HDA 2023 Traceability Seminar: An FDA DSCSA Overview

This year’s Healthcare Distribution Alliance (HDA) Seminar—pushed up by three months due to the urgency of Drug Supply Chain Security Act (DSCSA) legislation—was led off with a presentation by Leigh Verbois, director of the office of drug security, integrity, and response (ODSIR) within CDER’s office of compliance, and Connie Jung, RPh, senior advisor for policy in ODSIR in FDA’s Center for Drug Evaluation and Research.

HDA 2023 Traceability Seminar session, “Implementing DSCSA and Expectations for 2023 and Beyond.” August 30, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

Titled “Implementing DSCSA and Expectations for 2023 and Beyond,” the presentation aimed to “review DSCSA implementation and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level,” while also taking a look at recent industry guidances that are pertinent to supply chain security.

As previously reported by Pharma Commerce, via Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA “does not intend to take action to enforce” rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification) until Nov. 27, 2024. Rather, a “Stabilization Period” lasting until that time will be enacted, which is intended to provide the pharma supply chain with more time to implement and troubleshoot their systems and processes.

FDA was clear in noting that this additional time does not signify that trading partners should delay preparation to comply with 582(g)(1); rather, they should continue forward as they were, this time, allowing extra time to improve their aforementioned systems.

As Jung had originally noted at HDA’s Distribution Management Conference this past March, she reiterated the difference between a “suspect” product and an “illegitimate” product as it pertains to verification requirements. With suspect product, there is reason to believe that the product is possibly counterfeit, diverted, or stolen, while an illegitimate one should contain credible evidence. If this is the case, companies are to notify their respective trading partners—along with FDA—of illegitimate product within 24 hours, and will need to fill out Form 3911.

Reference: Implementing DSCSA and Expectations for 2023 and Beyond, HDA 2023 Traceability Seminar, August 30, 2023.