FDA Delays Verification Requirement for Salable Returned Drugs
The US Food and Drug Administration (FDA) on Monday issued a final guidance explaining that it will delay enforcing a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesale distributors to verify the product identifier of saleable returned drugs before they can be put back in distribution.FDA says it is delaying the requirement, originally slated to take effect on 27 November 2019, by one year "given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain." According to the agency, some wholesale distributors and other stakeholders voiced concerns over "industry-wide readiness" and "challenges … with developing interoperable electronic systems to enable such verification."
Under the compliance policy FDA says it does not intend to take action against wholesale distributors who do not verify the product identifier before distributing returned product until 27 November 2020.
The requirement stems from a provision of the DSCSA that added section 582(c)(4)(D) to the Federal Food, Drug & Cosmetic Act (FD&C Act), which specifies that wholesale distributors must verify the product identifier, including the standardized numerical identifier, on sealed homogenous cases of saleable returned drugs prior to further distribution. If the drugs are not in a sealed homogenous case, wholesale distributors must verify the product identifier on each sealed package.
FDA also says it is delaying another DSCSA requirement for wholesale distributors to include a transaction statement to purchasers that certifies the entity has systems and processes in place to comply with verification requirements by one year.
However, FDA notes that the enforcement delays only apply to specific provisions of section 582 of the FD&C Act, such as the requirement for wholesale distributors to verify whether returned product is suspect.
FDA says it is implementing the compliance policy via final guidance without first issuing a draft guidance for comment "because the agency has determined that prior public participation is not feasible or appropriate."
FDA, Federal Register Notice