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Published on Friday, March 17, 2023

FDA finalizes guidance on definitions of “suspect product” and “illegitimate product” for existing verification obligations under DSCSA

FDA released final guidance this week that will help dispensers better understand their obligations under the Drug Supply Chain Security Act (DSCSA) related to “suspect” and “illegitimate” products. The new guidance, titled “Definitions of “Suspect Product” and “Illegitimate Product” for Verification Obligations Under the DSCSA,” is effective immediately.

In this guidance, FDA clarifies its interpretation of the definitions of “suspect product” and “illegitimate product” to assist manufacturers, wholesalers, and dispensers in meeting verification requirements. The specific terms discussed in this guidance include counterfeit, diverted, stolen, fraudulent transaction, and unfit for distribution.

All pharmacies (referred to as “dispensers” under DSCSA) should already have systems, processes, and standard operating procedures in place related to suspect and illegitimate products.  This is because requirements for identifying, handling, and notification of such products have been in place since 2015. This guidance provides additional information on what dispensers should do and what constitutes a suspect or illegitimate product.

APhA is waiting to hear from FDA on our request for enforcement discretion for small business dispenser compliance with certain DSCSA requirements that go into effect in November 2023 and will update members as soon as that information becomes available. APhA members can contact FDA to request a delay in enforcing these DSCSA requirements for small business dispensers here.

For more information about DSCSA please visit www.dscsa.pharmacy, which is co-hosted by APhA.

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