FDA'S Response To Cargo Thefts

The FDA wants to make sure that drugmakers do more than bolster internal operations. In a new standard operating procedure, the agency wants the pharmaceutical industry to know that there are various obligations when a theft occurs and this includes alerting regulators and the public.

FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVESGENERAL OR MULTIDISCIPLINEFDA'S RESPONSE TO CARGO THEFTS - Effective Date: 03/23/2012

The purpose of this Standard Operating Procedure (SOP) is to provide a general procedure for determining FDA’s regulatory response when a cargo theft involving an FDA-regulated product has occurred. When followed in conjunction with the established procedures for product removal from the market, public notice, and handling medical product shortages, if applicable, the procedures described in this document will ensure that FDA’s regulatory response to cargo thefts is consistent and effective.

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