FDA Guidance on Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
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The FDA has extended its enforcement policies on wholesale distributor and dispenser verification requirements by one year (from November 27, 2023, to November 27, 2024).
This is a revision of the previous guidance of the same name, published in the Federal Register on October 23, 2020 (the 2020 Compliance Policies). The 2020 Compliance Policies relate to provisions in the FD&C Act, as added by the Drug Supply Chain Security Act (DSCSA), requiring wholesale distributors to verify the product identifier prior to further distributing saleable returned product and requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser’s possession or control.
Regulatory Background
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act. This section established product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers to facilitate the tracing of a product through the pharmaceutical distribution supply chain.
One requirement of the verification scheme outlined in the DSCSA is the verification of saleable returned product. Under section 582(c)(4)(D) of the FD&C Act, wholesale distributors must have systems in place that will enable them to verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of saleable returned product, or, if such product is not in a sealed homogeneous case, on each package of saleable returned product. A saleable returned product may not be further distributed until the product identifier is verified. The product should be handled as suspect product if the product identifier is not successfully verified (i.e., it should be quarantined and investigated).
Previous Guidance
Previously, on September 24, 2019, the FDA published a guidance entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy" (the 2019 Compliance Policy), where FDA announced a 1-year delay in enforcement of the requirement for wholesale distributors to verify saleable returned product as required under section 582(c)(4)(D) of the FD&C Act (21 U.S.C. 360eee1(c)(4)(D)). The 2019 Compliance Policy explained that the agency intended to delay enforcement of this requirement until November 27, 2020. Subsequently, the 2020 Compliance Policies announced FDA’s extension of the enforcement policy embodied in the 2019 Compliance Policy with respect to this requirement for an additional three years, until November 27, 2023.
Current Compliance Policies
Given many concerns expressed by wholesale distributors and dispensers, the FDA intends to not enforce the DSCSA’s enhanced drug distribution security requirements, i.e., for interoperable, electronic, packagelevel product tracing, including specified systems and processes, before November 27, 2024.
With respect to wholesale distributors, the FDA does not intend to enforce:
- The requirement under section 582(c)(4)(D) of the FD&C Act to verify a product identifier prior to resale or other further distribution of a package or sealed homogenous case of product
- The requirement under section 582(c)(4)(D) of the FD&C Act for providing a transaction statement 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
With respect to dispensers, the FDA does not intend to enforce:
- The requirement under section 582(d)(4)(A)(ii)(II) of the FD&C Act to verify the product identifier of the statutorily designated proportion of suspect product
- The requirement under section 582(d)(4)(B)(iii) of the FD&C Act to verify the product identifier of the statutorily designated proportion of product that is the subject of an illegitimate product notification by FDA or a trading partner
Notably, these compliance policies do not affect the requirement that a wholesale distributor or dispenser may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to section 582(a)(5) of the FD&C Act).
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