violating A Patient's Privacy; Discriminating against patients or their agents in a manner prohibited by State or federal laws; Intimidating or harassing a patient; or Failing to comply with the requirements of this Section.

What does drug product selection mean?

Interchange for a prescribed pharmaceutical product

Who can prescribe under hospital DEA numbers?

Interns, residents, and foreign-trained physicians may dispense, administer and prescribe controlled substances under the registration of the hospital or other institution, provided that it is under scope of practice and designates a specific internal code number for each such prescriber

What are exceptions to wholesale distributions?

Intracompany sales The purchase from yourself The purchase by a charitable organization Under common control, means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise. Emergency medical reasons ie transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, If you have a prescription Drug samples The sale, purchase, or trade of blood and blood components intended for transfusion.

If prescriber is a MLP, but the DEA number that starts with an A, B, F or G, what does that make the DEA number and RX?

Invalid

What is an OTC monograph?

Is developed for therapeutic classes of ingredients that are generally recognized as safe and effective (also referred to as "GRAS/E" No FDA approval needed by manufacture to market a product continuing an ingredient covered under an OTC monograph.

What is a pharmacy as detox compounder?

It compounds a controlled substance product for sale or distribution to a narcotic treatment program for purposes of addiction treatment. Note that the NTP must be registered with DEA.Do not confuse registration requirement for detox compounders with office use compounders!

Is it appropriate to reopen a pharmacy after hours to fill a prescription?

It depends on who is "reopening" the pharmacy. If the pharmacist comes back and re-opens that is no problem at all. If it is a tech or an unlicensed person, that is prohibited. A Tech CAN re-enter the pharmacy even if it is closed, but cannot fill a prescription or even dispense a previously filled prescription in the absence of a pharmacist. It also depends on the condition of the pharmacist. Was he out drinking? Did he have one drink before he was called to re-open the pharmacy? If so, the best answer would be that the pharmacist cannot re-enter the pharmacy to refill the prescription.

Can a pharmacist refill a prescription after the prescribing practitioner dies, retires, or relocates?

It is also generally understood that the patient is under the practitioner's professional care during the life of that prescription, including the number of authorized refills.The DFPR recommends that when a pharmacist becomes aware of this type of situation, he or she should counsel and inform the patient of the need to retain a new practitioner as soon as possible. A good option might be to refill the first time, and counsel the patient it is important to find a new physician.

Do pharmacists have to put the iron warning label on prescription labels?

It is not clear whether pharmacists are required to place this warning on prescription labels of the products they dispense, or whether it applies only to the original product manufacturer.

Is the CSOS system required?

It is optional, but offers many efficiencies that encourage the use of electronic ordering to replace the paper 222 forms

Who is responsible for determining at the retail level whether a prescription drug must be packaged in accordance with PPPA standards?

It is the responsibility of the dispensing pharmacist. Unless a prescription drug is expressly exempted from the regulations, or the customer or prescribing physician request noncomplying packaging, the drug must be dispensed in a special package.

If a pharmacy chooses to add sterile compounding to the services, what must happen?

It must be inspected by, and the compounding area must be approved by the department

What is the new provision of technician training beginning January 1, 2022?

It shall also be the joint responsibility of a pharmacy and its pharmacist in charge to ensure that all new pharmacy technicians are educated and trained using a standard nationally accredited education and training program, such as those accredited by the Accreditation Council for Pharmacy Education (ACPE)/the American Society of Health-System Pharmacists (ASHP) or other board approved education and training programs. Within 2 years of initial licensure as a pharmacy technician and within 6 months before beginning any new duties and responsibilities of a pharmacy technician, it shall be the joint responsibility of the pharmacy and the pharmacist in charge to train the pharmacy technician o All pharmacies shall maintain an up-to-date training program policies and procedures manual describing the duties and responsibilities of a pharmacy technician and registered certified pharmacy technician. o All pharmacies shall create and maintain retrievable records of training or proof of training as required in this Section.

What is the drug addiction treatment act?

It waived the requirement for a separate DEA registration as a opioid treatment program for practitioners who dispense or prescribe FDA- approved Schedules III-V narcotic controlled substances for use in maintenance or detoxification treatment.

If a Pharmacy compounds a certain amount of Prescriptions per month, is there a maximum amount it can compound in anticipation for the next month? Or do they just compound an anticipation of that amount?

Just compound in anticipation of receiving prescriptions, based on historical number of prescriptions received for that product.

What are emergency kits?

Kits containing those drugs which may be required to meet the immediate therapeutic needs of the patient, and which are not available from any other source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining the drugs from the other source, may be utilized.

What is misbranding?

Labeling is false or misleading in any particular, if in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; also, if any word, statement, or other information is not prominently placed on the label, with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use

What can licensed pharmacy preparing parenteral products have?

Laminar airflow hood workstation certified annually with replaced/cleaned prefilters monthly A sink Disposal containers Biohazard cabinetry Refrigerator and/or Freezer with termometer Temperature controlled container for off site deliveries

What equipment can a nuclear pharmacy have?

Laminar flow hood; Fume hood - minimum of 30 inches in height, which shall be vented through a filter with a direct outlet to the outside; Dose calibrator; Refrigerator; Class A prescription balance or a balance of greater sensitivity; Single-channel or multi-channel gamma scintillation counter; Microscope; Low level, thin-window portable radiation survey meter; Drawing station - lead glass and lead lined; Syringe shields; and Energy Compensated Geiger Mueller (GM) Probe or ion chamber.

Is a pet owner's name required to be on a prescription for a pet in addition to the pet's name? And, if so, do you think this refers to placing an owner's full name like TOM SMITH along with his dog's name FIDO SMITH on the Rx?? or is it sufficient just to add the owner's last name of SMITH to the pet's first name??

Last name is sufficient - "Fido Smith". For controlled substances, the Rx requires the full name and address of the animal owner, as well as the species or common name of the animal being treated.

What are the requirements to be a nuclear pharmacist?

Licensed as a pharmacist in IL Authorized user or under supervision of a pharmacist

What are the pharmacy requirements?

Licensed pharmacist must be on duty whenever they pharmacy is open to the public License or registration must be conspicuously displayed Must have adequate security, as defined by rule

What does a pharmacist in charge mean?

Licensed pharmacist whose name appears on a pharmacy license who is responsible for all aspects of the operation related to the practice of pharmacy.

What is the limit on DEA 222 forms?

Limit based on business activity of the registrant will be imposed on the number of DEA forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown

What are the refill limitations for CIII- CV?

Limited to five (5) refills in six (6) months.

What are transfer requirements for controlled substance prescriptions?

Limited to one time transfer. Under federal law, a transfer of a CS RX can occur only for purposes of refills. An original RX cannot be transferred.

What is a home pharmacy?

Location of a pharmacy's primary operations.

What are examples of physical safeguards?

Locked drawers and doors, alarms, identification badges

Under IL law, when are oral prescriptions permitted for CII prescriptions?

Loss of life or intense suffering.

What are the grounds for discipline by the DPR?

Lying, stealing, cheating, and illness (read all causes on page 80)

How are DEA 222 forms issued?

Mail with predetermined number of forms based on business activity

Under federal law, what are the reporting requirements for exempt narcotics?

Maintain records for 2 years

What is the state and federal controlled substances act regulate?

Manufacture, distribution, dispensinsing and delivery of controlled substances

What does FDA regulate?

Manufacturers of food, drugs and cosmetics

What are online pharmacy registration exemptions?

Manufacturers or distributors, non-pharamcy practitioners, any hospital or medical facility that is operated by an agency of the US, health care facility owned or operated by an indian tribe, mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance, A person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States, pharmacy registered whose dispensing of controlled substance via the internet consists of refilling a controlled substance or filling new prescriptions, pharmacy who delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a Long Term Care Facility when the registration of the automated dispensing system is held by that pharmacy

Does GMP apply to manufacturing or compounding?

Manufacturing. However, where pharmacists crosses line between compounding and manufacturing, FDA can apply GMPs to compounded products along with other FDCA requirements

When do nonresident special pharmacy registration expires?

March 31 of each even numbered year

When does every license issued under the pharmacy practice act expires?

March 31 of each even numbered year

When do licenses issued under the pharmacy practice act expire?

March 31 of each even numbered year (except the certificate of registration as a pharmacy technician which expires annually)

When do Illinois CS registration expire?

March 31 on even years

Under Illinois law, what are the refills if rx on exempt narcotics?

Max of 5 refills or 6 months, whichever comes first

What are the refill requirements of control 3-5 drugs?

May be refilled. Federal and state law limit refills of C-III and C-IV prescriptions to five refills and six months from date of issuance.

What do pharmacy technicians, students, and other support staff do while the pharmacist is on break?

May continue to perform duties. cannot do any duties that require professional judgement of a pharmacist

What are biologic products?

Means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. These have a large, complex molecular structure, and are difficult to produce or replicate.

What is Illinois/federal good faith standard?

Means the dispensing of CS pursuant to a prescription which in pharmacist's professional judgment is lawful. In making the judgment, pharmacist shall rely on accepted professional standards including: o lack of consistency of doctor-patient relationship o frequency of prescriptions for same drug by one prescriber for a large number of patients o quantities beyond those normally prescribed o unusual dosages o unusual geographic distances between patient, pharmacist and prescriber o consistent prescribing of habit forming drugs.

What is an automated pharmacy system?

Mechanical system located within the confines of the pharmacy or remote location that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information.

What are exceptions for medications or devices that were removed that cannot be reused or reissued?

Medical devices which can be properly sanitized prior to reuse or reissue; and Medication that is dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current U.S.P./National Formulary, or by the U.S.P. Conventions, Inc.

What is alcohol purchased on ATF-11 and ATF-1447 limited to?

Medicinal or scientific use, or in patient treatment

How often does the BOP meet?

Meets quarterly with annual meeting in January of each year

What are examples of narcotic treatment programs?

Methadone Levo-alpha-acetyl-methadol (LAAM) Programs engaged in the maintenance and detoxification treatment with narcotics

What does M stand for in the first letter of the DEA number?

Mid-level practioner • Nurse practitioners • Physician assistants • Optometrists • Pharmacists • Chiropractic, naturopaths • Psychologists

Misbranded or adulterated: Drug manufacturer and repackagers fail to register with FDA

Misbranded

Misbranded or adulterated: If the dispensed product is NOT supported by a valid prescription, and the container is labeled as if dispensed pursuant to a prescription

Misbranded

Misbranded or adulterated: if any word, statement or other information required by law to be on the label or labeling is not prominent, conspicuous and readable

Misbranded

Misbranded or adulterated: if either established name or, for multi-ingredient products, each active ingredient, is not identified on label

Misbranded

Misbranded or adulterated: if it fails to contain "adequate directions for use" and adequate warnings, unless exempt, or fails to contain information required by NDA

Misbranded

Misbranded or adulterated: if it has a misleading container, imitates another drug, or is offered for sale under the same of another drug

Misbranded

Misbranded or adulterated: if it's labeling is false or misleading in any particular

Misbranded

Misbranded or adulterated: if its packaging fails to identify the name and address of the manufacturer, packager or distributor, and quantity of drug

Misbranded

Misbranded or adulterated: if the drug contains any quantity of a habit forming substance, and the labeling fails to identify the name and proportion of the substance and in juxtaposition thereto the phrase "Warning - May be habit forming"

Misbranded

Misbranded or adulterated: if the drug is liable to deterioration, and labeling does not contain warnings to that effect

Misbranded

Misbranded or adulterated: if the product is dispensed pursuant to a valid prescription, but is dispensed without the proper RX label

Misbranded

Misbranded or adulterated: the dosage, frequency, duration or route of administration suggested in the labeling is dangerous

Misbranded

Misbranding or adulterated: failure to provide required warnings in OTC products containing salicylates

Misbranded

Misbranded or adulterated: when a pharmacist misfills a prescription

Misbranded- the product that is dispensed is not supported by a valid prescription or authorized refill, therefore there is no RX to support the dispensing, and the drug is being sold without a valid prescription.

Misbranded or adulterated: when a pharmacist dispenses without a RX or authorized refill

Misbranded- there is no RX to support the dispensing, and the drug is being sold without a valid prescription.

Misbranding or adulteration: prescription medication is dispensed without a valid prescription or authorized refill

Misbranding

What are examples of remuneration?

Money, gifts, anything of value - in exchange for a referral. Giving doctors a free PDA for e-prescribing in exchange for an agreement that he will send the prescriptions to your pharmacy is an example. Providing a doctor free office space in your building, next to your pharmacy, in exchange for his agreement to send patients to you, is another.

When do LTC pharmacies transmit patient medication profiles to the PMP?

Monthly or more frequency

How much elemental iron must be packaged in child-resistant packaging?

More than 250 mg of elemental iron

What must occur when transfering from and out of state pharmacy?

Must advise patient and notify the other pharmacy that the prescription must be cancelled before it can be filled or refilled

What are the sales restrictions for PSE and EPH products?

Must be 18 years old Products must be in blister packs (no more than 2 dosage units per blister) or in unit dose packets, no more than 3000 mg of drug Must be distributed by pharmacist or technician in pharmacy Non-pharmacy retailers may sell convenience packages only.

What are the product placement requirements on PSE and EPH products?

Must be behind counter, and convenience packages must be locked up

What are the pharmacy computer regulations?

Must be confidential Require transmission of electronic prescriptions from prescriber to pharmacist

What are requirements to complete in order to be an APRN with full practice authority?

Must be licensed and certified as a nurse practitioner, clinical nurse specialist, or nurse midwife, and complete 250 hours of CE and 4,000 hours of clinical experience.

Who must sign the DEA form 222?

Must be signed by original DEA registrant or person given power of attorney to order. Power of Attorney is given by the DEA registrant. For example, the pharmacist-in-charge may be given power of attorney for a particular store by a corporate chain.

When should inventory be taken place?

Must be stated whether it was taken at opening or close of business

What are the labeling requirements on OTC products containing salicylates?

Must conspicuously bear, on a clearly contrasting background, the warning statement: "Keep out of reach of children [highlighted in bold type]. In case of overdose, get medical help or contact a Poison Control Center right away".

What are the record keeping requirements for onsite institutional pharmacy services?

Must have unique identifier Name and dosage form of the drug The date of filling or refilling Quantity dispensed Label affixed to the drug container indicating pharmacist initial who approved dispensing No prescriptions may be dispensed for a period in excess of one year from the date of the original issuance of the prescription

What must be included in records regarding administration of vaccinations?

Must include Name, address, and DOB Date of administration and site of injection of vaccination Name, dose, manufacturer, lot number, and beyond use date Name and address of patient's primary health care provider named by the patient The name or unique identifier of the administering pharmacist Which VIS was provided

What are prescriptive authority for clinical psychologists?

Must maintain a written collaborative agreement with a collaborating physician. The delegation of prescriptive authority under the collaborative agreement may only include medications for the treatment of mental health disease or illness the collaborating physician generally provides to his or her patients in the normal course of his or her clinical practice with the exception of the following: (1) patients who are less than 17 years of age or over 65 years of age; (2) patients during pregnancy; (3) patients with serious medical conditions, such as heart disease, cancer, stroke, or seizures, and with developmental disabilities and intellectual disabilities; and (4) prescriptive authority for benzodiazepines that are Schedule III controlled substances.

What must be obtained for APRN in order to prescribe controlled substances?

Must obtain a mid-level practitioner controlled substance license the APRN must provide evidence of satisfactory completion of at least 45 graduate contact hours in pharmacology for any new license issued with Schedule II authority after the effective date of this amendatory Act the APRN must annually complete 5 hours of continuing education in pharmacology

What must a PA obtain before they can prescribe scheduled CS?

Must obtain mid-level practitioner controlled substances license

Under federal law, what identification is required for exempt narcotics?

Must provide 1 valid ID

Assume the doctor gives the patient 3 prescriptions at the same appointment dated 5/20, 6/20, and 7/20. On 5/21, the patient asks the pharmacist to fill the first RX, and to hold the other 2 for a later fill. Is this legal?

NO! Post-dating a prescription is NOT permitted. The date of issuance must reflect the date the patient is seen and/or the prescription is written.

What are the requirements for a prescription label?

Name and address of dispenser (pharmacy) Serial number of prescription Date of RX or date of filling Name of the prescriber Name of the patient, if stated on the prescription Directions for use, including precautions, if any, as indicated prescription ILLINOIS ALSO REQUIRES DRUG NAME TO APPEAR

What should be included in documentation of automated dispensing and storage systems?

Name and address of the pharmacy or facility where the automated dispensing and storage system is operational Manufacturer's name and model Quality assurance policy and procedures to determine continued appropriate use and performance of the automated device Policy and procedures

What are the labeling requirements for investigational new drugs?

Name of drug and strength Beyond use date Reference code to identify source and lot number A label indicating "for investigational use only" Name and location of patient

What are included in the record keeping for dispensing of orders for offsite institutional pharmacy services?

Name of resident Date of order; Name, strength and dosage form of drug, or description of the medical device ordered; Quantity dispensed (a separate record should be maintained when the quantity billed differs from the quantity dispensed, e.g., unit dose transfer systems); Directions for use; Quantity billed; Prescriber's name; Prescriber's signature and/or DEA number when required for controlled substances; and The drug name and identification code or the manufacturer in case of a generically ordered medication or a generic interchange.

What are the labeling requirements for medications dispensed to a specific resident or patient via unit dose for offsite institutional pharmacy services?

Name of the resident Resident's room and bed number Date of order Name, strength, and dosage form of drug, or description of the medical device ordered Directions for use Prescriber's name

What are the labeling requirements for medications prepared for immediate use for offsite institutional pharmacy services?

Name of the resident Resident's room and bed number Dispensing date Name, strength, and dosage form of drug, or description of the medical device ordered Quantity dispensed Directions for use Prescriber's name Beyond use date if less than 60 days from date of dispensing

What are the labeling requirements for pharmacies Pharmacies Preparing Sterile Parenteral Products?

Name, address, and telephone number of the licensed pharmacy, if not within facility, Administration date and identifying number if used on site, date dispensed and identifying number if used off site Patient's full name and room number, if applicable Name of drug, strength, and amount Directions for use and/or infusion rate if used off site Prescriber's full last name if used off premises Required controlled substances transfer warnings, when applicable Beyond use date and time Identify of pharmacist compounding and dispensing, or other authorized individual Auxiliary labels and storage requirements

What are the labeling requirements for offsite institutional pharmacy services?

