Section B - Laws, Rules, Regulations

Question 1

Pure Food and Drug Act

Answer 1

Prohibits drugs to be misbranded or adulterated.

Question 2

Food, Drug and Cosmetic Act (FDCA)

Answer 2

Requires new drug to be proven safe when used according to directions on label. Also must warn about habit-forming drugs on label.

Question 3

Durham-Humphrey Amendment

Answer 3

Separates OTC drugs (have to be labeled) and “legend” drugs (need adequate directions placed by pharmacist and “Caution: Federal law prohibits dispensing without a prescription”). Also provided for oral scripts and script refills.

Question 4

Kefauver-Harris Amendment of 1962

Answer 4

Called Drug Efficacy Amendment. All new USA drugs must be proven to be safe and effective. Made FDA in charge of regulating prescription drug advertising. Required informed consent of clinical research subjects, reporting adverse drug reactions, and creation of Good Manufacturing Practice (GMP).

Question 5

regulates OTC advertising

Answer 5

Federal Trade Commission (FTC)

Question 6

Regulates prescription drug advertising

Answer 6

FDA

Question 7

Medical Device Amendment of 1976

Answer 7

Classification of Medical Devices according to function, performance standards, pre-market approval standards, and reporting requirements

Question 8

Orphan Drug Act of 1983

Answer 8

Provides tax and licensing incentives to manufacturing drugs that treat rare diseases.

Question 9

Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)

Answer 9

• Streamlined the drug approval process for generic products using Abbreviated New Drug Application (ANDA)
• Only requires proof of bioequivalence with brand-name
• Brand name recieved 5 more years protection

Question 10

Prescription Drug Marketing Act of 1987

Answer 10

• Prescription Drug Wholsalers must be licensed
• Banning re-importation of drugs made in USA
• Banning sale, trade, or purchase of prescription drug samples
• Specifying precise storage, handling, and recordkeeping for prescription drug samples
• Prohibits resale of prescription drugs (except in hospitals or health care facilities)

Question 11

FDA Modernization Act of 1997

Answer 11

• Fast-track of some NDA to Tx serious or life-threatening conditions.
• Clarifications on when pharmacies can compound
• Manufacturers can submit supplemantal NDA’s for new uses of drugs
• Pediatric new NDA’s had additional 6 months of exclusivity

Question 12

Patient Protection and Affordable Care Act of 2010

Answer 12

• All individuals must have health insurance
• Requires financial and administrative transactions to be timely and transparent using standard electronic transactions
• Stop agreements between brands and generics that limit/delay competition
• Phase elimination of donut hole