FDA issued guidance to interpret the terms used in the definition of suspect product set forth in section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21), and the definition of illegitimate product set forth in section 581(8) of the FD&C Act, to assist trading partners in meeting verification obligations (including notification) and requirements that trading partners have systems in place to identify and handle suspect and illegitimate products.

The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the FD&C Act to establish requirements for product tracing, verification, and identification for certain drug products that are distributed in the United States. Many of the terms used in these requirements are defined in section 581 of the FD&C Act. This guidance is intended to help industry identify suspect and illegitimate product in the U.S. pharmaceutical distribution supply chain by interpreting certain terms used in the definitions of suspect product and illegitimate product. Trading partners are required to take specific actions if they identify such products.

Download draft guidance here.