Pharmacy Law Review with
questions and well verified
answers actual exam!!!
2026
1906 Pure Food and Drug Act - ANSWER -Prohibits the sale and transport of adulterated
or mislabeled food, drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Food, Drug and Cosmetic Act (FDCA) - ANSWER -This act requires that
manufacture prove a new drug is safe for human consumption.
Toxicological studies - done on animals.
Clinical trials - done on humans.
Gave rise to the Food and Drug Administration.
Manufacturer must submit New Drug Application (NDA) to FDA.
1951 Durham-Humphrey Amendment - ANSWER -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 prescription". Refills may
only be authorized by the subscriber.
, 1962 Kefauver-Harris Amendment - ANSWER -Required drugs be effective for the
purpose they were marketed for. Written in response to Thalidomide incident in Europe.
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA)
- ANSWER -Purpose is to regulate manufacture and sale of Narcotics. Drug Enforcement
Agency (DEA) was formed. Introduced a stair step schedule for narcotics based on their abuse
potential. Schedule I drugs have the highest abuse potential and Schedule V drugs have the
lowest abuse potential.
DEA Form 222 - to buy
DEA Form 224 - to sell
1970 Poison Prevention Packaging Act - ANSWER -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 nitroglycerin (Nitrostat SL), birth control pills, inhalers,
ointments and creams.
1972 Drug Listing Act - ANSWER -Authorized the FDA to compile a list of all legal drugs
for sale in the US. Assigned a unique identifier to all drugs called the National Drug Code (NDC)
12 digit code. Leading zero on the ones with only 4 digits in first sequence.
1983 Orphan Drug Act - ANSWER -Created to promote the research and development of
drugs needed for the treatment of rare diseases. (less than 200,000)
1987 Prescription Drug Marketing Act - ANSWER -Enacted to prevent the reimportation
of drugs from other countries. This act banned the sale, trade, or purchase of drug samples
except by those licensed to prescribe drugs.
1990 Omnibus Budget Reconciliation Act (OBRA 90) - ANSWER -This act requires a
pharmacist to conduct a Drug Utilization Review (DUR) or offer counsel to patients on all new
prescriptions. Pharmacist must provide name and description of drug, how much should be
taken, side effects, contraindications, interactions, adverse effects, storage, refill information,
and what to do if a dose is missed.
Administered by State Board of Pharmacies.
1996 Health Insurance Portability and Accountability Act (HIPAA) - ANSWER -This act
created rules regarding the privacy/security of patient health information. This act provides
limitations on who can access, distribute, and receive patient information. This act also makes
questions and well verified
answers actual exam!!!
2026
1906 Pure Food and Drug Act - ANSWER -Prohibits the sale and transport of adulterated
or mislabeled food, drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Food, Drug and Cosmetic Act (FDCA) - ANSWER -This act requires that
manufacture prove a new drug is safe for human consumption.
Toxicological studies - done on animals.
Clinical trials - done on humans.
Gave rise to the Food and Drug Administration.
Manufacturer must submit New Drug Application (NDA) to FDA.
1951 Durham-Humphrey Amendment - ANSWER -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 prescription". Refills may
only be authorized by the subscriber.
, 1962 Kefauver-Harris Amendment - ANSWER -Required drugs be effective for the
purpose they were marketed for. Written in response to Thalidomide incident in Europe.
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA)
- ANSWER -Purpose is to regulate manufacture and sale of Narcotics. Drug Enforcement
Agency (DEA) was formed. Introduced a stair step schedule for narcotics based on their abuse
potential. Schedule I drugs have the highest abuse potential and Schedule V drugs have the
lowest abuse potential.
DEA Form 222 - to buy
DEA Form 224 - to sell
1970 Poison Prevention Packaging Act - ANSWER -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 nitroglycerin (Nitrostat SL), birth control pills, inhalers,
ointments and creams.
1972 Drug Listing Act - ANSWER -Authorized the FDA to compile a list of all legal drugs
for sale in the US. Assigned a unique identifier to all drugs called the National Drug Code (NDC)
12 digit code. Leading zero on the ones with only 4 digits in first sequence.
1983 Orphan Drug Act - ANSWER -Created to promote the research and development of
drugs needed for the treatment of rare diseases. (less than 200,000)
1987 Prescription Drug Marketing Act - ANSWER -Enacted to prevent the reimportation
of drugs from other countries. This act banned the sale, trade, or purchase of drug samples
except by those licensed to prescribe drugs.
1990 Omnibus Budget Reconciliation Act (OBRA 90) - ANSWER -This act requires a
pharmacist to conduct a Drug Utilization Review (DUR) or offer counsel to patients on all new
prescriptions. Pharmacist must provide name and description of drug, how much should be
taken, side effects, contraindications, interactions, adverse effects, storage, refill information,
and what to do if a dose is missed.
Administered by State Board of Pharmacies.
1996 Health Insurance Portability and Accountability Act (HIPAA) - ANSWER -This act
created rules regarding the privacy/security of patient health information. This act provides
limitations on who can access, distribute, and receive patient information. This act also makes
