New FDA Regulation gives the Agency more Power during an Inspection

The U.S. Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority during inspections. Once the applicable regulation is finalized, it will allow FDA to administratively detain drugs, if an investigator during an inspection has reason to believe that the drug(s) are adulterated or misbranded. The FDA will then have a possibility to prevent right away distribution or subsequent use of drugs, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. That will mean that "drugs that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period".

The detention should not exceed 20 calendar days, unless the respective FDA District Director defines a longer period for further evaluation.

The detention order must be issued in writing, in the form of a detention notice, signed by the authorized FDA representative. The content of the notice will be defined in the regulation.

In a notice on their homepage, Duane Morris attorneys say that the new rules "appear to present a new risk to facilities during inspections. Facility owners should consider closely analyzing these risks prior to an inspection and developing a quick response to a detention order."

FDA proposes to amend 21 CFR part 1. The proposed amendment to part 1 consists of one section, § 1.501, under a new subpart, which is titled ''Subpart L- Administrative Detention of Drugs Intended for Human or Animal Use.'' The new regulation is similar to the current regulation for the administrative detention of devices (21 CFR 800.55).

Source: US Government Federal Register