FDA Moves to Implement Administrative Detention Authority for Human and Animal Drugs
The Food and Drug Administration is accepting through Sept. 13 comments on a proposed regulation that would implement the administrative detention authority granted to it by the Food and Drug Administration Safety and Innovation Act with respect to drugs intended for human or animal use. The FDA is also inviting comments through Sept. 13 on a draft guidance on circumstances that would constitute delaying, denying, limiting or refusing a drug inspection.
Under the proposed rule, which is closely modeled on the current regulation for the administrative detention of medical devices, the FDA would 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. Detention would prevent the use, movement or alteration of, or tampering with, such drugs until the FDA has had time to consider what action it should take and to initiate legal action, if appropriate. Detentions would generally be limited to 20 calendar days.
After the issuance of a detention order, the owner, operator or agent in charge of any factory, warehouse, other establishment or consulting laboratory where detained drugs are manufactured, processed, packed or held would be required to have, or establish, and maintain for two years adequate records relating to how the detained drugs may have become adulterated or misbranded, records on any distribution of the drugs before and after the detention period, records on the correlation of any in-process detained drugs that are put in final form to the completed drugs, records of any changes in, or processing of, the drugs permitted under the detention order, and records of any other movement. Such records would have to be provided to the FDA on request for review and copying.
The FDA intends to issue a final rule no later than July 9, 2014, with an effective date no later than Aug. 8, 2014.
FDASIA provides that a drug that has been manufactured, processed, packed or held in any factory, warehouse or establishment whose owner, operator or agent delays, denies or limits an inspection, or refuses to permit entry or inspection, will be considered adulterated. The FDA has now made available a draft guidance to define the types of action, inaction and circumstances that would be considered to constitute delaying, denying or limiting inspection or refusing to permit entry or inspection.