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Federal Pharmacy Law Review Questions and Answers (100% Pass)

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©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM WEST VIRGINIA UNIVERSIRTY- (WV) : 26506 1 Federal Pharmacy Law Review Questions and Answers (100% Pass) 1906 - Federal Food and Drug Act - ️️ This act prohibits the sale of adulterated or mislabeled food, drinksand drugs ...

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  • August 15, 2024
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©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM



WEST VIRGINIA UNIVERSIRTY- (WV) : 26506

Federal Pharmacy Law Review Questions and
Answers (100% Pass)


1906 - Federal Food and Drug Act - ✔️✔️This act prohibits the sale of adulterated or

mislabeled food, drinksand drugs


1914 - Harrison Narcotic Act - ✔️✔️This act limits the transport of opium. In order to

purchase opium, a prescription is required.


1938 - Food Drug and Cosmetic Act - ✔️✔️This act made the food and Drug Act more

comprehensive to include cosmetics. The act also defines misbranding or adulteration

of drugs to be illegal, This act requires drug companies to provide package

inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires

that a new drug has to be proven safe under FDA guidelines before marketing


1951 - Durham Humphrey Amendment - ✔️✔️This act distinguishes legend

drugs(prescription) from the over the counter drugs (OTC). This act requires companies

to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition",

requires physician supervision for the purchase of legend drugs. Also, over the counter

drugs without medical supervision are required to have on the label: Product Name,

Name and Address of manufacturer, Active ingredients, quantities of all other

ingredients whether active or not



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, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM



WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
1962 - Kefauver-Harris Amendment - ✔️✔️All drugs made from 1938 forward must be

proven save and effective. Also the FTC now handles drug advertisement. Stricter

requirements for drug approval. Manufacturersmust now register annually, be inspected

ever 2 years, and report adverse effects of drugs.


1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance

Act - CSA) - ✔️✔️Drug enforcement agency (DEA) was formed. Also controlled

substanced were placed in schedules I-V based on abuse potential.Schedule I drugs

have the highest abuse potential and schedule V drugs have the lowest abuse potential.


1970 - Poison Prevention packaging act - ✔️✔️This act required childproof packaging on

most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs

used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged

in such a small quantity it would not hard a child under 5 years old.


1983 - Orphan Drug Act - ✔️✔️This act enables the FDA to promote the research and

marketing of drugs needed for the treatment of rare diseases.


1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman

Amendment) - ✔️✔️This act streamlines the process for granting approval of generic

drugs. It also give manufacturers incentives to develop new drugs by giving patent

extensions. This act allows generic drug companies the ability to rely on safety and

efficacy findings of an innovator's drug after the expiration of the patent.




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