Federal Requirements part 1

Pure Food and Drug Act

(1906)

• Prohibits interstate commerce of misbranded and adulterated drugs and food.

• This legislation spurred because of the unsanitary meat packing industry revealed in the book “The Jungle”

Federal Food, Drug, and Cosmetic Act

(1938)

• Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application.

• Stated if the FDA does not take any action within 60 days, the drug is automatically approved

  (Note) Kefauver-Harris Amendment undoes this aspect

Durham-Humphrey Amendment

(1951)

Defines two specific categories for drug products

1. Legend Drugs (Rx)

2. OTC drugs

Kefauver-Harris Amendment

(1962)

• Establishes framework requiring drug manufacturers to scientifically prove that and medication is not only safe but EFFECTIVE

• FDA automatic 60 day rule became invalid