Final FDA Guidance:
Federal Food, Drug, and Cosmetic Act
Written-by: Deneen Fumich, RPh
On March 16, 2023, FDA announced: “the availability of a final guidance for industry entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.”
The guidance finalizes the June 4, 2021, draft guidance, to assist trading partners (manufacturers, repackagers, wholesale distributors and dispensers) in complying with section 582 of the FD&C Act. Trading partners must be able to identify a suspect or illegitimate product by interpreting certain terms used in the definitions of suspect product and illegitimate product.
The guidance lays out FDA’s current understanding and clarification of the following key terms used to define suspect and illegitimate product: “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution”.
Understanding the FDA thinking for the key terms is critical to industry as the Trading Partners must be able to identify suspect or illegitimate product through verification obligations, including notifications, and to have systems in place for identification and handling of suspect and illegitimate product.
After considering comments received on the 2021 draft guidance, the following changes to the draft has been incorporated into the final guidance:
(1) clarifying the definition of “diverted” by revising the examples clarifying that there are other scenarios besides product dispensed to a patient that could result in diverted product;
(2) clarifying FDA’s expectations for how trading partners should handle unaccounted for product that is not immediately identified as stolen product;
(3) expanding on the definition of “fraudulent transaction” to clarify how clerical errors or discrepancies in the product tracing information should be addressed; and
(4) clarifying that the definition of “unfit for distribution” in this guidance applies only to the verification provisions of the DSCSA and to identifying suspect and illegitimate product. In addition, editorial changes were made to improve clarity.
FDA has issued additional and specific guidance for industry addressing:
- The verification systems and other aspects of the verification requirements in the revised draft guidance for industry in March 2022: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.
- The process for notifying FDA and trading partners of illegitimate product, as well as terminating those notifications in the June 2021 guidance for industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
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