Pharmacy Law

compounding

"office use" means administration of non-patient specific compounded drug to a patient by a practitioner in the office or in a treatment setting; office use does not include pharmacy's delivery of compounded drug to an office pursuant to patient-specific prescription

Drug quality and security act (DQSA)

*creates an electronic system to track and trace certain prescription drugs in the US *regulates transactions between dispensers, pharmacies, manufacturers, wholesale distributors, third-party logistics providers *established product tracing, product verification to ensure the drug product is legitimate and unaltered. *clarified and strengthened the FDA's authority over large-scale sterile compounding pharmacies

Federal Controlled substances act/DEA pharmacist's manual

*creates closed system via registration. *establishes national uniformity. *enforced by DEA. *C1 no accepted medical use, high potential for abuse and lack of accepted safety info. (hallucinogens, some opiates, marijuana, methaqualone). *C2 - high potential for abuse (opium/opiates, cocaine, amphetamines, pentobarbital). *scheduling authority is vested in the attorney general who must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS. *Pharmacist should follow the stricter law of federal vs. state. *recommendation of secretary regarding scientific and medical issues is binding on AG, except when AG finds the drug must be placed into C1 to avoid hazard to safety. *attorney general may deny practitioner applicant registration if not in public interest. *AG can suspend/revoke registration if applicant falsified application, has been convicted of a felony, or has had state license/registration suspended, revoked or denied. *DEA inspections - has authority to inspect any place where controlled substance records are kept (held for 2 years) or persons are registered; NOT allowed to inspect financials other than shipping without PIC consent

Non-resident pharmacies

*division shall require and provide for annual non-residence special pharmacy registration for all pharmacies located outside of this state that dispense medications for IL residents and mail, ship, or deliver prescription medications into this state including home pharmacies of remote pharmacies *shall abide by all IL laws and rules when filling prescriptions for IL residents

Kefauver-Harris amendment

*drug efficacy amendment to FD&C. *all new drugs must be both safe & effective. *required informed consent for human research. *establishes current good manufacturing practices for all drugs. *FDA oversight of drug ads (OTC and RX). * FTC oversight of dietary supplements.

On-site institutional

*drugs may be dispensed from the emergency room only by a practitioner licensed to prescribe and dispense only to patients treated in the institution *limited to non more than a 72 hour supply *drugs must still need all labeling requirements

FDA modernization act

*established "fast track" NDA process for life-threatening diseases. (right to try law) *defined compounding and delineated nine activities that might cross the line from compounding to manufacturing. *added other requirements regarding compounding drugs. *stripped FDA of authority to consider compounded drugs as "new drugs" *Established "clinicaltrials.gov", trails had to be made available to the public.

OBRA 90

*first federal law directly regulating pharmacy practice standards *primary goal to save money *adopts the pharmacist care model that pharmacy developed for itself. *law establishes minimal requirements that states must adopt and requires that states must actually establish the standards to receive medicaid funds *rebates - requires manufactures to provide drug products to medicaid at best price *DUR - retrospective and prospective

HIPPA/HITECH

*general purpose is to improve efficiency and effectiveness of health care system *regulate privacy and security of health information *enforced by department of health and human services *targets transaction and code sets, NPIs, security & privacy of health information *HITECH - appropriates money to develop nationwide HIT infrastructure; objectives are to protect privacy of PHI, reduce medical errors, reduce costs by improving efficiency, improve coordination among providers, and improve public health and emergency response system

Offsite institutional

*medication dispensing in a sense of pharmacist: an after hours cabinet can ONLY be used when pharmacist is absent & a log shall be maintained within the cabinet where authorized personnel removing medication shall sign their name, name of medication removed, strength, quantity removed, and time of removal *emergency kits: drugs shall be removed from emergency kits only by authorized pharmacy personnel or persons authorized to administer medication pursuant to a valid physician's order; if the pharmacy is closed at the time, the kit shall be returned when its opened; automated dispensing/storage system may be used *when drugs NOT from night cabinets or emergency kits -> drugs may be obtained from pharmacy in sufficient quantity to meet immediate need by authorized nurse; copy of physician's order authorizing removal and container from which drug was removed must be left in pharmacy to be checked by pharmacist when they arrive

things needed for prescription

*name of patient *date when prescription is issued *name and strength of drug or description of medical prescribed *quantity *directions for use *prescriber's name/address/signature *DEA registration number

Medicare Part D

*offered through several private plans approved by CMS *Beneficiaries must choos a particular plan during enrollment period and may re-evaluate every year *once, enrolled, locked in for the year; one-time change allowed if plan has 5 stars

Drug price competition act

*patent protection for brand manufacturer for 5 years exclusively. *established therapeutically equivalent generics, must have bioequivalence. *established use of ANDA *AB rating means product meets bioequivalent requirements *established the orange book ranking: A = substitutable B = inequivalent, not substitutable the second letter = dosage form

Prescription drug marketing act (PDMA)

*requires state licensing of wholesalers. *bans reimport action of RX drugs except by manufacturer *bans sale, trade, or purchase of RX drug samples (pharmacies banned to dispense drug samples). *allows transfer by sale from institution to community pharmacy only in an emergency.

CONTROLLED SUBSTANCE ACT RULES

10 questions

ILLINOIS CONTROLLED SUBSTANCES ACT

10 questions

ILLINOIS PHARMACY MISC.

10 questions on exam

PHARMACY PRACTICE ACT RULES

15 questions on exam

Certified pharmacy tech:

20 hours of continuing pharmacy education during 24 months, preceding expiration date of certificate, 1 hour in pharmacy law, 1 hour in patient safety.

ILLINOIS PHRAMCY PRACTICE ACT

20 questions

Federal controlled substance regulation quiz questions

20 questions for previous quizzes

Federal regulation practice questions

20 total (from old quizzes)

Illinois controlled substance act/controlled substance act rules quiz questions

20 total questiosn

pharmacy shopping

3+ prescribers or 3+ pharmacies, or both, that do not utilize common electronic file for controlled substances within the course of 30-day period *prescription monitoring program may issue report informing them of potential medication shopping

License expiration/renewal

30 hours of pharmacy CE during 2 months, approved by ACPE

Illinois pharmacy practice act/pharmacy practice act rules quiz questions

30 old quiz questions (35 questions on exam)

1. A copy of a completed DEA Form 106 must be submitted to the Drug Compliance Unit how many days after a reported theft or loss of controlled substances? a. 1 business day b. 3 business days c. 7 business days d. 14 business days

A. 1 business day

1. A controlled substance prescription must be signed by a prescriber: I. Same manner as they would sign a check or legal document II. Rubber Stamp III. Typewriter IV. Computer-generated signature a. I only b. II and III only c. II and IV only d. All of the above

