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Trade & Channel Strategies 2023: A DSCSA Update

The seminar examines where members of the pharma supply chain stand in terms of preparation, being that the act has officially been enacted.

One of yesterday’s Trade & Channel Strategies presentations on the “Supply Chain and Distribution Operations” track featured a traceability theme in the form of “The State of DSCSA and Serialization” presentation. Hosted by Bob Celeste, founder of the Center for Supply Chain Studies, a neutral, non-profit 501 (c)(6) that works with the pharma industry to explore supply chain issues via reference model-based studies, the session looked into how prepared organizations truly are for this legislation, now that it is officially active as of Nov. 27. This date is when Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act had gone into effect.

As noted by Celeste, the Drug Supply Chain Security Act (DSCSA) outlines steps over 10 years for reaching interoperable, electronic tracing at the package level here in the United States. It also provides the FDA with a framework for instituting national licensure standards for both wholesale distributors and third-party logistics providers (3PLs) by requiring these parties to report any licensure to the FDA every year.

Meanwhile, it’s also important to note that FDA had previously decided to delay DSCSA enforcement, saying that the agency “does not intend to take action to enforce,” until Nov. 27, 2024, rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification), which has been referenced as a “stabilization period.”

However, Celeste reminded attendees that this “stabilization period” only applies to certain aspects of DSCSA; it is intended to implement and trouble systems, and to continue to build and validate these interoperable systems.

Upon examination of the pharma supply chain, complying and successfully being equipped to follow DSCSA is no simple feat. Challenges surrounding the legislation capabilities include:

  • Data exchange: Manufacturers and re-packagers will need to deal with aggregation, from package to case, while dispensers and small wholesalers have little data available pertain to transaction information.
  • Verification: The major wholesalers are the ones who have the most experience.
  • Tracing: Piloting activities are still in process, while interoperate specifications are continuing to stabilize.
  • Authentication & authorization: This is reliant on both tracing demand and verification.
  • Records retention: Small entities might ask for access to various manufacturer and/or wholesaler portals at any given time.

So how ready are these involved parties? Celeste envisions that major manufacturers and retailers will be prepared, and when asked by an attendee regarding his thoughts on implementation being pushed further back, he noted that “FDA is looking for effort” in meeting the aforementioned requirements.

In the meantime, for manufacturers and trade partners who need to notify the organization of illegitimate products, the FDA has a DSCSA portal known as CDER NextGen, which has become available as of Dec. 11.

Reference

The State of DSCSA and Serialization. December 12, 2023. Trade & Channel Strategies, Philadelphia.

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