APhA Complete Review for Pharmacy 2015 - Federal Pharmacy Law

If online pharmacy does not meet reporting thresholds for reporting period ____.

Must file report stating that it did not meet reporting thresholds.

DEA inspector is authorized to enter a pharmacy to conduct administrative inspection under what circumstances?

Must state purpose and present to owner, operator, or agent in charge or premises appropriate credentials and written notice of inspection authority (administrative inspection warrant).

What conditions must be met for the FDA to authorize a patient to obtain an investigational new drug or device, prior to FDA approval, to be used for diagnosis, monitoring, or treatment of a serious disease/condition in emergency situations?

(1) A licensed physician must determine no comparable/satisfactory alternative available and that probably risk from investigational drug/device is not greater than probable risk from disease/condition. (2) FDA determines sufficient evidence of safety and effectiveness to support use. (3) FDA determines provision will not interfere with initiation, conduct, or completion of clinical investigations to support marketing approval. (4) Sponsor or clinical investigator submits to Secretary of HHS a clinical protocol describing use of drug/device in single patient or small group of patients.

recordkeeping and reporting requirements for medical devices

(1) Device user facility must report deaths and serious injuries, establish and maintain ADE files, submit summary annual reports. (2) Manufacturer/importer must report deaths and serious injuries, report malfunctions, establish and maintain ADE files, submit specified follow-up reports. (3) Distributor must maintain records of incidents but required to report.

Unless the owner, operator, or agent in charge gives consent, FDA inspections do not include ____.

(1) Financial data. (2) Sales data other than shipment data. (3) Pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to the FDCA). (4) Research data (other than relating to new drugs, antibiotics, devices, tobacco products subject to reporting and inspection regulations under FDCA).

DEA registration number

(1) First letter: "A" for practitioners before October 1, 1985. "B" for practitioners after October 1, 1985. "M" for midlevel practitioners. "X" for practitioners approved to treat opioid dependency. (2) Second letter: First letter of registrant's last name. If registrant's name begins with a number, may be a number rather than a letter. (3) 7-digit sequential number following the 2 letters. The sum of digits 1,3,5 and 2 times the sum of digits 2,4,6 are added together. The last digit of the sum is the 7th digit.

requirements for distributing drug samples

(1) Manufacturer/distributor must receive written request signed by licensed practitioner. (2) Manufacturer/distributor must verify with state authority that requesting practitioner is licensed or authorized under state law to prescribe drug product. (3) Receipt signed by recipient when drug sample is delivered and returned to manufacturer/distributor.

labeling requirements for prescription drugs dispensed by a pharmacist

(1) Name and address of dispenser. (2) Serial number and date of the prescription or fill. (3) Name or prescriber. (4) Name of patient, directions for use, cautionary statements.

labeling requirements for unit-dose packaging

(1) Name of manufacturer/packer/distributor. (2) Quantity of active drug(s). (3) Generic and trade name. (4) Repackager's lot number. (5) Expiration. (6) Any other appropriate information.

labeling requirements for manufacturer

(1) Name or address of manufacturer/packer/distributor. (2) Established name of drug or drug product (3) Ingredient quantity and proportion of each active ingredient. (4) Inactive ingredients if not for oral use with some exceptions. (5) Generic and proprietary names. (6) Quantity by weight. (7) Net quantity of container. (8) Recommended/usual dosage or reference to package insert. (9) Lot or control number. (10) Legend "Rx only". (11) Route. (12) Storage instructions. (13) Expiration. --Every commercial container of a controlled substance except for nonnarcotics exempt by application must have printed on the label a symbol designating the schedule. If the container is too small, the symbol is not required as long as the symbol is printed on the box/package from which the container is removed when dispensing to ultimate user. The symbol is not required on commercial container or its labeling if the controlled substance is being used in clinical research involving blind or double-blind studies.

labeling requirements for OTC drugs

(1) Product identity. (2) Name or address of manufacturer/packer/distributor. (3) Net quantity of contents. (4) Cautions and warnings. (5) Adequate directions for use. --Conditions, uses, purposes. --Quantity/dosage for each intended use and for persons of different ages and physical conditions. --Frequency, duration, time, route/method of administration/application. --Preparation necessary for use. (6) Drug facts panel. --Active ingredients. --Purpose. --Uses. --Warnings. --Directions. --Other information are required. --Inactive ingredients in alphabetical order. --Section for "Questions?" and "Comments?" with telephone number.

What are the appropriate methods for a pharmacist to distribute "side effects" statement?

(1) Sticker attached to the unit package, vial, or container of the drug product (2) On a preprinted pharmacy prescription vial cap (3) On a separate sheet of paper (4) In consumer medication information (5) FDA approved Medication Guide that contains the side effects statement

The Official Compendia in the federal FDCA includes ____.

(1) United States Pharmacopeia (2) Homeopathic Pharmacopeia of the United States (3) National Formulary

No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug which was purchased by a public or private hospital or other health care entity, or which was donated or supplied at a reduced price to a charitable organization. This does not apply to ____.

(i) acquisition by a health care entity that is a member of a group-purchasing organization of a drug for its own use from the group-purchasing organization or from other health care entities that are members of such an organization (ii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization to a nonprofit affiliate of the organization (iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among health care entities under common control (iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons (v) a sale, purchase, or trade of a drug; an offer to sell, purchase, or trade a drug; or the dispensing of a drug pursuant to a prescription

Regulated seller may not in a single calendar day sell any purchaser more than ____ of what drugs?

--3.6 grams of ephedrine base. --3.6 grams of pseudoephedrine base. --3.6 grams of phenylpropanolamine base.

exceptions to DEA registration requirements regarding controlled substances

--Agent or employee of any registered manufacturer, distributor, dispenser of any controlled substance or list I chemical if acting in usual course of business/employment. Registered facility must assign identification numbers for each agent/employee who handles or prescribes controlled substances using the facility's DEA number. --Common or contract carrier or warehouseman, or employee thereof, whose possession of the controlled substance or list I chemical is in usual course of business/employment.

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

--Amends CSA by adding new regulatory requirements and criminal provisions to curtail proliferation fo rogue Internet sites that unlawfully dispense controlled substances. --Online pharmacy must be first registered with DEA as pharmacy. After registered as pharmacy, must apply for modification of registration to operate as online pharmacy.

Computers on which records are maintained may be located ____. Electronic application must be capable of _____.

--At another location but records must be readily retrievable at registered location. --Electronic application must be capable of printing out or transferring records ina format readily understandable at registered location.

readily retrievable prescription requirements

--At the time initially filed, face of prescription is stamped in red ink in lower right corner with "C" no less than 1 inch high and filed in appropriate prescription file. --Requirement to mark hard copy prescription with red "C" waived if pharmacy uses computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled.

conditions for off-label use of approved drugs

--Authorized prescribers may legally prescribe off-label uses of FDA-approved drugs. --Manufacturers cannot advertise off-label uses to consumers but may distribute peer-reviewed research papers that describe off-label uses.

requirements for taking inventory of open containers of controlled substances

--CI-II: must make exact count/measure of contents. --CIII-V: may make estimate count/measure of contents unless container holds >1000 tablets/capsules, in which case, must make exact count.

physical security controls for controlled substances for practitioners and nonpractitioners authorized to conduct research or chemical analysis under another registration

--CI: must be stored in securely locked, substantially constructed cabinet. --CII-V: must be stored in securely locked, substantially constructed cabinet; pharmacies and institutional practitioners may disperse throughout stock of noncontrolled substances in such a manner as to obstruct theft/diversion. --Carfentanil, etorphine hydrochloride, diprenorphine must be stored in safe or steel cabinet equivalent to US government Class V security container.

Faxed prescriptions for CII may be used as the original prescription without follow-up written prescription when ____.

--Compounded for direct administration to patient by parenteral, IV, IM, SC, or intraspinal infusion. --For resident of LTC facility. --For patient in hospice care program certified and/or paid for by Medicare or in hospice program licensed by state.

The personal use exemption under the Controlled Substances Act allows an individual with a CII-V lawfully obtained for his/her personal medical use or for administration to an animal accompanying him/her to enter/depart the US under what conditions?

--Controlled substance is in original container it was dispensed. --Declaration made to appropriate official of Bureau of Customs and Border protection stating that controlled substance possessed for personal use or animal accompanying him/her, trade/chemical name and symbol designating schedule if it appears on the container label or (if such name does not appear on the label) name and address of pharmacy or practitioner who dispensed and prescription number. --US resident may import no more than 50 dosage units combined of all controlled substances obtained abroad for personal medical use. Limit does not apply to controlled substances obtained in US pursuant to prescription issued by DEA registrant.