A. 1 only

1. Maximum beyond use date allowed for prepackaged drugs shall be the manufacturer's beyond use date or how many months, whichever is less. a. 12 months b. 6 months c. 10 months d. 24 months

A. 12 months

1. When a controlled substance is removed from an emergency kit at a long-term care facility, it must be recorded on a proof-of-use sheet. How long should these sheets be on file with the consultant pharmacist? a. 2 years b. 3 years c. 5 years d. 6 months

A. 2 years

1. What is the maximum day supply for a single Schedule II controlled substance? a. 30 days b. 15 days c. 60 days d. 90 days

A. 30 days

1. According to the Illinois Pharmacy Practice Act, all pharmacy records (e.g. prescription, inventory, immunization, etc) are to be kept on file for: a. 5 years b. 2 years c. 10 years d. 7 years

A. 5 years

1. For a Schedule II substance, the prescription for a patient in a LTCF may be partial filled be to how many days after the initial partial fill? a. 60 days b. 15 days c. 90 days d. 30 days

A. 60 days

1. How many days may an applicant for registration as a pharmacy technician assist a pharmacist in the practice of pharmacy while awaiting issuance of a certificate of registration if the applicant has submitted the required fee and an application for registration to the Department? a. 60 days b. 45 days c. 180 days d. 25 days

A. 60 days

1. A drug with a high potential for abuse and no current medical use in treatment in the United States is: a. Marijuana b. Codeine c. Amobarbital d. Secobarbital

A. Marijuana

1. Plan B can be sold: a. Without age or point-of-sale restriction b. Only from a licensed pharmacy, without age restriction c. Only from a licenses pharmacy to females only d. Only from a licensed pharmacy to purchasers over the age of 16

A. Without age or point-of-sale

1. Which of the following examples requires a pharmacy to obtain individual authorizations under HIPAA? a. A company selling blood pressure monitors pays a pharmacy to mail pamphlets to its patients with high blood pressure b. A company selling blood pressure monitors pays a pharmacy to hand out pamphlets at the pharmacy to patients picking up prescriptions c. A drug company pays a pharmacy for providing refill reminders to all of the pharmacy's patients; the payment covers the cost of the reminders d. A pharmacy receives financial remuneration from a drug company providing adherence communications that covers the cost of the communications

A. a company selling blood pressure monitors pays a pharmacy to mail pamphlets to its patients with high blood pressure

1. Which of the following best applies to the counseling provision in OBRA? a. Counseling can help prevent potential problems that may arise after a medication has been dispensed to a patient b. The pharmacist must counsel patients on specific matters as listed under OBRA c. Patients are not permitted to waive counseling by the pharmacist d. A goal of counseling is for all patients to receive the same information about a drug

A. counseling can help prevent potential problems that may arise after a medication has been dispensed to a patient

1. Tax-free alcohol may be used by: a. Hospital pharmacies for compounding medications for inpatients b. Hospital pharmacies for compounding medications for outpatients c. Community pharmacies for compounding medications for patients d. Outpatient charity clinics for compounding medications for patients, provided they charge the patients for the compound

A. hospital pharmacies for compounding medications for inpatients

1. A manufacturer marketed a topical cream with an herb as the active ingredient. The labeling claimed that the product would reduce inflammation and itching of the skin (a structure/function claim). Which of the following statements about this product is correct? a. It is likely a drug because it made a structure/function claim b. It is likely a dietary supplement because it is an herbal c. It is likely a dietary supplement because it made a structure/function claim, not a disease claim d. It is likely a cosmetic

A. it is likely a drug because it made a structure/function claim

1. Which of the following statements best describes the 1938 Food, Drug, and Cosmetic Act as enacted? a. It is the nucleus for today's Food, Drug, and Cosmetic Act b. The law required that new drugs must be proven safe and effective prior to marketing. c. The catalyst for the law was the thalidomide tragedy. d. The law did not include devices

A. it is the nucleus for today's food, drug, and cosmetic act

1. A 62-year-old patient comes to the pharmacy and presents a prescription for Sonata written by his podiatrist. A pharmacist shall: a. Not fill the prescription b. Fill the prescription c. Ask the patient to get a new prescription from an authorized prescriber d. Fill Sonata only after filling out the DEA 222 order form

A. not fill the prescription (not in scope of practice)

1. The Food, Drug, and Cosmetic Act (FDCA) defines a new drug as a drug: a. That has not been generally recognized by experts as safe and effective for the use recommended in the labeling b. Whose labeling has been changed to reflect stronger warnings. c. That has been approved by the FDA within the past five years d. That was marketed after 1906

A. that has not been generally recognized by experts as safe and effective for the use recommended in the labeling

1. The Food, Drug, and Cosmetic Act specifies which of the following about prescribing prescription drugs? a. That they may be prescribed by practitioners licensed by law b. Which practitioners may be licensed by law to prescribe (e.g. physicians, dentists, etc) c. The scope of prescriptive authority of a practitioner d. All of these are correct

A. that they may be prescribed by practitioners licensed by law

1. A pharmacist received a call from a prescriber asking the pharmacist to substitute a placebo for a particular drug and to type the drug name on the label. If the pharmacist complies: a. This violates the Food Drug and Cosmetic Act (FDCA) b. This does not violate the FDCA because the pharmacist is complying with the prescriber's orders, which overrides the FDCA c. This does not violate the FDCA because the FDCA does not prohibit labeling in this manner d. This does not violate the FDCA because the FDCA does not apply to prescription labels generated by the pharmacy.

A. this violates the Food, Drug, and Cosmetic act (FDCA)

1. Which of the following statements is correct about Telepharmacy? a. Written prescriptions presented to the remote dispensing site shall be scanned into the electronic data processing equipment to ensure initial dispensing and each refill and the original prescription may be viewed on the monitor at both the remote dispensing site and home pharmacy site b. A remote site does not require a pharmacist-in-charge c. All written prescriptions shall be delivered to the home pharmacy for filing within 48 hours d. All of the above

A. written prescriptions presented to the remote dispensing site shall be scanned into the electronic data provessing equipment to ensure initial dispensing and each refill and the original prescription may be viewed on the monitor at both the remote dispensing site and home pharmacy site

1. A pharmacy dispensed a prescription for a generic drug to a Medicare Part D patient. The NDC number for the generic drug had not yet been entered into the computer, and the claim was submitted for reimbursement with the NDC number of another generic drug. Although the pharmacy knew this, it believed this did not matter because the reimbursement sought by the pharmacy was the same for both drugs. Has the pharmacy violated the False Claims Act? a. Yes, it acted knowingly b. Yes, it acted negligently c. Yes, this is a strict liability statute d. No, there was no harm to the government

