This guideline allows the industry to: Pharmaceutical Supply Chain Security Act (DSCSA) requires suppliers to identify suspicious or illegal products. This guidance provides Agency interpretation of the terms “counterfeit”, “diverted”, “stolen”, “unauthorized”, and “unsuitable for distribution” that are not defined in the DSCSA.
This replaces the Draft Guidance published on June 4, 2021. (connection: FDA details DSCSA implementation plan in four guidances, Regulatory focus June 4, 2021)
Among the changes from the draft guidance is a clarification that the definition of diversion can include scenarios other than products dispensed to patients. In previous versions, the definition was changed to “include products that have been dispensed to a consumer or patient and then reintroduced into the U.S. pharmaceutical distribution supply chain and transacted with.” The final guidance adds language to indicate that other situations may arise, including diversion of products that would otherwise be removed from the U.S. pharmaceutical distribution supply chain.
The guidance also clarifies FDA’s expectations for handling missing products that are not considered stolen goods. This revision adds new text to indicate that trading partners “may encounter situations involving lost or missing products.” The FDA states that in such situations, companies should refer to their internal policies to “investigate the circumstances surrounding a lost or missing product to determine whether it is stolen, suspect, or illegal. I have to,’ he said.
In addition, this guidance expands the definition of “fraudulent transactions” to address clerical errors and discrepancies in product tracking information. The guidance states, “It may not be immediately apparent whether product tracking information has been deliberately falsified. In these situations, FDA recommends that trading partners take steps to determine whether the error can be resolved and whether the product is questionable or illegal.”
Editorial changes were also made to improve clarity.
Final guidance