DEA Form 222

--DEA Form 222 or CSOS required for distribution of CI-II. --Available through Attorney General. --Registrant obtains by submitting order form requisition with application for DEA registration (DEA Form 222a). To obtain forms, registrant must request in writing from local DEA office. --Executed form must be kept at least 2 years. --May authorize individual whether or not located at registered location to issue orders on registrant's behalf by power of attorney. --Purchaser prepares and executes all three copies of each DEA Form 222 simultaneously using typewriter, pen, or indelible pencil. --Purchaser retains copy 3 and sends copies 1 and 2 to supplier. Supplier retains copy 1 and sends copy 2 to DEA. --When purchaser receives order, must record # of containers received of each item and date received on copy 3.

labeling requirements for CII-V prescription

--Date of filling. --Pharmacy name and address. --Serial number of prescription. --Name of patient. --Name of prescribing practitioner. --Directions and cautionary statements.

What information must a transferring pharmacist provide a receiving pharmacist for electronic prescriptions transferred electronically, in addition to original electronic prescription data?

--Date of original dispensing. --# of refills remaining. --Dates and locations of previous refills. --Pharmacy name, address, DEA registration number, and prescription number from which it was originally filled. --Transferring pharmacy name, address, DEA registration number, and prescription number for each dispensing. --Name of pharmacist transferring.

prescription requirements for controlled substances

--Dated and signed on day issued. --Full name and address of patient. --Drug name. --Strength. --Dosage form. --Quantity. --Directions. --Name, address, registration number of practitioner.

Pharmacy registered to dispense controlled substance may distribute to another practitioner for the purpose of general dispensing by the practitioner to patients without registering to distribute under what conditions?

--Distribution recorded by distributing practitioner and receiving practitioner. --If CI-II, DEA Form 222 or CSOS is used. --Total # of dosage units of all controlled substances distributed by the pharmacy during each calendar year does not exceed 5% of total # of dosage units of all controlled substances distributed and dispensed during same calendar year.

Partial filling of CIII-V prescription permissible under what conditions?

--Each partial filling is recorded in same manner as refill. --No dispensing occurs after 6 months after date prescription was issued.

Controlled Substance Ordering System (CSOS)

--Electronic equivalent to DEA Form 222. DEA Form 222 or CSOS required for distribution of CI-II. --May use to purchase CI-V and noncontrolled substances. --Purchaser must retain each original signed order filled and all linked records for 2 years. --Purchaser must retain all copies of each unaccepted/defective order and each linked statement. --Supplier must retain each original order filled and linked records for 2 years. --Supplier must forward copy of electronic order or electronic report of order to DEA within 2 business days for each electronic order filled.

registration requirements for manufacturing/distributing/dispensing controlled substance

--Every person who manufactures/distributes or proposes to engage in the manufacture/distribution of any controlled substance or list I chemical must register annually with the Attorney General. --Every person who dispenses or proposes to dispense any controlled substance must register with the Attorney General every 3 years. This includes the act of prescribing. --Separate registration for each group of activities required for each principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, dispensed by a person with exclusion of warehouses for storage of controlled substances but not distribution, office used by agents for sales but not storage/distribution of controlled substances, office used by practitioner to prescribe but not storage/administration/dispensing controlled substances, freight-forwarding facilities.

"Notice of Privacy Practices" must include ____.

--How pharmacy intends to use and disclose PHI. --Legal duties of pharmacy to protect confidentiality. --Patient rights and how to exercise those rights. --How to complain of violations and file complaint. --Contact person for privacy concerns.

emergency situation

--Immediate administration necessary for proper treatment of intended ultimate user. --No appropriate alternative, including drug in different schedule. --Not reasonably possible for prescribing practitioner to provide written prescription prior to dispensing.

What situations do not require AIW?

--Informed and voluntary consent of owner, operator, or agent in charge of controlled premises. --Presentation of administrative subpoena issued under CSA. --Situations presenting imminent danger to health/safety. --Situations involving inspections of conveyances where there is reasonable cause to believe that mobility of conveyance makes it impracticable to obtain a warrant. --Exceptional/emergency circumstance where time or opportunity to apply for a warrant is lacking. --Situation where warrant is not constitutionally required.

Attorney General may require periodic reports of sales, deliveries, disposal of controlled substances from ____.

--Manufacturers of any controlled substance. --Distributors of narcotic controlled substances: must include registration number of person/entity to whom sale, delivery, disposal was made. --Pharmacists that dispense controlled substances by means of Internet must report total quantity of each controlled substance dispensed each month. No reporting required unless pharmacy has met 1 of following thresholds in the month for which reporting is required: 100+ prescriptions dispensed or 5000+ dosage units of all controlled substances combined dispensed.

responsibility of prescriber and dispenser over prescription

--May be prepared by secretary or agent for signature of prescriber but prescribing practitioner is responsible if prescription does not conform in all essential respects to law and regulations. --Corresponding liability upon pharmacist who fills prescription not prepared in conformance with DEA regulations.

How to dispose of controlled substance?

--May request assistance from Special Agent in Charge of local DEA office. --If registrant, must list controlled substances that he/she desires to dispose of on DEA Form 41 and submit 3 copies of that form to the local DEA office. --If not registrant, must submit letter stating name and address of the person; name and quantity of each controlled substance to be disposed; how the applicant obtained the substance if known; name, address, registration number of person who possessed prior to applicant if known.

FDA-approved drugs for purpose of maintenance or detoxification treatment in OTP are ____.

--Methadone and levo-alpha-acetyl-methadol (LAAM). --May not be dispensed by a pharmacist or prescribed for purpose of maintenance or detoxification treatment.

Electronic Prescriptions for Controlled Substances (EPCS)

--Modified regulations to give practitioners option of electronically writing prescriptions for controlled substances. --State law may restrict use of electronic prescriptions for controlled substances. --Practitioner may issue electronic prescription for CII-V if electronic prescription application used found to be consistent with regulations by third-party auditor or certification organization, two-factor authentication credential obtained from approved credential service provider of certified certification authority.

requirements for written authorization for use/disclosure of PHI

--Must be detailed and customized for particular use/disclosure. --Blanket authorizations not permitted. --Must contain expiration. "None" or until "end of research study" is acceptable. --Must be signed by patient. --Patient must receive copy of signed authorization.

When does each regulated person required to report mail-order sales of scheduled listed chemical products submit a report?

--Must submit written report containing details of sale on or before the 15th day of each month following the month in which distributions took place. --Upon request of and approval by DEA, submit electronic form via computer disk or direct electronic data transmission.

Pharmacist transferring a prescription must ____.

--Must write "Void" on face of invalidated prescription or add transfer information to prescription record for electronic prescriptions. --Must record on reverse of invalidated prescription the name, address, DEA registration number of pharmacy to which it was transferred, and name of pharmacist receiving information, or add this information to prescription record for electronic prescriptions. --Must record date of transfer and name of pharmacist transferring.

Pharmacist receiving a prescription transfer must ____.

--Must write "transfer" on face of transferred prescription, reduce to writing all information required to be on a prescription. --Must include date of issuance of original prescription, original number of refills authorized, date of original dispensing, # of valid refills remaining, dates and locations of previous refills; pharmacy name, address, DEA registration number, prescription number from which it was originally filled; pharmacy name, address, DEA registration number, prescription number from which it was transferred; and name of pharmacist transferring.

information that must be retrievable by prescription number

--Name and address of person to whom it was dispensed. --Name and dosage form of controlled substance. --Date filled or refilled. --Quantity dispensed. --Name or initials of dispensing pharmacist for each refill. --Total number of refills.

Records of receipt must contain ____.

--Name of substance. --Dosage form. --Strength. --# of dosage units or volume in container. --# of commercial containers received. --Date of receipt. --Name, address, registration number of supplier.

When is the symbol designating the schedule for a controlled substance not required on a label?

--Nonnarcotics exempt by application. --If the commercial container is too small and as long as symbol is printed on box/package from which the container is removed when dispensing to ultimate user. --If the controlled substance is being used in clinical research involving blind or double-blind studies.

Labeling requirements for CIII-V prescriptions do not apply if ultimate user is institutionalized and what conditions are met?

--Not more than 34-day supply or 100 dosage units of controlled substance dispensed at 1 time. --Controlled substance not in possession of ultimate user prior to administration. --Institution maintains safeguards and records regarding administration, control, dispensing, storage of controlled substance. --System used by filling pharmacist adequate to identify supplier, product, patient and to provide directions and cautionary statements.

Except for purchase by individual of a single sales package containing not more than ____ of ____, regulated seller must maintain written or electronic list (logbook) of each scheduled listed chemical product sale that ____.

