Govt pre-approval of drugs required; prohibited interstate commerce in adulterated/misbranded food, drink and drugs
Food Drug & Insecticide Administration 1927
Set up law enforcement agency that would be renamed in 1930 as the FDA
Food & Drug Administration 1930
Renamed the FDIA to FDA
Food Drug & Cosmetic Act (FDC) 1938
Requires new drugs be shown to be safe before marketing
Durham-Humphrey Amendment 1951
Defines what drugs require a prescription by a licensed practitioner; requires those drugs to include the legend on their label: "Caution: Federal Law Prohibits dispensing without a prescription" or "Rx only."
Kefauver-Harris Amendment 1962
Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
Poison Prevention Packaging Act 1970
Requires childproof packaging on all controlled and most Rx drugs dispensed by pharmacies, except if the prescriber or patient requests non-childproof.
Controlled Substance Act 1970
Classifies 5 levels of drugs (controlled substances) that have potential for abuse and restricts their distribution; set up the Drug Enforcement Agency (DEA) to enforce regulations