©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
1
, ©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.
2
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
1
, ©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.
2
