[Blog] FDA confirmed the DSCSA 2023 Interoperability Deadline will remain as planned

“There are no plans to extend the 2023 deadline for enforcing the interoperability requirements”

said Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research.

 

The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by the November 2023 deadline set by the Drug Supply Chain Security Act (DSCSA), with no plans to extend the deadline for manufacturers to comply with these requirements.

So confirmed Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research during a webinar sponsored by the Healthcare Distribution Alliance.

 

What’s new is up to come in 2023 for DSCSA?

 

Currently, transition information (TI) and transition statement (TS) are being electronically exchanged at the lot level, which is usually done with an advance ship notice (ASN).

In 2023, transition information must include the product identifier, which contains serial numbers and expiration dates. Thus, the U.S. pharmaceutical supply chain will be fully serialized, and the Electronic Product Code Information Services (EPCIS) which appears to be the standard the industry will use to enable this exchange.

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