HR 3995 · 99th Congress · Foreign Trade and International Finance
Pharmaceutical Export Amendments of 1986
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Subcommittee Hearings Held.(1986-04-28)
Plain Language Summary
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Pharmaceutical Export Amendments of 1986 - 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 if differing health conditions there make such shipments desirable, e. g. tropical diseases. Permits the export of an unapproved drug to a second tier country if such drug is approved for use in any first-tier country and not banned for use in any 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 su…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (20)
9 Democrats11 Republicans