The Food and Drug Administration (FDA) appears to be digging in its heels and insisting pharma stakeholders be ready to comply with interoperability requirements by November 27, 2023, the deadline mandated in the U.S. Drug Supply Chain Security Act (DSCSA).
Leigh Verbois, director of FDA’s Office of Drug Security, Integrity, and Response, indicated there would be no delays during a Healthcare Distribution Alliance (HDA) webinar on August 9.
As reported by Regulatory Focus, Verbois said, “It is FDA’s goal that we not extend the November deadline for interoperability … We have been working at a full tilt to make sure that we can make our goal of an interoperable system by 2023.”
Verbois also said that the FDA was continuing to develop a framework for interoperability, adding that the Agency knew there were “a number of important issues” to address and that regulators had been “working to understand the interplay between the elements that are necessary to build a system.”
Director Verbois’ comments at the HDA webinar come just two months after the FDA published draft and final guidance on key aspects of the DSCSA: product identifiers, suspect and illegitimate products, and enhanced drug distribution security.
- Product Identifiers under the Drug Supply Chain Security Act: Questions and Answers (final guidance)
- Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (final guidance)
- Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (revised draft guidance)
- Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (new draft guidance)
What are the DSCSA interoperability requirements?
The DSCSA requires pharma supply chain trading partners to exchange transaction information (TI) “in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”
Trading partners must provide TI and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” TI must “include the product identifier at the package level for each package included in the transaction.”
What’s changing in 2023?
Right now, TI and TS are being electronically exchanged at the lot-level, which is usually done with an advance ship notice (ASN).
In 2023, however, TI must include the product identifier, which includes serial numbers and expiration dates. This means the U.S. pharmaceutical supply chain will be fully serialized, and the Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange.
The transition from ASN to EPCIS is one of the “four pillars” of the regulations that we talked about in our three-part DSCSA 2023 webinar series in June, which you can view and download here. We also hosted a “Plan for DSCSA Readiness” webinar in March that you can view here.
As we reported in our blog, the FDA has twice delayed enforcement of the DSCSA Saleable Returns Requirement. Now, the table seems to be set for November 2023: No more delays, no more extensions.
The pace will only intensify. In just about two years, you’ll have to be up and running in a fully serialized U.S. pharmaceutical supply chain. Now, the question we’ve been asking for so long is even more critical: Will you be ready?
In terms of interoperability, ask yourself these questions:
- Can you send and receive serialized data?
- Can you send and receive aggregated data?
- Do you have procedures and training in place to support serialized data exchange?
Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help.