September 01, 2013


 FDA taking comments on drug detention rules

The Food and Drug Administration is accepting comments on proposed regulations that would let the agency hold drugs believed to be adulterated or misbranded.

The FDA announced in the July 15 Federal Register that the agency would, through Sept. 13, accept comments on the proposal, intended to prevent illnesses and deaths by giving the FDA time to consider what actions are needed when its inspectors detect potentially unsafe pharmaceuticals intended for use in human or veterinary medicine. The agency already has such authority to hold medical devices, tobacco, and food.

The FDA also accepted comments on the proposal April 9-May 9, but the Federal Register notice published at the time included fewer details and did not include the text of the proposed regulations. The July 15 notice includes that text, much of which FDA officials indicate is modeled on the regulations for administrative detention of medical devices.

In proposing the rule, the agency cites authority granted under the Food and Drug Administration Safety and Innovation Act, signed into law July 9, 2012.

Additional information is available here under docket number FDA-2013-N-0365. Comments can be submitted at that site or mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.