The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.
The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance sets out the agency’s interpretation of the terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution,” which are not defined by DSCSA.
It replaces the draft guidance issued on 4 June 2021. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021)
Among the changes from the draft guidance is a clarification that the definition of diverted can include other scenarios besides products being dispensed to a patient. The former version defined diverted to “include product that is dispensed to a consumer or patient and then reintroduced into the U.S. pharmaceutical distribution supply chain to a trading partner.” The final guidance adds language stating that there could be other situations involving diversion of products that are “otherwise removed from the U.S. pharmaceutical distribution supply chain.”…