Name, concentration and volume of the base parenteral solution Name and strength of drugs added Beyond use date and date of admixture. Beyond use date Reference code to identify source and lot number of drugs added

What are labeling requirements for medication for future use- parenteral solutions to which drugs or diluents are added?

Name, concentration and volume of the base parenteral solution; Name and strength of drugs added; Beyond use date and date of admixture. Beyond use date, unless otherwise specified in the individual compendia monograph shall be not later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and Reference code to identify source and lot number of drugs added.

What are the labeling requirements single dose or multi dose drugs that are for immediate use at an onsite institutional pharmacy service?

Name, concentration and volume of the base sterile solution Name and strength of drugs added Beyond use date and time of admixture

What is composed of the board of pharmacy?

Nine members: seven licensed pharmacists, two non-pharmacist public members

Are CIIs refillable?

No

Are NDC numbers required to appear on prescription labels?

No

Are automated dispensing and storage systems used for direct patient access to prescription medications?

No

Are partial fills counted as full refills?

No

Can a person who holds an active IL pharmacist license also hold an active IL certified pharmacy technician registration?

No

Can a pharmacist whose license has been denied, revoked, suspended or restricted for disciplinary purposes be eligible to be registered as a certified pharmacy technician?

No

Can occupational therapists prescribe in IL?

No

Can physical therapists prescribe in IL?

No

Can prescribers request that the name be omitted from label?

No

Can registered nurses prescribe in IL?

No

Can tax free alcohol be sold to other pharmacies or physician offices?

No

Can the DPR and Board impose greater requirements on either common electronic files or a hard copy system?

No

Can unlicensed person make the offer to counsel?

No

Do foreign graduates have to be required to become certified pharmacy technicians while completing their board approved clinical training?

No

Do practitioners have to change their DEA number if their last name changes?

No

Do residents or other physicians operating under a hospital's DEA registration have any limitations on prescriptive authority?

No

Does Illinois law permit pre-printed prescriptions?

No

Does Illinois require a beyond use date, discard after, or expiration date?

No

Does law enforcement agencies need DEA registration to take back controlled substances?

No

Does the department attorney have to be a pharmacist?

No

Does the inventory record have to be sent to the DEA?

No

Does the pharmacy have to close when the pharmacist is on break?

No

If a medication is considered a control in the state i.e. PSE, should you report it to the DEA with DEA form 106?

No

Is a change of ownership of a parent company that owns a pharmacy considered a change of ownership of the pharmacy?

No

Is alcohol a controlled substance?

No

Is maintenance of a person's addiction a legitimate purpose for a controlled rx?

No

Is patient consent required for drug interchange?

No

Is the physical delivery of a drug or medical device to a patient or patient's representative by a pharmacist's designee within a pharmacy or drugstore while the pharmacist is on duty and the pharmacy is open considered dispensing?

No

Is the physical delivery to a patient or a patient's representative in a home or institution by a designee of a pharmacist or by common carrier considered dispensing?

No

Is there record keeping requirements for sale of a syringe or needle?

No

Under IL law, Is self-prescribing controls allowed?

No

Under federal law, is there a limit as to the amount of CS a practitioner can legitimately prescribe?

No

What happens if investigation finds no theft or loss in controlled substances?

No DEA Form-106 need be filed. However, the registrant should notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA Form-106 was filed regarding the incident.

Who gets what copy of the DEA 222 form: A veterinarian purchases a bottle of Ketamine from a pharmacy?

No DEA form 222 required, because ketamine is not a CII

What is a pregnancy category b drug?

No adequate, well controlled studies have been conducted in pregnant women, but animal reproduction studies have failed to demonstrate a risk to the fetus.

Can inspectors have the right, without a subpoena, obtain reports, medication error reports?

No because pharmacies maintain those types of records voluntarily. The Department disagrees with this view, however. On the exam, if that type of question is asked, you can assume that since an inspector can investigate incompetence, and an error report may be evidence of incompetence, it can be reviewed by an inspector.

Are "will call" drugs counted in inventory?

No because those drugs are no longer in your inventory

What does a BO rating mean in the orange book?

No equivalent

Are computer generated or printed prescription forms pre-printed?

No if they are not prepared in advance of the time the patient is seen by the pracioner

When is a zero report submitted?

No later than the next business day

When a pharmacy intends on changing or adding to the type of pharmacy services it offers, when should the division be notified?

No less than 30 days prior to the change or addition

What is the limit of orders from CSOS?

No limit (paper form limited 10)

Can residents prescribe CIIs?

No limitations

Under federal law, what are the refills if rx on exempt narcotics?

No max time limit or refills

What is the minimum requirement of hour of operation for community pharmacy?

No minimum

What are the sale limits for PSE and EPH?

No more than 7500 mg of EPH or PSE within any 30 day period No more than one convenience package within a 24 hour period No more than two packages of products containing PSE or EPH (including convenience packages) per transaction

Under federal law, what are the possession limits on exempt narcotics?

No ruling

How do you order CIII-V substances?

No special form required. Must maintain all records in "readily retrievable" form, so that inspection can be accomplished efficiently.

Under federal law, what is the time limit for filling CII prescriptions?

No time limit

Is patient counseling required for onsite or offsite institutional pharmacy?

No unless drugs are dispensed by the pharmacy upon a patient's discharge from the institution

Can pharmacies compound for office use?

No unless they have a patient specific prescription, and are simply delivering a patient specific compound product to the doctor's office or are engaged in "anticipatory compounding" and delivering the product to the office prior to, but anticipation of, receiving a patient specific prescription OR pharmacy registered with FDA as outsourcing facility

Is there a particular method of destruction?

No, as long as they are "non-retrievable". This allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances

Are pentazocine combination products (i.e. pentazocine + APAP) also considered schedule II medications in Illinois?

No, combination products are considered schedule III medication

Is compounding of a product for OTC sales permitted?

No, it is considered manufacturing

Is review of PMP each time a CS is prescribed or dispensed required?

No, just reporting to PMP is mandatory

Does the hospital pharmacy need a separate registration from the hospital?

No, pharmacy is permitted to use the institutional dispenser registration issued to hospital.

Our local hospital sometimes calls upon my pharmacy to provide drugs for patient use within the hospital. Must these drugs be dispensed in special packaging?

No, provided they are to be used for institutionalized patients. The test is whether the package is likely to enter a home.

Are auto-refill programs automatically enrolled in prescriptions?

No, the patient has to enroll and have a refill on file to be eligible

The FDA requires tamper-evident packaging for over-the-counter drugs. Does this replace the requirement for special packaging?

No, the two systems are independent of one another. Although there are some special packages which are also tamper- evident (blisters, unit-of-use), a tamper- evident package is not necessarily child- resistant. The FDA requires that evidence of tampering be visually determined on initial contact. Special packages must meet specific performance standards. These include maintaining their child- resistance for the number of openings and closings customary for the life of the product.

My pharmacy provides drugs to a nursing home. Must these drugs be dispensed in special packaging?

No, traditional nursing homes where the nursing home staff administers doses to residents are considered to be institutions. This would not be true of senior citizen apartment complexes or assisted living facilities where residents store their drugs in their households. The test is whether the package is likely to enter a home.

Is the sale of compounded drugs to other pharmacies not under common ownership, or to clinics hospitals, or manufacturers allowed?

No, unless sales provided by pharmacies contracted to provide centralized prescription filling services, including compounding in anticipation of receiving a prescription or order based on routine, readily observed dispensing patterns

What happens if the patient no longer needs the controlled substance medication- can it be returned to the pharmacy?

No, when it is dispensed to the patient, it leaves the closed distribution network. It cannot re-enter that closed network

Can pharmacists prescribe in IL?

No, with exception of standing orders

Does being a board member grant you immunity?

No- Members of the Board shall have no liability in any action based upon any disciplinary proceedings or other activity performed in good faith as a member of the Board. The Attorney General shall defend all such actions unless he or she determines either that there would be a conflict of interest in such representation or that the actions complained of were not in good faith or were willful and wanton.

Can psychologists prescribe in IL?

No- except certain clinical psycholigists

Can a pharmacy be licensed if a PIC is not named?

No- identity of PIC is indicated on face of pharmacy

Can prescription copies be filled?

No- must stamp "for informational purposes only"

Can a State or other political subdivision establish packaging regulations that are less stringent than those promulgated by the CPSC?

No.

Does the HIPAA Privacy Rule restrict pharmacists from giving advice about over-the-counter medicines to customers?

No. A pharmacist may provide advice to customers about over-the-counter medicines. The Privacy Rule permits a covered entity to disclose protected health information about an individual to the individual.

Can an individual return their controlled substance prescription medication to a pharmacy?

No. An individual patient may not return their unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return their controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e. individual patient). The CFR does have a provision for an individual to return their unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred.An individual may dispose of their own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.

Can pharmacists or technicians act as an agent of a practitioner?

No. DEA takes the view that a pharmacy cannot provide in whole, or in part, pre-populated information on a document and have that document then become the prescription.

Can a practitioner outside a narcotic treatment program prescribe methadone or any other narcotic medication solely for the treatment of a patient's narcotic addiction?

No. Individual must receive the narcotics at a registered narcotic treatment program

If a practitioner orders a controlled substance for office administration by issuing a patient specific prescription, does the pharmacy need multiple registration?

No. Pharmacy is acting as a dispenser when it fills that order so all that is required is a dispenser registration

Can a doctor write prescriptions (controlled and non-controlled) for himself or his family members?

No. Self-Prescribing or Self-Dispensing of controlled substances is no longer permitted. Also, a practitioner may not prescribe controlled substances to an immediate family member unless there is a bona fide practitioner-patient relationship and appropriate records are maintained

If the pharmacist is aware that one of his/her customers prefers conventional packaging for his/her prescriptions, can the pharmacist make this decision without the customer's specific request?

No. The pharmacist may advise the customer that he/she has the option of having the prescription dispensed in noncomplying packaging, but the choice must be that of the customer.

Does the regulatory reference to "dosage forms intended for oral administration" include drugs intended for topical application to the teeth or mouth, or in a dosage form intended for inhalation?

No. The regulations intend "oral administration" to pertain to drugs that are taken by mouth for a systemic and not local effect. Sublingual preparations are considered "orally administered" even though they are not swallowed. Their effect is systemic and not local to the mouth. Because of the need for quick access to the drug, sublingual nitroglycerin was excluded from the oral prescription drug regulation when it was adopted in 1973.

Can a long term care facility return a resident's unused controlled substance medication to a pharmacy?

No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., resident of a LTCF). Most long term care facilities are not licensed by their respective state to handle controlled substances and therefore are not registered with DEA. Long term care facilities act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.

Can a State or other political subdivision establish packaging regulations that are more stringent than those promulgated by the CPSC?

No. With certain narrow exceptions, they must be identical. However, a State may require child-resistant packaging of a substance not regulated by CPSC.

What are requirements of faxes of a electronically transmitted prescription?

Non-fading and remain legible

Do new pharmacies have to inventory new stock?

Not required. Required copies of invoices and DEA 222 will suffice

What schedule is ephedrine under federal law?

Not scheduled

What schedule is pseudoephedrine under federal law?

Not scheduled

How soon do you have to document medication therapy management services?

Not to exceed 48 hours

If the prescription is printed in advanced, can it be filled?

Not until verfied

What is the law for prescription pick up and drop off?

Nothing contained in this Act shall prohibit a pharmacist or pharmacy, by means of its employee or by use of a common carrier or the U.S. mail, at the request of the patient, from picking up prescription orders from the prescriber or delivering prescription drugs to the patient or the patient's agent at the residence or place of employment of the person for whom the prescription was issued or at the hospital or medical care facility in which the patient is confined. Conversely, the patient or patient's agent may drop off prescriptions at a designated area.

What are the physical requirements of a pharmacy?

Notification shall be submitted to the division that an existing pharmacy prior to remodeling All dispensing and drug storage areas of the pharmacy must be contiguous The pharmacy area and all store rooms shall be well-lighted and properly ventilated Refrigerators exclusive use of prescription drugs Pharmacy are shall not be used for storage of merchandise that interferes with the practice of pharmacy Suitable current reference sources either in books or electronic data form i.e. facts and comparisons, etc. Telephone shall be immediately accessible in the pharmacy area

What must be notified to the DPR when pharmacy ceases operations?

Notify DPR and forward to DPR a copy of the closing inventory of controlled drugs and a statement concerning intended manner of disposition of all legend drugs and prescription files

What should you do if any unused DEA form 222 reported stolen or lost is subsequently recovered or found?

Notify SAIC of DEA

How do you cancel or void a DEA 222?

Notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing "canceled" in the space provided for the number of items shipped.

What is pharmacy shopping?

Obtain a controlled substance from a pharmacy while being supplied with any controlled substance by another pharmacy w/o disclosing the fact of the existing controlled substance to the pharmacy from which the subsequent controlled substance is obtained.

What are patient profiles/patient drug therapy records?

Obtaining, recording, and maintenance of patient prescription information, including prescriptions for controlled substances, and personal information.

Where is documentation as to type of equipment, serial numbers, content, policies and procedures and locations be maintained?

On site in the pharmacy for review by the DPR

What must be done in addition notifying the division within 30 days of the departing PIC?

On the effect date of the change, inventory all CII by actual physical count and other scheduled drugs by estimated count

Can drugs be returned or exchanged?

Once a dispensed drug is removed from premises ya patient or the patient's agent,that drug shall not be accepted for return or exchange by a pharmacy or pharmacist. Does not apply to drugs returned for purposes of destruction. The returned drugs must be stored separately from the pharmacy's active stock.

Does IL require certain CEs for pharmacists?

One hour of sexual harassment prevention training

What does each form consist of?

One single sheet

What are the audit requirements for CSOS software?

One-time, independent, third-party audit of any vendor's software for CSOS purchaser or supplier functions to certify that it performs the necessary PKI functions. McFaul said the agency would not routinely be checking purchasers' and suppliers' systems, but that it might check a system if a concern exists about it.

Under Illinois law, who can sell exempt narcotics?

Only a pharmacist can "sell" an exempt narcotic. This means a pharmacist must complete the log book, verify the age of the seller, etc. After that part of the transaction is complete, however, anyone can ring up the sale.

Who can transfer a controlled substance rx?

Only a pharmacist may transfer a CS rx, even if transfer is done electronically. For all other prescriptions, an electronic transfer is not considered to be a transfer.

What is prescriptive authority for optometrist for Schedule III-V controlled substances?

Only analgesic agents in a quantity sufficient to provide treatment for up to 72 hours

When can drugs be dispensed from the emergency room?

Only by a practitioner licensed to prescribe and dispense, only to patients treated in the institution and only during hours in which outpatient institutional pharmacy services are not available.

Who can take out drugs from emergency kits?

Only by authorized pharmacy personnel, persons authorized to administer medication pursuant to a valid physician's order or a physician licensed to practice medicine in all of its branches in Illinois.

What prescriptions are allowed at remote consultation sites?

Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are allowed at these sites. The home pharmacy fills the RX, and delivers it to the Remote Consultation Site, where the drug is stored and later given to the patient.

Can a sterile compounded drug be delivered to the prescribing practitioner's office for administration?

Only if pursuant to a valid patient-specific prescription

Can a practitioner who is not part of a narcotic treatment program administer narcotic substances to an addicted individual to relieve individual's acute withdrawal symptoms?

Only if you make arrangements to refer the individual to a narcotic treatment program

When can oral pharmaceutical agents be prescribed to children under 5 years of age?

Only in consultation with a physician licensed to practice medicine in all its branches

Who can conduct drug utilization evaluations or review and validation within the remote pharmacy?

Only licensed pharmacists at the pharmacy providing remote pharmacy services

Who can be considered as an authorized collector?

Only manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies

Who has access for removal of prescription medications for patient use?

Only persons properly licensed under Illinois laws who have authority to administer medications or persons working under the direct supervision of those individuals

What prescriptions can be dispensed while the pharmacist is on break?

Only prescriptions that have received final verification by a pharmacist may be dispensed while the pharmacist is on break

Who has has to be licensed in IL if the pharmacists providing remote prescription/medication order processing for a community pharmacy licensed in IL from a community pharmacy licensed in IL but located out of state?

Only the PIC of the remote pharmacy must be licensed in IL

Who has access to prescription drugs after the closing date?

Only the pharmacist-in-charge, or other designated pharmacist, of the pharmacy discontinuing business shall have access to the prescription drugs until those drugs are transferred to the new owner or other purchaser or are properly destroyed.

When can a patient med pack be accepted for returns and re-dispensed?

Only when a medication must be added or removed, or when drug therapy is discontinued. Med paks returned to the pharmacy can only be re-dispensed for the same patient. Medications removed from the med pak shall not be reused and must be disposed of properly. The revised med pak shall be given a new serial number.

Where is the POA maintained?

Onsite at the registered location with DEA Forms 222

If you have employees and discharge patients, what labeling requirements should you follow?

Onsite pharmacy

What are the criteria for formulary inclusion?

Orange book or department of public health notification list All products must have an approved NDA or ANDA All products must be manufactured under cGMPs All products must meet FDA bio equivalent requirements Products found to be ineffective in FDA's DESI review, but not yet removed from market, are excluded

What will DEA forms contain?

Order form number and be issued with the name, address and registration number of the registrant, the authorized activity, and schedules of the registrant.

Who receives the copy of IL CII duplicate order?

Ordering registrant

What is the general rule for transmitting CII prescriptions to pharmacy?

Original written and hand signed prescription is required (no fax or telephone prescriptions permitted). Electronic prescriptions that comply with federal DEA requirements are also permitted

What is off-site for an onsite institutional pharamcy?

Outside the institution within which the pharmacy is located

What is "off-site"?

Outside the licensed premises of a pharmacy

What is remote prescription processing?

Outsourcing of certain prescription functions to another pharmacy or licensed non-resident pharmacy, including the dispensing of drugs.

Who must notify DPR of the new PIC?

Owner of the pharmacy

Whose responsibility is it to notify the department and arrange the inspection?

PIC

Whose responsibility is it to ensure that all pharmacy staff are adequately trained?

PIC- make sure documentation of this training is maintained by the pharmacy at all times

What is tamper-resistant packaging?

Package that has "an indicator or barrier to entry, which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." i.e. blister packs, film wrappers, aerosol containers, tape seals, break away caps, and foil paper or plastic pouches

What are requirements for partial dispensing of CII in a LTCF and terminally ill patients?

