US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

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).

Background

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:

• Very large volume of saleable returned products requiring verification
• Need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots 
• Complexities of building an interoperable, electronic system with the capabilities to timely and efficiently verify the large volume of saleable returned products amid immature technologies

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,

• against wholesale distributors who do not verify a PI prior to resale or other further distribution of a package or sealed homogenous case of product,
• against a wholesale distributor for providing a transaction statement (as defined in section 581(27) of the FD&C Act) to a subsequent purchaser of product on the basis that such wholesale distributor does not yet have systems and processes in place to comply with the saleable return verification requirements,
• against dispensers who do not verify the PI of suspect product,
• against dispensers who do not verify the PI of illegitimate product that are the subject of a notification from FDA or a trading partner.

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.