Insight - Fall 2020

Fall 2020 | 22 Drug Supply Chain Michael Dodd, Pharm.D., R.Ph., CPM, Associate Director of Clinical and Pharmacy Regulatory Affairs The next phase of the Drug Supply Chain and Security Act (DSCSA) is right around the corner: November 27, 2020. So, now is a good time to make sure you are up-to-date on the new requirements. Transact Products Only with an Appropriate Product Identifier Transact only products encoded with product identifiers unless grandfathered exempt, waived, or excepted. Starting November 27, 2020, “a dispenser may only engage in transactions involving product if such product is encoded with a product identifier.” 1 Product identifier is a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product. 2 It is important to note that dispenser exemptions exist for this requirement for products that were in the supply chain before November 27, 2018. The FDA “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier” Guidance for Industry provides details outlining exemptions 3 : Under section 582(a)(5)(A), packages and homogenous cases of product that are not labeled with a product identifier are eligible to be exempted from the requirements of section 582 if they are “in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of this section (i.e., section 582).” For the purposes of this guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer or repackaged by a repackager before November 27, 2018 . 4 In 2017, manufacturers were required to apply a DSCSA “product identifier.” In 2018, repackagers were required to do the same. 5 While most products in the marketplace currently contain a product identifier, it is probable that products will still exist is the supply chain that were packaged before November 27, 2018; so according to DSCSA and FDA guidance, these products may still be transacted if there is documentation that such product(s) were packaged or repackaged before November 27, 2018. 6 The Drug Supply Chain and Se