Pharmaceutical Export Amendments of 1985

Summary

Pharmaceutical Export Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs (including biological products) intended for human or animal use even though such drugs have not been approved or licensed for use in the United States. Directs the Secretary of Health and Human Services to establish and update a two-tiered list of countries with adequate governmental health authorities which in the first tier includes developed regulatory procedures and tests with experienced scientific personnel and in the second tier includes sufficient ability to assure consistency of labeling information. Permits shipments to nonlist countries where differing health conditions make such shipments desirable. Permits the export of an unapproved drug to a second-tier country if such drug is approved for use in a first-tier country. Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety. Sets forth other criteria and restrictions on the export of such drugs, including notice requirements.

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1 official file

• Introduced in Senate

  summary · EN · 17 October 1985

  Open at official source

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