FDA Guidance on Identifying Suspect Products in the Drug Supply Chain

The FDA recently published the final guidance[i] on the identification of suspect product and notification. The guidance is intended to aid pharmaceutical trading partners (manufacturers, re-packagers, wholesale distributors, and dispensers) in identifying a suspect product and notifying FDA and other partners in the supply chain.

Since the implementation of the Drug Supply Chain Security Act (DSCSA) back in of January 1, 2015, pharmaceutical trading partners are required to have systems in place to determine if products in their possession or control are suspect and to notify FDA and trading partners upon making the determination. To ensure industry followed this requirement, the DSCSA also mandated that FDA publish a guidance on the subject.

The DSCSA defines a Suspect product as a product for which there is reason to believe it

  1. is potentially counterfeit, diverted, or stolen;
  2. is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
  3. is potentially the subject of a fraudulent transaction;
  4. appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

FDA’s final guidance identifies some of the red flags which may indicate a product is suspect or increase the risk of a suspect product entering the pharmaceutical distribution supply chain.  The guidance also sets out the procedures for notifying the agency and other trading partners.

The integrity of the pharmaceutical supply chain remains a high priority for FDA. As the projected 10-year implementation timeframe for the DSCA drives forward, pharmaceutical trading partners must continue to build strong and secure supply chain networks with trusted partners.

[i] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400470.pdf

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