Major Federal Laws & Regulations for the PTCB Exam

Food, Drug, and Cosmetic Act (FDCA) – 1938

• Purpose: Ensures drug safety before marketing.

• Why it matters: Required FDA approval for new drugs.

• Triggered by: Elixir Sulfanilamide tragedy (107 deaths).

Durham-Humphrey Amendment – 1951

• Purpose: Created a distinction between prescription (legend) and OTC drugs.

• Key rule: “Caution: Federal law prohibits dispensing without a prescription.”

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Kefauver-Harris Amendment – 1962

• Purpose: Requires proof of effectiveness (not just safety) before marketing.

• Also called: “Drug Efficacy Amendment.”

• Why: After thalidomide birth defects in Europe.

Controlled Substances Act (CSA) – 1970

• Purpose: Created the DEA and drug schedules (C-I to C-V).

• Key features:

  • Regulation of manufacture, distribution, and dispensing.

  • Mandatory inventory and recordkeeping.

Poison Prevention Packaging Act (PPPA) – 1970

• Purpose: Protect children from accidental poisoning.

• Key rule: Requires child-resistant caps for most medications.

• Exceptions: Nitroglycerin, birth control packs, some inhalers.

Occupational Safety and Health Act (OSHA) – 1970

• Purpose: Workplace safety.

• Key for pharmacies: Protect workers from exposure to chemicals, including hazardous drugs (e.g., chemo).

Drug Listing Act – 1972

• Purpose: Requires all drugs to be listed with the FDA.

• Key result: NDC Number system created.

  • 10-digit number identifying labeler, product, and packaging.

Federal Anti-Tampering Act – 1982

• Purpose: Prevent product tampering.

• Required: Tamper-evident packaging.

• Why: Result of Tylenol cyanide poisoning cases.

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) – 1984

• Purpose: Streamlines generic drug approval.

• Allowed: ANDA (Abbreviated New Drug Application).

Prescription Drug Marketing Act (PDMA) – 1987

• Purpose: Prevent counterfeit drugs.

• Key rules:

  • Prohibits reimportation of drugs.

  • Bans sale of drug samples.

Omnibus Budget Reconciliation Act (OBRA ’90)

• Purpose: Improve Medicaid patient care.

• Key rules:

  • DUR (Drug Utilization Review)

  • Pharmacist counseling required on new prescriptions.

Health Insurance Portability and Accountability Act (HIPAA) – 1996

• Purpose: Protect patient privacy and health information.

• Key elements:

  • Patient rights

  • Confidentiality

  • Minimum necessary rule

Medicare Prescription Drug Improvement and Modernization Act – 2003

• Purpose: Created Medicare Part D, the prescription drug plan.

• Also known as: MMA (Medicare Modernization Act).

Combat Methamphetamine Epidemic Act (CMEA) – 2005

• Purpose: Regulates pseudoephedrine sales to prevent meth production.

• Key rules:

  • Daily limit: 3.6 g

  • Monthly limit: 9 g

  • Requires photo ID, logbook

Affordable Care Act (ACA) – 2010

• Purpose: Expand healthcare access, reduce costs.

• Pharmacy role: Increased demand for medication therapy management (MTM) services.