A bill to amend the Federal Food, Drug, and Cosmetic Act respecting the new drug provisions of such act and for other purposes.

Summary

Revises the new drug provisions of the Federal Food, Drug, and Cosmetic Act by providing that any ingredient of a drug found to be unnecessary to fulfill the use of such drug under the conditions prescribed, recommended, or suggested in the labeling thereof may be removed without affecting the legal status of such durg under the Act. Provides that the removal from labeling or restriction in labeling of any recommended use of a drug shall not affect the legal status of such drug otherwise exempted from being deemed a new drug under the Act. Provides that on the seventh anniversary date of the approval of a new drug application under this Act, the drug shall no longer be considered a "new drug" and shall no longer be subject to the new drug provisions of the Act.

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Documents

1 official file

• Introduced in House

  summary · EN · 29 April 1974

  Open at official source

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