--Not more than 60 milligrams of pseudoephedrine. --Identifies products by name, quantity sold, names and addresses of purchasers, dates and times of sales. Must include notice: "WARNING: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both".

Labeling requirements for CII prescriptions do not apply if ultimate user is institutionalized and what conditions are met?

--Not more than 7-day supply of controlled substance dispensed at 1 time. --Controlled substance not in possession of ultimate user prior to administration. --Institution maintains safeguards and records regarding administration, control, dispensing, storage of controlled substance. --System used by filling pharmacist adequate to identify supplier, product, patient and to provide directions and cautionary statements.

Medications may be mailed via USPS if ____.

--Outside packaging does not have any markings indicating nature of contents. --Only pharmacist or medical practitioner who dispenses the medicine mails to patients under their care. --Poisonous drugs and medicines are sent only from the manufacturer/dealer to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, veterinarians. --For mailable controlled substances, mailer and addressee are registered with DEA or exempt from DEA registration.

Pharmacist may dispense CIII-V prescriptions that are ____.

--Paper prescription signed by practitioner. --Fax of signed paper prescription transmitted by practitioner or practitioner's agent to the pharmacy. --Electronic prescription. --Oral prescription promptly reduced to writing by pharmacist containing required information except for signature of practitioner.

Pharmacies may transfer refill information under what conditions?

--Permitted by state law. --1 time basis unless pharmacies share real-time, online database. If so, may transfer refill information up to maximum number of refills permitted by prescription or by law. --Transfer may take place only by direct communication between 2 licensed pharmacists. --Transferring pharmacist: Must write "Void" on face of invalidated prescription or add transfer information to prescription record for electronic prescriptions. Must record on reverse of invalidated prescription the name, address, DEA registration number of pharmacy to which it was transferred, and name of pharmacist receiving information, or add this information to prescription record for electronic prescriptions. Must record date of transfer and name of pharmacist transferring. --Receiving pharmacist: Must write "transfer" on face of transferred prescription, reduce to writing all information required to be on a prescription. Must include date of issuance of original prescription, original number of refills authorized, date of original dispensing, # of valid refills remaining, dates and locations of previous refills; pharmacy name, address, DEA registration number from which it was originally filled; pharmacy name, address, DEA registration number from which it was transferred; and name of pharmacist transferring.

Requirements for distribution of Notice of Privacy Practices include ____.

--Pharmacies must provide to each patient on day pharmacy first provides service. In emergency, provide as soon as reasonably practicable after emergency treatment situation. Pharmacist may email notice to patient if patient agrees to electronic notice. --If pharmacy has Web site, notice must be posted prominently on Web site.

Under what conditions can a pharmacist dispense a CII-V that is not a prescription drug to a purchaser at retail without a prescription?

--Pharmacist dispenses. Transaction/delivery may be completed by nonpharmacist. --Not more than 240 cc (8 oz) of opium-containing controlled substance and not more than 120 cc (4 oz) of other such controlled substance dispensed to same purchaser in any given 48-hour period. --Not more than 48 dosage units of opium-containing controlled substance and not more than 24 units of other such controlled substance dispensed to same purchaser in any given 48-hour period. --Purchaser at least 18 years old. --Pharmacist requires every purchaser not known to him/her to furnish suitable identification, including proof of age where appropriate. --Bound record book for dispensing nonprescription controlled substances containing name and address of purchaser, name and quantity of controlled substance purchased, date of each purchase, name or initials of dispensing pharmacist. --Prescription not required for distribution/dispensing of the controlled substance pursuant to any other federal, state, or local law. --Central fill pharmacies may not dispense.

Partial filling of CII prescription permissible under what conditions?

--Pharmacist unable to supply full quantity. --Pharmacist makes notation of quantity supplied on face of written prescription or in electronic prescription record. --Date, quantity dispensed, remaining quantity to be dispensed, dispensing pharmacist should be noted in record for each partial refill. --Remaining portion of prescription may be filled within 72 hours of 1st partial filling. If remaining not filled within 72-hour period, pharmacist must notify the prescriber. --No further quantity may be supplied beyond the 72 hours without a new prescription. --To permit dispensing of individual dosage units to patients in LTC facilities and to patients who are terminally ill. Pharmacist must record on prescription whether patient is "terminally ill" or "LTCF patient".

recordkeeping requirements of controlled substances

--Pharmacy must keep records of inventory, drugs received, drugs dispensed. --Kept for at least 2 years at place of registration. --Financial and shipping records may be kept at a central location rather than registered location if registrant has notified DEA.

PPI distribution requirements

--Potentially dangerous drugs required to be dispensed with patient package insert include Accutane, statins, OCP, estrogen-containing products. --All dispensers are required to distribute PPIs. --Manufacturers are required to provide dispensers with sufficient number of PPIs. --In hospitals and LTC facilities, pharmacists must distribute PPIs to both outpatients and inpatients. For inpatients, PPIs must be distributed before initial dose and then every 30 days as long as therapy continues. --Pharmacists do not meet legal obligations by distributing PPIs to the prescriber. Dispensers must give PPIs to the patient.

requirements for executing power of attorney for individual to issue orders for CI-II on registrant's behalf

--Power of attorney must be retained in files with executed DEA Form 222 bearing signature of attorney. --Power of attorney must be available for inspection together with other order records. --Registrant may revoke power of attorney at any time by executing notice of revocation. --Registrant that grants power of attorney must report to DEA Certification Authority within 6 hours if person with power of attorney has left employ of institution or has had privileges revoked. --Registrant must maintain record that lists each person granted power of attorney to sign controlled substances orders.

Opioid Treatment Programs (OTP)

--Practitioner may administer or dispense directly, but not prescribe, a narcotic listed in any schedule to narcotic-dependent person for purpose of maintenance or detoxification treatment if practitioner separately registers annually with DEA as an OTP. --Registration is in addition to DEA registration as a dispenser. Additional registration requirement waived for practitioners who qualify under Drug Addiction Treatment Act. --Only drugs FDA-approved for this purpose may be administered/dispensed.

Drug Addiction Treatment Act (DATA) (Office-Based Treatment)

--Practitioners who dispense narcotic drugs for maintenance treatment or detoxification treatment must obtain annually a separate registration for that purpose in addition to DEA registration as a dispenser. Additional registration requirement waived for practitioners who qualify under DATA to treat addiction in office-based practice. --Registered practitioner who qualifies under DATA may dispense and prescribe FDA-approved CIII-V narcotics for use in maintenance or detoxification treatment without obtaining separate registration as OTP. Before initial dispensing, must submit to Secretary of HHS notification of intent to begin dispensing drugs for such purpose. Notification of intent must state that practitioner is a qualifying physician, has capacity to refer patients to counseling and other ancillary services, total # of patients at any 1 time NTE 30 for the 1st year. After 1st year, practitioner may submit 2nd application to treat up to 100 patients with approval of Secretary. --Secretary determines within 45 days of receiving notification. Attorney General assigns identification to practitioner that is included in registration as dispenser. --Practitioner may begin to prescribe or dispense during 45-day period if it facilitates treatment of individual patient and practitioner notifies Secretary and Attorney General of intent to begin prescribing/dispensing.

conditions for waiving dispensing prescription without child safety closure

--Prescriber may waive safety closure for that prescription and any refills but may not request blanket waiver for all future prescriptions for that patient. --Patient may request blanket waiver for all prescriptions. Pharmacist should obtain written waiver and periodically check with patient.

Exceptions for dispensing prescriptions with child-resistant safety closures include ____.

--Prescriber specifies that safety closures should not be used. --Patient indicates he/she does not want safety closure. --Container used in facility in which drugs remain under control of health care professionals.

exceptions to controlled substance inventory requirements

--Prescribing of CII-V by practitioners acting in course of practice unless in course of maintenance/detoxification treatment. --Administering of CII-V unless practitioner regularly engages in dispensing/administering controlled substances and charges patients or unless administered in course of maintenance/detoxification treatment. --Use of controlled substances at registered establishments that qualify for drug research exemption. --Use of controlled substances at registered establishments that keep records with respect to such substances in preclinical research or teaching. --Exemption granted by Attorney General.

Records of drugs dispersed include what types of records?

--Prescription orders. --Nonprescription CV sales. --Distributions from a pharmacy to another practitioner. --Institutional medication orders. --Reports of disposal or destruction of controlled substances (DEA Form 41). --Reports of theft or loss (DEA Form 106).

Poison Prevention Packaging Act of 1970

--Protect children under 5 years. US Consumer Product Safety Commission (CPSC) has responsibility of overseeing enforcement). --Requires child-resistant closures to almost all prescription drugs dispensed direct to consumers, nonprescription drugs, hazardous household products.

