A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the certification of certain drugs other than insulin and antibiotics and to provide for the submission of certain additional information on drugs by the producers of such drugs.

Summary

Gives the Secretary of Health, Education, and Welfare authority to require batch-by-batch certification of all drugs when needed. States that regulations providing for such certification shall contain such provisions as are necessary to carry out the purposes of this Act, including provisions prescribing: (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; and (4) administration and procedure. Directs the Secretary to promulgate regulations exempting specified drugs from the requirements of this Act. States that any interested person may file a petition with the Secretary proposing the issuance of any regulation contemplated by this Act. Directs that such proposal shall be made public and all interested persons shall be afforded an opportunity to present their views concerning such proposal. Requires the Secretary to make public his action upon the proposal. Provides that under specified circumstances any interested person may request a public hearing on the Secretary's action. Requires drug manufacturers to maintain records and make reports to the Secretary concerning clinical experience and other data determined by the Secretary to be necessary to insure that such drug complies with the requirements of this Act. Authorizes the Secretary to require the submission of data concerning the amount of production or distribution for a specific period of time with regard to any drug which is required to be listed.

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1 official file

• Introduced in Senate

  summary · EN · 24 March 1975

  Open at official source

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