Pharmacy Law MPJE Exam: Federal Law
EXAM QUESTIONS AND ANSWERS 100%
SOLVED (Newest 2025) What did the Federal Controlled Substances Act do? Why was it implemented? - Correct Answers ✅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? - Correct Answers ✅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) - Correct Answers ✅Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce 1 / 4
Pharmacy Law MPJE Exam: Federal Law
EXAM QUESTIONS AND ANSWERS 100%
SOLVED (Newest 2025) 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 Labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs Describe the FDCA - Correct Answers ✅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? - Correct Answers ✅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? - Correct Answers ✅Established 2 classes of drugs; prescription and OTC 2 / 4
Pharmacy Law MPJE Exam: Federal Law
EXAM QUESTIONS AND ANSWERS 100%
SOLVED (Newest 2025) Allows refills on prescriptions and oral prescriptions Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication - Correct Answers
✅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? - Correct Answers ✅Required all drugs to not only be proven safe but also EFFECTIVE 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 - Correct Answers ✅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? - Correct Answers ✅Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of rare 3 / 4
Pharmacy Law MPJE Exam: Federal Law
EXAM QUESTIONS AND ANSWERS 100%
SOLVED (Newest 2025) disease or conditions (those conditions that affect < 200,000 Americans) What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? - Correct Answers ✅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? - Correct Answers ✅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) Requires state licensing of wholesalers Prohibits ANY SAMPLES for any reason in a retail pharmacy
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