Computer application may be used as alternative for storage and retrieval of refill information for original paper prescription orders for CIII-IV if what conditions are met?

--Provides online retrieval (via computer monitor or hard-copy printout) of original prescription order information for those prescription orders currently authorized for refilling. --Provides online retrieval of current refill history for prescription orders authorized for refill during past 6 months. --Pharmacist must document that refill information entered into computer is correct. --Provides hard-copy printout of each day's controlled substance prescription order refill data that must be verified, dated, and signed by individual pharmacist who refilled prescription order. Must be maintained in separate file at that pharmacy for 2 years from dispensing date. --In lieu of printout, pharmacy must maintain bound logbook or separate file in which individual pharmacist involved in dispensing must sign a statement each day, attesting to the fact that refill information entered into computer that day has been reviewed by him/her and is correct as shown. Must be maintained for 2 years after date of dispensing. In event of system downtime, pharmacy must have auxiliary procedure for documentation or CIII-IV prescription order refills.

Before completing retail sale of scheduled listed chemical product, ____.

--Purchaser must present identification card that provides photograph and is issued by state or federal government or document considered acceptable for purposes of employment. --Purchaser must sign logbook. --If purchaser enters information, seller must determine that the name entered corresponds to that provided on identification and that date and time entered are correct. --If seller enters information, prospective purchaser must verify that the information is correct. --Regulated seller must enter into logbook the name of the product and quantity sold.

Prior to shipping scheduled listed chemical product for mail-order sale at retail, regulated person must ____.

--Receive from purchaser a copy of identification card that provides photograph and is issued by state or federal government or document considered acceptable for purposes of employment. --Determine that name and address on identification correspond to that provided by purchaser as part of sales transaction. --If being shipped to a third party, verify that purchaser and person to whom product is being shipped live at addresses provided.

activities allowed coincident to registration as controlled substance dispenser

--Registered dispenser may conduct research and instructional activities with those substances except that midlevel practitioner may conduct such research only to extent authorized under state statute. --Pharmacist may manufacturer narcotic controlled substance in CII-V in proportion NTE 20% of complete solution/compound/mixture. Pharmacy may need to register as manufacturer under FDCA. --Retail pharmacy may perform central fill pharmacy activities.

components of prospective review

--Screening (of prescriptions): To identify potential drug therapy problems. Pharmacist must conduct review of drug therapy before each prescription is filled or delivered. --Patient counseling: Pharmacist must offer to counsel each patient or caregiver in person or via telephone service toll-free for long-distance calls. Pharmacist not required to verify offer to provide counseling or refusal of offer. --Patient profile: Pharmacist documentation of relevant patient information. Must make reasonable effort to obtain, record, maintain at minimum name, address, telephone number, DOB or age, gender, history (including disease states, allergies, drug reactions), comprehensive list of medications and relevant devices, comments relevant to drug therapy.

controlled substance inventory requirements

--Separate inventory must be taken initially and then every 2 years for each registered location and each independent activity registered. Biennial inventory may be prepared on general inventory date as long as within 6 months of biennial inventory date that would otherwise apply. --Inventory for newly scheduled drug must be taken on effective date of regulation. --Inventories must be kept at least 2 years.

When may or may not a supplier endorse an order to another supplier to fill?

--Supplier may not endorse electronic order to another supplier to fill. --Written DEA Form 222 may be endorsed to another supplier if original supplier cannot fill order.

Prescribing practitioner may authorize addition refills of CIII-IV on original prescription via oral refill authorization transmitted to the pharmacist under what conditions?

--Total quantity authorized does not exceed 5 refills nor extend beyond 6 months from date of issue of original prescription. --Pharmacist obtaining oral authorization must record on reverse of original paper prescription or annotate electronic prescription record with date, quantity of refill, and number of additional refills authorized. --Pharmacist must initial paper prescription or annotate electronic prescription record showing who received refill authorization from prescribing practitioner who issued the original prescription. --Quantity of each additional refill authorized is equal to or less than quantity authorized for initial filling of original prescription.

Authorized hospital staff may administer/dispense narcotic in hospital to maintain or detoxify a patient under what conditions?

--Treatment is incidental to other medical or surgical treatment of conditions other than addiction. --Treatment is to relieve intractable pain for which no relief or cure is possible or none has been found after reasonable efforts.

Parent or guardian has access access to PHI of minor unless ____.

--Under state law, minor has right to consent to health care service. --Court or person authorized by law consents to health care service. --Parent or guardian agrees to confidentiality.

Before filling an order submitted via CSOS, supplier must ____.

--Verify integrity of signature and order using software that complies to validate the order. --Verify digital certificate has not expired. --Check validity of certificate holder's certificate by checking Certificate Revocation List. Supplier may cache Certificate Revocation List until it expires. --Verify registrants eligibility to order controlled substances by checking certificate extension data.

Registrant must notify local DEA in writing of theft or significant loss of any controlled substances within ____ of discovery of such loss or theft.

1 business day.

Supplier must forward copy of electronic order or electronic report of order to DEA within ____ for each electronic order filled.

2 business days.

Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

2 parallel, mandatory reporting systems for serious ADEs: OTC and dietary supplements.

Each entry in the written or electronic logbook of scheduled listed chemical product sales must be maintained for not fewer than ____.

2 years after the date on which the entry is made.

Electronic records regarding controlled substance prescriptions must be maintained electronically for ____.

2 years from date of creation or receipt (unless federal or state law requires longer period).

Original and transferred prescriptions must be maintained for a period of ____.

2 years from the date of last refill.

Every person who dispenses or proposes to dispense any controlled substance must register with the Attorney General every ____.

3 years

Prescription for CIII-IV cannot be refilled more than ____ times within ____ period. After this, ____.

5 times within 6-month period. After this, prescriber must issue new prescription.

No prescription for CIII-IV can be filled or refilled more than ____ after date of issue.

6 months.

Copies of notices, written acknowledgements of receipt of "Notice of Privacy Practices", or documentations of good faith efforts to obtain written acknowledgements must be retained for ____.

6 years.

CII prescriptions for patients in LTC facility or with terminal illness are valid for period not to exceed ____ unless ____.

60 days from issue date unless terminated sooner by discontinuation of medication.

Prescribing individual practitioner must deliver written prescription for emergency quantity of CII orally prescribed of via oral prescription within ____.

7 days.

At least how many days before introducing/delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must the manufacturer/distributor submit to the FDA information on which basis the manufacturer/distributor has concluded that the dietary supplement can reasonably be expected to be safe?

75

Regulated seller may not sell to the same person more than ____ of listed chemical product within ____ period except for sales through ____ which are limited to no more than ____ per ____ period.

9 grams within 30-day period except for sales through mobile retail vendors and mail-order sales which are limited to no more than 7.5 grams per 30-day period.

Individual practitioner may issue multiple prescriptions authorizing patient to receive total of up to ____ of CII under what conditions?

90-day supply under following conditions: --Written instructions on each prescription indicating earliest date on which a pharmacy may fill each prescription. --Individual practitioner concludes that providing patient with multiple prescriptions does not create undue risk of diversion/abuse. --Permissible under applicable state laws.

drug product substitution ratings

A: bioequivalent and therapeutically equivalent to brand-anme; substitutions of same strength and dosage forms permitted. B: not bioequivalent; substitutions not permitted. AB: have had problems with bioequivalence but have been resolved; substitutions of same strength and dosage forms permitted.

FDA Amendments Act of 2007

Additional FDA authority over premarketing and postmarketing safety. Postmarketing studies and clinical trials, safety labeling changes, REMS. Required "side effects" statement that notifies patients to report ADEs. FDA pre-review direct to-consumer ads. FDA only makes recommendations about ad and may require change only if change addresses serious risks associated with drug use.

When does retrospective review occur?

After drugs have been dispensed.

Dispensers required to distribute side effects statement with ____.

All new and refill prescriptions. Must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088".

Practitioner must register with DEA ____ to treat addicts in an OTP.

Annually.

Flunitrazepam

Any person convicted of possession shall be imprisoned and/or fined.

DEA Form 224

Application for new DEA Certificate of Registration.

cosmetic

Articles intended to be rubbed, poured, sprinkled, sprayed to the body for cleansing, beautifying, promoting attractiveness, altering appearance. Does not include soap. Does not require premarket approval. Manufacturers not required to register with FDA or follow GMPs. Must list ingredients in descending order or predominance. Must conform to PPPA. Warnings, if applicable, required: (1) inhaling contents under pressure may be harmful or fatal; (2) the safety of the product has not been determined; (3) the presence of coal tar in hair dye.

When does prospective review occur?

At point of dispensing before prescription is dispensed.

____ may ____ a registration or limit to particular schedule(s).

Attorney General may deny, revoke, or suspend a registration. Suspension or revocation may be limited to particular schedule(s).

