FDA Timeline

Events

Food and Drug Administration (FDA)

1862 - Present
  • Practice of Pharmacy is governed by a series of laws, regulations, and rules
  • Legal liabilities
  • Morals and ethics

Division of Chemistry

1901 - Present
  • Evaluated applications for new drugs for use in humans or animals, food and color addictive, medical devices, and infant formulas
  • The name changed to Bureau of Chemistry

United States Pharmacopoeia & National Formulary

Approx. 1906

USP:
- Drugs had to meet standards of:
* Strength, Quality, and Purity
NF
- Guidelines
- Any variations listed on product label
- No misleading info
- All ingredients included

Harvey Wiley

1906
  • Pure Food and Drug Act (Wiley Act)
  • Theodore Roosevelt signed it * Gave government the power to administer an prohibit the interstate transport unlawful food or drugs
  • Law made it so additional ingredients to substitute food was prohibited
  • Establishing scientific authority by researching the effects of chemical preservatives used in the production of food and drugs
  • Expose hazards in products
  • Focus on consume safety
  • Led to first passage of major legislation (Pure Food and Drug Act)

FDA Suffered

1912
  • Supreme Court said the law enforcing the regulation of drugs did not apply to false therapeutic claims
  • Supreme court undermined the Wiley Act
  • Manufacturers won court case and made it so products can be sold to consumers

Wiley Resigned from FDA

1912

The Bureau focused on drug regulation

Franklin D. Roosevelt & FDA

1933
  • Took over FDA
  • Changed authority to include both quality and identity standards for food or drugs and coverage of cosmetics and medical devices
  • Inspect Factories
  • Control advertising of products

Tennessee

1937
  • Drug Company in Tennessee advertised a new sulfonamides elixir for children
  • Untested and more than 100 children died (mostly children)
  • Solvent similar to antifreeze

Federal Food, Drug, and Cosmetic Act

1938
  • Required manufacturers to prove to the FDA that a drug was safe before marketing
  • Mandated standards for foods

Durham-Humphrey Amendment

1951

Clarification of what constituted a prescription drug versus and over-the-counter drug

Kefauver-Harris Drug Amendment

1962

Ensure safety and effectiveness of medication

Drug Abuse and Control Amendment

1965

Controlled the use of amphetamines, barbiturates and other potentially addictive agents

Drug Enforcement Administration (DEA)

1968 - Present

Consumer Product Safety Commission

1973

Federal Control over hazardous toys, flammable fabrics, and potential poisons.

Medical Device Amendments

1976

Allowed FDA to regulate and approve medical devices and to also recall hazardous or ineffective devices

Orphan Drug Act

1983

Brought wide ranges of research and access to new treatments for AIDS, cancer, and genetic diseases