A. yes. it acted knowingly

1. Which of the following drug(s) is/are TRUE about Remote Consultation Sites? I. These sites have no prescription inventory. II. Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are allowed at these sites. III. All written prescriptions presented at a remote consultation site shall be delivered to the home pharmacy within 24 hours. a. I only b. I and II only c. II and III only d. All of the above

B. 1 and 2 only

1. Which of the following drugs is/are classified as Schedule III controlled drug(s)? I. Fiorinal II. Fioricet III. Codeine a. I only b. I and II only c. II and III only d. All of the above

B. 1 and 2 only

1. Annual controlled substance inventories must be maintained on file for no less than how many years? a. 1 year b. 2 years c. 5 years d. 7 years

B. 2 years

1. How many sequential 30-day supply prescriptions for the same Schedule II controlled substances to authorize a 90-day supply may a prescriber issue? a. 1 b. 3 c. 5 d. 2

B. 3

1. An emergency oral prescription for Schedule II controlled drugs must be mailed to dispensing pharmacy by an authorized prescriber within: a. 48 hours b. 7 days c. 10 days d. 72 hours

B. 7 days

1. For a Schedule II substance, the remaining portion of a prescription must be dispensed how long after the initial partial fill? a. 24 hours b. 72 hours c. 10 days d. 30 days

B. 72 hours

1. For patients treated in an institution, the quantity of a drug dispensed by a licensed practitioner in an emergency room shall be limited to a: a. 12-hour supply of the drug b. 72-hour supply of the drug c. 24-hour supply of the drug d. 48-hour supply of the drug

B. 72-hour supply of the drug

1. Which of the following has enforcement authority of Opioid Treatment Programs? a. FDA b. SAMHSA ( c. DHHS d. All of these are correct

B. SAMHSA (substance abuse and mental health services administration)

1. A faxed prescription for any C-II from the prescriber to the pharmacy is acceptable in place of the original for which of the following situations? a. Any situation b. A resident of a long-term care facility (LTCF) c. An emergency situation d. For terminally ill patients

B. a resident of a long-term care facility (LTCF)

1. Which of the following statements regarding pseudoephedrine (PSE) products is correct? a. PSE is listed as a CV under federal law b. Community pharmacies are permitted to sell a maximum of 3.6 g of PSE to a single purchaser per day under federal law c. Only pharmacies are permitted to sell PSE products under federal law d. State laws are often less strict regarding PSE products

B. community pharmacies are permitted to sell a maximum of 3.6g of PSE to a single purchaser per day under federal law

1. If a pharmacist has not received a written prescription for an emergency dispensing of a Schedule II controlled substance after 7 days, who should the pharmacist contact? a. Local police department b. Department of Financial and Professional Regulation c. Illinois State Police d. Department of Human Services

B. department of financial and professional regulation

1. Pharmacists are required to dispense Medication Guides (MedGuides): a. For all prescription drugs b. For prescription drugs the FDA has determined required MedGuides c. For prescription drugs that, in the pharmacist's professional judgement, required MedGuides d. For oral contraceptives

B. for prescription drugs that FDA has determined required medguides

1. Members of the State Board of Pharmacy are appointed by: a. Secretary of the Department of Financial and Professional Regulation b. Governor c. Directed of the Division of Professional Regulation d. Chief Pharmacy Inspector

B. governor

1. A patient presents a C-II prescription to the pharmacist and would like only half of the number of tablets now and the balance later. Is the partial filling of a C-II drug permitted (under Federal Law)? a. It is not permitted b. It is permitted up to 30 days from the date the prescription was issued c. It is permitted, but the balance may not be dispensed d. It is permitted up to 30 days from the date the prescription was issued, but the balance must be provided in one filling

B. it is permitted up to 30 days from the data the prescription was issued

1. Which of the following is the source of legal authority for pharmacists to engage in drug product substitution? a. The Food, Drug, and Cosmetic Act b. State law c. The Orange Book d. Professional judgement

B. state law

1. Which of the following statements regarding PDMPs is not correct? a. PDMPs required pharmacies to report dispensed controlled substance prescriptions to a database b. States are mandated by the DEA to report all schedules of controlled substances c. States may share reported information across state lines d. States can determine which individuals have access to the database

B. states are mandated by the DEA to report all schedules of controlled substances

4. Right-to-try laws apply most directly to: a. Tobacco smokers b. Terminally or seriously ill persons c. Marijuana smokers d. Pediatric patients

B. terminally or seriously ill persons

1. Which of the following is not correct about disposition of legend drugs on cessation of pharmacy operations under an Illinois Pharmacy Law? a. The Department of Professional Regulation of the State of Illinois shall approve the intended manner of disposition of all legend drugs prior to disposition of such drugs by the pharmacist in charge b. The pharmacist in charge of a pharmacy which has its pharmacy license revoked or otherwise ceases operation shall notify the Department of Professional Regulation of the State of Illinois and forward to the Department of Professional Regulation of the State of Illinois a copy of the closing inventory of controlled substances and a statement indicating the intended manner of disposition of all legend drugs and prescription files within 7 days of such revocation or cessation of operation c. The Department of Professional Regulation of the State of Illinois shall notify the pharmacist in charge of approval of the manner of disposition of all legend drugs, or disapproval accompanied by reasons for such disapproval, within 30 days of receipt of the statement from the pharmacist in charge d. All of the above

B. the PIC of a pharmacy which has its pharmacy license revoked or otherwise ceases operations shall notify the department of professional regulation of the state of Illinois and forward to the department of professional regulation of the state of Illinois a copy of the closing inventory of controlled substances and a statement indicating the intended manner of disposition of all legend drugs and prescription files within 7 days of such revocation or cessation of operation

2. Which amendment to the Food Drug and Cosmetic Act (FDCA) clarified and strengthened the FDA's authority over large-scale sterile compounding pharmacies? a. The Kefauver-Harris Amendments b. The Drug Quality and Security Act c. The Food and Drug Administration Modernization Act d. The Food and Drug Administration Amendments Act

B. the drug quality and security act

1. The Illinois State Board of Pharmacy revoked the license of a pharmacist practicing in Illinois. The pharmacist also held a license in another state and moved there to practice. Which of the following statements is correct? a. The other state pharmacy board would likely revoke the pharmacist's license, and the pharmacist would not be entitled to a hearing b. The other state pharmacy board would likely revoke the pharmacist's license, and the pharmacist would be entitled to a hearing c. The other state pharmacy board would not likely find out about the revocation in Illinois d. The other pharmacy board would not likely take any action against the pharmacist's license, even with knowledge of the revocation in Illinois

B. the other state pharmacy board would likely revoke the pharmacist's license, and the pharmacist would be entitled to a hearing