Secure and Responsible Drug Disposal Act (Disposal Act)

Authorized DEA to develop methods for disposal of controlled substances that have been dispensed to an ultimate user. 3 additional voluntary disposal options available to ultimate users: take-back events, mail-back programs, collection receptacle programs.

reverse distributor

DEA registrant to whom pharmacy can return unwanted, unusable, or outdated controlled substances.

Regulated seller must place listed chemical products ____ and delivery product ____.

Behind-the-counter and delivery product directly into custody of the purchaser.

Registrant shall not employ any person who has access to controlled substances, and who has ____.

Been convicted of a felony offense relating to controlled substances or at any time had application for DEA registration denied or had registration revoked/surrendered for cause.

FDA-approved drugs for purpose of maintenance or detoxification treatment under DATA qualification are ____.

Buprenorphine sublingual tablets (Subutex) and buprenorphine/naloxone tablets (Suboxone).

classes of medical devices

Class I: least potential harm to users. Class II Class III: life-sustaining; require premarket approval.

classes of drug recalls

Class I: serious adverse health consequences. Class II: temporary/reversible. Class III: unlikely to cause.

Which drugs of their own separate order forms?

Carfentanil, etorphine hydrochloride, diprenorphine.

gamma-hydroxybutyric acid (GHB)

CIII for FDA-approved uses. Available only through single centralized pharmacy as part of restricted distribution program.

pregnancy warning categories

Category A: clear evidence of no risk to fetus. Category B: animal studies fail to show risk to fetus. Category C: risk to fetus undetermined. Category D: positive evidence of risk to fetus. Category E: risk to fetus outweighs any possible benefit.

When central fill pharmacies contract with private, common, or contract carriers to transport filled prescriptions to retail pharmacy, ____ is responsible for reporting in-transit losses upon discovery of such loss.

Central fill pharmacy is responsible for reporting by use of DEA Form 106.

Pharmacies that compound in the regular course of business may advertise/promote ____.

Compounding service, not a particular drug that it compounds.

When dispensed to/for a patient, CII-IV prescription label shall contain concise warning that ____.

Concise warning that it is a crime to transfer the drug to any person other than the patient.

covering practitioner

Conducts medical evaluation at request of a practitioner who has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through telemedicine within previous 24 months and is temporarily unavailable to conduct evaluation of the patient.

medical food

Consumed or administered enterally under supervision of physician and intended for specific dietary management of disease or condition for which distinctive nutritional requirements are established by medical evaluation.

Contents of package inserts include ____. The format requires ____.

Contents include the following: (1) Description of the drug. (2) Clinical pharmacology. (3) Indications and usage. (4) Contraindications. (5) Warnings. (6) Precautions. (7) ADRs. (8) Potential for abuse or dependence. (9) Symptoms and treatment of overdose. (10) Dosage and administration. (11) Available dosage forms. (12) Date of most recent revision of labeling. (13) Recommended/usual dosage. The format requires the following: (1) Highlights section. --Immediate access to information about benefits and risks. --Boxed warnings. --Indications. --Dosage and administration. (2) Table of contents. (3) Date of initial product approval. (4) Toll-free number and Internet reporting information to encourage reporting of side effects. (5) Section on "patient counseling information" to encourage communication between health professionals and patients.

disclosure of PHI to business associations

Covered entity may disclose PHI to business associate and may allow business associate to create or receive PHI on its behalf if satisfactory assurance that business associate appropriately safeguards information.

Pharmacist receiving a transferred electronic prescription must ____.

Create an electronic record for the prescription that includes the receiving pharmacist's name and all information transferred with the prescription.

Department of Homeland Security Appropriations Act of 2007

Created Canadian Personal Use Exemption for individual patients transporting FDA-approved prescription drugs from Canada into US.

No controlled substance that is a prescription drug may be ____ by means of the Internet without ____.

Delivered, distributed, dispensed without valid prescription. Valid prescription is issued for legitimate medical purpose in usual course of professional practice by practitioner who has conducted at least 1 in-person medical evaluation.

Products exempt from tamper-evident packaging are ____.

Dermatological, dentifrice, insulin, lozenge.

Abbreviated New Drug Application (ANDA)

Different company submits to market generic drug after innovator company patent expires. New drug requires proof of similar pharmacokinetic properties, bioavailability, clinical activity.

Written prescription for CII not required when ____.

Dispensed directly to ultimate user by practitioner other than pharmacist.

maintenance treatment

Dispensing for a period in excess of 21 days of narcotic in treatment of an individual for dependence upon morphine-like drugs.

detoxification treatment

Dispensing for a specified period of time of narcotic in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from continuous or sustained use of narcotic. Method of bringing individual to narcotic drug-free state within such period of time.

Reimportation of drug products is legal when ____.

Done by the original manufacturer for emergency use. Otherwise, reimportation of drug products is illegal.

Exportation of drug products is legal when ____.

Done by the original manufacturer or licensed wholesaler and no intention to reimport.

prescriptions for multiple CII

Each prescription for CII must be a separate prescription.

What is the retrospective review requirement of OBRA '90?

Each state must establish a DUR board consisting of physicians, pharmacists, and other health care professionals to review the use of drugs over a specified period of time to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and individuals receiving Medicaid benefits, or associated with specific drugs or groups of drugs. The committee may suggest changes to prescribing habits and may initiate educational programs for prescribers and pharmacists.

Practitioner may issue electronic prescription for CII-V if ____.

Electronic prescription application used found to be consistent with regulations by third-party auditor or certification organization, two-factor authentication credential obtained from approved credential service provider of certified certification authority.

Electronic Signatures in Global and National Commerce Act of 2000 (E-Sign)

Electronic records, signatures, contracts in interstate commerce recognized as legally valid.

Oral prescriptions for CII not permitted unless ____. Conditions include ____.

Emergency situation. Conditions include: --Quantity prescribed and dispensed limited to amount adequate to treat during emergency period. Dispensing beyond must be pursuant to paper/electronic prescription signed by prescribing individual practitioner. --Prescription must be immediately reduced to writing by pharmacist and contain all required information except for signature of prescribing individual practitioner. --If prescribing individual practitioner not known to pharmacist, must make reasonable effort to determine that oral authorization came from registered individual practitioner. --Dispensing pharmacist must receive from prescribing individual practitioner a written prescription for emergency quantity prescribed within 7 days. Prescription must have "Authorization for Emergency Dispensing" written on its face. Paper prescription may be delivered in person or by mail, but if by mail, must be postmarked within 7-day period. Upon receipt, dispensing pharmacist must attach this paper prescription to the oral emergency prescription earlier reduced to writing. For electronic prescriptions, pharmacist must annotate record of electronic prescription with original authorization and date of oral order. --Pharmacist must notify nearest DEA office if prescribing individual practitioner fails to deliver written prescription.

Medicaid Maximum Allowable Cost Program

Encourage generic substitution for more expensive brand-name drugs. Set upper limit on what Medicaid would reimburse for certain multisource drugs. Drug product selection laws vary from state to state: mandatory substitution states and permissive substitution states.

Methamphetamine Production Prevention Act of 2008

Encourages and facilitates use of electronic logbooks to discourage smurfing. Federal grants provided to states to develop electronic logbook systems to prevent smurfing across state lines.

FDA Food Safety Modernization Act of 2011

Ensure US food supply is safe. Shift focus from responding to contamination to preventing it.

For CIII-V prescription refills, pharmacist must ____.

Enter each refill on the back of the prescription or appropriate document or electronic prescription record.

Scheduled listed chemical products include ____ which are precursors to ____.

Ephedrine, pseudoephedrine, phenylpropanolamine which are precursors to methamphetamine.

Durham-Humphrey Amendment of 1951 (Prescription Drug Amendment)

Established 2 classes of drugs: Rx and OTC. Legend: "Caution: Federal law prohibits dispensing without a prescription". Authorized oral prescriptions and refills.

Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act) (CSA)

Establishes closed system for distribution of controlled substances. Only persons/entities registered with DEA may legally engage in manufacturing, distributing, dispensing controlled substances.

Omnibus Reconciliation Act of 1990 (OBRA '90)

Expanded standards of practice for pharmacists to save federal government money. Theory that improving quality of drug therapy would reduce costs of health care. One of primary mechanisms to accomplish goal is DUR.

Risk Evaluation and Mitigation Strategy (REMS)

FDA Amendments Act of 2007 authorized FDA to require sponsors to include REMS in pending NDA if necessary to ensure that benefits outweigh risks.

Safe Medical Devices Act of 1990

FDA additional authority over medical devices. Postmarketing approval. Require health care facilities to report problems to FDA. FDA new authority to recall.

Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act)

FDA authority to regulate manufacturing, distribution, marketing of tobacco.

medical device tracking

FDA issues tracking order to manufacturer of Class II or III device that meets 1 of 3 criteria: (1) Failure of device likely to have serious adverse health consequences. (2) Intended to be implanted in body for >1 year. (3) Life-sustaining or life-supporting device used outside device user facility.

expedited approval (fast track)

FDA may grant if new drug intended to treat serious or life-threatening condition and addresses unmet medical need. Sponsor must agree to conduct postapproval studies to validate use.

Compassionate Use Policy

FDA permits personal importation of small amounts of drugs under following conditions: --Drug is not approved for use in this country. --Drug treats serious condition for which no satisfactory treatment is available in the US. --Drug does not pose unreasonable risk. --Patient seeking to import drug provides name of US physician treating patient with unapproved drug.

Orange Book

FDA publishes to help determine bioequivalence of generic drugs.

Federal Anti-Tampering Act of 1982

Federal crime to tamper with OTC. Required tamper-resistant packaging on selected OTC drug products and cosmetics accessible to the public while held for sale. Barrier that provides visible evidence of entry if disturbed and directions to consumer on how to determine if tampering has occurred.

Generic Drug Enforcement Act of 1992

Felony to make false statement, bribe, fail to disclose material-related facts, etc.

Food Additives Amendment of 1958

Food additives require premarket approval for safety.

Anabolic Steroid Control Act of 2004

Includes anabolic steroids in CIII and provides automatic schedule without need to prove they promote muscle growth.

Investigational New Drug Application (INDA)

Includes animal studies and proposed clinical protocols for humans. FDA has 30 days to determine whether drug is suitable for testing.

Dispensing controlled substances includes ____.

Includes prescribing and administering controlled substance and packaging, labeling, compounding necessary to prepare substance for delivery to ultimate user.

requesting PHI amendment

Individual has right to have covered entity amend PHI. Covered entity may deny request for amendment if it determines that PHI was not created by covered entity or if PHI is accurate and complete.

Pharmacy Website exempt from definition of online pharmacy if ____.

Internet-related activity regarding controlled substances is limited to filling new prescriptions in CIII-V and/or refilling those prescriptions. Filling new prescriptions means that pharmacy previously dispensed the controlled substance to the patient by means other than the Internet pursuant to valid prescription, and pharmacy has contacted the prescriber who issued the original prescription at the request of the patient to determine if the prescriber will authorize issuance of a new prescription after determining there is legitimate medical purpose.

____ are appropriate records of receipt for CIII-V.

Invoices.

Administrative Inspection Warrant (AIW)

Issued by federal judge upon showing probably cause. Must be served during normal business hours. Requirements for obtaining AIW are much less than requirements for obtaining search warrant under Fourth Amendment.

prescribing or dispensing a narcotic for the purpose of maintenance or detoxification treatment

It is illegal to prescribe or dispense narcotic drugs for the purpose of maintaining an addiction or detoxifying an addict.

National Drug Code (NDC) components

Labeler's code identifies manufacturer or distributor. Second segment identifies specific strength, dosage form, formulation. Last component identifies trade package size and characteristics. FDA has standard 10-digit number while HIPAA has 11-digit standard.

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendment)

Make generics more readily available. Incentives to develop new drugs.

Nutrition Labeling and Education Act of 1990

Mandated nutrition labeling on food productions. Authorized health claims on product labeling. Standardized labeling terms with health implications.

PPPA exemptions

Manufacturers or packers may apply for exemption.

Phase 4 - Postmarketing Surveillance

Manufacturers submit yearly reports on new information about drug.

Uses/disclosures requiring patient's written authorization include ____.

Marketing. Research. Employment applications. Insurance coverage applications.

Pharmacist may dispense CII only after receiving ____ unless ____.

May dispense after receiving written prescription unless in emergency situation.

Registrant presented with AIW by DEA inspector may ____.

May not refuse to consent to inspection.

Best Pharmaceuticals for Children Act of 2002

Mechanisms for studying on- and off-patent drugs in children. Extended provision from 1997 FDA Modernization Act that offered additional 6 months patent exclusivity for on-patent drugs being tested for pediatric use.

Medical Device Amendment Act of 1976

Medical device classification according to function and requires premarket approval. Established performance standards, GMP, recordkeeping, reporting requirements.

Prescription Drug Marketing Act of 1987

More stringent controls on distribution to address diversion. Limit distribution beyond conventional retail. Specify storage, handling, recordkeeping for prescription drug samples. Ban sale, trade, purchase or prescription drug samples. Illegal for pharmacy to possess prescription drug samples. Prohibit health care entities from reselling pharmaceuticals to other businesses with some exceptions. Require state licensing of prescription drug wholesalers. Ban reimportation of prescription drugs produced in the US.

Logbook of scheduled listed chemical product sales must be kept ____ except ____.

Must be kept at regulated seller's place of business where transaction occurred except may be kept at single, central location of regulated seller if regulated seller has notified DEA.

pharmacy paper prescriptions for CIII-V

Must be maintained at registered location in separate prescription file or in such form readily retrievable from other prescription records of the pharmacy.

pharmacy paper prescriptions for CII

Must be maintained at registered location in separate prescription file.

pharmacy inventories and records of CIII-V

Must be maintained separately from all other records of the pharmacy or in such form that information is readily retrievable from ordinary business records of the pharmacy.

pharmacy inventories and records of CI-II

Must be maintained separately from all other records of the pharmacy.

oral prescription requirements

Must be promptly reduced to writing by pharmacist and filed. Limitations for CII.

Food, Drug, and Cosmetic Act of 1938

New drug could not be marketed until proven safe.

Kefauver-Harris Amendment of 1962 (Drug Efficacy Amendment)

New drugs to be proved effective as well as safe. Transferred prescription advertising jurisdiction from FTC to FDA. Required all advertising carry labeling on possible side effects. Established GMP requirement, registration with FDA by manufacturers, recordkeeping requirements, regular inspections, animal testing before human testing, informed consent of research subjects before participating in clinical trial, reporting of ADEs.

Dietary Supplement Health and Education Act of 1994

No premarket approval required if manufacturers of dietary supplements follow GMPs and do not make structure or function claims that indicate the dietary supplement is intended to diagnose, treat, cure, prevent any disease; otherwise, would require FDA approval.

CII prescription refills

No refills permitted for CII.

Central fill pharmacies are ____ to prepare CII upon oral authorization from retail pharmacist or individual practitioner.

Not authorized.

Prescriptions that exceed a practitioner's prescribing authority are ____.

Not legal prescriptions.

use/disclosure of de-identified information

Not subject to HIPAA and may be used/disclosed without patient authorization.

DEA Form 223

Number of the DEA Certificate of Registration that is displayed at the registrant's location.

Online pharmacy must ____ and afterward, ____ to operate as online pharmacy.

Online pharmacy must be first registered with DEA as pharmacy. After registered as pharmacy, must apply for modification of registration to operate as online pharmacy.

Behind-the-counter drugs may be sold by ____.

Only pharmacists.

requirements for faxed prescriptions for CII

Original written (paper or electronic) signed prescription must be presented to pharmacist for review prior to actual dispensing of controlled substance. Faxed prescriptions for CII may be used as the original prescription without follow-up written prescription if: --Compounded for direct administration to patient by parenteral, IV, IM, SC, or intraspinal infusion. --For resident of LTC facility. --For patient in hospice care program certified and/or paid for by Medicare or in hospice program licensed by state.

Written prescriptions include ____.

Paper and electronic.

Canadian Personal Use Exemption

Patients transporting FDA-approved prescription drugs from Canada into US in quantity NTE 90-day supply. Not a controlled substance or biological product.

long-term detoxification treatment

Period more than 30 days but not in excess of 180 days.

short-term detoxification treatment

Period not in excess of 30 days.

HIPAA policies and procedures in the pharmacy

Pharmacies must identify privacy officer to oversee pharmacy's compliance programs. Must train personnel. Must provide and enforce sanctions against employee who violates.

Prescription that is noncompliant with Tamper-Resistant Prescription Law can be filled if ____.

Pharmacist fills on emergency basis provided that the pharmacy obtains compliant prescription within 72 hours of fill date. Compliant prescription may be in the form of written prescription on tamper-resistant paper or may be obtained by verbal communication with prescriber by fax or e-prescription.

permissive substitution

Pharmacist may choose to substitute less expensive generic for brand-name drug only if prescriber writes prescription in a way that permits substitution.

Requirements for acknowledgement of receipt of "Notice of Privacy Practices" include ____.

