HDA 2024 Traceability Seminar: DSCSA Implementation and Readiness
Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain.
The first day of HDA’s Traceability Seminar was certainly not lacking educational sessions. Another fascinating one that I attended revolved around “Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness,” featuring Elizabeth A. Gallenagh, general counsel and SVP, supply chain integrity, HDA; Tish E. Pahl, principal, Olsson Frank Weeda Terman Matz PC; and Brian P. Waldman, partner, ArentFox Schiff LLP.
As noted in previous session coverage, a WEE, or Waiver, Exception, or Exemption (WEE) request, is evaluated by FDA on a case-by-case basis.
The panel started off the discussion by reminding the audience of the small dispenser exemption that the FDA recently made, which essentially exempts dispensers with 25 or few full-time licensed pharmacists and qualified pharmacy technicians from package-level 2023 requirements until Nov. 27, 2026.
It’s important to note that although the deadline for trading partners to submit requests was Aug. 1, 2024, requests can be made at any time, but the FDA is unable to guarantee that it was act or make a ruling prior to the Nov. 27, 2024 date.
The panel outlined that a WEE should explain:
- What specific DSCSA requirements you need relief from
- What you’ve done so far/progress that’s been made
- Why you are requesting more time
- Why this specific request won’t create an issue for downstream trading partners.
- Ways to maintain supply chain security
Waldman also noted that as WEE should be a narrow as possible, meaning that if one needs an additional six months to comply, one should request six months, as opposed to more time, but nothing is guaranteed—as Pahl advised, “be prepared for what happens if you don’t get what you want.”
On July 29, the National Association of Chain Drug Stores (NACDS) submitted a letter—which Gallenagh noted is fully supported by HDA, who themselves have recommended a phased approach three times—to the FDA in which they asked for a phased approach when it came to implementation. In NACDS’ opinion,manufacturers should need to comply by the existing Nov. 27, 2024, while wholesale distributors should achieve full compliance 6-8 months later. As for dispensers—larger ones who have not been previously exempt by FDA—should have until Feb. 27, 2026 to comply.
Some might be wondering what NACDS’ justification is on these suggestions. The association believes that pharmacies shouldn’t be penalized for suppliers’ lack of compliance. They are also concerned for lack of compliance to result in supply disruptions, including drug shortages.
As the panel also stated, it even raises additional WEE concerns that could hold implications down the road, such as additional clarity being needed where a downstream trading partner seeks exemption for supplier non-compliance; the suggestion that WEE should be at national drug code level or NDC, not lot level; that granted WEEs should be applicable to all transactions with all trading partners; and FDA should post all NDCs that are subject to exemptions and waivers in order to keep the entire supply chain informed.
This raises a key question for the FDA: being that the agency has vowed to prioritize patient access to medications, how does it proceed? Does it choose to break the DSCSA law in order to stay true to that oath?
Reference
Gallenagh EA, Pahl TE, Waldman BP.Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness. August 27, 2024. HDA 2024 Traceability Seminar. Washington, DC.
