History of Drug Control and Standards

Question 1

1820 - United States Pharmacopeial (USP) Convention

Answer 1

• Monitored strength, purity, quality, preparation of medicinal compounds
• Revised every 5 years
• Enforced by FDA

Question 2

1888 - National Formulary (NF)

Answer 2

• Book of USP
• Public pharmacopeial standards
• Expanded efforts to set national standards for drug quality
• New drug development (multiple laws): old/ineffective drugs removed, new/more effective drugs added (after study/research/tests)

Question 3

1906 - Food and Drug Act

Answer 3

• Required labeling
• Potent and harmful drugs on market = reduced
• USP and NF = print standards

Question 4

1914 - the Harrison Narcotic Law

Answer 4

• Legally defined “narcotic”
• 1st effective regulation for distribution of certain drugs known for abuse potential
• Tax levied on registered dealers in opium and coke

Question 5

1938 - Federal Food, Drug, and Cosmetic Act

Answer 5

• Required toxicity tests

- Developed FDA review

Question 6

1951 - the Durham-Humphrey Amendment

Answer 6

-Defined prescription vs. non-prescription (OTC) drugs

Question 7

1962 - Kefauver-Harris Amendment

Answer 7

• Laxity in drug development and marketing procedures

- Requires drug manufacturer to prove that new drugs = safe and effective

Question 8

1970 - Control Substance Act

Answer 8

• Defined drug abuse
• Established DEA (Drug Enforcement Agency)
• Abuse potential; manufacturing, distribution, dispensing regulations
• 5 DEA schedules: I = highest abuse potential, V = least abuse potential
• Inventory rules = counting
• NYS PMP (Prescription Monitoring Program)

Question 9

1983 - Orphan Drug Act

Answer 9

-Provided incentives (usually money) for development of orphan drugs for treatment of rare diseases