Partial quantities may be dispensed at any time Pharmacist must write "long term care patient" or "terminally ill" on prescription For each partial fill, the date, quantity dispensed, and quantity remaining, and identification of pharmacist, shall be recorded on back of RX, or another appropriate record, uniformly maintained and readily retrievable. If procedure is followed, prescription shall be valid for 60 days.

What are requirements to fill a prescription which is on file at another location?

Patient is advised that prescription on file at other store has been canceled; Pharmacist determines that prescription is valid and refillable; Transferor pharmacy is notified that the prescription must be canceled; Record in writing the prescription order, the name of the transferor pharmacy, prescription number, drug name and original amount dispensed, date of issuance, and number of refills remaining. Consent of prescriber should be obtained if necessary in the professional judgment of the pharmacist. Interference with professional judgment of pharmacist by other pharmacist, his agents, or employees shall be grounds for revocation or suspension of pharmacy license.

What is the distribution requirements of PPI of OC in acute care hospitals and long-term care facilities?

Patient package inserts for oral contraceptives dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first oral contraceptive and every 30 days thereafter, as long as the therapy continues.

What information should be included in the records of Pharmacies Preparing Sterile Parenteral Products?

Patient profile Medication record system Purchase records Lot numbers of the components used in compounding sterile prescriptions/orders traceable to a specific patient, if not included on patient profile and if the product is not utilized within 48 hours of preparation.

What are the requirements for patient profile or medication record system for Pharmacies Preparing Sterile Parenteral Products?

Patient's full name, date of birth or age, Sex Sterile products dispensed Date dispensed, if off site Drug content and quantity Patient directions, if preparation being administered off site Identifying number Identification of dispensing pharmacist and, if applicable, pharmacy technician Other drugs or supplements the patient is receiving, if provided Known drug sensitivities and allergies to drugs and foods Diagnosis Lot number of components or individual medicine if product is not used within 48 hours of preparation

What changes can a pharmacist NOT make to a schedule II prescription?

Patient's identity Drug prescribed (other than generic substitution); Date on the prescription or add a date Identity of the prescriber or the prescriber's signature. If any of these changes are necessary to properly dispense the Schedule II controlled substance prescribed, a new written prescription must be obtained from the prescriber.

What is the process for reinstatement of an expired license for 5 years or less?

Payment of all lapsed renewal fees and proof of 30 hours of continuing education

What is the process for reinstatement of an inactive status of 5 years or less?

Payment of current renewal fee and proof of 30 hours of continuing education

What are requirement for faxing CIIs for home infusion pharmacies, hospice, and long term care facilities?

Permits the fax to serve as the original A C-II prescription may be transmitted by facsimile by the prescriber to the pharmacy providing the home infusion service if the substance is to be compounded for direct administration to a patient in a private residence, long-termcare facility or hospice program. For patients in a certified Medicare hospice, the prescriber may transmit a prescription via facsimile or electronically to the dispensing pharmacy. However the prescriber must note on the prescription that it is for a hospice patient If a home infusion pharmacy is dispensing a solid or liquid oral dosage form, or an IV form to be injected by the patient (as opposed to infused), the original written RX is still required.

What is a definition of an online pharmacy?

Person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet.

What does it mean when the alcohol in pharmacies are tax exempt?

Pharmacies are not charged the federal alcohol tax when purchasing alcohol for compounding

What is the duty to dispense pursuant to a lawful prescription?

Pharmacies have a duty to deliver lawfully prescribed drugs to patients and to distribute nonprescription drugs approved by the USFDA for restricted distribution by pharmacies except for professional judgement, national or state emergencies, potentially fraudulent prescriptions, unavailability of drug or not carried in similar practice settings in the state

What are onsite institutional pharmacy services?

Pharmacies located in facilities licensed under the Nursing Home Care Act, the Hospital Licensing Act, or the University of Illinois Hospital Act, or that are operated by the Department of Human Services or the Department of Corrections, and that provide pharmacy services to residents, patients, employees, prescribers and students of these facilities

What are nuclear pharmacy services?

Pharmacies that provide and/or offer for sale radiopharmaceuticals

What are examples of CE's?

Pharmacies, hospitals, blue cross blue shield of IL, prescription switch vendors i.e. NDC/relay health Pharmacy benefit managers are CEs and BAs Pharmaceutical companies are generally not CE's, except with respect to their own employee health plans

What is anticipatory compounding?

Pharmacist compounds small amounts of drug before receiving prescription, based on previously filled valid prescriptions within an established practitioner - patient - pharmacist relationship, and the RX is kept on file.

What are requirements for documentation of drug interchange?

Pharmacist must indicate on prescription the name or other identification of the manufacturer of the dispensed product.

Who must approve the prescriptions orders before they are released from the automated dispensing device?

Pharmacist or prescriber when the RAPS is located on the same premises as the prescriber

What is required before a pharmacist can dispense naloxone?

Pharmacist shall complete a training program approved by the Department of Human Services. The training program shall include, but not be limited to, proper documentation and quality assurance.

What is a pharmacist in charge?

Pharmacist whose name appears on pharmacy license; and who is responsible for all aspects of the operation related to pharmacy practice. All pharmacies must have a PIC.

Who can input drug information when using electronic data processing equipment?

Pharmacist, pharmacy technician, or a certified pharmacy technician under the supervision of a pharmacist

What is the hypodermic syringes and needles act?

Pharmacists may dispense syringes and needles to patients pursuant to a prescription. However, sales without a prescription are also permitted.

Whose responsibility is it to train technicians?

Pharmacy and pharmacist in charge.

What must be done before a pharmacy can process electronic prescriptions for controlled substances?

Pharmacy application provider has to obtain a 3rd party audit or certification review that it is compliant. Pharmacy can continue to use pharmacy application to store and process information from paper or oral controlled substances prescriptions it receives, but the paper records must be retained

Pharmacy investigators report to who?

Pharmacy coordinator or a deputy pharmacy coordinator

What is the exemption of product registration requirements?

Pharmacy is exempt from registration when they are in conformance with local law, and are regularly engaged in dispensing prescription drugs or devices, upon prescription of practitioners licensed to administer such drugs and devices to patients under their care in the course of professional practice, and do not manufacture, prepare, propagate, compound, or process drugs or devices for resale other than in the regular course of their business of dispensing or selling at retail.

What are electronic equipment requirements for remote pharmacies?

Pharmacy shall have a computer, scanner, fax capability, and printer All prescriptions shall be scanned and sequentially numbered, and the prescription labels shall be produced on site and viewed at the home pharmacy. Scanned prescriptions can be viewed All patient's demographic and prescription information viewed Prescriptions dispensed at the remote pharmacy site must be distinguishable from those dispensed at the home pharmacy Original prescription shall be retained on file

What is the bound log book of refill data?

Pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in the dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown.

What are examples of BA's?

Pharmacy software vendors Pharmacy lawyers and accountants Pharmacy benefit managers are CEs and BAs

What is an emergency remote pharmacy?

Pharmacy that is not located at the same location as its home pharmacy and at which pharmacy services are provided during an emergency situation

Where do syringes or needles need to be stored?

Pharmacy that limits access to syringes or needles to pharmacists employed at the pharmacy or persons designated by the pharmacists

What is prescriptive authority of PAs?

Physician may, through a written delegation of authority, delegate limited prescriptive authority to a physician assistant; may, but not required to include prescription of Schedule II, III, IV, or V controlled substances. Medication orders issued by a physician assistant shall be reviewed periodically by the supervising physician. The supervising physician shall file with the Division of Professional Regulation ("DPR") notice of delegation of prescriptive authority to a physician assistant and termination of delegation, specifying the authority delegated or terminated. PA must have a "written supervision agreement" with the delegating physician.

Who cannot be considered authorized collectors?

Physicians and other practitioners, hospitals without a pharmacy, and clinics without a pharmacy

What should you do if the loss is not significant?

Place a record of the occurence in your theft and loss file for future reference

What is a pharmacy?

Place where drugs, medicines, or poisons are dispensed, where prescriptions of health care professional within the limits of their license are compounded filled, or dispensed

What are phase 4 studies?

Post Marketing Surveillance - monitor use of drug for additional information regarding safety and effectiveness. Manufacturer collects data, and submits yearly reports to FDA. Note: reporting of adverse effects by health care practitioners to FDA or the manufacturer is voluntary; reporting by manufacturer of information received is mandatory.

What are the three requirements for interchanging prescribed pharmaceutical products?

Prescriber must not prohibit Product must be included in the IL formulary Product dispensed must have a lower cost than the product prescribed Patient consent is no longer required

What are requirements for prescribing benzodiazepines or schedule II narcotic drugs for advanced practice registered nurses with full practice authority?

Prescribing benzodiazepines or Schedule II narcotic drugs, such as opioids requires a consultation relationship with a physician. The consultation relationship shall be recorded in the Prescription Monitoring Program website, and is not required to be filed with the Department. The specific Schedule II narcotic drug must be identified by either brand name or generic name; the specific Schedule II narcotic drug, such as an opioid, are limited to oral, topical, or transdermal application (injectables, transmucosal, buccal, etc. are not permitted) At least monthly, the APRN and the physician must discuss the condition of any patients for whom a benzodiazepine or opioid is prescribed.

What is the exception to the requirement that all practitioner have their own dispenser's registration number?

Prescribing under hospital DEA number

Who can fill prescriptions in remote dispensing sites?

Prescriptions can be filled by pharmacy techs with at least one year experience, and who are also certified.

What is the new drug application?

Presents to FDA reviewers the entire history of the development of the drug product. FDA reviews data and determines whether the product meets the criteria for marketing in the U.S.

What are requirements of electronic record keeping system?

Preserved for a period of not less than 5 years the original, or an exact, unalterable image, of every written prescription and the original transcript or copy of every verbal prescription filled, compounded, or dispensed, in such pharmacy; and such book or file of prescriptions shall at all reasonable times be open to inspection to the pharmacy coordinator and the duly authorized agents or employees of the Department. Every prescription filled or refilled shall contain the unique identifiers of the persons authorized to practice pharmacy under the provision of this Act who fills or refills the prescription.

What is the purpose of adequate security systems and procedures of automated dispensing and storage systems?

Prevent unauthorized access or use; Comply with any applicable federal and State regulations; and Maintain patient confidentiality.

What consists of in vivo animal studies in the first step of the drug approval process?

Primarily evaluate pharmacology and potential toxicities. Once complete, sponsor submits an Investigational New Drug Application ("IND")

Under IL law, what is the exception to DEA authorization for destruction?

Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction.

When should you provide verbal counseling?

Prior to dispensing a prescription to a new patient, a new medication to an existing patient, or a medication that has had a change in the dose, strength, route of administration or directions for use,

Who qualifies for verbal counseling?

Prior to dispensing a prescription to a new patient, a new medication to an existing patient, or a medication that has had a change in the dose, strength, route of administration or directions for use, the pharmacist, or a student pharmacist directed and supervised by the pharmacist, shall provide verbal counseling to the patient or patient's agent on pertinent medication information.

What is the abbreviated new drug application?

Process by which generic products are approved following expiration of patent held by innovator company; proof that the generic drug's pharmacokinetics, bioavailability and clinical activity are similar to the innovator product is required.

What is non-retrievable?

Process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes When it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue

What is a public key infrastructure?

Process where CSOS requires that each individual purchases enrolled with DEA has to acquire a CSOS digital certificate

What is adulteration?

Product that consists in whole or in part of any filthy, putrid, or decomposed substance; or if it has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

How much of dihydrocodeine is considered Schedule 5 drugs?

Products containing not more than 10 milligrams of dihydrocodeine; or any of its salts, per 100ml or per 100 grams are also considered to be CV substances

What are narcotic treatment programs?

Programs that use controlled substances for patients going through withdrawal from other narcotics

What is prescriptive authority for optometrist for Schedule II controlled substances?

Prohibited except for dihydrocodeinone (hydrocodone) with one more more active, non-narcotic ingredients only in a quantity sufficient to provide treatment for 72 hours

What is the Food and Drug Act?

Prohibited the marketing of adulterated (meaning, contaminated) and misbranded food and drugs. Produces were subject to seizure by the government. Did not limit the claims a manufacturer can make with respect to their product as long as the product was correctly identified. Did not require premarket inspections and approval

Is sterile compounding for office use allowed?

Prohibited unless the pharmacy is in full compliance with 21 USC 353b, including becoming registered as an outsourcing facility and licensed as a wholesale drug distributor pursuant to the Wholesale Drug Distribution Licensing Act.

What does the Illinois Department of Public Health have to provide to pharmacies that choose to sell needels and syringes?

Proper disposal of needles and syringes

What is protected by HIPAA?

Protected health information and individually identifiable health information that is transmitted or maintained by electronic media or transmitted or maintained by any other form or medium

What is the Health Insurance Portability and Accountability Act of 1996 ("HIPAA")?

Protects the confidentiality of protected health information (PHI) Violators subject to both civil penalties and criminal sanctions Enforced by office of civil rights of the US department of Health and human services

What is a power of attorney?

Provide authority to execute federal order forms to obtain schedule II controlled substances

What is the purpose of the poison prevention packaging act?

Provide special packaging to protect children under the age of 5 from accidental poisoning.

How are PPI for estrogen dispensed products handled in acute-care hospitals or long-term care facilities?

Provide to the patient before administration of the first estrogen and every 30 days thereafter, as long as the therapy continues

What is pharmacist care?

Provision by a pharmacist of medication therapy management services, with or without the dispensing of drugs or devices, intended to achieve outcomes that improve patient health, quality of life, and comfort and enhance patient safety.

What is a telepharmacy?

Provision of pharmacist care by a pharmacist that is accomplished through the use of telecommunications or other technologies to patients or their agents who are at a distance and are located within the United States, and which follows all federal and State laws, rules, and regulations with regard to privacy and security.

When the offsite institutional pharmacy is closed, who is prohibited access to filling and dispensing area?

Public and employees not registered under the act

What are the recordkeeping requirements on PSE and EPH products?

Purchasers of PSE and EPH products must sign a log including purchaser's name and address, the date and time of the transaction, the brand, product name and quantity of PSE / EPH distributed.

If a pharmacist consumes any amount of alcohol, can he legally be in the pharmacy and engage in dispensing?

Questions with this type of fact pattern are testing your knowledge of protecting the public. Always err on the side of saying that even one drink might cause impairment, and chose the option that would protect the public by making sure the potentially impaired pharmacist is not engaged in the practice of pharmacy.

What are prescription requirements of APRNs and PAs?

RX requires delegating practitioners name, but signation and DEA number (if controlled substance prescribed) of the mid-level practitioner.

What are unprofessional and unethical conduct?

Read page 82

What are regulations that identify additional, specific conduct that constitutes a violation?

Read page 83

What is a Class I Recall?

Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

What are examples of remote prescription processing?

Receiving, interpreting, evaluating, or clarifying prescriptions. Entering prescription and patient data into a data processing system. Transferring prescription information. Performing a drug regimen review. Obtaining refill or substitution authorizations or otherwise communicating with the prescriber concerning a patient's prescription. Evaluating clinical data for prior authorization for dispensing. Discussing therapeutic interventions with prescribers. Providing drug information or counseling concerning a patient's prescription to the patient or patient's agent, as defined in this Act.

What are the powers and duties of the board of pharmacy?

Recommend development and selection of licensure examinations to DPR Evaluate the professional and training of reciprocal applicants Conduct disciplinary hearings, and report findings of fact, conclusions of law, and recommendations regarding discipline to DPR Swear in witnesses at disciplinary hearings Disbursement of funds from license renewals, which are set aside within the IL state pharmacy disciplinary fund Make written recommendations to DPR, which are required before the director may take any action Prepare annual reports of the year's activities for DPR and public Review ACPE list of accredited pharmacy programs in order to determine whether minimum criteria are met Make written recommendations to DPR concerning restoration of suspended or revoked licenses Executive administration and chief enforcement officer of the Pharmacy Practice Act

What records should be maintained for 5 years for remote prescription/medication order processing?

Records of medication orders processed; Records of the electronic communication system maintenance. The remote prescription/medication order processing pharmacy shall maintain a record containing the names and license numbers of all pharmacies to which they are providing services and the number of hours per day the services are being provided.

What are requirements for oral prescriptions?

Reduced to writing by pharmacist with same rx requirements

What should you do if a patient or patient's agent refuses to accept patient counseling?

Refusal shall be documented

Who stocks and restocks all medications of the automated dispensing and storage systems?

Registrants under the act

When prescribing buprenorphine (subutex and suboxone), the prescriber has to proved what?

Regular DEA and specially assigned DEA registration number that starts with X to indicate that the prescriber has received the waiver and is permitted to treat addictions on an outpatient basis

What is the function of the division of professional regulation?

Regulates all professions and occupations in IL, including pharmacy Enforces the pharmacy practice act, with the assistance of the board of pharmacy Has quasi-executive, quasi-legislative and quasi-judicial powers Administers act with assistance of Board of pharmacy

Can controlled substances be returned for purposes of destructions?

Remember that controlled substances CANNOT be returned to the pharmacy, even if for purposes of destruction, except in the event of a recall or a dispensing error!

What are three types of telepharmacy?

Remote dispensing sites Remote consultation sites Remote automated pharmacy sites

What happens if there are lost and stolen DEA forms 222 and unable to state the serial numbers of the DEA 22 forms?

Report the date or approximate date of issuance.

What happens if there are lost and stolen DEA forms 222?

Report the theft or loss to the Special Agent in Charge of the DEA in the Divisional Office stating serial number

What is the federal law of patient counseling and DUR?

Required all states to pass laws by 1/1/93 to address counseling and DUR. States could pass laws that went beyond federally paid prescriptions.

What should be included in policy and procedures for the automated dispensing and storage system?

Requirement for pharmacist review of the prescription or medication order prior to the system profiling and/or removal of any medication from the system for immediate patient administration List of medications to be stored in each system; List of medications qualifying for emergency or first dose removal without pharmacist prior review of the prescription or medication order

What is the Kefauver-Harris Amendment?

Requires drug manufacturers to show the effectiveness of their products as well as its safety, to report adverse events to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of their products. Informed consent was required from participants in clinical studies. The FDA also was given jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory submission known as a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of drug manufacturers was mandated every 2 years.

What is the Food, Drug, and Cosmetics Act?

