PTCE Acts and Amendments

PTCE 2026

Pure Food and Drug Act (1906)

Prohibits interstate commerce of misbranded (inaccurately labeled) and adulterated (doesn’t meet standards) drugs and foods.

Federal Food, Drug, and Cosmetic Act (1938)

Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application before marketing them; essentially created FDA

Durham-Humphrey Amendment (1951)

Kefauver-Harris Amendment (1962)

Controlled Substances Act (CSA) (1970)

Poison Prevention Packaging Act (PPPA) (1970)

Federal Anti-Tampering Act (1983)

Prescription Drug Marketing Act (1987)

Omnibus Budget Reconciliation Act (OBRA) (1990)

Dietary Supplement Health and Education Act (DSHEA) (1994)

Health Insurance Portability and Accountability Act (HIPAA) (1996)

Food and Drug Administration Modernization Act (FDAMA) (1997)

Drug Addiction Treatment Act (DATA) (2000)

Combat Methamphetamine Epidemic Act (CMEA) (2005)