FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Guidance Lists Suspect Product Scenarios Requiring FDA Notification

Dec. 15, 2016

The FDA finalized guidance yesterday on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency, trading partners and wholesale distributors.

A new section in the final guidance, detailing three levels of risk, described how a manufacturer should notify the agency within 24 hours after determining:

  • That there is a “high risk” that a product that the manufacturer has reason to believe is in an immediate trading partner’s possession is illegitimate, such as when a manufacturer learns that a suspect product has been found in the U.S. pharmaceutical distribution supply chain, or if a product has been stolen or diverted while not in their possession.
  • That there is a “specific high risk” that would increase the likelihood of the illegitimate product entering the supply chain, as when a wholesale distributor informs a manufacturer that it believes it has a suspect product, or they believe it has been stolen, diverted or intentionally adulterated.
  • Or if there exists an “other high risk” as determined by FDA, for example, a manufacturer learns that a licensed health care practitioner is administering an oncology drug to patients that purports to have been manufactured by that manufacturer, but the manufacturer determines that there is a high risk that the drug is suspect; the patient suffers an adverse event; or the manufacturer determines discrepancies in transaction history between distributors.

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