1. A pharmacy receives a prescription for a C-III medication. The medication strength was not indicated on the prescription. Which of the following statements is correct? a. The pharmacist may legally add it without contacting the prescriber b. The pharmacist may legally add it after contacting the prescriber and documenting that the prescriber agreed to the strength c. The prescription is not valid and cannot be dispensed d. The prescription is not valid and cannot be dispensed; however, the pharmacist may contact the prescriber and execute a new verbal order

B. the pharmacist may legally add it after contracting the prescriber and documenting that the prescriber agreed to the strength

1. A state decided to reschedule all opioid drug products scheduled as C-III under federal law to C-II pursuant to state law. Which of the following statements is correct? a. The federal CSA preempts states from scheduling drug products b. The state law would not conflict with federal law and likely not be preempted c. Pharmacies should follow federal law and dispense the products as C-III d. The state law conflicts with federal law and would be invalidated in federal court

B. the state law would not conflict with federal law and likely not be preempted

1. How many years should a pharmacy store executed DEA 222 ordering forms? a. 3 years b. 5 years c. 2 years d. 10 years

C. 2 years

1. A 24-hour pharmacy must have the following security measures: I. Basic alarm system II. Video surveillance system III. Secured, locked, substantially constructed cabinet for Schedule IIs a. I only b. I and III only c. III only d. All of the above

C. 3 only

1. How many total hours of continuing pharmacy education must a pharmacist complete during the 2-calendar year licensing period? a. 15 hours b. 45 hours c. 30 hours d. 60 hours

C. 30 hours

1. For a Schedule III-V substance, the prescription may be partial fill within how many months of the date of issuance? a. 3 months b. 7 days c. 6 months d. 12 months

C. 6 months

3. The label of a drug product not listed in the USP states that the drug is 0.25 mg. In actuality, the product strength is 0.50 mg. This product is: a. Adulterated b. Misbranded c. Both adulterated and misbranded d. Neither adulterated nor misbranded

C. Both adulterated and misbranded

1. How has the Employee Retirement Income Security Act (ERISA) affected state efforts to regulate third-party prescription insurance plans? a. ERISA has had little effect on state efforts to regulate the plans b. ERISA has enhanced state efforts to regulate the plans c. ERISA has hindered state efforts to regulate the plans d. ERISA has does not impact state efforts to regulate the plans

C. ERISA has hindered state efforts to regulate the plans

1. Which of the following statements about drug recalls is correct? a. Manufacturers are responsible for notifying the FDA, not pharmacies b. The FDA is responsible for notifying pharmacies c. Pharmacists are responsible for knowing that a product has been recalled d. Class III recalls are the most serious

C. Pharmacists are responsible for knowing that a product has been recalled

1. A pharmacist just passed their licensure exam and wants to work for an independent pharmacy across town. Which of the following statements regarding the CSA is correct? a. The pharmacist must register as an individual pharmacist with the DEA under the registration of the pharmacy prior to being allowed to handle controlled substances at the independent pharmacy b. The pharmacist must register as an individual pharmacist with the DEA prior to being hired as a pharmacist c. The pharmacist need not register as an individual pharmacist with the DEA and can work under the DEA registration of the independent pharmacy d. Neither the pharmacist not the employing pharmacy needs to register with the DEA

C. The pharmacist need not register as an individual pharmacist with the DEA and can work under the DEA registration of the independent pharmacy

1. Which of the following statements regarding the FDA is most accurate? a. It issues guidance documents that carry the same legal authority as regulations b. The Center for Drug Evaluation and Research is under the Office of Global Regulatory Operations and Policy c. The president appoints the FDA commissioner with the confirmation of the Senate. d. FDA advisory committee members are FDA employees

C. The president appoints the FDA commissioner with the confirmation of the senate

1. Friendly's Pharmacy is located across the street from Chainlet, a large chain drug store. The pharmacist at Chainlet has called over to Friendly's on a number of occasions to purchase controlled drugs from Friendly's. The pharmacist at Friendly's sells Chainlet the products at cost, which Chainlet then uses to fill prescriptions. Should Friendly's Pharmacy be concerned with the CSA with this particular activity? a. No, the CSA has no prohibitions or limits applicable to Friendly's selling controlled drugs to Chainlet b. No, Friendly's activities could never constitute distributing under the CSA c. Yes, Friendly's needs to register as a distributor if it sells over 5% of the total units of controlled substances per year d. Yes, the CSA requires Friendly's to be registered as a distributor prior to selling any controlled drugs to Chainlet

C. Yes, Friendly's needs to register as a distributor if it sells over 5% of the total units of controlled substances per year

1. Current Good Manufacturing Practices (CGMPs): a. Does not apply to dietary supplements b. Do not apply to generic drugs c. Are a set of regulations establishing requirements for manufacturing methods, facilities, and controls d. All of these are correct

C. are a set of regulations establishing requirements for manufacturing methods, facilities, and controls

1. Drug P is the original patented drug product. Drugs X, Y, and Z are generic drug products to Drug P. The Orange Book classifies Drug X as A rated to Drug P. It classifies Drugs Y and Z as B rated to Drug P. Which statement is correct? a. Drugs X, Y, and Z are therapeutically equivalent to Drug P b. Drugs Y and Z are therapeutically equivalent to one another c. Drugs P and X are therapeutically equivalent to one another d. Drugs Y and Z are therapeutically equivalent to one another, and Drugs P and X are therapeutically equivalent to one another

C. drugs P and X are therapeutically equivalent to one another

1. Mrs. Smith brings a prescription for alprazolam to the pharmacy. You notice the prescriber is out-of-state. What should be done with this controlled substance prescription? a. Prescription from out-of-state prescribers cannot be dispensed only if it is a Schedule II b. Prescription from out-of-state prescribers cannot be dispensed if it is a controlled substance c. Fill the prescription as long as the prescriber is within scope of practice and has a valid license and DEA registration d. Prescriber must be called prior to dispensing

C. fill the prescription as long as the prescriber is within scope of practice and has a valid license and DEA registration

1. A dentist issued a prescription to a patient for a statin drug for the purpose of reducing the patient's cholesterol level. This prescription is: a. Valid because a dentist has prescriptive authority under state law b. Valid because a dentist has prescriptive authority under federal law c. Invalid because the dentist has exceeded the scope of practice under state law d. Invalid because the dentist has exceeded the scope of practice under federal law

C. invalid because the dentist has exceeded the scope of practice under the state law

1. All of the following are classified as Schedule II controlled substances EXCEPT: a. Oxycodone b. Morphine c. Meprobamate d. Pentazocine

C. meprobamate

1. At a minimum, how often must LTCF residents have their drug regimen and medical chart reviewed by a pharmacist? a. Daily b. Weekly c. Monthly d. Quarterly