Responsible for regulating all aspects of the manufacturing and, to a lesser extent, wholesale distribution of both prescription and non-prescription drugs

What happens after step 3 of the drug approval process?

Results are tabulated, analyzed and then submitted as a new drug application (NDA)

If on the exam you get a question about an ER patient, what prescription labeling requirements should you follow?

Retail pharmacy prescription labeling

What does L stand in the first letter of the DEA number?

Reverse distributor

What are the rights of pharmacist investigators?

Right to enter and inspect, during business hours, any pharmacy or any other place in this State holding itself out to be a pharmacy where medicines, drugs or drug products, or proprietary medicines are sold, offered for sale, exposed for sale, or kept for sale.

What are the powers of the division of professional regulation?

Rulemaking, discipline, licensing, and variances

What are the requirements necessary for those licensed pharmacies that prepare cytotoxic drugs?

Safety and containment techniques for compounding cytotoxic drugs shall be used Disposal of cytotoxic waste shall comply with all applicable local, state and federal requirements Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside and shipped in a manner to minimize the risk of accidental rupture of the primary container Must have as a reference Safe Handling of Hazardous Drugs Video Training Program and Workbook

What is packaging requirements on OTC products containing salicylates?

Safety closures that prevent access to the drug by young children are also recommended to guard against accidental poisonings.

What are quality assurance monitors that automated dispensing and storage system include?

Safety monitors (e.g., wrong medications removed and administered to patient); Accuracy monitors (e.g., filling errors, wrong medications removed); and Security monitors (e.g., unauthorized access, system security breaches, controlled substance audits).

What is a pregnancy category C drug?

Safety of the drug during human pregnancy has not been established, and animal studies are either positive for fetal risk, or have not been conducted. Drug should not be used in human females during pregnancy unless the potential benefit outweighs the potential risk to the fetus.

What are the requirements of Schedule 3-5 prescriptions?

Same for CII but CII-V prescriptions may be written, faxed, or oral, and may be refilled with limitations

Controlled substance analogs (essentially an illegal copy of a FDA/DEA approved controlled substance) is what schedule drug?

Schedule 1

Heroin is what schedule drug?

Schedule 1

LSD is what schedule drug?

Schedule 1

Marijuana (even medical marijuana, but not marinol) is what schedule drug?

Schedule 1

Mescaline is what schedule drug?

Schedule 1

Methaqualone is what schedule drug?

Schedule 1

Peyote is what schedule drug?

Schedule 1

What schedule are amphetamines?

Schedule 2

What schedule are short acting barbiturates i.e. pentobarbital or secobarbital that are oral and injectable?

Schedule 2

What schedule is Amphetamine?

Schedule 2

What schedule is Cocaine?

Schedule 2

What schedule is Codeine sulphate or phosphate?

Schedule 2

What schedule is Tincture of opium?

Schedule 2

What schedule is Actiq?

Schedule 2 (brand name for fentanyl)

What schedule is Duragesic?

Schedule 2 (brand name for fentanyl)

What schedule is Sublimaze?

Schedule 2 (brand name for fentanyl)

What schedule is Dilaudid?

Schedule 2 (brand name for hydromorphone)

What schedule is Dolophine?

Schedule 2 (brand name for methadone)

What schedule is MS contin?

Schedule 2 (brand name for morphine)

What schedule is Percocet?

Schedule 2 (brand name for oxycodone/apap)

What schedule is Nembutal?

Schedule 2 (brand name for pentobarbital)

What schedule is Methamphetamine?

Schedule 2 (brand name is desoxyn)

What schedule is Oxymorphone?

Schedule 2 (brand name is numorphan)

What schedule is Secobarbital?

Schedule 2 (brand name is seconal)

What schedule is Demerol?

Schedule 2 (brand name of mepiridine)

What schedule is Morphine?

Schedule 2 (generic for MS contin)

What schedule is Hydromorphone?

Schedule 2 (generic for dilaudid)

What schedule is Methadone?

Schedule 2 (generic for dolophine)

What schedule is Pentobarbital?

Schedule 2 (generic for nembutal)

What schedule is Vyvanse?

Schedule 2 (generic is lisdexamfetamine)

What schedule is Desoxyn?

Schedule 2 (generic is methamphetamine)

What schedule is Ritalin?

Schedule 2 (generic is methylphenidate)

What schedule is Percodan?

Schedule 2 (generic is oxycodone hcl)

What schedule is Seconal?

Schedule 2 (generic is secobarbital)

What schedule is Nucynta?

Schedule 2 (generic is tapentadol)

What schedule is Oxycodone/APAP?

Schedule 2 (generic name for percocet)

What schedule is Lortab?

Schedule 2 (hydrocodone/apap is the generic)

What schedule is Talwin?

Schedule 2 (petnazocine is the generic)

What schedule is Meperidine?

Schedule 2 (the brand name is demerol)

What schedule is Methylphenidate?

Schedule 2 (the brand name is ritalin)

What schedule is Hydrocodone/apap?

Schedule 2 (vicodin, lortab, norco is the brand)

What schedule is Hydrocodone/ibuprofen?

Schedule 2 (vicoprofen is the brand)

What schedule are combination barbiturates?

Schedule 3

What schedule is Acetaminophen with codeine?

Schedule 3 (Empirin #3, Empirin #4; Tylenol #3 or #4 are brand names)

What schedule is GBH?

Schedule 3 (Gamma Hydroxybutyric Acid preparations is the generic)

What schedule is Gamma Hydroxybutyric Acid preparations?

Schedule 3 (Xyrem, GHB, gamma hydroxybutyrate are the brand)

What schedule is Empirin #3?

Schedule 3 (acetaminophen with codeine is the generic)

What schedule is Empirine #4?

Schedule 3 (acetaminophen with codeine is the generic)

What schedule is Tylenol #3?

Schedule 3 (acetaminophen with codeine is the generic)

What schedule is Tylenol #4?

Schedule 3 (acetaminophen with codeine is the generic)

What schedule is Aprobarbital?

Schedule 3 (alurate is the brand)

What schedule is Testoderm?

Schedule 3 (anabolic steroids is the generic)

What schedule is Winstrol?

Schedule 3 (anabolic steroids is the generic)

What schedule is Alurate?

Schedule 3 (aprobarbital is the generic)

What schedule is Didrex?

Schedule 3 (benzphetamine is generic)

What schedule is Suboxone?

Schedule 3 (buprenorphine is generic)

What schedule is Subutex?

Schedule 3 (buprenorphine is generic)

What schedule is Butibel?

Schedule 3 (butabarbital is generic)

What schedule is Fiorinal?

Schedule 3 (butalbital is the generic)

What schedule is Butabarbital?

Schedule 3 (butisol, butibel is brand)

What schedule is Butalbital?

Schedule 3 (butisol, fiorinal are the brand names)

What schedule is Soneryl?

Schedule 3 (butobarbital is generic)

What schedule is Benzphetamine?

Schedule 3 (didrex is brand)

What schedule is Synalgos-dc?

Schedule 3 (dihydrocodeine is the generic)

What schedule is Butalbital w APAP?

Schedule 3 (fioricet with esgic is the brand)

What schedule is Ketlar?

Schedule 3 (ketamine is the generic)

What schedule is Ketamine?

Schedule 3 (ketlar is the brand name)

What schedule is Pentobarbital rectal suppositories?

Schedule 3 (nembutal suppositories is the brand name)

What schedule is Nembutal suppositories?

Schedule 3 (pentobarbital rectal suppositories are the generic)

What schedule is Thiopental?

Schedule 3 (pentothal is the brand)

What schedule is Plegine?

Schedule 3 (phendimetrazine is the generic)

What schedule is Phendimetrazine?

Schedule 3 (plegine is the brand)

What schedule is Butobarbital?

Schedule 3 (soneryl is brand)

What schedule is Buprenorphine?

Schedule 3 (suboxone and subutex is brand)

What is the entry point for newly scheduled controlled drugs?

Schedule 4

What schedule are long acting barbiturates such as phenobarbital?

Schedule 4

What schedule is Phenobarbital?

Schedule 4

What schedule is Alprazolam?

Schedule 4 (Xanax is the brand)

What schedule is Xanax?

Schedule 4 (alprazolam is the generic)

What schedule is Zolpidem?

Schedule 4 (ambien is brand)

What schedule is Lorazepam?

Schedule 4 (ativan is brand)

What schedule is Stadol?

Schedule 4 (butorphanol is generic)

What schedule is Soma?

Schedule 4 (carisoprodol is generic)

What schedule is Soprodal?

Schedule 4 (carisoprodol is generic)

What schedule is Vanadom?

Schedule 4 (carisoprodol is generic)

What schedule is Noctec?

Schedule 4 (chloral hydrate is generic)

What schedule is Librium?

Schedule 4 (chlordiazepoxide)

What schedule is Klonopin?

Schedule 4 (clonazepam is generic)

What schedule is Pemoline?

Schedule 4 (cylert is brand name)

What schedule is Flurazepam?

Schedule 4 (dalmane is brand)

What schedule is Propoxyphene?

Schedule 4 (darvon, darvocet is brand)

What schedule is Valium?

Schedule 4 (diazepam is generic)

What schedule is Midrin?

Schedule 4 (dichloralphenazone is generic)

What schedule is Lusedra?

Schedule 4 (fospropofol is generic)

What schedule is Triazolam?

Schedule 4 (halicion is brand)

What schedule is Zopiclone?

Schedule 4 (imovane is brand)

What schedule is Chlordiazepoxide?

Schedule 4 (librium is brand)

What schedule is Ativan?

Schedule 4 (lorazepam is generic)

What schedule is Fospropofol?

Schedule 4 (lusedra is brand)

What schedule is Equanil?

Schedule 4 (meprobamate is generic)

What schedule is Miltown?

Schedule 4 (meprobamate is generic)

What schedule is Dichloralphenazone?

Schedule 4 (midrin is brand)

What schedule is Chloral Hydrate?

Schedule 4 (noctec is brand)

What schedule is Serax?

Schedule 4 (oxazepam is generic)

What schedule is Cylert?

Schedule 4 (pemoline is generic)

What schedule is Darvocet?

Schedule 4 (preopoxyphene is generic)

What schedule is Darvon?

Schedule 4 (propoxyphene is generic)

What schedule is Butorphanol?

Schedule 4 (stadol is the brand)

What schedule is Halcion?

Schedule 4 (triazolam is generic)

What schedule is Tramadol?

Schedule 4 (ultram is brand)

What schedule is Diazepam?

Schedule 4 (valium is brand)

What schedule is Sonata?

Schedule 4 (zaleplon is generic)

What schedule is Ambien?

Schedule 4 (zolpidem is generic)

What schedule is Imovane?

Schedule 4 (zopiclone is generic)

What schedule is Acetaminophen with codeine elixir?

Schedule 5

What schedule is Actifed with Codeine?

Schedule 5

What schedule is Dimetane-DC?

Schedule 5

What schedule is Novahistine DH?

Schedule 5

What schedule is Phenergan VC with Codeine?

Schedule 5

What schedule is Phenergan with Codeine?

Schedule 5

What schedule is Robitussin AC with Codeine?

Schedule 5

What schedule is Robitussin DAC with Codeine?

Schedule 5

What schedule is Triaminic Expectorant with Codeine?

Schedule 5

What schedule is ephedrine under IL law?

Schedule 5

What schedule is Lomotil?

Schedule 5 (diphenoxylate with atropine is generic)

What schedule is Potiga?

Schedule 5 (ezogabine is generic)

What schedule is Vimpat?

Schedule 5 (lacosamide is generic)

What schedule is Diphenoxylate with Atropine?

Schedule 5 (lomotil is brand)

What schedule is Pregabalin?

Schedule 5 (lyrica is brand)

What schedule is Ezogabine?

Schedule 5 (potiga is brand)

What schedule is Lyrica?

Schedule 5 (pregabalin is generic)

What schedule is Lacosamide?

Schedule 5 (vimpat is brand)

What can you order from CSOS?

Schedules I, II, III, IV, and V drug orders. (The paper form can be used only for Schedules I and II drugs.)

Who is required to appoint a chief pharmacy coordinator?

Secretary of DFPR

What are examples of administrative safeguards?

Security procedures, security agreements, disaster recovery plan

What is Dichloralphenazone used for?

Sedative for tension relief/ vascular headaches

What is Fospropofol (Lusedra) used for?

Sedative/hypnotic; note - NOT propofol (Diprivan)

What are the six things technicians cannot do?

Sell C-V (exempt narcotics) Dispense in the absence of a pharmacist (can remain in pharmacy but cannot practice) Transfer a prescription to another pharmacy Be in pharmacy when CII are not secured (unless RPh is present) Counsel patients Participating in drug regimen review or clinical conflict resolution

What are responsibilities that registered pharmacy technicians cannot do?

Sell CV (exempt narcotics) Dispense in absence of a pharmacist- can remain in pharmacy but cannot practice unless a pharmacist is in the establishment Transfer a prescription to another pharmacy except when transferring non-controlled substances using real-time, on-line electronic database Be in pharmacy when CII are not secured unless RPh is present Administer drugs, including vaccinations

Who receives the original IL CII duplicate order?

Selling/transferring registrant

Where do you send DEA form 106?

Send the original to the DEA diversion field office and keep a copy for its records

What must be forwarded to DEA after controlled substances have been destroyed?

Signed copies of the DEA form 41 must be forwarded to DEA

What is phase 1 of Clinical trials?

Small group of healthy subjects receive drug; evaluation of toxicological, pharmacokinetic and pharmacologic properties; assessment of safety of drugs in humans.

What are software requirements for CSOS?

Software packages allows purchaser to enter the NDC number and automatically retrieve the product description

What is an owner of a pharmacy?

Sole proprietor, partner or shareholder who owns in excess of 5% of outstanding stock of a corporation, or spouse or child of sole proprietor, partner or shareholder. This section does not apply to pharmacy owned by corporation which is publicly traded.

Under federal law, what are the requirements for emergency kits with controlled kits in LTCF?

Source must be DEA registered hospital/clinic, pharmacy or practitioner Security safeguards must be made to limit access to kit Proper control and accountability of emergency kit i.e. supplying registrant and accurate records and inventory Authorized personnel can only administer controlled substances

What are the requirements of a nuclear pharmacy?

Space commensurate Radioactive storage and product decay facility separate from and exclusive of the "hot" laboratory, compounding, dispensing, quality assurance and office areas

What are other types of alcohols that are tax-exempt?

Specially denatured alcohols

What are specially denatured alcohols?

Specially formulated grain alcohol that is unfit for consumption, used by drug companies for pharmaceutical processing, and in small quantities in commercial products, including some mouthwash

What is specific schedule II CS delegated for PAs?

Specific Schedule II controlled substances by oral dosage or topical or transdermal application may be delegated, provided that the delegated Schedule II controlled substances are routinely prescribed by the supervising physician. This delegation must identify the specific Schedule controlled substances by either brand name or generic name. Schedule II controlled substances to be delivered by injection or other route of administration may not be delegated o any delegation must be of controlled substances prescribed by the supervising physician o CII prescriptions must be limited to no more than a 30-day supply, with any continuation authorized only after prior approval of the supervising physician o the physician assistant must discuss the condition of any patients for whom a controlled substance is prescribed monthly with the delegating physician

What are the requirements of a remote dispensing site?

Staffed by pharmacy techs with at least one year experience with home pharmacy has audio and video connection to the pharmacy

What is USP 797?

Standard followed by 503A sterile compounding pharmacist. Adopted by most states in pharmacy practice laws and regulations

What is good manufacturing practices?

Standards by which drugs are to be manufactured, processed, and packaged.

What is labeling requirements for ipecac syrup?

Statement in boxed and red letters "for emergency use to cause vomiting in poisoning. Before use, call physician, the poison control center, or hospital emergency room immediately for advice" and "warning- keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested.''

What is a pedigree?

Statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.

What are the four steps of the drug approval process?

Step 1: In vivo animal studies Step 2: Investigational New Drug Application (IND) Step 3: Clinical Trials (three phases) Step 4: New Drug Application (NDA)

What are requirements for pharmacies that dispense compounded sterile preparations to patients in facilities off site or in the patient's residence?

Stock supplies and medications appropriate for treatment of allergic or other common adverse effects, to be dispensed upon the prescription or order of an authorized prescriber.

What are pharmaceutical compounding standard requirements?

Storage area separate for materials used in compounding Scales and balances for the compounding done in the pharmacy An area of the pharmacy used for compounding activities A heating apparatus A logbook or record keeping system A book or reference containing formulas The pharmacy operations manual shall contain the policies and procedures Consumable materials The pharmacy may compound drug products to be used by practitioners in their office for administration to patients. Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or manufacturers are not allowed, except for sales provided by pharmacies contracted to provide centralized prescription filling services pursuant to Section 25.5 of the Act, including compounding in anticipation of receiving a prescription or order based on routine, readily observed dispensing patterns.

Who is exempt from certification requirements?

Student pharmacists

What is a pregnancy category X drug?

Studies in animals, or reports in pregnant women, indicate that the risk of damage to the fetus clearly outweighs any possible benefit to the pregnant woman.

What is the department of financial of professional regulation?

Sub-unit of DFPR that regulates pharmacy

What is the medication locking closure package pilot project?

Subject to appropriation, effective January 1, 2016, the Department shall by rule implement a pilot project requiring that every new or refilled prescription for a Schedule II controlled substance containing hydrocodone dispensed by a pharmacy that voluntarily decides to participate in the pilot program shall only be dispensed in a non-reusable medicine locking closure package. The Department shall not expend more than $150,000 on this pilot program. The Department may contract with third parties to implement the pilot program in whole or in part. The medicine locking closure package must be dispensed by the pharmacy with instructions for patient use unless the prescriber indicates orally, in writing, or electronically that a medicine locking closure package shall not be used. The manufacturer of the medicine locking closure package must make available assistance online or through a toll-free number for patient use. Prescriptions reimbursed via the Medicare Part D and Medicaid programs, including Medicaid managed care plans, are exempt from the provisions of this Section. Prescriptions for individuals residing in facilities licensed under the Nursing Home Care Act are exempt from the provisions of this Section.

What is the supplemental new drug application?

Submitted after NDA approved for changes in synthesis, production procedures, manufacturing locations, packaging, labeling, indications, etc.

What are the requirements of a certified pharmacy technician?

Submitted written application At least 18 Good moral character Graduated pharmacy technician training meeting, obtained documentation from PIC where they are employed and completed training program and objective assessment mechanism Passed an examination Paid required certification fees

Under IL law, what is the requirement for home infusion pharmacies, hospice and LTCF to send in CII faxes?

