Insight - Fall 2020

Fall 2020 | 23 urity Act: Notes for Dispensers Important takeaways from the grandfathering policy guidance: • A product or homogenous case that is not labeled with a product identifier, but documentation is provided in the form of transaction information or transaction history indicating a sale before November 27, 2018, can be concluded that the product is grandfathered. 7 • If the transaction information or transaction history does not include a sale before November 27, 2018, then a dispenser can rely on the Transaction Statement as indication that the product was in the supply chain before November 27, 2018 and thus is grandfathered. Dispensers can request packaging date information frommanufacturers and repackagers. 8 • Trading partners may transact grandfathered products until product expiry. 9 Since 2015, all DSCSA products have been required to have a Transaction Statement as part of the Transaction Data (3Ts: Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS)). 10 Therefore, any product received after November 27, 2020 without a product identifier can be considered grandfathered when the 3Ts are provided unless documentation shows a packaging or repackaging date after November 27, 2018. There is nothing in FDA guidance that requires a dispenser scan product upon receipt to confirm the presence of a product identifier. Additionally, the November 27, 2020 requirements do not require exchange of product identifier data. The exchange of product identifier data is set for the November 27, 2023 interoperability requirements. 11 Verification of Suspect Product Identifiers The second requirement for November 27, 2020 relates to verification of the product identifier when investigating suspect product. Suspect Product means a product which there is reason to believe that such product is potentially counterfeit, diverted, or stolen; is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; is potentially the subject of a fraudulent transaction; or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans. 12 Since 2015, dispensers have been required to have policies and procedures to detect and investigate suspect product.