C. monthly

1. Most state pharmacy boards are composed of: a. Community pharmacists b. Hospital pharmacists c. Pharmacists from different practice settings d. Pharmacists elected by voters

C. pharmacist from different practice settings

1. Which of the following terms is often used for state laws regulating the practice of pharmacy? a. Licensing Act b. Pharmacy Board Act c. Pharmacy Practice Act d. Pharmacy Licensing Act

C. pharmacy practice act

1. Which of the following parts of OBRA '90 involves the pharmacist actively resolving problems through a comprehensive review of a patient's prescription order at the point of dispensing? a. Retrospective review b. Educational review c. Prospective drug use review d. Demonstration projects

C. prospective drug use review

1. What is RAPS under Illinois Pharmacy Law? a. Regional Authorized Prescribing System b. Rare Administrative Policy and Statues c. Remote Automated Pharmacy System d. Regional Advanced Public Safety

C. remote automated pharmacy system

1. A state board of pharmacy inspector found a pharmacy in violation of the law. The pharmacy was fined and sent a notice of violation within two weeks. The notice provides that the pharmacy has the option to pay the fine or contest the violation, in which case the pharmacy could face license revocation or suspension. Which of the following statements is correct? a. This is legal, provided the board is following state law b. This is legal, even without a state law to the effect c. This violates the pharmacy's due process rights d. This is illegal because boards cannot issue fines

C. this violates the pharmacy's due process rights

1. Why does society choose to license pharmacies and pharmacists? a. To ensure the honesty and integrity of pharmacists b. To protect the profession c. To protect the public d. To increase healthcare costs

C. to protect the public

1. The authority to place an unscheduled drug into a schedule is best described as: a. Vested solely with DHHS b. Vested solely with Attorney General of the US c. Vested jointly with DHHS and Attorney General of the US d. Vested solely with the DEA

C. vested jointly with DHHS and attorney general of the US

1. A pharmacist may substitute a biosimilar to the prescribed biologic: a. Whenever the exercise of professional judgement warrants b. When the biosimilar is "highly similar" to the prescribed biologic c. When the Purple Book designates the biosimilar with an "I" d. All of these are correct

C. when the purple book designates the biosimilar with an "I"

physical security controls

C2 shall be stored in securely locked, substantially constructed cabinet C3-5 shall be stored in same cabinet OR they may be dispersed throughout the stock of non-controlled meds

Partial filling

C3-5 permissible within 6 months provided that total quantity prescribed is not exceeded and each partial fill is recorded in the same manner as refill *C2 permissible if pharmacist unable to supply full quantity and makes notation of quantity supplied on face of written prescription; **remaining portion may be filled within 72 hours after first partial fill and if it cannot be then a new prescription would be required & pharmacist should notify the prescriber **LTCF: may be filled in partial quantities, valid for 60 days with documentation that the patient has terminal illness, quantity dispensed must not exceed quantity prescribed

Durham-Humphrey amendment

Created two classes of drugs: 1. prescription only (Legend). "Rx only" appear labeling. "safe" use under medical supervision 2. OTC class. Also allowed verbal orders and transcription of the prescription, and allowed refills. specifies minimum information that a dispensed RX label must contain. Expiration or BUD on dispensed RX label required pursuant to state laws. *gave three methods for switching drugs to OTC: 1. SNDA: product-specific switch 2.Petition: product-specific switch 3. adding or amending an OTC drug monograph: affects all products in the class. *practice considerations: refill authorization issues, prescriptive authority issues, collaborative practice agreements, authority to dispense

1. Who may provide patient counseling according to the Pharmacy Practice Act? a. A pharmacist b. A student pharmacist, under the direct supervision of a pharmacist c. A certified registered pharmacy technician, under the direct supervision of a pharmacist d. A and B

D. A & B

1. A physician owns a clinical laboratory on the same block as his office. He instructs patients to get the lab tests he orders done at his laboratory. Is this legal for Medicare patients? a. Yes b. Yes, providing the physician informs his patients that he owns the lab c. Yes, providing the physician informs his patients that he owns the lab, and the lab charges the same as other labs d. No

D. No

1. Dr. Jones is a new dentist in town. He asks the pharmacist at Friendly's Pharmacy if he can obtain Ativan, a schedule IV anti-anxiety drug, to administer to his patients in the office prior to procedures. Dr. Jones would like to write a prescription for office use. Is this allowable? a. Yes, practitioners have no restrictions in writing controlled substance prescriptions for office use b. Yes, Dr. Jones is an individual practitioner under the law and is permitted to obtain schedule III-V medications in this manner c. No, Dr. Jones is a dentist, not a physician, and is therefore unable to obtain Ativan in this manner for office use d. No, pharmacies are restricted from filling controlled substance prescriptions written for office use

D. No, pharmacies are restricted from filling controlled substance prescriptions written for office use

1. Pharmacy student Susie is taking an antidepressant medication. While on rotation at the pharmacy where Susie has the medication dispensed, pharmacy student Max notices the medicine Susie is taking and tells other classmates about it. Has Max violated HIPAA? a. No, HIPAA does not apply to Max while on rotation because he is not an employee of the pharmacy b. No, this is not a violation of HIPAA because Max did not make the disclosure at the pharmacy c. Yes, Max should not have access to any protected health care information as a student on rotation d. Yes, even pharmacy students have to abide by HIPAA while on rotations

D. Yes, even the pharmacy students have to abide by HIPAA while on rotations

1. Which of the following statements is correct regarding standards of practice? a. In order to be considered a practice standard, laws or regulations must state it b. Making a practice standard a law or rule makes it harder to enforce the standard c. Practice standards must be stated in the code of ethics d. A practice standard would include an activity that most pharmacists are expected to perform

D. a practice standard would include an activity that most pharmacists are expected to perform

1. A registered pharmacy technician may not perform which of the following tasks: a. Patient counseling b. Drug regimen review c. Clinical conflict resolution d. All of the above

D. all of the above

1. Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: I. A licensed practitioner prescribes the Schedule II controlled substances for direct administration to a patient undergoing home infusion/IV pain therapy. II. A licensed practitioner prescribes the Schedule II controlled substances for direct administration to a patient living in an LTCF. III. A licensed practitioner prescribes the Schedule II controlled substances for direct administration to a patient living in a hospice certified by Medicare. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. If the lawfully prescribed drug is NOT in a stock in a pharmacy, a pharmacist may: I. Contact the prescriber to address the issue. II. If requested by the patient or his or her agent, return unfilled lawful prescriptions to the patient or agent. III. If requested by the patient or his or her agent, communicate or transmit the original prescription information to a pharmacy of the patient's choice that will fill the prescription in a timely manner. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following areas of training are required for the training of a registered pharmacy technician: a. The duties and responsibilities of the technicians and pharmacists b. Pharmaceutical and medical terminology c. Compounding, packaging, labeling, and storage d. All of the above