Pharmacist must make good faith effort to obtain written acknowledgement of receipt of "Notice of Privacy Practices" from patient. If cannot be obtained, must document efforts to obtain and reason acknowledgement was not obtained. Pharmacist may not refuse to treat a patient who refuses to sign the acknowledgement.

If prescribing individual practitioner fails to deliver written prescription for emergency quantity of CII orally prescribed, ____.

Pharmacist must notify nearest DEA office.

mandatory substitution

Pharmacist required to substitute less expensive generic for brand-name drug unless prescriber indicated to "Dispense as written" or similar notation.

refill requirements

Pharmacists should note refills on back of written prescription or by other recording method, such as computer system. Pharmacist May not refill prescription unless specific authorization oral or written from authorized prescriber. Secretary can communicate refill or new prescription authorization but pharmacist should confirm that someone who has prescribing authority has actually authorized. Prescribers may limit number of refills.

Pharmacy may dispense controlled substances pursuant to electronic prescription if ____.

Pharmacy application approved by third-party auditor or certification organization that has found it to conform to regulations.

central fill pharmacy

Pharmacy permitted by law in the state in which it is located to prepare valid prescription orders for controlled substances transmitted from registered retail pharmacy and to return labeled, filled prescriptions to retail pharmacy for delivery to ultimate user. Authorized to fill on behalf of retail pharmacy only if contractual relationship.

Requirement to mark hard copy prescription with red "C" waived if ____.

Pharmacy uses computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled.

Drug Supply Chain Security Act

Requirements for tracing prescription drug products through pharmaceutical supply distribution chain.

To obtain a supply of controlled substances for general dispensing to patients, practitioner may not ____ but may ____.

Practitioner may not obtain supply of controlled substances by issuing prescription for general dispensing to patients. Practitioner may purchase from pharmacy, manufacturer, or wholesaler using invoice and receipt.

prescription requirements for gamma-hydroxybutyric acid (GHB)

Practitioner must note on face of prescription the medical need of the patient for the prescription.

Registered practitioner may dispense and prescribe FDA-approved CIII-V narcotics for use in maintenance or detoxification treatment without obtaining separate registration as OTP if ____.

Practitioner qualifies under DATA.

Chemical Diversion and Trafficking Act of 1988

Precursor chemicals, essential chemicals, tableting and encapsulating machines commonly used in illegal manufacture of controlled substances placed under federal control by imposing recordkeeping and import/export reporting requirements on transactions involving these materials.

Medicare Prescription Drug Improvement and Modernization Act of 2003 (Medicare Part D)

Prescription drug and preventive health care benefits added to Medicare. Donut hole limits benefits: seniors had to pay 100% of drug costs above $2250 until they reached $3600 out-of-pocket and then Medicare would pay 95% of drug costs. Affordable Care Act minimized impact of donut hole. Electronic prescriptions authorized. Allow wholesale importation of drugs from Canada only if Secretary of HHS certifies that program would pose no additional risk to public health and safety and would significantly reduce prescription drug costs.

When may or may not a prescription be issued for maintenance or detoxification treatment?

Prescription may not be issued unless by qualifying prescriber under DATA for FDA-approved drug for that purpose.

Federal Antitrust Laws

Prevents individual competitors from entering agreements that reduce competition and affect consumer interest in cost containment.

Behind-the-counter placement includes _____.

Product stored in locked cabinet in area of facility where customers do not have direct access. Mobile retail vendors must store products in locked cabinet.

Pure Food and Drug Act of 1906

Prohibit manufacture, sale, delivery, holding, or offering for sale of misbranded and adulterated food, drug, device, tobacco, or cosmetic. Prohibit false efficacy claims.

Delaney Clause (Anticancer Clause)

Prohibits approval of food additives that might cause cancer.

Anti-Kickback Statute

Prohibits from knowingly and willfully solicity, receiving, offering, paying any remuneration in exchange for inducing referrals or furnishing any goods or services paid for by Medicare or Medicaid.

False Claims Act

Prohibits from knowingly presenting false/fraudulent claim to federal government for payment. Prohibits making/using false record or statement to get false claim submitted to federal government paid or approved.

Health Insurance Portability and Accountability Act (HIPAA)

Protects PHI and imposes penalties on covered entities that make unauthorized disclosures of PHI.

Color Additives Amendment of 1960

Requires manufacturers to establish safety of color additives. Contains anticancer clause prohibiting approval of any color additive that might cause cancer.

To issue a prescription for maintenance or detoxification treatment, a qualifying practitioner under DATA must ____.

Provide identification number issued by Attorney General after certification by Secretary of HHS. If within 45-day application period, written statement that prescriber is acting under good faith belief that practitioner qualifies under DATA, that practitioner has applied for number, that the Secretary will certify practitioner, and identification number will be issued.

smurfing

Purchasing products containing ephedrine, pseudophedrine, phenylpropanolamine from many different pharmacies that maintain only written logbooks.

Incidental disclosure of PHI to permitted use or disclosure is not a violation of HIPAA if ____.

Reasonable safeguards have been taken to protect PHI.

adulteration

Referring to composition/purity. (1) Contains filthy/putrid/decomposed substance, unapproved color additive, ingredient as substitute for active drug. (2) Prepared/packaged/held under unsanitary conditions. (3) Manufactured under conditions that do not meet GMP standards. (4) Contains drug recognized in official compendia but strength/purity/quality lower than official standards unless plainly stated on label. (5) Contains drug not recognized in official compendia but strength/purity/quality lower than listed on label. (6) Container composed of poisonous/deleterious substance that may leach into product contents.

misbranding

Referring to labeling. (1) False, misleading. (2) Missing name or location of manufacturer/packer/distributor. (3) Does not contain a word, statement, information required by law displayed in prominent, readable manner. (4) Does not include established name of active drug. (5) Does not have each active ingredient and its quantity identified (unless prescription not for human use). (6) Does not have each inactive ingredient listed in alphabetical order (unless prescription not for human use or nonprescription cosmetic). (7) Does not state "Rx only" if drug available only by prescription (unless prescription dispensed to consumers). (8) Does not contain precautionary statement concerning drug subject to deterioration. (9) Missing accurate statement of quantity of contents in terms of weight, measure, numerical count (reasonable variations permitted and exemptions for small packages). (10) Inadequate directions for use of nonprescription drugs or does not include appropriate warnings required to protect those using medication or packaging. (11) Inadequate information for use (prescription drugs). (12) Does not conform to requirements as prescribed in official compendium if listed. (13) Offers sale of drug under name of another drug. (14) Offers sale of imitation of another drug. (15) Prescribes, recommends, suggests dosage dangerous to health. (16) Does not conform to requirements for packaging and labeling of color additives. (17) Does not include all advertisements and other descriptive material required for prescription drugs (information for use). (18) Container misbranded. (19) Manufactured, prepared, propagated, compounded, processed in establishment not duly registered under applicable law. (20) Not manufactured using tamper-evident or tamper-resistant packaging as required by law. (21) Does not conform to PPPA of 1970. (22) Pharmacy dispenses prescription-only drug without legal prescription or authorized refill.

A pharmacy that repackages OTC products or changes the container/wrapper/labeling in any way for resale must ____.

Register as a manufacturer.

DEA Form 106

Registrant must complete and submit to report theft or loss of controlled substances.

Combat Methamphetamine Epidemic Act of 2005

Regulates OTC sale of any product containing precursors to methamphetamine by placing them into new category of CSA known as "scheduled listed chemical products". Precursors include ephedrine, pseudophedrine, phenylpropanolamine.

FDA Modernization Act of 1997

Regulatory procedures to ensure expedited availability of safe and effective drugs and devices. Increased FDA public accountability. Compliance plan in consultation with industry representatives, scientific experts, health care professionals, consumers. Fast-track approval for drugs for serious or life-threatening diseases. Replaced legend "Caution: Federal law prohibits dispensing without a prescription" with "Rx only". Clarified conditions under which pharmacists may perform extemporaneous compounding of prescriptions. Pharmacists exempt from GMP standards and NDA requirements. Data bank for clinical trial information. Authorized scientific panels to review clinical investigations. Rights of manufacturers to disseminate unlabeled use information and require specification that such use is not FDA approved. Encourage manufacturers to conduct research for new uses of approved drugs and submit SNDAs for these uses. Eliminated manufacturer requirement that certain substances carry label "Warning--May be habit forming". OTC ingredient labeling requirements for inactive ingredients and preempted states from establishing labeling requirements for OTC drugs and cosmetics when federal requirements exist. Mandated priority review for breakthrough technologies for medical devices. Allow FDA to contract with outside scientific experts for review of medical device applications. Allowed investigational new drug to be accessible outside clinical trial to treat patients with immediate or life-threatening diseases for which no satisfactory alternative is available if reasonable basis to conclude that drug may be effective and would not expose patients to unreasonable and significant risk.

