On March 2, 2018, FDA issued draft guidance on the definitions of “suspect product” and “illegitimate product” for verification obligations under the Drug Supply Chain Security Act (DSCSA). FDA intends the new draft guidance to assist trading partners in meeting the verification obligations of the DSCSA.
The DSCSA, which was enacted on November 27, 2013, established requirements for product tracing, verification, and product identification for certain drug products sold in the US. More particularly, the verification obligations of the DSCSA require trading partners to identify a suspect product and make a determination about whether that product is an illegitimate product.
FDA clarifies its interpretation of the following four terms used in the definitions of “suspect product” and “illegitimate product”: (1) counterfeit, (2) diverted, (3) fraudulent transaction, and (4) unfit for distribution. While not exhaustive, in this guidance, FDA identifies the most common scenarios that FDA believes trading partners will encounter with respect to these terms.