15/16 November 2023
In October 2020 the FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product guidance (the 2020 Compliance Policies). The agency now decided to revise and extend the 2020 Compliance Policies for an additional year (from 27 November 2023 to 27 November 2024).
The 2020 Compliance Policies relate to provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), requiring wholesale distributors to verify the product identifier (PI) prior to further distributing saleable returned product and requiring dispensers to verify the PI for suspect or illegitimate product in the dispenser’s possession or control. However, stakeholders have explained to FDA that the following issues still exist:
Thus, to minimize possible disruptions in the distribution of certain prescription drugs in the US, the agency does not intend to take action before 27 November 2024,
However, this does not affect other activities required (e.g., dispensers must still quarantine product, conduct investigations, and disposition illegitimate product). In addition, it does not relieve a manufacturer of its verification obligations pursuant to the FD&C Act upon receiving a request for verification from an authorized dispenser.
For more information see FDA's guidance Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product.