D. all of the above

1. Which of the following information is/are TRUE ABOUT kiosk under the Illinois State Pharmacy Law? I. A home pharmacy may only use the kiosk with prior approval of a patient. II. A kiosk is a device that maintains individual patient prescription drugs that were verified and labeled at the home pharmacy. III. A kiosk located on the same premises or campus of the home pharmacy shall operate under the same license as the home pharmacy. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following is an element(s) cannot be changed by a pharmacist for a Schedule II prescription? I. Name of medication II. Name of patient III. Name of prescriber IV. Date written a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following is correct about becoming a registered certified pharmacy technician under Illinois Law? a. Applicant should be age 18 or over b. He or she is of good moral character, as determined by the Department c. He or she has successfully passed an examination accredited by the National Commission for Certifying Agencies, as approved and required by the Board d. All of the above

D. all of the above

1. Which of the following is/are TRUE under Illinois State Pharmacy Law? I. For every prescription dispensed, the prescription record shall contain the name, initials or other unique identifier of the pharmacist who dispenses the prescription drugs. II. No prescription may be dispensed after one year from the date of the original issuance of the prescription by the prescriber. III. Whenever a prescription is dispensed by a registered pharmacy technician under the supervision of a pharmacist, the prescription record shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following statements are TRUE regarding after-hour cabinets? I. After-hour cabinets shall only be used in the absence of a pharmacist. II. When medication is removed from the cabinet or enclosure, written physician's orders authorizing the removal of the medication shall be placed in the cabinet or enclosure. III. 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. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following statements is/are TRUE when a drug is not available from night cabinets or emergency kits, and the drug is required to treat the immediate needs of a patient? I. The drug may be obtained from the institutional pharmacy by an authorized nurse, in sufficient quantity to meet the immediate need. II. A copy of the physician's order authorizing the removal of said medication shall be conspicuously placed in the institutional pharmacy with the container from which the drug was removed. III. A form shall be available in the institutional pharmacy upon which shall be recorded the signature of the authorized person who removed the medication, the name, strength and quantity of medication removed. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. Which of the following statements regarding an emergency kit is/are TRUE? I. Emergency kits containing those drugs that may be required to meet the immediate therapeutic needs of the patient. II. Emergency kits shall be sealed in some manner which will indicate when the kit has been opened. III. The expiration date of the emergency kit shall be the earliest expiration date of any drug contained in the kit. a. I only b. I and II only c. II and III only d. All of the above

D. all of the above

1. A prescription for a C-III drug may be communicated to the pharmacy in which of the following ways? a. Phone order b. Electronically c. Fax d. All of these are correct

D. all of these are correct

1. The CSA requires complete and accurate records for which of the following? a. Inventory records b. Drugs received c. Drugs dispensed d. All of these are correct

D. all of these are correct

1. The Medicare Conditions of Participation for hospitals require: a. Policies and procedures to minimize drug errors b. That the pharmacy be directed by a pharmacist c. That the hospital develops a formulary system d. All of these are correct

D. all of these are correct

1. USP Chapter 800 establishes that pharmacies must: a. Maintain a list of hazardous drugs b. Employ competent personnel c. Maintain policies for hazardous waste segregation and disposal d. All of these are correct

D. all of these are correct

1. Under OBRA '90, documentation and maintenance of information about patients' drug therapy should: a. Provide a reference for other pharmacists in the same pharmacy b. Contain information for surveyors who need to record what was done and connect that action with an outcome, if possible c. Show enforcement officials that OBRA '90 requirements are being met d. All of these are correct

D. all of these are correct

1. Which of the following aspects of health information does HIPAA target? a. National provider identities b. Privacy c. Transaction and code sets d. All of these are correct

D. all of these are correct

1. Which of the following do most states require from pharmacist licensure applicants? a. Attainment of a specified age b. Completion of internship requirements c. Demonstration of good moral character d. All of these are correct

D. all of these are correct

1. Which of the following does the CSA require to be on the pharmacy label of a dispensed controlled substance in schedule II, III, and IV? a. Patient name b. Pharmacy address c. The statement "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" d. All of these are correct

D. all of these are correct

1. Which of the following is a common justification for disciplinary action against a pharmacist at the state level? a. Providing false information when applying for a license b. Being convicted of an act involving moral turpitude c. Engaging in unprofessional conduct d. All of these are correct

D. all of these are correct

1. Which of the following is a typical state requirement for pharmacist licensure? a. Graduation from pharmacy school b. Attainment of a specified age c. Demonstration of good moral character d. All of these are correct

D. all of these are correct

1. Which of the following must register with the DEA? a. A pharmacy dispensing controlled substances b. A distributor of controlled substances c. A physician prescribing controlled substances All of these are correct

D. all of these are correct

1. Which of the following statements about whether there should be a third class of drugs, also known as "behind-the-counter" or "under conditions for safe use," is correct? a. Pharmacies favor the concept b. The FDA has opposed the concept until recently c. Medical organizations oppose the concept d. All of these are correct

D. all of these are correct

1. Which of the following statements regarding controlled substance prescriptions is correct? a. Mid-level practitioners may prescribe controlled substances if authorized by state law b. An agent or employee of an individual practitioner may communicate the prescription to a pharmacist c. An agent or employee may prepare the prescription for the individual practitioner's signature d. All of these are correct

D. all of these are correct

1. The corresponding responsibility doctrine requires that the prescriber: a. Correspond with the pharmacist prior to selecting any controlled drugs for a patient b. Correspond with other practitioners seen by the patient prior to prescribing any controlled drug for a patient c. And pharmacist keep corresponding documentation regarding a patient's controlled drugs d. And pharmacist assure the proper prescribing and dispensing of controlled substances

D. and pharmacist assure the proper prescribing and dispensing of controlled substances

1. Which of the following must a pharmacist specifically consent to in writing for a DEA inspection? a. Controlled substance records being examined b. Controlled substance reports being copied c. An inventory of controlled substances d. Inspection of financial records

D. inspection of financial records

1. Under CSA pharmacy security requirements, a pharmacy: a. Must store C-II drugs in a securely locked cabinet b. Must disperse C-II drugs throughout the inventory c. May either store C-II drugs in a securely locked cabinet or disperse them throughout the inventory

