Hazardous Drug Export Prevention Act

Summary

Hazardous Drug Export Prevention Act - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain unapproved drugs if specified conditions are met. Includes among such conditions that such drug: (1) has been shown safe and effective; (2) has been approved by the importing country; (3) has not been disapproved by any country on a list of countries with highly developed regulatory procedures and testing requirements for drugs; and (4) is clearly labeled for export to a named country on the shipping label. Sets forth application procedures for exporting such drugs. Lists countries with a highly developed drug regulatory program which may receive such drugs. Provides for additions and deletions to such list. Requires an approved exporter to report any changes in the importing country's regulation of the drug in question to the Secretary of Health and Human Services, requiring termination of such exporting permission should the drug be disapproved. Prohibits a change in labeling for approved new or animal drugs exported if such change affects the safety or efficacy of the drugs. Permits civil actions as specified to restrain such misbranding and to restrain the export of drugs to an unauthorized country.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Introduced in House

  summary · EN · 16 December 1985

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.