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FDA SOP on Drug Cargo Theft Includes Public Notification Provision

Apr 8th, 2012

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FDA has published an internal SOP covering industry and agency responsibilities when pharmaceutical cargo thefts occur that provides for the agency to make the final decision regarding if and when the public will be notified of the thefts.  The new SOP is included in the agency’s “Staff Manual Guide.”

In explaining the procedure’s purpose, FDA states that it is “very concerned” about the increase in cargo and warehouse thefts of FDA regulated products, including prescription and over-the-counter medicines, vaccines, medical devices and infant formula.

These crimes threaten the public health, the document emphasizes, “because product that has left the legitimate supply chain poses potential safety risks to consumers.”  The agency points out that that “there have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling.”

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