This post was written by Jennifer Pike.
On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act. Once finalized, FDA would be able to detain drugs encountered during an inspection that are reasonably believed to be adulterated or misbranded. According to FDA, the 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. Comments on the proposed rule should be submitted in writing, or electronically at www.regulations.gov, on or before September 13, 2013.