LogiPharma USA 2023: Making a List and Checking It Twice

LogiPharma USA 2023 session, "DSCSA – Final Checks to Have Before Deadlines.” October 5, 2023. LogiPharma USA 2023, Boston, Mass. Image Credit: Nicholas Saraceno.

Here at LogiPharma USA in Boston, there are a plethora of keynotes and discussions to participate in. As the deadline for the Drug Supply Chain Security Act (DSCSA) is technically approaching—the official date is Nov. 27, 2023, which is when Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, will go into effect—a panel met to discuss “DSCSA – Final Checks to Have Before Deadlines.”

However, it’s important to note that FDA’s 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.”

This edition of DSCCSA coverage was moderated by Sath Rao, head of global manufacturing strategy at Zebra Technologies, featuring Tracy Nasarenko, GS1 US’ senior director of community engagement for pharmaceuticals; Gregg Gorniak, VP of manufacturing operations and data services, secure supply chain lead, Cencora, Justin Macy, director of innovation, National Association of Boards of Pharmacy; and Matt Campasano, senior serialization consultant and practice lead with Converge Consulting.

In essence, as noted by LogiPharma staff, the panel spoke on the best practices for manufacturers to both create and maintain serialized transactions information, transaction statements, and securely exchanging DSCSA traceability data with wholesale distributors, health systems and retail dispensers (such as via EPCIS).

How is the supply chain responding?

As opposed to letting up, Campasano noted that now is the time to continue to power through by ramping up activities. Candidly, Macy added that dispensers are struggling in this department; he would predict that they are 50-50 in regard to meeting requirements.

Is there hope?

Gorniak, who noted that Cencora has onboarded about 75,000 dispensers during this process, expressed his opinion that there is hope, but that stabilization period is quite necessary. In fact, according to him, 80% of their manufacturers have converted to their interoperable system, but only 50% of that data is falling in.

Bouncing back and following industry best practices

An interesting question was raised by Rao when he asked for advice for manufacturers who may feel that they are falling behind as it pertains to compliance. Campasano explained that this uneasiness could stem from a lack of human resources/technological resources, which could signify an issue with supply chain communication.

Externally, in order to help remedy this, manufacturers ought to reach out their respective software suppliers, but internally, should further determine what they are doing from a project management perspective to in order to address these compliance requirements.

When it comes to best practices for the industry, as was a topic of discussion at HDA’s Traceability Seminar, communication with trading partners is paramount, Nasarenko stressed. This should not only be within one’s four walls—the earlier the better when it comes to initiating that communication.