Insight: Winter 2021

Winter 2021 | 23 Drug Supply Chain Michael Dodd, Pharm.D., R.Ph., CPM, Associate Director of Clinical and Pharmacy Regulatory Affairs As noted in the fall edition of Insight , the FDA delayed the enforcement of key provisions of the Drug Supply Chain Security Act (DSCSA) by three years. On October 22, 2020, the FDA published new guidance delaying enforcement of provisions previously set for November 27, 2020 to November 27, 2023. The delay in enforcement discretion applies to wholesaler verification of returns prior to resale and dispenser verification of product identifiers for suspect and illegitimate products. 1 Wholesaler Distributor Verification Requirement for Saleable Returned Drug Product Wholesaler verification of prescription drug returns prior to resale was previously delayed from 2019 to November 27, 2020. With the October announcement, wholesale distributors do not have to verify a return’s identifier with the product’s manufacturer prior to resale until November 27, 2023. Additionally, the FDA announced that prior to November 27, 2023, it does not intend to take action against wholesale distributors whose transaction statement does not contain the statement “that the entity transferring ownership in a transaction had systems and processes in place to comply with verification requirements under section 582 of the FD&C Act.” 2 Dispenser Verification of Product Identifiers for Suspect and Illegitimate Products Pharmacies and dispensers also received a three-year delay in enforcement for product identifier verification of suspect and illegitimate products. The FDA stated that it “does not intend to take action against dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product before November 27, 2023. This policy represents a three-year delay in enforcement of the requirements for dispensers to verify the product identifier when investigating suspect or illegitimate product.” 3 The three-year delay comes upon the expression of concerns from various stakeholders and representative organizations over logistics and disruptions in the supply chain due to the COVID-19 pandemic. Notably, APhA, ASHP, HDA, NASPA, NACDS, and NCPA expressed concerns in two joint letters sent to the FDA in May and October urging for delays in enforcement discretion. The FDA believes that the three-year delay will allow for distributors and dispensers to further develop systems and processes to comply with provisions and ensure interoperability by November 27, 2023. 4 Sources: 1-4 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies; Guidance for Industry; Availability. Department of Health and Human Services and the Food and Drug Administration. 10/23/20. Web. Accessed: 01/18/21. www The Drug Supply Chain Security Act: FDA Postpones Enforcement of Key Provisions by Three Years Image Source