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Compliance for Imports of Human Drugs and Biologics

BayBiotech.NET
Interstate shipment(which includes importation and exportation) of unapproved new drugs is prohibited by the Federal Food, Drug, and Cosmetic Act.Clearly, the drugs that lack approval if imported either for personal use or otherwise,violates the Act.In this context,the definition of unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval.

Imported products regulated by the FDA are inspected at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs) and the shipments that are not found to comply with the law must be either brought into compliance, destroyed, or re-exported.

The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. Drug Enforcement Administration (DEA). Further information on compliance can be obtained at the DEA Office of Diversion Control website.

A draft guidance on current agency policy regarding drugs marketed in the US that lack required FDA approval can be read by clicking here.

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