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Summary: Administrative Detention of Drugs Intended for Human or Animal Use (Final Rule)

Summary: Administrative Detention of Drugs Intended for Human or Animal Use (Final Rule)

This final rule gives FDA the authority to implement administrative detention with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.

Regulatory Impact Analysis

Administrative Detention of Drugs Intended for Human or Animal Use (Final Rule) (PDF - 254KB)

Federal Register: 79 FR 30716-30721, May 29, 2014

Docket: FDA-2013-N-0365