DSCSA Provisions Delayed until November 2024
In July 2023, several pharmacy organizations (NABP, APhA, NACDS) sent a joint letter to the Food and Drug Administration (FDA). The letter asked the FDA to use its authority to delay the final implementation deadline for the Drug Supply Chain Security Act (DSCSA) until February 2026. The FDA responded to this request with an announcement on 8/25/23 that the effective date for full implementation of the DSCSA will be delayed for one year, becoming effective and enforceable on 11/27/24.
It is important to note that this action by the FDA only delays the effective date for the Phase III interoperability provisions, specifically the requirement for all transaction information to be sent in a secure electronic interoperable manner among trading partners. The other DSCSA requirements, such as product and trading partner verification, identifying and reporting suspect products, and unit-level serialization will all become effective and enforceable on 11/27/23.
The FDA’s delay allows dispensers, wholesalers, and manufacturers additional time to fully implement the use of serialized electronic product tracing and documentation. A future delay is not expected, and pharmacies should begin preparing now for the final stage of DSCSA compliance. If you intend to engage a third-party DSCSA compliance solution, be mindful that onboarding and implementation times may vary. The FDA has recommended that supply chain partners adopt Phase III serialized product tracking as soon as possible to support a successful industry-wide adoption.
If you have questions about DSCSA or options for compliance, check out the following resources:
Webinar: How the DSCSA Impacts Your Pharmacy featuring Advasur
Webinar: DSCSA: What Pharmacies Need to Know featuring Infinitrak