1906 Pure Food and Drug Act – correct 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) – correct 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 – correct 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 – correct 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) – correct
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 – correct 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 – correct 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 – correct 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 – correct 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) – correct 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) – correct 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 health insurance portable for
people switching jobs. Violations punishable by fine up to $250,000.00 per incident
Class I Recall – correct answer -An attempt must be made to notify the patient that the drug he/she may
be taking could cause serious harm or death
Class II Recall – correct answer -The probability of serious harm is not likely and the effects may be
temporary or reversable. This recall does not go to the customer level and is usually due to problems
with consistency of potency
Class III Recall – correct answer -Not likely to cause any serious adverse effects and does not go to the
customer level