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 Secretaty 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 section, 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; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service.

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Documents

1 official file

• Introduced in Senate

  summary · EN · 21 February 1973

  Open at official source

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