Laws of Pharmacy

Events

Pure Food & Drug Act

1906

Prohibits the interstate distribution or sale of adulterated or mislabeled food, drinks, & drugs.

Food, Drug, & Cosmetic Act

1938

Created FDA; requires all drug manufacturers file a new drug application & meet the approval of FDA.

Durham-Humphrey Amendment

1951

Distinguishes prescription (legend) from nonprescription (OTC) drugs; allowed phone Rx.

Kefauver-Harris Amendment

1963

Required all drugs to be pure, effective, and safe to use on humans.

Poison Prevention Packaging Act

1970

Requires childproof packaging on most drugs.

Comprehensive Drug Abuse Prevention & Control Act (Controlled Substances Act)

1970

DEA formed; controlled substances placed into schedules (CI-CV).

Drug Listing Act

1972

Assigns a unique and permanent drug code to each medication.

Orphan Drug Act

1983

Promote research & marketing of drugs needed for the treatment of rare diseases.

Omnibus Budget Reconciliation Act

1990

Requires pharmacist to offer counseling; requires pharmacies to maintain patient profiles.

Health Insurance Portability and Accountability Act

1996

Privacy/ security of patient protected health information (PHI).

FDA Modernization Act

1997

Main focus is safe compounding and the regulation of medical devices.

Combat Methamphetamine Epidemic Act

2005

Limits the purchase of pseudoephedrine & ephedrine