Substance is to be compounded for direct administration to the patient. If certified medicare hospice, there has to be note that patient is hospice

What are scheduled drugs?

Substances that have the potential for abuse, or can cause addiction are scheduled into one of 5 schedules

What are an A rating in orange book ?

Substitutable

What does AP stand for?

Substitutable injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions

What does AO stand for?

Substitutable injectable oil solutions

What does AN stand for?

Substitutable solutions and powders for aerosolization

What does AT stand for?

Substitutable topical products

Who verifies the accuracy of the ordered entered by pharmacy technicians or certified pharmacy technicians?

Supervising pharmacist. Identify of the supervision pharmacist and technician shall be maintained in the prescription record

What drug only applies to the IL CII duplicate order?

Talwin (pentazocine)

What is the toll free telephone service requirements for non resident pharmacies?

That during its regular hours of operation, but not less than 6 days per week, for a minimum of 40 hours per week, a toll free telephone service is provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records. The toll free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this state

Does FDA regulate the practice of medicine or practice of pharmacy?

That function is left to the states. As long as pharmacy is being practiced, as opposed to manufacturing, the FDA does not regulate pharmacies either.

What role does the Commission play in the professional education of health care personnel with respect to the special packaging program?

The CPSC staff interacts with the State Boards of Pharmacy. CPSC personnel participate in meetings with pharmaceutical, medical, and packaging groups and prepare articles for publication in their journals. One of the areas where the CPSC staff has been particularly active has been in encouraging pharmacists to demonstrate special package usage to their customers who need help with the proper method of opening and closing a special package.

What types of special packaging have been approved by the Commission for use with prescription drugs and other regulated household substances?

The Commission does not approve or certify special packaging. In fact, the PPPA itself specifically prohibits the Commission from prescribing specific package designs, product content, package quantity, and, with the exception of appropriate labeling for allowable single, noncomplying package sizes, labeling. The ultimate determination of whether a particular package complies with the standards is the responsibility of the manufacturer. The Commission assesses compliance on the basis of human performance tests.

What role does the U.S. Consumer Product Safety Commission play in informing and educating the public in the use of, and need for, special packaging?

The Commission has issued news releases and other audio-visual material encouraging the use of special packaging. In addition, the CPSC is the Secretary of the Poison Prevention Week Council and plays an important role in Poison Prevention Week each year.

What is the basis for determining which products will be covered by the PPPA?

The Commission must establish a relationship between a particular household substance (because of the way it is packaged) and the potential for serious injury or illness to young children as a result of ingesting, handling, or using that substance. Some substances do not lend themselves to this requirement. Ingestion of a product by children does not automatically result in the need for special packaging. For example, many soaps and detergents are frequently ingested but do not cause serious injury or illness to children. Alternatively, it is not necessary to document serious injury to children for the Commission to require special packaging of a toxic product.

What are citations that can be issued by the department?

The Department may issue citations to any licensee for any violation of this Act or the rules. The citation shall be issued to the licensee or other person alleged to have committed one or more violations and shall contain the licensee's or other person's name and address, the licensee's license number, if any, a brief factual statement, the Sections of this Act or the rules allegedly violated, and the penalty imposed, which shall not exceed $1,000. The citation must clearly state that if the cited person wishes to dispute the citation, he or she may request in writing, within 30 days after the citation is served, a hearing before the Department. If the cited person does not request a hearing within 30 days after the citation is served, then the citation shall become a final, non-disciplinary order and any fine imposed is due and payable. A citation must be issued within 6 months after the reporting of a violation that is the basis for the citation. The Department may adopt rules for the issuance of citations in accordance with this Section.

What are the requirements of a department attorney?

The Department shall also employ at least one attorney to prosecute violations of the pharmacy law and rules

What is the National Drug Code (NDC) Number?

The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identified and reported using a unique, three- segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs.

What law governs the labeling of iron that has been repackaged?

The FDA governs labeling, but the Poison Prevention Packaging Act also regulates labeling of iron containing products.

Who must notify DPR that they are no longer PIC?

The PIC

Who can be a POA?

The POA can be assigned to anyone - not just pharmacists, including non-pharmacist owners, technicians, pharmacy interns (students), and even unlicensed persons. However, read exam questions carefully, because it is always preferable (even if not legally required) that only pharmacists order controlled substances. Under state law, the ordering, securing and dispensing of controlled substances is responsibility of PIC, regardless of whether the PIC is the registrant, and regardless of whether the PIC has POA.

What is the pharmacist's role in remote dispensing sites?

The RPh at the "home" pharmacy has an audio and video connection to the pharmacy, and is required to verify the prescription, and the product placed into the prescription vial, prior to dispensing.

What are requirements for returning medications from automated dispensing and storage systems?

The automated dispensing and storage systems shall provide a mechanism for securing and accounting for medications once removed from and subsequently returned to the automated dispensing and storage systems (e.g., return bin). No medication or device shall be returned directly to the system for immediate reissue or reuse by a non-registrant under the Act. The automated dispensing and storage systems shall provide a mechanism for securing and accounting for wasted medications or discarded medications.

None of the disciplinary functions, powers, and duties enumerated in this act shall be exercised by the department except upon the review of who?

The board

What does the inventory required to be completed with a PIC departs also constitute as?

The closing inventory of the departing pharmacist-in charge and the initial inventory of the incoming pharmacist-in-charge

What is recall of drugs from market?

The correction or removal, and notification to the company, of a product which is in violation of the law. Three levels of recall

What references can a nuclear pharmacy have available?

The current edition or revision of the United States Pharmacopoeia - Dispensing Information; The current edition or revision of the United States Pharmacopoeia/National Formulary; State and federal regulations governing the use of applicable radioactive material; and U.S. Public Health Service Radiological Health Handbook.

For disposal of controlled substances CIII-V, the DEA recommends that the pharmacy maintain a written record showing what of the following?

The date of the transaction. The Name,strength,dosage form,and quantity of the controlled substance. The supplier or manufacturer's name, address, and registration number.

Who regulates the practice of pharmacy?

The department of financial and professional regulation and board of pharmacy

When does it not constitute a transfer?

The dispensing by a pharmacist licensed in this State or another state of a prescription contained in a common database shall not constitute a transfer, provided that (i) all pharmacies involved in the transactions pursuant to which the prescription is dispensed and all pharmacists engaging in dispensing functions are properly licensed, permitted, or registered in this State or another jurisdiction, (ii) a policy and procedures manual that governs all participating pharmacies and pharmacists is available to the Department upon request and includes the procedure for maintaining appropriate records for regulatory oversight for tracking a prescription during each stage of the filling and dispensing process, and (iii) the pharmacists involved in filling and dispensing the prescription and counseling the patient are identified. A pharmacist shall be accountable only for the specific tasks performed. Nothing in this Section shall prohibit a pharmacist who is exercising his or her professional judgment from dispensing additional quantities of medication up to the total number of dosage units authorized by the prescriber on the original prescription and any refills.

What must the dispensing pharmacist or the pharmacist's designee do within 5 business days following the dispensing of the biological product?

The dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer

What is maintenance treatment?

The dispensing, for a period in excess of 21 days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug

What is detoxification treatment?

The dispensing, for a period not in excess of 21 days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such a period of time

Who must be also be informed of when pharmacy acquiring prescriptions records from a closing pharmacy transaction is going to take place?

The division

What are the requirements of a drug take back in institutional health care facilities?

The drugs were stored in compliance with applicable laws The drugs are not contaminated, deteriorated or beyond their use date The returns were properly documented Obtaining payment twice for the same drug is prohibited

What are specific practice sites and job responsibilities of technicians?

The duties and responsibilities of the technicians and pharmacists. Tasks and technical skills, policies, and procedures. Compounding, packaging, labeling, and storage. Pharmaceutical and medical terminology. Record keeping requirements. The ability to perform and apply arithmetic calculations.

Who regulates alcohol?

The federal bureau or alcohol, tobacco, and firearms.

What is the verifying element of a patient ID for an animal or individual that is not a set standard?

The final verifying element of a patient ID for an animal or individual is not a set standard. Each pharmacy or chain may adopt its own standard. The concern is that if a standard is too rigid, the enterprise's business activity will suffer. Any of the following may be used. If the primary choice is not available (e.g., if the patient is an undocumented alien), another choice may be used: A) Driver's license or equivalent, state issued ID;B) Telephone number of the patient's residence (include area code); C) An internal pharmacy ID system;D) Employer ID;E) StudentID;F) Insurance ID.

What if the departing PIC refuses to complete the inventory, PIC is incapacitated or decreased?

The initial inventory for the incoming pharmacist- in-charge shall be the inventory as completed by the incoming pharmacist-in-charge. The incoming pharmacist-in-charge will not be responsible for any discrepancy that may exist in the inventory prior to his or her initial inventory.

What is the error on the DEA form 41?

The instructions on the form directs the registrant to ship the drugs to be destroyed to the special agent in charge at DEA. this is NOT correct! The form is sent to the SAIC and the registrant should then await instructions from the SAIC response on how to proceed

What is the procedure once an emergency kit has been used or seal has been broken or upon the occurrence of the beyond use date?

The kit shall be returned to the pharmacy to be checked and/or restocked by the last authorized user. If the pharmacy is closed at such time, the kit shall be returned when it opens.

What are labeling/advertising requirements for salicylate preparations that offers its use in arthritis or rheumatism?

The label and labeling should clearly state that the beneficial effects claimed are limited to: "For the temporary relief of minor aches and pains of arthritis and rheumatism.'' The qualifying phrase "for the temporary relief of minor aches and pains'' should appear with the same degree of prominence and conspicuousness as the phrase "arthritis and rheumatism''. The label and labeling should bear in juxtaposition with such directions for use conspicuous warning statements to the effect: "Caution: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.''

What is the Ryan Haight online consumer protection act?

The law provides that it is illegal under federal law to deliver, distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy. Thus, any person who knowingly or intentionally dispenses a controlled substance by means of the Internet that does not have a modification of DEA registration allowing such activity is in violation and subject to potential criminal prosecution and (in the case of DEA registrants) loss of DEA registration

Suppose a pharmacist dispenses a prescription drug in a conventional package. What is the CPSC's position?

The law requires that the pharmacist dispense regulated drugs in special packaging. The only exceptions are those instances when the consumer or prescribing physician stipulates that a noncomplying package be used. Pharmacists who violate the regulations may be criminally prosecuted. Individuals may be sentenced to 1 year imprisonment and fined up to $250,000. Organizations may be fined up to $500,000. The Commission could also seek court orders enjoining violators or authorizing seizure of noncomplying products supplied by manufacturers in consumer packages.

What is the basis for selecting the noncomplying package, which the law permits for over-the-counter drugs, regulated under the PPPA?

The manufacturer may select one of its package sizes as its noncomplying package so long as it also supplies the product in popular size packages, which comply with the PPPA standards. The Commission may require a manufacturer to use only special packaging if the manufacturer has not supplied the product in popular size packages which comply with the standards and the Commission finds, after the opportunity for a hearing, that the exclusive use of special packaging is necessary to accomplish the child protection intended by the PPPA.

What are required on a prescription label?

The name and address of the pharmacy where in the same is sold or dispensed The name or initials of the person, authorized to practice pharmacy under the provisions of this Act, selling or dispensing the same The date on which such prescription was filled The name of the patient The serial number of such prescription as filed in the prescription files The last name of the practitioner who prescribed such prescriptions The directions for use thereof as contained in such prescriptions The proprietary name or names of the established name or names of the drugs, the dosage, and the quantity, except as otherwise authorized by regulation of the department Federal "legend" on all rx medications: "caution: federal law prohibits dispensing without a prescription"

What information is required for refilling a prescription?

The name and dosage form of the drug The date of each refilling The quantity dispensed The name or initials of the pharmacist and the pharmacy technician, if applicable in each refilling The total number of refills for the prescription If the pharmacist doesn't otherwise indicate in a uniformly maintained record, he/she shall be deemed to have dispensed a refill for the full face amount of the prescription. Partial fills are not treated as full refills!

What are the labeling requirements for patients being discharged, emergency room patient, and/or employee at an onsite institutional pharmacy service?

The name and dosage form of the drug The date filled The quantity dispensed Directions for use

What is required in the PPI of OC drug products?

The name of the drug. A summary including a statement of effectiveness, contraindications,risks and benefits A boxed warning concerning cigarette smoking Special considerations w medical conditions Side effects Precautions The drug product and the patient package insert Other indications

What is required in the PPI for estrogen drug products?

The name of the drug. The name and place of business of the manufacturer, packer, or distributor. A statement regarding the benefits and proper uses of estrogens. The contraindications to use, i.e., when estrogens should not be used. A description of the most serious risks associated with the use of estrogens. A brief summary of other side effects of estrogens. Instructions on how a patient may reduce the risks of estrogen use. The date, identified as such, of the most recent revision of the patient package insert.

What must each requisition show?

The name, address, and registration number of the registrant and the number of DEA forms 222 desired

What should every prescription record contain?

The name, initials or other unique identifier of the pharmacist who dispenses the prescription drugs

What information should be included in record of remote prescription/medication order processing?

The name, initials or other unique identifier of the pharmacist who verifies the medication order or prescription; The name of the patient or resident; The name, dose, dosage form, route of administration and dosing frequency of the drug; The date and time of verification; The name of the prescribing/ordering practitioner; Any other information that is required by the dispensing pharmacy being served for use in its own records.

What is the difference in scope of practice for certified technician and technician?

The only thing a certified technician can do that a non-certified technician cannot do is work at a remote dispensing site pharmacy.

What must be included for a lawful CS oral prescription?

The oral prescription shall include a statement concerning the circumstances constituting the emergency for which the oral prescription was used.

When Doctors are ordering a CIII-CV controlled substance "for office use", do they need to fill out a DEA 222?

The order must be placed on a purchase order or invoice, and not on a prescription that identifies the doctor as the patient, with directions for use stating "For Office Use". Also, the order should not be processed as a prescription, and should not be filed with prescription records. It should be treated as a wholesale transaction, and filed with those records.

Who gets what forms when obtaining CII from another pharmacy in an emergency situation?

The ordering pharmacy prepares the 222, and submits it to the supplying pharmacy. Supplying pharmacy retains original, and sends copy 2 to DEA. Thus, supplier acts as temporary distributor.

What should a purchaser do if they receive an unaccepted order of DEA 222?

The original DEA Form 222 and the statement must be retained in the files of the purchaser

What are exceptions for faxed CII prescriptions?

The original must be presented before the CS is dispensed.

Does the drug manufacturer or packager have to test the packaging to determine if it complies with the PPPA standards?

The packages must meet the standards. Failure to meet the standards is a violation of federal law. Most packaging manufacturers will test their packaging to determine if it is complies.

Who doesn't need registration of CS?

The patient that has a legitimate medical need for the medication and accesses it through a valid prescription

Who signs the inventory?

The person taking the inventory

When systems are used within a licensed pharmacy, who is responsible for dispensing the product?

The pharmacist

What is the responsibility of the pharmacist under the PPPA?

The pharmacist must dispense oral prescription drugs in special packaging unless the drug is exempted or the patient or prescribing practitioner requests non- special packaging.

What happens if the written prescription of the oral prescription of the CII is not received?

The pharmacist must notify DEA and the Illinois Department of Human Services, Office of Alcoholism and Substance Abuse, or the emergency dispensing authority is voided.

What if the pharmacist cannot put the entry electronically?

The pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means

What are inspection requirements for RAPS?

The pharmacist-in-charge of the home pharmacy, or a designated registrant, shall conduct and complete monthly inspections of the remote telepharmacy dispensing machine site. Inspection criteria must be included in the policies and procedures for the site. The report must be available to the pharmacy investigators when requested.

How should breaks be schedules if pharmacy is staffed by 2 or more pharmacists?

The pharmacists shall stagger breaks so that at least one pharmacist remains on duty during all times that the pharmacy remains open for the transaction of business.

What are physical requirements of pharmacies preparing sterile parenteral products?

The pharmacy shall have a designated area for preparing compounded sterile preparations. The area shall be designed to minimize outside traffic and airflow disturbances from activity within the facility. It shall be of sufficient size to accommodate a laminar airflow hood, barrier isolation chamber or biological safety cabinet and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation and security. It shall be ventilated in a manner not interfering with the proper operation of the parenteral products preparation apparatus.

What is required before issuance of a pharmacy license to practice as a nuclear pharmacy?

The pharmacy shall provide a copy of its Illinois Radioactive Material License issued by the Illinois Emergency Management Agency in accordance with the Radiation Protection Act. The Division shall conduct an on-site inspection of the facility

How can a pharmacist or pharmacy determine if the prescription packages they use meet the special packaging standards?

The pharmacy should request special packaging test data from the manufacturer or supplier of the prescription packages. When ordering packaging, pharmacists should be aware that vials and closures from different manufacturers may not function properly when used together. Pharmacists are responsible for ensuring that the packages they use comply with the PPPA.

What is compounding?

The preparation and mixing of components, excluding flavoring. As the result of a prescriber's prescription drug order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. "Compounding" includes the preparation of drugs or devices in anticipation of receiving prescription drug orders based on routine, regularly observed dispensing patterns.

Whenever a prescription is dispensed by a registered pharmacy technician or certified pharmacy technician under the supervision of a pharmacist, what does the prescription require?

The prescription record shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician or certified pharmacy technician who dispenses the prescription.

What are the requirements on the written prescription of a previously oral prescription of CII?

The prescription shall have written on its face "Authorization for Emergency Dispensing", and the date of the emergency prescription. The written prescription may be delivered to the pharmacist in person, or by mail. o "Mail box" rule - if mailed by prescriber, must be postmarked within 7 days. Upon receipt, the dispensing pharmacist shall attach this prescription to the emergency oral prescription earlier received and reduced to writing.

What are qualifications to register as an authorized collector?

The registrant must be registered to handle schedule II controlled substances

What is the first letter of the DEA number?

The registrant type

What are good manufacturing practice for dietary supplements?

The regulations require supplement manufacturers to submit to FDA inspections and "assure potency, purity, and consistency in dietary supplement products".

What are the requirements for patient package inserts of OC?

The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient (or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either). The patient package insert is required to be placed in or accompany each package dispensed to the patient.

What is the illinois medical marijuana act?