D. may either store C2 drugs in a securely locked cabinet or dispense them throughout the inventory

1. Pregabalin is classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

D. schedule V

Food, Drug, and cosmetic (FD&C) Act

New drugs to be proven regulates cosmetics & devices creates the FDA established NDA approval process labeling for "adequate directions" label warnings about habit forming medications

record retention

No less than 5 years

mid-level practioners

PA who has been delegated authority to prescribe through written delegation of authority by physician licensed full-practice *APRN who has been delegated authority to prescribe through written delegation of authority by physician licensed full-practice *APRN certified as NP, nurse midwife, or clinical nurse specialist who has been granted authority to prescribe by hospital affiliate *animal euthanasia agency *prescribing psychologist

cessation of pharmacy operations

PIC shall notify department and forward a copy of the closing inventory of all controlled substances AND a statement indicating the intended manner of disposition of all legend drugs and prescriptions files within 30 days

prescription monitoring program (PMP)

PMP advisory committee to assist in implementing & peer review committee to review professional performance of prescribers and dispensers

Emergency & C2 prescriptions

Within 7 days after issuing an emergency prescription the written prescription for the emergency quantity is to be delivered to the dispensing pharmacist with "authorization for emergency dispensing" written with date of emergency RX *written prescription can be delivered by mail or in-person but if by mail must be postmarked within the 7-day period *dispensing pharmacist shall attach prescription to emergency oral prescription & shall notify IDFPR if the prescriber fails to deliver the authorization *all RX issued for schedule 2 shall include both written and numerical notation of the quantity on the face of the prescription & cannot be refilled

price-disclosures

a pharmacy must disclose the current U&C retail price of any brand or generic prescription drug or medical device that the pharmacy offers for sale to the public *prices quoted are for information purposes only and are valid only the day of inquiry *2021 CHANGE: pharmacy must post notice informing customers that they may request the current U&C of any brand or generic that the pharmacy offers

Manner of Issuance of Prescription for controlled substances

all CS prescriptions shall be dates as of, and singed on, the day when issued and shall bear full name and address of the patient, drug name/strength/dosage/quantity, directions, and name/address/DEA number of practitioner *practitioner may sign paper prescription in same manner as would sign document *paper prescriptions shall be written with ink or printed and shall be manually signed *computer-generated prescription that is printed out or faxed must be manually signed *prescription may be prepared by the secretary or agent for the signature of a practitioner (neither a pharmacist nor pharmacy tech may act as an agent for a practitioner)

security requirements

all applicants and licensees shall provide effective controls and procedures to guard against theft and diversion of controlled substances *physical security controls shall be commensurate with the schedule & quantity/type/form in the possession of the licensee in normal business operations *any additional security evidence, including but not limited to; video surveillance, computer access logs or records, or falsified prescription/medical documentation that demonstrates or captures diversion or other illicit activity involving CS shall be made available to the division upon request along with a copy of any DEA form 106 *personal bags of any kind are prohibited in any area where CS are handled or stored *basic alarm system that detects unauthorized entry into pharmacy area required but NOT for 24-hour pharmacies that do not close *all pharmacies required to maintain a key to the licensed pharmacy area

Topical eye medication prescription act

any insurer that provides coverage for prescription topical eye medication shall NOT deny coverage for the refilling of a prescription when the refill is requested by the insured prior to the last day of prescribed dosage period and after at least 75% of the predicted days of use

pharmacy tech CANNOT:

counsel patients, complete DUR, or complete clinical conflict resolution

pharmacist may not change the following components of C2

date written or add the date, name of the patient, name of prescriber or add signature, name of drug

21st century cures act

designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently

Practice of pharmacy

drug administration limited to the administration of oral, topical, injectable and inhalation as follows: *vaccination of patients 7 years of age and older (eligible vaccines listed on CDC) *initial administration of long-acting or ER form opioid antagonists by a physician *administration of injections of alpha-hydroxyprogesterone caproate *administration of injections of long-term antipsychotic medications

electronic visual image prescriptions

electronic image shall constitute the original prescription and a hard copy of the prescription drug orders is not required: *computer system must be capable of providing all the prescription information required by law if requested to the department within 72 hours of the request

department may allow a pharmacy that is not located at the same location as its home pharmacy and at which pharmacy services are provided during an emergency situation, as defined by rule, to be operated as an emergency remote pharmacy

emergency remote pharmacy operating under this subsection shall operate under the license of the home pharmacy

self-inspection

every licensed pharmacy should conduct annual self inspecting using forms provided by the division *should be conducted during the same month annually *documentation should be maintained for 5 years

Record & inventory

every licensee shall keep records and maintain inventories in conformance with the record keeping and inventorying requirements of federal law *all prescription information for electronic CS prescriptions shall be readily retrievable and immediately available to any division inspector upon request *annual inventory with actual count of inventory on hand for all C2s and approximate inventory for C3-5 shall be maintained for at least 5 years *after loss or theft of CS, approximate count inventory should be conducted with stated date of the last inventory for the CS that was lost/stolen *form 106 copy should be sent to the division within one business day after submission to the DEA, along with printed name of person who signed the form *prescriptions should be maintained for at least 5 years

change of PIC

expires 30 days after PIC dies or is no longer employed *owner of pharmacy has to notify the department of change in PIC

record keeping

federal and Illinois controlled substances act -> 2 years all records *Illinois pharmacy practice act -> 5 years all records *HIPPA -> 7 years *Medicare -> 10 years

Uniform prescription drug information card act

health benefit plan must issue prescription drug cars containing BIN, processor control number if required for claims adjudication, group number, card issuer identifier, cardholder ID number, and cardholder name *mandatory elements on back of card include; claims submissions names and addresses $ help desk telephone numbers and names

epinephrine injector act

health care practitioner may prescribe epi injectors in the same of an authorized entity for use in accordance with this act, and pharmacists/health care practitioners may dispense epi injectors pursuant to a prescription issued in the name of an authorized entity, prescriptions valid for a period of 2 years *authorized entity may acquire and stock supply of undesignated epi injectors *employee or agent of authorized entity may supply or administer epi injector to individual on the property of the authorized entity who is in anaphylaxis

managed care reform and patient rights act

health insurer that provides prescription drug benefits must within 72 hours after receipt of PA form either approve or deny the PA *in the case of expedited coverage determination: insurer must approve or deny PA within 24 hours after receipt of PA form *1/1/23 -> health insurance carriers must ensure at least 10% of individual health care plans offered in each applicable service area and at each level of coverage apply a flat-dollar copayment structure to the entire drug benefit; 1/1/24 -> at least 25% *if health insurance carrier offers fewer than 4 plans in a service area, they shall ensure that one plan applies a flat-dollar copayment structure to entire drug benefit *1/1/24 -> every health insurance carrier that offers group health plan that provides coverage for prescription drugs shall offer at least 2 group health plans *the flat-dollar copayment structure for prescription drugs must be applied pre-deductible and be reasonably graduated and proportionally related in all tier levels such that the copayment structure as a whole does not discriminate against or discourage the enrollment of individuals with significant healthcare needs *A healthcare plan may not refuse to contract with a pharmacy provider that meets the terms and conditions established by the health care plan *A health care plan shall apply the same co-insurance, copayment, and deductible factors to all drug prescriptions filled by a pharmacy provider that participates in their network *A health care plan may not set a limit on the quantity of drugs that an enrollee may obtain at one time with a prescription unless the limit is applied uniformity to all pharmacy providers in the health care plan's network

