FDA Timeline


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

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

Harvey Wiley

  • 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

  • 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


The Bureau focused on drug regulation

Franklin D. Roosevelt & FDA

  • 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


  • 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

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

Durham-Humphrey Amendment


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

Kefauver-Harris Drug Amendment


Ensure safety and effectiveness of medication

Drug Abuse and Control Amendment


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

Drug Enforcement Administration (DEA)

1968 - Present

Consumer Product Safety Commission


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

Medical Device Amendments


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

Orphan Drug Act


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