FDA Proposes New Regs on Administrative Detention of Drugs
The Food and Drug Administration issued a proposed rule to implement its authority to administratively detain drugs, provided for in the 2012 Food and Drug Administration Safety and Innovation Act. The proposed regulation is “closely modeled” on existing provisions on administrative detention of devices, with only minor technical changes, FDA said. Under the proposed rule, FDA would be able to administratively detain drugs when an agency official has “reason to believe” they are adulterated or misbranded. Comments are due by Sept. 13.
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“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,” FDA said. FDA already has the authority to administratively detain devices, tobacco, and food it believes to be adulterated or misbranded.
Detention if FDA Has ‘Reason to Believe’ Drugs are Adulterated or Misbranded
The proposed rule would add new 21 CFR 1.501 on administrative detention of drugs, outlining procedures for FDA detention of drugs when the agency thinks a product is adulterated or misbranded. FDA would be able to order administrative detention if an agency official, during an inspection, has “reason to believe” drugs are adulterated or misbranded. Before the FDA official issues the detention order, the FDA district director would have to give approval. Once the order is issued, the FDA official issuing the detention order would mark the drugs as detained. Appeals of detentions would have to be filed within five working days of receipt of the order.
Maximum 30 days. Once detained, drugs would not be able to be “used, moved, altered, or tampered with in any manner by any person during the detention period,” except under written FDA approval, or if the detained drugs are not in final form and the manufacturer wants to move them within the same establishment to complete manufacturing. The detention order would remain in place for 20 calendar days. FDA would be able to extend the detention period by another 10 calendar days. The overall detention period would not be permitted to go longer than 30 days, unless an appeal is pending.
Two-year recordkeeping. If subject to 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” must retain records on the detention for two years. Required records would include information on distribution, processing, movement, and how the drugs may have become adulterated or misbranded in the first place.
(Federal Register 07/15/13)