dispensing controlled substances

in good faith may dispense CS to any person upon written or electronic prescription of any prescriber, dated and signed by the person prescribing, bearing the name and address of the patient, including the full name, address, and registry number relating to the prescriber *the practitioner filling the prescription should write the date of filling and sign on the face of the written prescription *written prescription shall be retained on file for a period of 2 years *C2 should NOT exceed 30 day supply & is valid for up to 90 days after date of issuance *C3-5 shall NOT be filled or refilled more than 5 times or more than 6 months after the date *physicians may issue multiple prescriptions (3 sequential 30-day supplies) but must provide written instructions indicating earliest fill on each prescription *may dispense C3-5 upon receiving facsimile of a written signed prescription or upon lawful oral prescription (shall also NOT be filled or refilled more than 6 months after date thereof or refilled more than 5 times) *prescriber shall NOT pre-print a prescription for a CS *prescriber can use electronic device to print prescription but still must sign manually *except for any non-prescription targeted methamphetamine precursor (pseudophed) regulated by the methamphetamine precursor control act, a CS included in schedule V shall not be dispensed other than for a medical purpose and then ONLY personally by person registered to dispense schedule V CS, personally by a pharmacist to a person 21+ with 2 documents of identification: **name and address of purchaser, name and quantity of the product, date and time of sale, and dispenser's signature should be recorder **no person shall purchase more than 120ml or 120g during a 96-hour period **federal differences - 18 years old, 1 valid ID, no max limit or refills, initials of purchasers, date of sale, initials of pharmacist

biological products

interchangeable: FDA has licensed and determined it to need standards & has determined it's therapeutically equivalent as set forth in purple book (will be designated with an "I") *pharmacist may substitute intercangeable biological product if FDA has determined it to be interchangeable, prescribing physician does NOT say that substitution is prohibited, patient is informed of substitution, and within 5 days

drug prepackaging

label must have at a minimum: name, strength of drug, name of manufacture, BUD, and lot number. *Max BUD should be the manufacturer's BUD or 12 months, whichever is less

medication take-back program

must have appropriate equipment to provide readily retrievable information/records in cause of on-site inspection; hard copy printout must be provided to the agency within 48 hours upon request & records must be maintained for minimum of 3 years after date of medication acceptance

Dispensing

no person shall compound, sell or offer for sale, or cause to be compounded, any medicine or preparation under or by a name recognized in the US pharmacopoeia national formulary OR any drug preparation with a strength/purity that falls below professed standard strength/purity *if the prescriber, when transmitting oral or written prescription, does not prohibit drug product selection then a different brand or non-brand name drug product of same generic may be dispensed by pharmacist *generic drug determined to be therapeutically equivalent by FDA shall be available for substitution in IL in accordance with this and the Illinois FDA *prescribers should check may not substitute and sign to direct pharmacist in dispensing if they do NOT want them to substitute the written drug. *preprinted or rubber stamped marks, or other deviations from the above prescription format may not be permitted, the prescriber shall sign the form in his or her handwriting to authorize issuance of the prescription

pharmacist, student pharmacist, or pharmacy technician working requirements:

not required to work longer than 12 continuous hours per day, inclusive of breaks requires *if working 6 continuous hours or longer - required to take one 30min uninterrupted meal break and one 15min break *if working 12 continuous hours or longer - one additional 15min break required. *if pharmacy does not close during this time, the pharmacist shall remain within licensed pharmacy or within establishment in which the pharmacy is located

Dispensing

nothing prohibits a pharmacist from filling or refilling prescription for prescription drugs which is on file and has been transferred from one pharmacy to another by any means upon the following conditions: *dispensing pharmacist required to follow all requirements of IL law which apply to dispensing of drugs *prescriptions for C3-C5 may be transferred only once, however pharmacies electronically sharing real-time online database may transfer up to the maximum refills

opioid antagonists

pharmacist may dispense after completing training program

hypodermic syringes and needles act

pharmacist may sell up to 100 sterile syringes or needles to a person who is at least 18 years of age; may only be sold from the pharmacy department of the store

Emergency refills

pharmacist must use professional judgement *pharmacy has previously dispensed or refilled the med *not for a control *pharmacist informs patient that physician authorization required for future fills *emergency dispense is documented *pharmacy informs prescriber of emergency fill *fill limited to amount needed for emergency period *total dispensed amount should NOT exceed 30 day supply

theft or loss of controlled substances

pharmacy must file with DEA a form 106 theft or loss of controlled substances & copy should concurrently be sent to the division, attention of the drug compliance unit, along with printed name of person who signed the form

electronic transmission of prescriptions

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 of his/her choice

Purpose of issuance of prescriptions for controlled substances

prescription for a CS to be effective must be issued for a legitimate medical purpose by individual practitioner actin in usual course of his/her professional practice *responsibility for proper prescribing/dispensing of CS is upon the prescribing practitioner, but corresponding responsibility rest with pharmacist who fills the RX *practitioner shall not self-prescribe or self-dispense CS *practitioner may not prescribe controlled substances to an immediate family member unless there is a bona fide practitioner-patient relationship

Federal regulation MISC questions

quiz questions (10 questions)

Board of pharmacy

shall consist of 9 members, 7 of whom scheduled be licensed pharmacists (each of the 7 members must have at least 5 years), 2 public members *secretary shall appoint chief pharmacy coordinator who's a licensed pharmacist with at least 5 years of experience *shall employ pharmacy investigators as necessary who should each be licensed pharmacist & should employ at least one attorney to prosecute violations *duly authorized pharmacy investigators shall have the right to enter and inspect *2021 CHANGE: one of the licensed pharmacist shall have primary site at inpatient hospital pharmacy & there shall be one member who is a pharmcy tech.

distribution

unlawful for manufacture to distribute prescription drug without charge or for less than its fair market value *does NOT prohibit distribution of prescription drugs to patient by pharmacist in response to a request written and signed by medical practitioner which designates the quantity to be distributed

Anti-epileptic product selection

when prescriber has indicated "may not substitute" a pharmacist may not interchange an anti-epileptic drug or formulation of an anti-epileptic drug without notification and documented content of prescriber and the patient: *if a pharmacist substitutes any generic prescription in the place of a brand name anti-epileptic drug, the pharmacist shall provide written notice to the patient no later than the time the prescription is dispensed

technician training

within 2 years of initial licensure within 6 months before beginning new duties, its joint responsibility of pharmacy and PIC to train registered pharmacy tech