The sale of medical marijuana is not considered to be part of the practice of pharmacy and will NOT be on the exam.

What is the 5% rule?

The sale of prescription drugs by a pharmacy to practitioners, providing the sales do not exceed 5% of the annual dollar purchases or prescription drugs by the pharmacy and providing the pharmacy maintains a log of sales to practitioners that includes date of sale, practitioner's name and address, drug and strength, size of package, and quantity sold

What is the max salicylate dose that is allowed in OTC salicylate preparations?

The salicylate dosage should not exceed 60 grains in a 24-hour period or 10 grains in a 4-hour period. If the article contains other analgesics, the salicylate dosage should be appropriately reduced.

What is required if the hours of the pharmacy differ from the establishment of the pharmacy is located?

The schedule during which pharmacy services are provided shall be conspicuously displayed Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, a sign stating that situation shall be conspicuously displayed .No prescription may be "dispensed" when a pharmacist is not physically present in the establishment and on duty.

What are some factors to consider for determining significant loss?

The schedule of the missing items. The abuse potential of the missing items. The abuse potential in your area of the missing substance. The quantity missing (one tablet vs. one bottle or container). Is this the first time this loss has occurred? Has a similar loss occurred before? Was this loss reported to local law enforcement authorities? If there is a question as to whether a loss is significant, a registrant should err on the side of caution and report it to DEA.

What is the second letter of the DEA number?

The second letter is usually (but is not always) the first letter of the prescriber's last name.

What are the labeling requirements of the outer container for nuclear pharmacy?

The standard radiation symbol The works "caution-radioactive material" The name of the radionuclide The name of the chemical form The amount of radioactive material contained Container volume in ml if liquid the requested calibration time for the amount of radioactivity contained Prescription number the name or initials of nuclear pharmacy filling

What are the labeling requirements of the immediate container for nuclear pharmacy?

The standard radiation system The words "Caution-radioactive material" The name and address of the pharmacy The prescription number the name of radionuclide The name of chemical form

What if state law and federal law overlap?

The state law must be more stringent that federal law to be valid

Where does the supplier forward copy 2?

The supplier is required to forward Copy 2 (green) to the "Special Agent in Charge" of the DEA in the area in which the supplier is located

What actions should be taken on unaccepted or defective DEA forms 222?

The supplier must return the original DEA form 222 to the purchaser with a statement as to the reason

How do you verify a DEA number?

The two letters are followed by 7 numbers. The numbers follow a formula that can be used to verify the number: Add digits 1, 3, and 5 Add digits 2, 4, and 6, and multiply the sum by two. Add the results of the above and the last number of the summation should equal last number in the DEA number

What are the requirements to be a witness of disposal or destruction by pharmacy?

The witnesses should be either a licensed physician, pharmacist, mid-level practitioner, nurse, a state or local law enforcement officer, or other person or entity authorized by the state.

Can a C2 Prescription be postmarked within 7 days of the Emergency C2 fill rather than received within the 7 days? And the Pharmacist needs to contact DEA, DHS, and DASA if Prescription is not received?

The written prescription may be delivered to the pharmacist in person, or by mail, but if delivered by mail it must be postmarked within the 7-day period Illinois Law provides: "The written prescription may be delivered to the pharmacist in person, or by mail, but if delivered by mail it must be postmarked within the 7-day period". Federal Law States: "in the case of an emergency situation, as defined by the Secretary in Sec. 290.10 of this title .... if delivered by mail, it must be postmarked within the 7 day period."

What if the long term care facility changes pharmacy provider services?

Their new provider must obtain the orders from the long term care facility and verify the authenticity and accuracy of the orders with the prescriber.

What are products for which in vivo demonstration of BE was deferred are listed as?

Therapeutic inequivalent or B rated

What are the federal laws that addresses recordkeeping for non-controlled substances?

There are none. Illinois governs all non-controlled substance records

What is a pregnancy category D drug?

There has been positive evidence of risk to the human fetus, based mainly on adverse reaction data from investigational or marketing experience. Drug should be administered only if potential benefits to pregnant women may be acceptable despite its potential risks.

What is the federal and state emergency CII dispensing quantity limit? Is it 3 days worth?

There is no arbitrary # of day's limitation - it is based on the facts and circumstances presented. Federal and state would both limit dispensing to an amount that will get the patient through the emergency period. There is no arbitrary # of day's limitation - it is based on the facts and circumstances presented. For example, if the patient needs the medication, and cannot see the doctor to get a written RX for2 weeks, then the pharmacist could dispense a 2 week supply pursuant to an emergency prescription phoned in by the doctor.

Is prescribing non-controls to yourself or family members allowed?

There is no prohibition against self-prescribing or prescribing to family members. When reviewing examination questions, however, remember that the pharmacist must always exercise good faith. This could result in refusing to fill prescriptions for controls or non-controls written for self-use, or use by a family member, or for large quantities. The good faith requirements apply to the dispensing of all drugs, not just controlled substances.

May the manufacturer supply to the pharmacist one size of a regulated prescription drug in a conventional package under Section 4 of the PPPA in the same manner as supplying a non-complying size for over-the-counter drugs?

There is no provision for a manufacturer or packager to market a single size of a prescription drug in noncomplying packaging as is the case for over-the- counter medications. Every unit of a prescription drug subject to the PPPA which is packaged by the manufacturer in a package intended to be dispensed to a consumer must be in special packaging. Regulated prescription drugs may be dispensed in non-special packaging only when the prescribing physician directs its use, or the purchaser requests noncomplying packaging. In those cases, the pharmacist would have to repackage the drug with a conventional, non-special package.

What are record retention requirements?

There shall be kept in every drugstore or pharmacy a suitable book, file, or electronic record keeping system in which shall be preserved for a period of not less than 5 years the original of every written prescription and the original transcript or copy of every verbal prescription filled, compounded, or dispensed, in such pharmacy; and such book or file of prescriptions shall at all reasonable times be open to inspection to the pharmacy coordinator and the duly authorized agents or employees of the Department.

How long should you keep electronic records?

There shall be kept in every drugstore or pharmacy a suitable book, file, or electronic record keeping system in which shall be preserved for a period of not less than 5 years the original, or an exact, unalterable image, of every written prescription and the original transcript or copy of every verbal prescription filled, compounded, or dispensed, in such pharmacy

What are remote automated pharmacy systems?

These are automated dispensing devices that will dispense prescription drugs directly to a patient. These sites have prescription inventory, which must be secured in an automated dispensing device connected to the home pharmacy.

What are remote dispensing sites?

These are pharmacy locations where an inventory of drugs are maintained, but they are staffed not by pharmacists, but by certified pharmacy technicians.

What is a remote consultation site?

These sites have no prescription inventory, and are staffed by technicians or pharmacy technicians.

How can a registrant send the DEA form 41?

They can list the controlled substance which they want to dispose on the DEA form 41 and submit three copies of that form to the special agent in charge in their area. Form 41 is prepared in quadruplicate

What are the pharmacists CE requirements?

Thirty (30) hours of ACPE approved CE during each two year licensure period; waived for first renewal after initial licensure. CE must include 1 hour of sexual harassment prevention training

May a pharmacist dispense a prescription drug in a noncomplying package in response to a standing order from a physician that it be so dispensed?

This can be done only when it applies to refills of a prescription where the physician has prescribed noncomplying packaging for that prescription. However, a drug dispensed to the same person on a different prescription of the same or another prescriber must be dispensed in special packaging, unless the prescription directs the use of noncomplying packaging or the purchaser requests it.

When the doctor writes "medically necessary" on the script, what does that mean?

This is a phrase that is used to prevent substitution in some states for Medicare and Medicaid prescriptions. IT HAS NO MEANING UNDER ILLINOIS LAW. THEY MAY BE GETTING AT THE REQUIREMENT (IN SOME STATES AND UNDER MEDICAID) THAT THE BRAND NAME DRUG BE DISPENSED. If you get a question like this, answer that you need to call the doctor to obtain permission to dispense the generic.

The Ryan Haight registration addresses what issue?

This law is intended to address the issue of prescribing solely pursuant to an internet consultation, and is not directed to legitimate pharmacies that also have a website. Most retail and mail order pharmacies have websites that allow patients to order refills, including controlled substances. The Ryan- Haight registration requirements do NOT apply to these type of pharmacies.

What is the exception of prescriptions that can be dispensed while the pharmacist is on break?

Those prescriptions that require counseling by a pharmacist, including all new prescriptions and those refill prescriptions for which a pharmacist has determined that counseling is necessary

What are the two approaches of prescription filing systems

Three separate files - one for C-IIs, one for C-III, IV and Vs, and one for non-controlled legend drugs.; Two files - one for C-IIs and one for all others; if Schedules III, IV, and V controlled substances are filed with non-controls, the must be "readily retrievable" Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for non controlled substances. However, if a pharmacy employs a computer application then red C is waived

Under federal law, when is inventory taken?

To be taken biennially, on any date within two years of the previous biennial inventory.

What are requirements of an electronically transmitted prescription?

To maintain confidentiality, adequate security and systems safeguards designed to prevent and detect unauthorized access, modification or manipulation

What is the drug quality and security act part 503A?

Traditional compounding. If done properly, exempt from Food Drug and Cosmetic Act NDA, cGMP and labeling requirements, must operate in compliance with state law, patient specific prescription required

What are the requirements for a physical transfer?

Transferor must write VOID on face of transferred prescription, record on reverse side the name, address and DEA number of pharmacy to which it is transferred, and the name of the pharmacist receiving the transfer information, and record the date and name of the pharmacist transferring the information. Pharmacist receiving the transfer must write"TRANSFER"on the face of the prescription, and record (1) issuance date; (2) original number of refills authorized; (3) date of original dispensing; (4) number of valid refills remaining; (5) pharmacy's name, address, DEA number and original RX number; and (6) name of transferor pharmacist.

How long should you file your inventory records?

Two years

Under IL law, how long should DEA 106 forms be maintained?

Two years

Under federal law, how long should power of attorney authorization to sign order forms be maintained?

Two years

Under IL law, how long should records of disposal of controlled substances be maintained?

Two years, must retain DEA form 41

How should the purchaser prepare and execute a DEA form 222?

Typewriter, computer printer, pen, or indelible pencil

What are the requirements of initial licensure for pharmacists?

US citizen or legally admitted alien Graduate of an approved pharmacy school or program Application fee Completion of 400 hours of apprenticeship under the direct supervision of an IL registered pharmacist, fulfilled during clinical rotations while enrolled in pharmacy school Pass state board exam

Who governs all pharmaceutical compounding standards, both sterile and nonsterile?

USP-NF

What does breach mean?

Unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information, except where an unauthorized person to whom such information is disclosed would not reasonably have been able to retain such information.

Who maintains and supplies emergency kits?

Under the supervision of a pharmacist

What are the responsibilities of a student pharmacist?

Under the supervision of a pharmacist, assist in the practice of pharmacy and perform any and all functions delegated to him or her by the pharmacist.

How are medications stored in the automated dispensing and storage systems packaged?

Unit of use for single patient use (unit dose tab/cap, tube of ointment, inhaler,etc. )

Can registrants use existing stocks of triplicate DEA form 222?

Until October 30, 2021. As soon as they run out, they can use the new single sheet DEA form 222

What is a Class III Recall?

Use of or exposure to product is not likely to cause serious adverse health consequences.

What is a Class II Recall?

Use of or exposure to product may cause a temporary or medically reversible adverse health consequence, or where the probability of serious health consequences is remote.

What are examples of technical safeguards?

Uunique user ID, encryption, automatic time- out, audit log

What are "VAWD"?

VAWD means "verified accredited wholesale distributor", and is a "seal of approval" given to RX drug wholesale distributors. Again, the idea is that wholesalers that receive this accreditation meet certain standards set by the National Association of Boards of Pharmacy, and can be trusted. Also, several states (but not Illinois) include VAWD accreditation as a condition of licensure in their state, or will relax some of the pre-approval inspection requirements if a wholesaler is VAWD accredited.

What are "VIPPS"?

VIPPS means "verified accredited internet pharmacy provider", and is a "seal of approval" given to pharmacies that have an internet presence. The idea is that a pharmacy that appears on-line and has VIPPS accreditation meets certain standards set by the National Association of Boards of Pharmacy, and can be trusted.

Where does the pharmacy report vaccination adverse events?

Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider named by the patient.

What is required at time of application for licensure or renewal?

Valid address and email address to the department.

How can pharmacist give vaccinations?

Valid prescription, a standing order from a physician, or pursuant to hospital pharmacy and therapeutics committee policies and procedures.

What warning should be placed on iron products?

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Is IL an "opt in" or "opt out" state?

We are Opt-in state. It requires the patient to affirmatively enroll in the program. Some states have an "opt out" program, meaning that the pharmacy can enroll the patient, and the patient is required to opt out to stop receiving automatic refills

When does the PDMP report to prescribers that there is potential medication shopping?

When a person has been described as having 3 or more prescribers or 3 or more pharmacies that do not utilize a common electronic controlled substances w/in the course of a continuous 30-day period

When can investigational new drugs be authorized?

When authorized by the FDA and pursuant to a valid prescription of the principal physician investigator or his authorized clinician

What is the procedure of accessing medication in the absence of night cabinets or emergency kits?

When medication is removed from the pharmacy by an authorized nurse, a copy of the physician's order authorizing the removal of said medication shall be conspicuously placed in the pharmacy with the container from which the drug was removed so that it will be found by a pharmacist and checked promptly. A form shall be available in the pharmacy upon which shall be recorded the signature of the authorized nurse who removed the medication, the name, strength (if applicable) and quantity of medication removed.

When should new substances be inventoried?

When new substances are scheduled, they must be inventoried on the date of official scheduling

How should transferring pharmacy enter a prescription into its system when prescription information is transferred to another pharmacy for the purposes of original fill?

When prescription information is transferred to another pharmacy for the purposes of original fill, the transferring pharmacy must enter a prescription into its system as if that prescription were filled at that pharmacy.

What are procedures for transferor pharmacy?

When satisfied that request is valid and legal, transferor pharmacist shall provide information accurately and completely; shall record on face of RX the name of the transferee pharmacy and pharmacist and date of transfer; and shall cancel RX by writing "VOID" on its face. No further information shall be given or medication dispensed pursuant to original RX. If transferred RX is not picked up by patient, transferee pharmacist shall cancel RX and notify original pharmacy of same.

What are the special rules about substitution of anti-epileptic drugs?

When the prescribing physician has indicated on the original prescription "may not substitute", a pharmacist may not interchange an anti epileptic drug or formulation of an anti epileptic drug for the treatment of epilepsy without notification and the documented consent of the prescribing physician and the patient or the patient's parent, legal guardian, or spouse. This Section does not apply to medication orders issued for anti epileptic drugs for any in patient care in a licensed hospital. The gist is that for all other drugs, the doctor can prohibit substitution only by checking the "MNS" box. For anti-epileptics, however, the doctor can check the box or write "MNS" on the RX to prohibit substitution.

What are requirements when transferring a prescription that has an interchange in medication?

When transferring a prescription, pharmacists are to designate the prescriber's original intent concerning drug product selection on every prescription record transferred to another pharmacy, irrespective of the method of transfer. The receiving pharmacy shall record the prescriber's drug product selection intent on the original prescription record of the transferred prescription.

What are the security requirements in a pharmacy?

Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area) must be secured and inaccessible to non-licensed persons (employees and public). This may be accomplished by measures such as walling off, locking doors or electronic security equipment, as approved by the Division. Schedule II drugs shall be secured in rooms, vaults, safes, cabinets, etc., under lock, whether by key, combination or electronically. Schedule II drugs shall not be distributed among regular stock.

If you see an impaired pharmacist on the job, who must you notify? Who would discipline the impaired pharmacist?

While there is no duty to notify anyone, the best answer would be to report the conduct to the Department of Financial and Professional Regulation. IDFPR is also the entity that would discipline the impaired pharmacist. Remember also that you could be disciplined if you do not report, based on the theory that you have aided and assisted the pharmacist in his violation of the law, who violated the law by working while impaired. Any time questions appear on the exam that ask whether conduct could subject the pharmacist to discipline, think of the enumerated grounds for discipline, but in a close question, err on the side of choosing the answer that says yes, the pharmacist can be disciplined.

What is central record keeping?

With appropriate notice to DEA, pharmacies may arrange to have financial and shipping records (such as invoices and packing slips but not executed 222 order forms) maintained at a central location, rather than at the registered location.

What are requirements for tamper resistant packaging?

With few exceptions, OTC drug products must have one or more barriers to entry that, if breached or missing from the package, provide consumers with evidence that tampering may have occurred. Packages must contain unique designs or other characteristics that typically cannot be duplicated. Additionally, to alert the consumer to the specific tamper-evident features, the retail package must contain a statement that identifies the feature, is prominently placed on the package, and is placed in a way that it will be unaffected if the tamper-evident feature is missing or breached. For example, the statement on a bottle with a shrink band might say, "For your protection, this bottle has an imprinted seal around the neck."

Where should new substances that are scheduled be filed?

With most recent inventory

Can a pharmacist dispense naloxone?

With written, standardized procedures or protocols developed by the Department with the Department of Public Health and the Department of Human Services if the procedures or protocols are filed at the pharmacy before implementation and are available to the Department upon request.

How soon does the DPR have to approve or disapprove closing inventory procedures?

Within 30 days of receipt of pharmacist's statement 30 days

How soon should a hard copy printout be provided to the division upon request of refill data?

Within 48 hours

If a licensee or registrant is disciplined in another state, how soon do you have to notify the division?

Within 60 days

When inspectors request information, what is the turn-around time that the pharmacy must send information to them by?

Within 60 days

When should a written CS prescription for the emergency quantity prescribed be delivered to the dispensing pharmacist?

Within 7 days after issuing an emergency prescription, the prescriber shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.

How soon should one notify the DEA for a controlled substance theft or loss?

Within one business day of discovery of a theft or significant loss of controlled substances, a pharmacy must contact the nearest DEA Diversion Field Office by telephone, facsimile or by a brief written message explaining the circumstances.

Where should the electronic device in the pharmacy that receives the electronically transmitted prescription be located?

Within the pharmacy area

Is ipecac syrup available with or without a prescription?

Without prescription if it is packaged in a quantity of 1 fluid ounce (30 ml) and has specific labeling

What kind of prescriptions are required for schedule II controlled substances?

Written (no verbal or fax)

What is a pre-printed prescription?

