FDA Sets Regulations on Administrative Detention of Drugs
The Food and Drug Administration is issuing a final rule to implement its authority to administratively detain adulterated and misbranded drugs, as provided for in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The regulations are “closely modeled” on existing provisions on administrative detention of devices, with only minor technical changes, FDA said. They adopt a July 2013 proposed rule without any substantive changes beyond a renumbering (see 13071211). Effective June 30, FDA will be able to administratively detain drugs when an agency official has “reason to believe” they are adulterated or misbranded.
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“Administrative detention is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that may 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 final rule adds new 21 CFR 1.980 on administrative detention of drugs, outlining procedures for FDA detention of drugs when the agency thinks a product is adulterated or misbranded. Under the new regulations, FDA may 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 has to give approval. Once the order is issued, the FDA official issuing the detention order marks the drugs as detained. Appeals of detentions have to be filed within five working days of receipt of the order.
Maximum 30 days. Once detained, drugs may not 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 will remain in place for 20 calendar days. FDA is able to extend the detention period by another 10 calendar days. The overall detention period may not 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 include information on distribution, processing, movement, and how the drugs may have become adulterated or misbranded in the first place.
(Federal Register 05/29/13)