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Pharmacy Law MPJE Exam: Federal Law Practice Questions and Answers What did the Federal Controlled Substances Act do? Why was it implemented? - ANSWER- Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Create...

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  • November 4, 2024
  • 36
  • 2024/2025
  • Exam (elaborations)
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  • pharmacy law mpje exam federal law practice quest

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Copyright © KAYLIN 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED FIRST PUBLISH NOVEMBER, 2024




Pharmacy Law MPJE Exam: Federal Law

Practice Questions and Answers


What did the Federal Controlled Substances Act do? Why was it implemented? - ANSWER✔✔-

Legislators very concerned in the 1960s about legal and illegal drugs being abused




They were given the opportunity to design an act/law




Created the DEA to promulgate and enforce the law




Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient.


What did the Pure Food and Drug Act of 1906 do? - ANSWER✔✔-Prohibited the adulteration and

misbranding of foods and drugs in interstate commerce; DID NOT have to be proven safe or effective; did

not require the label to list ingredients, directions for use, or provide warnings


What did the Food, Drug, and Cosmetic Act do? (started in 1938) - ANSWER✔✔-Provides for the

comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce




Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its

intended use and approved by the FDA


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Labels must contain adequate directions for use and warnings about habit-forming properties of certain

drugs


Describe the FDCA - ANSWER✔✔-The purpose of the FDCA is to protect consumers from adulterated or

misbranded foods, drugs, cosmetics, or devices; provided that no new drug could be marketed until

proven safe for use under the conditions described on the label and approved by the FDA; also started

the labeling requirements; applies to devices as well; all drugs before 1938 are exempt from the

requirement that new drugs be proven safe


If you get in trouble with the board of pharmacy can you get in trouble with the government too? What

about the a lawsuit with a patient? - ANSWER✔✔-Yes, you can have an administrative lawsuit, a civil

lawsuit, and a criminal lawsuit separately for the same offense


What did the Durham-Humphrey Amendment of 1951 do? - ANSWER✔✔-Established 2 classes of drugs;

prescription and OTC




Allows refills on prescriptions and oral prescriptions


Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication -

ANSWER✔✔-Caution: federal law prohibits dispensing without a Rx; they do not need adequate

directions for use like OTC (talking about the MANUFACTURERS label here; there is no take this

medication x amount of times daily on the manufacturer labeling)


What did the Kefauver-Harris Amendment of 1962 do? - ANSWER✔✔-Required all drugs to not only be

proven safe but also EFFECTIVE


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Transferred the regulation of drug advertising from the FTC to the FDA


The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during

what time period - ANSWER✔✔-1938-1962; drugs produced before 1938 were just grandfathered in and

did not have to prove their efficacy


What did the Orphan Drug Act of 1983 do? - ANSWER✔✔-Provided tax and exclusive licensing incentives

for manufacturers to develop agents for the treatment of rare disease or conditions (those conditions

that affect < 200,000 Americans)


What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? - ANSWER✔✔-Made

generic drugs more readily available to the public and at the same time provided incentives for

manufacturers to develop new drugs




Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved

more easily


What did the Prescription Drug Marketing Act of 1987 do? - ANSWER✔✔-Established sales restrictions

and recordkeeping requirements for prescription drug samples




Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the

hospitals were getting the drugs for a discount then reselling them)




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Requires state licensing of wholesalers




Prohibits ANY SAMPLES for any reason in a retail pharmacy




Bans importation of prescription drugs except by manufacturers and for emergency use




Mandates record keeping requirements for drug samples for 3 years


What is the Prescription Drug User Fee Act of 1992 - ANSWER✔✔-Drug companies volunteered to pay

tax and the money was used to hire more FDA scientist in hopes to speed up NDA reviews; however the

price of drugs just went up to cover the fee being paid by the drug manufacturers


What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do? - ANSWER✔✔-

Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as

food than drugs


Define dietary supplement per the law - ANSWER✔✔-A product that is intended for *ORAL* ingestion,

intended to supplement the diet, and contains any one or more of the following: a vitamin, mineral, herb

or other botanical, an amino acid, dietary substance or use by humans to supplement the diet by

increasing the total dietary intake and a concentrate, metabolite, constituent, extract or combination of

the previous.


All dietary supplements must be claimed as - ANSWER✔✔-A dietary supplement; they CANNOT say they

are drugs or anything else on the labeling




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