A physician who is not specifically registered to conduct a narcotic treatment program may administer, but not prescribe, narcotic for purpose of ____. Not more than ____ may be administered for maximum of ____.

Relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than 1 day's medication administered at 1 time for maximum of 3 days.

DEA Form 224a

Renewal application that DEA mails to registrants approximately 60 days before expiration of DEA Certificate of Registration.

Pharmacist must report to DEA any unusual or excessive loss or disappearance of scheduled listed chemical product. Report must be ____ and ____ must be filed within ____.

Report must be made orally, if possible, as soon as possible, and written report must be filed within 15 days after pharmacist becomes aware of loss.

Prescription Drug User Fee Act of 1992

Require manufacturers to pay fees for applications and supplements when FDA reviews clinical studies. Provide revenues to hire additional reviewers to speed up NDA reviews.

When retail pharmacies contract with private, common, or contract carriers to retrieve filled prescriptions from central fill pharmacy, ____ is responsible for reporting in-transit losses upon discovery of such loss.

Retail pharmacy is responsible for reporting by use of DEA Form 106.

If prescription for controlled substance is filled at a central fill pharmacy, central fill pharmacy must affix to the package a label showing ____.

Retail pharmacy name and address and unique identifier (central fill pharmacy's DEA registration number) to indicate that prescription was filled at central fill pharmacy.

Drug Use Review (DUR) components include ____.

Retrospective review. Educational programs. Prospective review.

Supplemental New Drug Application (SNDA)

Same company submits change to approved drug.

Electronic copies of prescription records must be _____.

Sortable by prescriber, patient, drug dispensed, date filled.

____ will authorize and instruct applicant to dispose of controlled substance in what possible ways?

Special Agent in Charge will authorize and instruct to dispose in 1 of following ways: --Transfer to person registered under the act and authorized to possess the controlled substance. --Delivery to DEA agent or nearest DEA office. --Destruction in presence of DEA agent or other authorized person. --Other means as Special Agent in Charge may determine to ensure that controlled substance does not become available to unauthorized persons. --If registrant is required to dispose of controlled substances on regular basis, may authorize to dispose without prior DEA approval. Registrant must keep records of each disposal and file periodic reports with Special Agent in Charge summarizing disposals. Special Agent in Charge may place conditions on disposal.

What is the educational program requirement of OBRA '90?

State DUR boards must provide active and ongoing educational outreach programs to educate practitioners on common drug therapy problems with the aim of improving prescribing or dispensing practices.

New Drug Application (NDA)

Submitted after phases 1,2,3 of clinical trails. FDA has at least 6 months to review.

special dietary food

Supply special dietary need that exists by reason of physical, physiological, pathological, or other condition.

Orphan Drug Act of 1983

Tax and exclusive licensing incentives to develop and market drugs or biological products for treatment of rare diseases/conditions that affecting <200,000 Americans.

Medicare and Medicaid Fraud and Abuse Statute

The Part D program requires pharmacies to have a comprehensive program to prevent and correct waste, fraud, and abuse. Illigal to make false statement/representation of material fact in any application for benefit or payment.

Every person who owns or operates any establishment in any state engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs must register with ____ every ____ and include ____. Those exempt are ____.

The Secretary of Health and Human Services (HHS) every year and include name and places of business. Separate registration must be made for each establishment. Pharmacists compounding in the regular course of business, pursuant to a prescription or in anticipation of a prescription are exempt.

____ certifies qualifying practitioners under DATA rather than the DEA.

The Substance Abuse and Mental Health Services Administration.

A pharmacy must report breaches of unsecured PHI occurring on or after September 23, 2009. Depending on the seriousness, notifications must be made to ____.

The individual, media, and Secretary of HHS.

If pharmacist merely initials and dates back of prescription or annotates electronic prescription record, it is deemed that ____.

The pharmacist has dispensed the full face amount of the prescription.

Importation of drug products is legal when ____.

There are personal use exceptions. Otherwise, importation is illegal.

Prescription drug labeling must contain "adequate information for use" designed for ____ which must include ____. Prescription drugs dispensed by a pharmacist are exempt if they bear a label containing ____.

This information is designed for the health care provide. It includes the following: (1) Indications. (2) Side effects. (3) Dosages. (4) Routes, methods, frequency, duration of administration. (5) Contraindications. (6) Warnings and precautions that enable practitioner to administer/prescribe/dispense safely. Prescription drugs dispensed by a pharmacist are exempt from these requirements if they bear a label containing the following: (1) Name and address of dispenser. (2) Serial number and date of the prescription or fill. (3) Name or prescriber. (4) Name of patient, directions for use, cautionary statements.

Controlled Substance Registrant Protection Act of 1984

To combat threat of robberies, burglarries, violent crimes, mandates federal investigation under following circumstances: --Replacement cost of controlled substances $500+. --Person killed or suffers significant injury as result of crime. --Interstate/foreign commerce involved in planning/execution of crime.

child-resistant test panel requirement

To pass child-resistant test, 80% of children under 5 years should not be able to open package within 10 minutes and 90% of adults between 50-70 years should be able to open package within 5 minutes and 2nd time within 1 minute.

Each regulated seller must ensure that all individuals responsible for delivering products into the custody of purchasers or who deal directly with purchasers by obtaining payments for products are ____. Regulated seller must submit to the DEA ____ and maintain a copy and all records demonstrating.

Trained in regulations governing the sale of schedule listed chemical products. Must submit to DEA self-certification that all such individuals have undergone training.

Permissible uses and disclosures of PHI without written patient authorization include ____.

Treatment. Payment. Health care operations.

approval process - chemical classifications

Type 1: new molecular structure from existing drugs used for therapeutic purpose; new and unique. Type 2: new derivative of molecular structure already approved in US. Type 3: new formation of drug already marketed in US. Type 4: new combination. Type 5: new company manufactured drug. Type 6: new indication for already approved drug. Type 7: already marketed without approved NDA. Type 8: OTC switch. Type 10: new indication submitted as distinct NDA, not consolidated. No type 9.

approval process - review classifications

Type P: priority; no other effective drugs available for particular illness or significant advantage over currently marketed drugs. Type S: standard; similar to others currently on the market. Type O: treats rare disease.

____ has the authority to add drugs to, transfer drugs between, remove drugs from schedules by ____ from ____. What is the exception to this?

US Attorney General has the authority but must request scientific and medical evaluation from the Secretary of HHS. The exception is when the Attorney General finds scheduling a substance in schedule I is necessary to avoid imminent hazard to public safety and may do so temporarily without obtaining recommendation from the Secretary of HHS.

The responsibility of designating generic names is held by ____ and approved by ____.

United States Adopted Names Council (USANC) and Secretary of HHS gives final approval.

DEA Form 222a

Used to obtain DEA Form 222 to order CI-II. To obtain forms, registrant must request in writing from local DEA office.

DEA Form 363

Used to register for narcotic treatment programs.

DEA Form 225

Used to register under CSA for manufacturers, wholesalers, distributors, importers/exporters, research.

DEA Form 41

Used to return, dispose, or destroy drugs per DEA approval. 3 copies of the form must be submitted to the local DEA office.

DEA Form 104

Used to surrender controlled substances/permit on a voluntary basis. Usually used to close a pharmacy.

Drug Quality and Security Act of 2013 (DQSA)

Voluntary registration with FDA for facilities that compound drugs outside traditional pharmacy practice as outsourcing facility exempt from registering as manufacturer and other FDA requirements. Registered outsourcing facilities are subject to risk-based inspection schedule.

MedGuide requirement

When mandated for a specific drug by FDA, required to be dispensed to outpatients for new and refill prescriptions. Manufacturer is responsible for providing MedGuides to dispensers.

Unlawful to distribute CI-II except pursuant to ____ or ____. Exceptions include ____.

Written order on DEA Form 222 or Controlled Substance Ordering System. Exceptions include lawful exportation and delivery to common carrier in lawful and usual course of business or delivery to/by warehouseman for storage in lawful and usual course of business.

Tamper-Resistant Prescription Law

Written prescriptions (excluding electronic, oral, faxed) for Medicaid-covered outpatient drugs must be issued on tamper-resistant paper. Prescription form must be designed to prevent unauthorized copying of completed or blank prescription pad, erasure or modifications of information written on prescription pad by prescriber, and use of counterfeit prescription forms. If prescription form does not comply, pharmacist may fill on emergency basis provided that the pharmacy obtains compliant prescription within 72 hours of fill date. Compliant prescription may be in the form of written prescription on tamper-resistant paper or may be obtained by verbal communication with prescriber by fax or e-prescription.