Administrative Detention Authority for Human and Animal Drugs Implemented by FDA
The Food and Drug Administration has issued a final rule that, effective June 30, will implement the administrative detention authority granted to the agency by the Food and Drug Administration Safety and Innovation Act with respect to drugs intended for human or animal use. The FDA notes that this final rule is unchanged from the July 2013 proposal.
The FDA rule is closely modeled on the regulation for the administrative detention of medical devices and includes the following provisions.
- The FDA will be able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. Detentions will generally be limited to 20 calendar days.
- Drugs that the FDA orders detained may not be used, moved, altered or tampered with in any manner by any person until the detention is terminated or expires. However, detained drugs not in final form for shipment may be moved within the establishment where they are detained to complete the work needed to put them in final form. In addition, authorized FDA representatives may approve the movement of detained drugs for certain reasons, including destroying them or bringing them into compliance.
- Detention orders must be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe the drugs are adulterated or misbranded, and issued to the owner, operator or agent in charge of the place where the drugs are located. If detention of drugs in a vehicle or other carrier is ordered, a copy of the detention order must be provided to the shipper of record and the owner of the vehicle or other carrier if their identities can be readily determined.
- An FDA representative issuing a detention order must label or mark the drugs with official FDA tags that include specified information and remain with the drugs until the detention is terminated or expires.
- If the FDA determines that detained drugs are adulterated, misbranded or both, it may initiate legal action against the drugs, the responsible individuals or both or request that the drugs be destroyed or otherwise brought into compliance under FDA supervision.
- 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 will be required to have, or establish, and maintain for a maximum of 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 must be provided to the FDA on request for review and copying.
- When a detention is terminated or expires, an authorized FDA representative will issue a notice releasing the drugs to any person who received the original detention order or that person's representative and will remove or authorize in writing the removal of the required labels or tags.