Pharmaceutical Export Amendments of 1984

Summary

Pharmaceutical Export Amendments of 1984 - 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 keep current a list of foreign countries having adequate governmental health authorities to which such drugs may be shipped. Provides for additions to and removals from the list. Includes among the first countries to be listed Australia, Canada, the Federal Republic of Germany, France, Japan, Sweden, Switzerland, and the United Kingdom. Sets forth criteria any unapproved drug must meet to be permitted export to both listed and unlisted countries. Requires, at a minimum, that the drug: (1) be approved or licensed in a listed country; (2) be either exempt for investigational use in the United States, or be intended for diseases or health conditions in a foreign country which do not exist in the United States; (3) has completed sufficient Phase I clinical investigation, if intended for human use, to permit the initiation of Phase II or Phase III clinical studies; and (4) has not had its sale in the foreign country declared contrary to public health and safety. Makes labeling requirements. Adds further criteria for export to a listed country. Requires periodic notification to foreign governments of U.S. regulatory decisions, actions, information, and labeling requirements.

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1 official file

• Introduced in Senate

  summary · EN · 26 July 1984

  Open at official source

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