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On July 15, 2013, the US Food and Drug Administration (FDA) published in the Federal Register a proposed rule [Docket No. FDA-2013-N-0365] to implement administrative detention authority 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).
Once the applicable regulation is finalized, FDA’s administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during an inspection that an officer or employee conducting an inspection has reason to believe are adulterated or misbranded. 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. Submit either electronic or written comments on the proposed rule by September 13, 2013. |
