Blogs
November 5, 2025 / November 6, 2025 by Gina Breckenridge
The Drug Supply Chain Security Act (DSCSA) protects patients by ensuring a traceable, interoperable drug supply chain. By November 27, 2025, every trading partner—manufacturers, repackagers, wholesalers, and dispensers—must be able to electronically trace and verify medications at the package level.
This final milestone marks the end of the Food and Drug Administration’s (FDA) stabilization period and the beginning of full traceability and interoperability. To understand how these changes impact stakeholders, especially hospital pharmacies, it’s essential to examine the systems and processes required for secure product data exchange, timely FDA response, and ensuring only legitimate, safe products reach patients.
These deadlines reflect the FDA’s extended stabilization period, which provided supply chain partners time to refine systems for accurate tracking, tracing, and verification. Next, let’s break down the specific requirements dispensers must address by their compliance date.
The DSCSA defines a dispenser as retail and hospital pharmacies, chain pharmacies under common ownership, and affiliated warehouses that do not act as wholesalers.
To comply, dispensers must:
Small dispensers—meaning pharmacies that employ 25 or fewer full-time pharmacists or technicians—were granted an FDA exemption through November 27, 2026. Additional information can be found here: FDA Exemption for Small Business Dispensers.
If your organization qualifies for a waiver or exemption, you may submit requests electronically to the FDA. This is the preferred method to submit requests. Details and submission instructions are available via VCU Regulatory Affairs Guidance.Alternatively, send paper requests by mail. Address them to: Food and Drug AdministrationCenter for Biologics Evaluation and ResearchDocument Control Center10903 New Hampshire Ave., Building 71, Room G11Silver Spring, MD 20993-0002For biologics-related requests, submissions may be made in eCTD format via the Electronic Submissions Gateway.
Replacing manual processes with RFID automation can streamline operations and save time, especially during audits, by expediting drug diversion investigations and recalls.
GS1 is the global standard for pharmaceutical products used worldwide to comply with drug supply chain security guidelines. “Verified by GS1” is the global standard for validating identifiers such as GLNs (locations) and GTINs (products). GLN stands for Global Location Number; it is a 13-digit number used to identify an item’s location within the supply chain. GTIN stands for Global Trade Item Number, which is a 12-digit product identifier.Accurate identifiers improve product tracing, recall efficiency, and safety verification. Pharmacies and other drug dispensers can utilize these tools as a cross-check for DSCSA compliance:
Pre-tagged medications support serialization and electronic recordkeeping as required by DSCSA. Additionally, RFID-tagged medications comply with GS1 global standards, which are critical to ensuring patient safety and supply chain efficiency. GS1 standards create a digital thread through their globalized standards that can trace products, proactively identify counterfeit or unsafe products, and facilitate effective recall management in the event of a national drug recall.
Pharmacists must have procedures in place to quarantine and investigate any drug that appears counterfeit, diverted, stolen, adulterated, or otherwise unfit for distribution. If suspicion is confirmed, the following steps are required within 24 hours:
Full FDA guidance on how to report suspected illegitimate drugs can be found here: Identifying and Reporting Illegitimate Products.
How Pharmacies Can Prepare for DSCSA Regulations As the final November 2025 deadline approaches, pharmacies should: Test serialization and interoperability systems Proactively train staff on product verification and required reporting procedures Confirm all trading partners are DSCSA-compliant Pay special attention to 340B organizations, which may have unique tracing workflows Industry expert Justin Macy, Director of Implementation at the National Association of Boards of Pharmacy, emphasized on DSCSA Town Hall webinar that “dispensers are one of the most fragmented parts of our drug supply chain. This next phase of DSCSA implementation will be unlike any before.” Full DSCSA implementation strengthens the U.S. drug supply chain and enhances patient safety by ensuring that every medication can be verified and traced at every point along its journey. Hospital pharmacies should also look at their “internal supply chain,” extending their inventory visibility and DSCSA implementation to patient medication administration. Mature technologies, such as RFID, are used to ensure accurate, end-to-end tracking and tracing from manufacturer to patient.Developing and testing early compliance processes enables uninterrupted operations and can further protect patients from harmful or unsafe medications.
As the final November 2025 deadline approaches, pharmacies should:
Industry expert Justin Macy, Director of Implementation at the National Association of Boards of Pharmacy, emphasized on DSCSA Town Hall webinar that “dispensers are one of the most fragmented parts of our drug supply chain. This next phase of DSCSA implementation will be unlike any before.”
Full DSCSA implementation strengthens the U.S. drug supply chain and enhances patient safety by ensuring that every medication can be verified and traced at every point along its journey. Hospital pharmacies should also look at their “internal supply chain,” extending their inventory visibility and DSCSA implementation to patient medication administration. Mature technologies, such as RFID, are used to ensure accurate, end-to-end tracking and tracing from manufacturer to patient.Developing and testing early compliance processes enables uninterrupted operations and can further protect patients from harmful or unsafe medications.