Written RX in which the drug name has been indicated prior to the time of issuance, including any pre-inked stamp that would be applied to a RX blank

What is an "ongoing relationship"?

Written agreement between manufacturer and distributor

What must occur when a medication is removed from the after hour cabinet?

Written physician's orders authorizing the removal of the medication shall be placed in the cabinet or enclosure. A log shall be maintained within the cabinet or enclosure and authorized personnel removing medication shall indicate on the log the signature of the authorized personnel removing the medication, name of the medication removed, the strength (if applicable), the quantity removed and the time of removal.

What are requirements in order to for disposal or destruction by pharmacy?

Written request to DEA requesting permission to destroy the controlled substances, proposing a date and method of destruction and listing the names of at least two people who will witness the destruction

What is a prescription?

Written, oral, facsimile, or electronically transmitted order for drugs or medical devices, issued by a physician, dentist, veterinarian, or podiatrist, or optometrist, within the limits of their licenses, by a physician assistant, or by an advanced practice nurse

How should the inventory be taken?

Written, typed, or printed format, provided that all the descriptive requirements are met. If a tape recorder is used, it must be promptly transcribed and reduced to writing

Is it important to be familiar with various types of insulin?

YES! Become familiar with various types of insulin, and be able to identify which require a prescription, and which insulins do not (Humilin brand insulin)

May a doctor who has been treated for addiction, or is presently undergoing treatment for addiction, prescribe controlled substances?

YES, unless the doctor is the subject of a disciplinary order that prohibits it, or has had his state controlled substance license or DEA registration suspended or revoked.

Can a pharmacist who has been treated for addiction, or is presently undergoing treatment for addiction, prescribe controlled substances?

YES, unless the pharmacist is the subject of a disciplinary order that prohibits it.

What if the doctor dates the three prescriptions "5/20/18", but writes on the second RX "do not fill until 6/19/18" and on the third "do not fill until 7/19/18". Would these RXs be valid?

YES. Remember that in the past, a CII RX was valid for 7 days from the date of issuance, regardless of the date that is written on the RX, or any instructions by the prescriber asking that the prescription be filled at a later date. The result was that this type of prescribing would not work, because when the patient appeared at the pharmacy on 6/19, the RX would have expired. Now, Illinois law provides that a CII RX expires 90 days after the date of issuance, so these prescriptions are valid. The DEA also endorses this practice.

How often must a laminar air flow hood be certified?

Yearly

Are patients permitted to destroy controlled substances themselves?

Yes

Are pharmacies permitted to sell poisons?

Yes

Can CII prescriptions be electronically prescribed by a practitioner?

Yes

Can IL pharmacies fill a valid prescription transmitted by an out of state prescriber?

Yes

Can IL pharmacies fill or refill valid prescriptions on file in a licensed pharmacy in another state?

Yes

Can a practitioner outside a narcotic treatment program prescribe methadone or any other narcotic to a narcotic addict for analgesic purposes?

Yes

Can a supplier of special packaging include an equal number of noncomplying closures with each carton of complying packaging shipped to pharmacies?

Yes

Can agents prepare a CS RX for a practitioner's signature?

Yes

Can an automated dispensing and storage system be used as an after hour cabinet?

Yes

Can an automated dispensing and storage system be used as an emergency kit?

Yes

Can law enforcement agencies take back controlled substances?

Yes

Does each type telepharmacy need a separate licensed pharmacy?

Yes

Does the same rule apply to drugs dispensed in dropper bottles?

Yes

If a product such as insulin is frozen then thawed out, it's adulterated, right?

Yes

If the Rx is partially filled, and remaining quantity is filled within 72 hours, can the patient still pick it up after the 72 hours has passed?

Yes

If the package by the manufacturer with a safety cap, should it be dispensed with a safety cap?

Yes

In a non-retail setting, do all pharmacists practice at a remote pharmacy have to be licensed in IL?

Yes

In federal law, are returns to distributor or manufacturer permitted?

Yes

Is faxing CIII-V okay?

Yes

Is medication shopping illegal?

Yes

Is the NDC number required on all OTC products?

Yes

When Doctors are ordering a CII controlled substance "for office use", do they need to fill out a DEA 222?

Yes

Are inspections and information obtained during an investigation confidential?

Yes - All information collected by the Department in the course of an examination or investigation of a licensee or applicant, including, but not limited to, any complaint against a licensee filed with the Department and information collected to investigate any such complaint, shall be maintained for the confidential use of the Department and shall not be disclosed. The Department may not disclose the information to anyone other than law enforcement officials, other regulatory agencies that have an appropriate regulatory interest as determined by the Secretary, or to a party presenting a lawful subpoena to the Department. Information and documents disclosed to a federal, State, county, or local law enforcement agency shall not be disclosed by the agency for any purpose to any other agency or person. A formal complaint filed against a licensee by the Department or any order issued by the Department against a licensee or applicant shall be a public record, except as otherwise prohibited by law.

Under federal law, can remaining portions of partially filled prescriptions for CII be filled?

Yes as long as it is no later than 30 days after the date on which the prescription is written

Can the PSE and EPH logs be electronic?

Yes as long as it maintains all rules

Can electronic prescriptions of controlled substances be filled?

Yes as long as prescribed is authorized

Can a prescriber specific that no safety caps to be used?

Yes but only applies to individual prescription, cannot make blanket waiver

Can MDs and DOs prescribe outside area of specialization?

Yes but read fact patterns carefully. Dentists, veterinarians, optometrists, podiatrists - all have more limited scopes of practice.

Does IL allow electronic prescription?

Yes provided that the system used to transmit the rx to the pharmacy complies with all federal requirements (there is a lot, just read them on pg 35)

Does RAPS have to be licensed?

Yes with the division

Are prescriptions issued by prescribers licensed and located in a US territory or a foreign country valid in IL?

Yes, US territories include Puerto Rico, Guam, and US Virgin Island

Are pharmacies required to let customers know of less expensive alternatives to their medications?

Yes, a pharmacist or authorized employee is required to inform customers of a less expensive, generically equivalent drug product for her or his prescription and whether the cost-sharing obligation to the customer exceeds the retail price of the prescription in the absence of prescription drug coverage.

Can the electronically transmitted prescription serve as the record of prescription?

Yes, as long as the electronically submitted prescription can be stored and is readily retrievable so as to comply with federal and State record keeping requirements.

Can a dispenser voluntarily limit their DEA registration?

Yes, by selecting only certain schedules when completing the DEA registration application or renewal

Can pharmacies be registered multiple times with the federal DEA?

Yes, depending on their activity

Can DPR refuse to issue license of owner?

Yes, if owner applying for license owned store which previously had license revoked, unless rehabilitation shown If complaint filed against store previously owned by applicant owner, DPR may refuse to issue license, or approve change of ownership, or change of location, until decision rendered If previous pharmacy closes for any reason while a complaint is pending, and owner applies for license for new pharmacy, DPR shall conduct hearing on previous complaint even if prior pharmacy is no longer licensed. If prior conduct would result in revocation, new application will be denied.

Can a patient indicate that they do not want a safety cap?

Yes, may provide blanket authorization for non-child resistant caps. However, authorization for a single prescription cannot be used to justify use of a non-child resistant cap for future prescriptions. No special form required. No signature required.

Are military/department of defense exempt from registration?

Yes, practitioners are exempt from registration under state law. For prescriptions issued by these practitioners, his/her branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and his/her DOD identification number, in lieu of the license number of the practitioner required by this Part. The DOD identification number for a Public Health Service practitioner is his or her social security identification number. Each prescription shall have the name of the officer stamped or printed on it, as well as the signature of the officer.

Is a pharmacist permitted to have customer acknowledge receipt of the notice by signing or initialing the log book that they already sign when they pick up prescriptions?

Yes, provided that the individual is clearly informed on the log book of what they are acknowledging and the acknowledgment is not also used as a waiver or permission for something else that also appears on the log book (such as a waiver to consult with the pharmacist). The HIPAA Privacy Rule provides covered health care providers with discretion to design an acknowledgment process that works best for their businesses.

May I, as a hospital pharmacist, dispense a regulated drug in a conventional package for use by a patient in the hospital?

Yes, provided that the patient is confined in the hospital. Drugs dispensed for outpatient use must be packaged in accordance with the applicable regulations for special packaging.

May controlled substances be electronically prescribed by a practitioner?

Yes, provided that the system used for transmitting the prescription complies with federal DEA regulations, and the prescription is valid under federal law. This includes CII prescriptions.

Are transfer from out of state pharmacies permitted?

Yes, subject to IL rules

Can technicians sell EPH and PSE products?

Yes, that includes obtaining the required identification and patient signature

May an individual request that all of his/her prescriptions be filled in conventional (non-special) packaging?

Yes, the law does not preclude a pharmacist from relying upon a specific request from a patient to have all of his/her medications placed in non-special packaging. Many pharmacies choose to have this request in writing, i.e., a blanket waiver. However, a single request from a patient to dispense a specific prescription in non-special packaging is not a basis for the pharmacist to infer the patient wants all subsequent prescriptions to be dispensed in non-special packaging. Such a request is not a blanket waiver. A patient who previously requested blanket non-special packaging may later change his/her mind about the use of such packaging because of changing personal circumstances, but may not remember to inform the pharmacist of the change in packaging preference. It is a prudent practice for the dispensing pharmacist to periodically check with all patients who have blanket waiver requests on file to ensure that noncomplying packaging continues to be the preferred packaging choice for the patients' prescription drugs.

Are partial fills on CIII-V prescriptions permitted?

Yes, they should be recorded on rx and six month time limitations still applies

Is it correct that according to the FDA, if you take OTC products and repackage them and then sell them WITHOUT A PRESCRIPTION, you need a manufacturer's license.

Yes, unless it is a hospital that is re-packaging for its own internal use. Of course, if you are presented with a prescription for an OTC product, that is not re-packaging, that is dispensing.

Can the DEA limit a dispenser's registration?

Yes, when the DEA believes that continued registration in all categories is inconsistent with the public interest

Can physician assistants prescribe in IL?

Yes, within the limits of their license. PA must have written supervision agreement with the delegating physician. For scheduled drugs, they must obtain mid-level practitioner controlled substance license

Can Podiatrists prescribe in IL?

Yes, within the limits of their licenses

Can dentists prescribe in IL?

Yes, within the limits of their licenses

Can optometrist prescribe in IL?

Yes, within the limits of their licenses

Can physicians prescribe in IL?

Yes, within the limits of their licenses

Can veterinarians prescribe in IL?

Yes, within the limits of their licenses

Can advance practice nurse prescribe in IL?

Yes, within the limits of their licenses. Must have collaborating physician to delegate prescriptive authority. To prescribe scheduled drugs, must obtain a mid-level practitioner controlled substance license

Can a patient have a friend or family member pick up a prescription for her?

Yes. A pharmacist may use professional judgment and experience with common practice to make reasonable inferences of the patient's best interest in allowing a person, other than the patient, to pick up a prescription. For example, the fact that a relative or friend arrives at a pharmacy and asks to pick up a specific prescription for an individual effectively verifies that he or she is involved in the individual's care, and the HIPAA Privacy Rule allows the pharmacist to give the filled prescription to the relative or friend. The individual does not need to provide the pharmacist with the names of such persons in advance.

Can random inspections occur in RAPS?

Yes. A pharmacist with access to the system must be available at the site within one hour

Are pharmacies required to provide price information to customers?

Yes. Current usual and customary retail price disclosure. Upon request, a pharmacy must disclose the current usual and customary retail price of any brand or generic prescription drug or medical device that the pharmacy offers for sale to the public. This disclosure requirement applies only to requests made in person or by telephone for the prices of no more than 10 prescription drugs or medical devices for which the person making the request has a prescription. Prices quoted are for informational purposes only and are valid only on the day of inquiry. The requests must specify the name, strength and quantity of the prescription drug.

Can a physician simply check a box on a prescription blank to indicate to the pharmacist that a drug be dispensed in noncomplying packaging?

Yes. However, the CPSC staff discourages the use by physicians of prescription blanks having a box to check for noncomplying packaging, on the basis that the practice would tend to encourage excessive use of noncomplying packaging.

Can advance practice nurses and physician assistants use institution's DEA registration to prescribe controlled substances?

Yes. In a licensed hospital, hospital affiliate, or licensed ambulatory surgical treatment center ("institution") a licensed advanced practice nurse or a physician assistant may be granted clinical privileges, including the authority to select, order and administer, and issue discharge prescriptions for, controlled substances under the DEA registration number of the hospital, hospital affiliate or licensed ambulatory surgical treatment center by whom he or she is employed.

Can a doctor or pharmacy be paid to make a prescription refill reminder without a prior authorization under the HIPAA Privacy Rule?

Yes. It is not marketing for a doctor to make a prescription refill reminder even if a third party pays for the communication. The prescription refill reminder is considered treatment and is therefore excluded from the definition of marketing and does not require a prior authorization. Similarly, it is not marketing when a doctor or pharmacy is paid by a pharmaceutical company to recommend an alternative medication to patients. Communications about alternative treatments are excluded from the definition of marketing and do not require a prior authorization. The simple receipt of remuneration does not transform a treatment communication into a commercial promotion of a product or service. However, a covered entity would require an authorization if it sold protected health information to a third party for the third party's marketing purposes.

Must inspectors be pharmacists?

Yes. Note that Illinois law has changed, and inspectors are once again required to be pharmacists. However, inspectors who were not pharmacists, if hired before the law took effect in August 2015, can continue to be inspectors.: Each pharmacy investigator shall be a licensed pharmacist unless employed as a pharmacy investigator on or before August 27, 2015

Are Investigational New Drugs (INDs) subject to the PPPA standards?

Yes. Oral INDs are subject to the oral prescription drug regulation, if the IND is a drug that is for oral administration to humans, can be dispensed only on or by an order of a licensed medical practitioner, and is to be dispensed directly to the patient. Such drugs must be packaged in a special package except as described at http://www.cpsc.gov/BUSINFO/trials.pdf. In addition, if INDs contain any substances regulated under any of the other PPPA regulations, they would be required to be packaged in special packaging if they are dispensed for household use.

I know of several physicians who dispense prescription drugs for a fee. Are they subject to the provisions of the PPPA?

Yes. Physicians who dispense drugs (including drug samples), are, and always have been, subject to the regulations under the PPPA. It is important to note, however, that for the purpose of accommodating elderly and disabled consumers who have difficulty using special packaging, Section 4(b) of the PPPA gives medical practitioners the authority to specify conventional packaging for drugs they prescribe.

If a drug is dropped on the ground, is it adulterated?

Yes. See the definition of adulteration in the notes. Even if you have a clean floor, the drug could become contaminated, and is therefore adulterated. Actual contamination is not required for a finding of a violation.

Are licensed personnel permitted in the pharmacy when the pharmacist is not present?

Yes. Technicians are considered licensed personnel

Can health care providers engage in confidential conversations with other providers or with patients, even if there is a possibility that they could be overheard?

Yes. The HIPAA Privacy Rule is not intended to prohibit providers from talking to each other and to their patients. Provisions of this Rule requiring covered entities to implement reasonable safeguards that reflect their particular circumstances .... The Privacy Rule also recognizes that overheard communications in these settings may be unavoidable and allows for these incidental disclosures.

Can a pharmacist use protected health information to fill a prescription that was telephoned in by a patient's physician without the patient's written consent if the patient is a new patient to the pharmacy?

Yes. The pharmacist is using the protected health information for treatment purposes, and the HIPAA Privacy Rule does not require covered entities to obtain an individual's consent prior to using or disclosing protected health information about him or her for treatment, payment, or health care operations.

Does anything happen to you for the few days that you were practicing without a valid license?

You are subject to discipline for practicing without a license.

Under federal law, can you change the date of a CII RX?

You can add a date, but cannot change a date once it has been placed on the rx by prescriber

What are the requirements for refilling a prescription for glass bottles?

You can use glass container, but the plastic cap must be replaced

What is a terminal?

a patient whose medical condition indicates his/her life expectancy to be 6 months or less.

What is a compounded sterile preparation?

a sterile pharmaceutical that has been prepared by a pharmacist, or under the supervision of a pharmacist. It shall be a preparation prepared for or in anticipation of a specific patient prescription or medication order issued by a prescribing practitioner. The preparation may include commercially available dosage forms that may need to be altered by the pharmacist to meet a specific patient's need.

What is a drug sample?

a unit of prescription drug that is not intended to be sold and is intended to promote the sale of the drug. Samples may only be distributed by a practitioner licensed to prescribe, or to the pharmacy of a hospital or health care entity (at the written request of a prescriber)

What is de-identification?

all the following must be removed or need statistician's opinion that inclusion of the data element will provide only very small risk that the person can be identified such as name, address, date of birth, telephone numbers, etc.

What is a barrier isolation chamber?

an appartus designed to provide a Class 5, 6 or 7environment as spelled out in the ISO 14644-1 for preparation of sterile products using solid walls rather than air movement (laminar air flow) to create a critical zone for product handling, a HEPA filtration system that conditions the air flowing through the unit to remove initial particles and particles generated within the controlled environment, and a means by which products are introduced and people interact with the product being prepared within the unit.

What is a medicine locking closure package?

any alphanumeric combination locking closure mechanism that can only be unlocked with a user-generated, resettable alphanumeric code in combination with an amber prescription container that forms a package that allows only the person with a prescription access to the medicine.

What is a laminar airflow hood?

appartus designed to provide a Class 5, 6 or 7 environment as spelled out in the ISO 14644-1 for preparation of sterile products using air circulation in a defined direction that passes through a HEPA filter to remove the initial particles and particles generated within the controlled environment.

How soon do customers of the closure have to notified in advance of the closing date and where the customer's records will be maintained?

at least 15 days

What are PIC responsibilities of a telepharmacy?

be responsible for the practice of telepharmacy performed at a remote pharmacy, including the supervision of any prescription dispensing machine or automated medication system; ensure that the home pharmacy has sufficient pharmacists on duty for the safe operation and supervision of all remote pharmacies; ensure, through the use of a video and auditory communication system, that a certified pharmacy technician at the remote pharmacy has accurately and correctly prepared any prescription for dispensing according to the prescription; be responsible for the supervision and training of certified pharmacy technicians at remote pharmacies who shall be subject to all rules and regulations; and ensure that patient counseling at the remote pharmacy is performed by a pharmacist or pharmacist intern

What is an interchangeable biological product?

biological product that the United States Food and Drug Administration: (1) has (A) licensed and (B) determined it to meet the standards for interchangeability pursuant to 42 U.S.C. 262(k)(4); or (2) has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the United States Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

What are requirements for a pharmacist to be immunizer?

complete a course of training accredited by ACPE or similar health authority or professional body approved by the Division current Basic Life Support Certification for Healthcare Providers issued by the American Heart Association or the American Red Cross.

