FDA Delays Enforcement of Some DSCSA Requirements by 3 Years
The FDA has delayed the verification of salable returns requirement under the Drug Supply Chain Security Act (DSCSA) until November 27, 2023. On October 22, 2020, FDA released a Guidance delaying enforcement of the provision that requires wholesale distributors to verify the product identifier, including standardized numerical identifier, for salable returned product prior to further distribution of such product. The delay was requested by industry and is reflective of the lack of industry-wide readiness, and specifically, the creation of an interoperable, electronic system to enable product verification. There were also concerns that implementation may cause drug supply chain disruptions including potential drug shortages from quarantined products.
The extension does not affect the current requirement of wholesale distributors to only engage in transactions for products having product identifiers and to have a verification system in place to determine when a returned product is a suspect product. Additionally, returns of salable product currently require T3 documentation. The extension delays the verification requirements. That is, by 2023 wholesalers must verify saleable returned products prior to further distribution and have verification systems in place to comply with the requirements. Repackagers will need systems in place that will allow them to respond to requests from trading partners to confirm that a particular product identifier, including the standardized numerical identifier, on the product that is the subject of the request corresponds to the product identifier that was affixed or imprinted on that product by the repackager of that product.
Additionally, at the request of various pharmacy groups, FDA is also delaying until 2023 enforcement implementation of the verification requirement for dispensers as well. The provision would have required verification of the product identifier of suspect or illegitimate product in the dispenser’s possession or control.
How Frier Levitt Can Help
Frier Levitt regularly counsels wholesalers, drug distributors and pharmacies on various regulations set forth by federal and state agencies including, but not limited to, DSCSA. We can help you navigate FDA’s DSCSA guidances or if you have general questions concerning regulations in the drug supply chain, today to speak with an attorney.