FDA Proposes more Authority during an Inspection

FDA issued a proposed regulation to implement administrative detention authority 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 finalized, FDA’s administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. This regulation is similar to the one in place for medical devices already.

Specifically, FDA will be able to administratively detain drugs (animal or human) encountered during an inspection that an FDA official conducting an inspection has reason to believe are adulterated or misbranded. The detention order will be issued in writing and may last up to 20 days or 30 days, if more time is needed to seize the drugs.  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.”

Read the proposed regulation here.