Deadline will not be extended
As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.
As asserted by Leigh Verbois, director of the FDA’s Office of Drug Security, Integrity and Response at which she spoke at an event sponsored by the Healthcare Distribution Alliance. ” 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 we can make our goal of an interoperable system by 2023″.
Earlier this month Gilead specified that tampered and counterfeit versions of its HIV drugs were found in circulation within the US drug supply chain networks. Also Janssen notified that illegitimate versions of its drug Symtuza were counterfeit.
Verbois spoke to attendees that the FDA is working to develop a framework for interoperability. “We recognize that there are a number of important issues associated with the enhanced systems and the architecture and the system attributes. We have been working within the agency to understand the interplay between the elements that are necessary to build a system.”
In a bold statement, Verbois asserted that the US has “one of the safest supply chains in the world”, the DSCSA is still required to counter threats within the drug distribution network.
What are the DSCSA interoperability requirements?
Trading partners must exchange (TI) transaction information in a secure, interoperable, and electronic manner. The TS and transactions statement (TS) to the subsequent owner of a product “prior to, or at the time of each transaction.” The TI must have the product identifier at the package level of each package.
Upcoming 2023 Changes
Currently part of the T3, the TI and TS are being electronically sent at the lot-level by ASN exchanged using EDI.
When 2023 arrives, data will then be switched to being electronically exchanged at a fully serialized level using industry chosen Electronic Product Code Information Services (EPCIS).
New Rulemaking to be announced soon
Verbois also stated that the FDA “will very soon” be announcing a new ruklemaking on licensing requirements for wholesalers and third-part logistics providers. No specific dates were mentioned.
“Please know that we are working really hard within the agency to move that forward … we are committed to ensuring that this part of DSCSA is implemented. We feel it is a very important part of DSCSA.” said Verbois.
About the Author: Christian Souza is the
Co-Founder of TrackTraceRx