Stakeholders Urged to Prioritize Interoperability Mandates as DSCSA 'Stabilization Period' Looms

The FDA is providing a one-year soft launch for the Drug Supply Chain Security Act mandates, effective November 27.

Pharmaceuticals suppliers, manufacturers and other stakeholders are being urged to use the looming "stabilization period" for the Drug Supply Chain Security Act (DSCSA) to reach compliance with federal interoperability regulations, and "not take your foot off the gas."

The Food and Drug Administration on August 30 said it would exercise enforcement discretion during the one-year period, effective Nov. 27, 2023, "to accommodate additional time that trading partners in the pharmaceutical supply chain may need" to validate DSCSA mandates.

At a Healthcare Distribution Alliance seminar in late August, stakeholders were cautioned that the stabilization period is not an opportunity to slack off on compliance.

"The point of the stabilization period isn't to take your foot off the gas," Gregg Gorniak, vice president of the Manufacturer Operations and Data Services and Secure Supply Chain Lead, Cencora, told attendees at the seminar, while urging them to prioritize meeting the interoperability requirements laid down in DCSCA.

"This whole thing is around the safety of the patient," Gorniak says. "We need to make sure we get it right."

That advice was seconded by FDA officials who attended the seminar.  

"This [stabilization period] should not be viewed as justification to stop implementation," Leigh Verbois, FDA director of Drug Security, Integrity and Response, told the gathering. "We want this implementation to be done by 2024."

Connie T. Jung, FDA senior advisor for policy, told the gathering that the agency's actions is "only intending for the stabilization period to apply to [FDA's final guidance for Enhanced Drug Distribution Security Requirements Under Section] 582(g)(1)," and emphasized."

"This does not mean to stop anything," she says.  

Stakeholder Concerns

The HDA and other drug supply chain stakeholders have raised concerns with the FDA about DSCSA's requirements and the "uneven state of industry readiness for November 2023, underscoring that the progress of implementation and the law's single compliance date for all trading partners could lead to supply chain disruptions and interruptions to patient care."

HDA CEO / President Chip Davis praised the FDA's decision to ease into the mandate, saying "the agency heard the concerns of distributors, manufacturers and pharmacists and provided guidance that will ultimately minimize the potential for disruptions in the short term."

The FDA says it will use the stabilization period to fine-tune DSCSA guidance, with a focus on wholesaler/3PL provider licensing. Additionally, the agency is planning to survey small dispensary readiness and hold additional public hearings.  

Help for Independent Pharmacists

In particluar, independent pharmacies have raised concerns about the special compliance challenges facing smaller dispensaries.

"If you look at most of the larger chains, they're ready, or they [would have been ready] to flip this on in November, but not necessarily be getting data because their trading partners may not be ready to send data," Ilisa Bernstein, chief lobbyist for the American Pharmacists Association, told seminar attendees.

"But for the small dispensers, the independent pharmacies ... they were just not ready."