HDA 2024 Traceability Seminar: An FDA Perspective on DSCSA

The Traceability Seminar's “State of Implementation: FDA’s Perspective" session

Day 1 of this year’s Healthcare Distribution Alliance’s (HDA) Traceability Seminar started off with arguably one of the more anticipated sessions of the conference, being that it featured the FDA, who authored the Drug Supply Chain Security Act (DSCSA).

Titled “State of Implementation: FDA’s Perspective,” the presentation was led by both Leigh Verbois, director of the office of drug security, integrity, and response (ODSIR) within CDER’s office of compliance, and Abha Kundi, JD, MPH, team lead. The goal was to “review DSCSA implementation and trading partners’ feedback on progress and to achieve interoperable, electronic tracing of products at the package level,” while also examining FDA activities that are in the works.

Verbois reminded attendees that the DSCSA was originally enacted Nov. 27, 2013, with the objective of providing interoperable, electronic tracing of products at the package level, while tracking and tracing drugs as they flow through the US pharmaceutical supply chain. As noted in its name, it is meant to protect consumers from encountering counterfeit or stolen drugs, removing them once they’re detected. DSCSA also creates national licensure standards for wholesale drug distributors and third-party logistics (3PL) providers.

Industry members may recall that minutes before FDA was set to hit the stage at last year’s Traceability Seminar, the agency had announced two compliance policy guidelines that established a one-year stabilization period until Nov. 27, 2024—thereby choosing to delay enforcement of Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act—which provided the pharma supply chain with more time to implement and troubleshoot their systems and processes.

FDA had held firm in stating that this extra time does not mean that trading partners should delay preparation to comply with 582(g)(1); instead, they should take advantage of the extension by “building and validating” their systems.

The agency has also stated the stabilization period will not extended any longer. However, per Section 582, FDA can issue exemptions, and has done with small dispensers (less than 25 employees) until Nov. 27, 2026. Other stakeholders can file for a Waiver, Exception, or Exemption (WEE) request, which will be evaluated by FDA on a case-by-case basis.

At the same time, the agency did express where its priorities lie, which is in providing patients access to their medications in a secure manner. In that light, it decided to re-open its RFI (request for information) on “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act” until Sept. 12, 2024.

The RFI is intended to answer multiple questions such as:

• How stakeholders are using the stabilization period to troubleshoot and mature secure, electronic, interoperable systems and processes for enhanced drug distribution security with upstream and downstream trading partners
• Significant challenges stakeholders have overcome, and the strategies used to overcome them
• Systems and processes that have been operationalized
• Next steps to provide implementation of the drug distribution security requirements by this November

Be sure to continue to visit https://www.pharmaceuticalcommerce.com/latest-conference for continuous conference coverage.

Reference

Verbois L, Kundi A. State of Implementation: FDA’s Perspective. August 27, 2024. HDA 2024 Traceability Seminar. Washington, DC.