What is a biological safety cabinet?

containment unit suitable for the preparation of low to moderate risk agents when there is a need for protection of the product, personnel and environment

Patient John Smith brings in a prescription for Prozac 20mg QTY #30, with 3 refills. The patient, who has a history of suicidal behaviors, would like a quantity of 90 and the insurance will pay for it. You should: a) Fill it for 90 b) Fill it for 30 c) Call the insurance company d) Call the MD and ask if it is ok before dispensing 90

d) Call the MD and ask if it is ok before dispensing 90 The best answer is D under Illinois law. Although you can legally fill it for #90, given the "hint" about suicidal tendencies, the best answer would be to get the MD's approval. The same analysis should be used if the drug is a controlled substance. Legally, you can combine refills, but if the question suggests that contacting the MD is an option, that would be the best response. The answer implies that you are getting consent from the MD, and you can assume that if consent is given, you are changing the prescription. B is also correct, since you "can" dispense 30 like the Rx says, but it is not the best answer. If the drug was changed to Lasix, for example, and there were facts that showed the patient has been on the medication and has been compliant, your answer might be different. The law is that you are not required to get the prescriber's permission, but you MUST always use professional judgment, and act in the best interest of the patient.

What are labeling requirements for compounded drug dispensed to patients?

i) Name, address and telephone number of the licensed pharmacy, if not used within the facility; ii) Date dispensed and identifying number, if used off site; iii) Patient's name and room number, if applicable; iv) Name of each drug component, strength, amount and dosage form; v) Directions for use and/or infusion rate, if used off site; vi) Prescriber's name, if used off site; vii) Required controlled substances transfer warnings, when applicable; viii) Beyond-use date, and time if appropriate; ix) If used offsite, identity of compounding and dispensing pharmacist or other authorized individual; and x) Auxiliary label with storage requirements, if applicable.

What is the minimum information required for a patient profile or medication record system?

i) Patient's name; ii) Date of birth or age; iii) Gender; iv) Compounded sterile drugs dispensed; v) Date dispensed, if off site; vi) Date compounded; vii) Drug content and quantity; viii) Patient directions, if drug is administered off site; ix) Other drugs or supplements the patient is receiving, if provided by the patient or his or her agent; and x) Known drug sensitivities and allergies to drugs and foods.

What are automated dispensing and storage systems?

i.e. pyxis and omnicell mechanical systems that perform activities other than counting, compounding, or administration, relative to the storage, packaging or dispensing of medications and which collect, control, and maintain all transaction information

When can new prescriptions or refill prescriptions that the pharmacists has determined that counseling is necessary can be dispensed when the pharmacist is on break?

if the patient or other individual who is picking up the prescription on behalf of the patient declines to wait, a telephone number at which the patient or other individual who is picking up the prescription on behalf of the patient can be reached is obtained; after returning from the break, the pharmacist makes a reasonable effort to contact the patient or other individual who is picking up the prescription on behalf of the patient and provide counseling the pharmacist documents the counseling that was provided or documents why counseling was not provided after a minimum of 2 attempts, including a description of the efforts made to contact the patient or other individual who is picking up the prescription on behalf of the patient; the documentation shall be retained by the pharmacy and made available for inspection by the Board or its authorized representatives for at least 2 years.

When can pharmacist use alternative forms of patient information?

if, in the pharmacist's professional judgment, oral counseling is not practicable for the patient or patient's agent

Under Illinois law, what are the reporting requirements for exempt narcotics?

maintain records for 2 years and send copy to IDPR by 15th of next month

Can a pharmacist that is electronically sharing real-time on line computerized systems have transfer limits for Control III-V drugs?

may transfer up to the maximum refills permitted by law and the prescriber's authorization. There has been a change in the law. The "transfer" of a prescription between pharmacies that share a common database is no longer considered a transfer. This means: (1) technicians can effectuate the transaction, and (2) there is no limit on the movement of controlled substance prescriptions.

What does dispense or dispensing mean?

means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to or use by a patient in accordance with applicable State and federal laws and regulations

What are business associates of CE's?

o A person or entity that performs services on behalf of a CE and which needs to receive, use, or disclose PHI in order to perform those services. o Business Associate must enter into a Business Associate Agreement with its Covered Entity, containing various required terms

What is the procedure for notifying a breach?

o Business associate to notify Covered Entity of breach it causes o Covered Entity to notify patient without unreasonable delay, but not later than 60 days after discovery by CE o Media notice required if the unsecured PHI of more than 500 people reasonably believed to have been, accessed, acquired, or disclosed during the breach.

How does the special agent in charge authorize and instruct to dispose of the controlled substances?

o By transfer to person registered under the Act and authorized to possess the substance o By delivery to an Agent of the Administration or to the nearest office of the Administration o By destruction in the presence of an Agent of the Administration or other authorized person; or o By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons.

What is the minimum necessary standard?

o CE or BA must make reasonable efforts to limit use or disclosure of PHI to the minimum necessary to accomplish the intended purpose of the use of the information. o For use and disclosure on a routine and recurring basis, provider must establish protocols that state what information is necessary for that purpose o For non-routine requests, must allow for individual review of the request to determine minimum amount of information used or disclosed to meet the purpose o Not applicable to TPO

What are the requirements of multiple/sequential CII prescriptions?

o Each prescription issued is for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice. o The individual practitioner must provide written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription. o The issuance of multiple prescriptions is permissible under applicable state laws. o The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and implementing regulations, as well as any additional requirements under state law.

What are covered entities?

o Health care providers that transmit any health information in electronic form for billing purposes o Health plans o Health care clearinghouses

What is the notice of privacy practices?

o In order to use or disclose PHI without the patient's specific written authorization, the CE must provide patient with Notice of Privacy Practices, which describes the specific ways in which it may use or disclose PHI and of other patient rights.

What is individually identifiable health information?

o Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and o Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and o That identifies the individual; or o With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

What are requirements that must be met to have a laminar airflow hood workstation?

o Laminar airflow equipment shall be certified annually in accordance with ISO 14644-1. o In the event the preparation apparatus is moved from its site of certification, recertification shall occur. o Prefilters must be replaced or cleaned monthly and documentation of this maintained

What should be included in the DEA form 106?

o Name and address of firm (pharmacy). o DEA registration number. o Date of theft (or when it was discovered if known). o Name and telephone number of local police department if notified. o Type of theft (night break in, armed robbery, etc.). o Listing of symbols or cost code used by pharmacy in marking containers (if any). o Listing of controlled substances missing from theft or significant loss.

What must be documented if a medication is removed from the system from on-site administration?

o Name of the patient or resident; o Patient's or resident's unique and permanent identifier, such as admissions number or medical records number; o Date and time medication removed from the system; o Name, initials, or other unique identifier of the person removing the drug; and o Name, strength and dosage form of the drug or description of the medical device removed. The documentation may be on paper, via electronic media or via any other media or mechanisms as set forth by the Act or this Part or as approved by the DPR.

What are labeling requirements for sterile solutions to which drugs have been added for medications for future use inside the institution or facility and not intended for immediate dispensing to a specific patient?

o Name, concentration and volume of the base sterile solution; o Name and strength of drugs added; o Beyond use date and time of the admixture; o Reference code to identify source and lot number of drugs added.

What are label requirements of sterile solutions to which a drug or diluent has been added, or which are not in their original manufacturer's packaging?

o Name, concentration and volume of the base sterile solution; o Name and strength of drugs or diluent added; o Date and beyond use date of the admixture. The beyond use date, unless otherwise specified in the individual compendia monograph, shall be no later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged; and Reference code to identify source and lot number of drugs or diluent added.

What are the patient's rights in HIPAA?

o Patient has right to request copies of his or her PHI, o Patient has right to request amendment of PHI

What kind of policies and procedures must be included in the manual of remote prescription/medication order processing?

o Protecting the confidentiality and integrity of patient information; o Ensuring that pharmacists performing remote prescription /medication order processing have access to appropriate drug information resources; o Ensuring that medical and nursing staff when appropriate, understand how to contact a pharmacist; o Maintaining records to identify the name, initials, or identification code of each pharmacist who performs any processing function; o Complying with federal and State laws and regulations; o Operating or participating in a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; o Reviewing the written policies and procedures and documenting the review annually.

What if there is question on accuracy, relevance, or completeness of any submitted documentation because of lack of information, discrepancies or conflicts in information given?

o Provide information as may be necessary o Appear for an interview before the Board to explain the relevance or sufficiency, clarify information given, or clear up any discrepancies or conflict of information.

What are requirements for written authorization?

o Required for non-TPO disclosures o Must be in writing o Must be separate from acknowledgment of Notice of Privacy Practices

What are limits for prescribing Schedule II CS for APRNs?

o Specific Schedule II controlled substances by oral, topical or transdermal application only may be delegated, provided that the delegated Schedule II controlled substances are routinely prescribed by the collaborating physician or podiatrist. o This delegation must identify the specific Schedule II controlled substances by either brand name or generic name. Schedule II controlled substances to be delivered by injection or other route of administration may not be delegated.

How does one obtain a MLP controlled substance license in IL?

o State PA or APN license number; o License number and CS number of the delegating physician; o A "notice of delegation of prescriptive authority", signed by the physician indicating the schedule of CS the MLP may prescribe or dispense.o DEA registration and state CS license will be limited to those schedules delegated by supervising physician.

What is included in the hard copy printout of each day's refill data?

o The name and dosage form of the drug o The date of each refilling; o The quantity dispensed; o The name or initials of the pharmacist in each refilling and the pharmacy technician, if applicable o The patient's name o The prescriber's name; and o The prescription number for the prescription;

What must be reported in the PMP?

o The patient's name. o The patient's address. o The patient's date of birth o The patient's gender o The national drug code (NDC) number of the controlled substance dispensed. o The date the controlled substance is dispensed. o The quantity of the controlled substance dispensed and days supply. o The dispenser's US Drug Enforcement Administration (DEA) registration number. o The prescriber's US DEA registration number. o The dates the controlled substance prescription is filled. o The payment type used to purchase the controlled substance (i.e. medicaid, cash, 3rd party insurance) o The patient location code (ex. Home, nursing home, etc) for the controlled substance other than those filled at a retail pharmacy. o Any additional information required by administration rule for instance that includes information required for compliance with the criteria for electronic reporting. o DHS may by rule require that additional information be reported, and may also require reporting of other select drugs that are not included in Schedule II, III, IV, or V.

What should be included in electronically transmitted prescription?

o The transmitting prescriber's facsimile number, if applicable o The time and date of the transmission o The identity of the person sending the prescription; o The address and contact information of the person transmitting the prescription.

What are labeling requirements of non-parenterals repackaged for future use in automated dispensing and storage systems?

o Trade and/or generic name; o ii) Strength (if applicable) o iii) Beyond use date. Unless otherwise specified in the individual monograph, the beyond use date shall be no later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged o iv) Reference code to identify source and lot number.

What are limits for prescribing controlled substances for APRNs?

o any delegation must be of controlled substances prescribed by the collaborating physician or podiatrist o all prescriptions must be limited to no more than a 30-day supply, with any continuation authorized only after prior approval of the collaborating physician or podiatrist o the APRN must discuss the condition of any patients for whom a controlled substance is prescribed monthly with the delegating physician or podiatrist or in the course of review as required by the Nurse Practice Act;

What are information of records and/or electronic data that are kept by automated dispensing and storage systems?

o identity of system accessed; o identification of the individual accessing the system; o type of transaction; o name, strength, dosage form and quantity of the drug accessed; o name of the patient for whom the drug was ordered; o identification of the registrants stocking or restocking and the pharmacist checking for the accuracy of the medications to be stocked or restocked in the automated dispensing and storage system o such additional information as the pharmacist-in-charge may deem necessary.

How can a pharmacy technician participate in patient counseling?

o obtaining medication history o providing the offer for counseling by a pharmacist or intern o acquiring a patient's allergies and health conditions.

What information must be provided to DPR about the installation or removal of an automated storage and dispensing system?

o the name and address of the pharmacy; o the address of the location of the automated dispensing and storage system, if different from the address of the pharmacy; o the automated dispensing and storage system's manufacturer and model; o the pharmacist-in-charge; and o a written description of how the facility intends to use the automated storage and dispensing system.

What are examples of patient counseling?

obtaining a medication history; acquiring a patient's allergies and health conditions; facilitation of the patient's understanding of the intended use of the medication; proper directions for use; significant potential adverse events; potential food-drug interactions; and the need to be compliant with the medication therapy.

Can commercially available products be compounded?

only if: -the commercial product is not reasonably available from normal distribution channels in a timely manner to meet the patient's needs -and the prescribing practitioner has requested that the drug be compounded.

Precisely what does the term "special packaging" mean?

packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance within a reasonable time and not difficult for normal adults to use properly

What is a parenteral?

sterile preparations of drugs for injection through one or more layers of the skin.

What are products exempt from PPPA?

sublingual nitroglycerin tablets; sublingual and chewable isosorbide dinitrate tablets in doses of 10 mg. or less; effervescent aspirin or acetaminophen tablets; oral contraceptives packaged in "dial-packs"; unit dose potassium supplements; cholestyramine and colestipol powder; aerosol inhalation products.

What if the registrant is required regularly to dispose of controlled substances?

the Special Agent in Charge may authorize the registrant to dispose of such substances without prior approval of DEA in each instance, on the condition that (1) the registrant keep records of such disposals and (2) file periodic reports with the Special Agent in Charge summarizing the disposals made by the registrant. In granting such authority, the DEA Special Agent in Charge may place such conditions as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports. Must also follow all of the other requirements set forth above (witnesses, completion of form 41, etc.)

What is the license under the pharmacy act that does not expire like the rest of the others?

the certificate of registration as a pharmacy technician expires annually

How do you access medication in absence of night cabinets or emergency kits?

the drug may be obtained from the pharmacy in sufficient quantity to meet the immediate need by a nurse authorized by the PIC.

What happens if a doctor prescribes conventional alcohol?

there is no law that precludes a pharmacy from selling the alcohol pursuant to the prescription. However, for non- prescription, retail sales of alcohol, the pharmacy must have a retail liquor dealer's stamp from ATF, and will also likely need a liquor license issued by the local government (city, village, county, state) where the pharmacy is located.

How soon do you have to notify them and forward the DPR a copy of the closing inventory?

within 30 days

What are the exceptions to authorization- authorization is not required for certain types of non TPO uses or disclosures?

• Fundraising - may use or disclose demographic information and dates of health care when raising funds for itself • Face-to-face encounters • Communications involving promotional gifts of nominal value • Communications involving treatment, provider's services, DSM, or coordination of care • Communications concerning general health issues

How do you determine validity of prescription?

• It is in accordance of prescribers intent • Prescriber • In all cases pharmacist can exercise professional discretion to fill, or to refuse to fill, a prescription issued by an out-of-state prescriber.

Authorization is required for what following types of uses/disclosures?

• Marketing - communication about product or service that encourages recipient to purchase or use the product or service • Fundraising - when raising funds for entity other than itself • Employment determinations (pre-employment physicals/drug screens) • Pre-enrollment underwriting • Psychotherapy notes • Any other non-TPO purpose

Can contractors (business associates) use protected health information for their own marketing purposes?

• No. While covered entities may share protected health information with their contractors who meet the definition of "business associates" under the HIPAA Privacy Rule, that definition is limited to contractors that obtain protected health information to perform or assist in the performance of certain health care operations on behalf of covered entities. Thus, business associates, with limited exceptions, cannot use protected health information for their own purposes. • Further, the Privacy Rule expressly prohibits health plans and covered health care providers from selling protected health information to third parties for the third party's own marketing activities, without authorization. So, for example, a pharmacist cannot, without patient authorization, sell a list of patients to a pharmaceutical company, for the pharmaceutical company to market its own products to the individuals on the list.

What is the HIPAA security rule?

• Only applies to electronic PHI • Outlines administrative, physical and technical security safeguards that CE's must follow to assure the confidentiality of ePHI

The PIC shall maintain what records for 5 years?

• Records of medication orders and medication administration to patients • Procurement records for controlled substances • Records of packaging, bulk compounding or manufacturing • Records of actions taken pursuant to drug recalls.

What must authorizations contain?

• Right to revoke authorization • Patient's signature and date of signature and expiration date • Description of information to be used or disclosed • Name or type of entity receiving the information • Notification that once the information is used or disclosed pursuant to authorization, it can be re-disclosed and may no longer be protected • Descriptions of each use or disclosure

What are the exceptions where authorization is not required and CE and BA may (but is not required) to disclose PHI?

• Uses or disclosures required by law • To public health officials authorized by law to prevent or control disease, investigate child abuse or neglect, or to FDA • Adverse event reporting • Facilitation of product recalls • Post-marketing surveillance • Response to court order, subpoena, discovery request, or other lawful purpose

May pharmacists leave messages for patients at their homes, either on an answering machine or with a family member, to remind them of appointments or to inform them that a prescription is ready?

• Yes. The HIPAA Privacy Rule permits health care providers to communicate with patients regarding their health care. This includes communicating with patients at their homes, whether through the mail or by phone or in some other manner. In addition, the Rule does not prohibit covered entities from leaving messages for patients on their answering machines. However, to reasonably safeguard the individual's privacy, covered entities should take care to limit the amount of information disclosed on the answering machine. For example, a covered entity might want to consider leaving only its name and number and other information necessary to confirm an appointment, or ask the individual to call back. (continued) • A covered entity also may leave a message with a family member or other person who answers the phone when the patient is not home. The Privacy Rule permits covered entities to disclose limited information to family members, friends, or other persons regarding an individual's care, even when the individual is not present. However, covered entities should use professional judgment to assure that such disclosures are in the best interest of the individual and limit the information disclosed.

What are requirements to sell poisons?

• in unbroken packages, for nonmedicinal use in the arts or industries or for insecticide purposes; • properly and adequately labeled as to content and such nonmedicinal usage, • "Poison" shall be printed on the label in prominent type and the name of a readily obtainable antidote with directions for its administration