News
Article
Author(s):
As of today, Aug. 27, wholesale distributors must fully comply with the Drug Supply Chain Security Act’s enhanced drug distribution requirements, closing the FDA’s exemption period and advancing efforts to strengthen patient safety and supply chain integrity.
Today, Aug. 27, marks an important milestone for Drug Supply Chain Security Act (DSCSA) implementation: the close of the exemption period for pharmaceutical distributors.
The DSCSA is enforced by the FDA. It was originally signed into law as part of the Drug Quality and Security Act (DQSA) in November of 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain.1
It was designed as a unified federal standard for pharmaceutical drug tracing, giving manufacturers, distributors, and dispensers steps to establish an interoperable electronic system to identify and trace prescription drugs at the package level to prevent harmful drugs from entering the US drug supply and protect healthcare providers and patients from counterfeit, unapproved, or potentially dangerous products.
Enforcement of this legislation has been delayed by the FDA several times before, with the most recent delay being Oct. 9, 2024, 49 days before the end of the one-year stabilization period. The FDA issued an exemption for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements.
Aside from the wholesale distributor exemption, the exemption for manufacturers and repackagers has also previously passed on May 27 of this year, while dispensers with 26 or more full-time employees have until Nov. 27, 2025. This excludes small dispensers, which are exempt until Nov. 27, 2026.
Chester Chip” Davis, Jr., president and CEO of the Healthcare Distribution Alliance (HDA), the national organization representing healthcare distributors, issued a statement2 this morning, noting that, “With today’s DSCSA distributor deadline, we have reached a milestone that goes beyond just compliance—it is about strengthening the safety and security of the entire healthcare supply chain for patients. HDA is pleased that, at the conclusion of the FDA’s exemption period, the distribution sector has been successful in meeting its implementation responsibilities. According to the most recent survey of HDA members, as of early June, the median level of accurate data exchange between trading partners at the pieces level was 98.5%. This high completion rate was only made possible through FDA’s willingness to extend the implementation period, and we thank the agency for their leadership.”
The rest of the industry also expressed joy from the latest milestone, including Matthew Sample, SVP of manufacturer, quality, and replenishment operations with Cencora, one of the industry’s Big Three wholesalers.
“After 12 long years, DSCSA hits it biggest (yet not last) milestone. It's when the pharmaceutical supply chain requires that every unit of Rx product sold to have an accompanying piece of data before subsequent purchasers can take ownership of the product (the wholesalers) ,i.e., the data quality is just as important as the drug quality,” he wrote in a LinkedIn post.3 “ … We can have lifesaving drugs on our receiving dock—no DSCSA data? No bueno. It doesn't move, we'll turn trucks away too if they don't have data. By law, we can't take ownership, no exceptions (well other than the legal exceptions).
“We, along with many of our manufacturer partners, and wholesale peers, and large customers, have invested in making sure we keep the supply chain moving, keeping lifesaving drugs getting to those in need. We have tried to help the industry for the last 12 years learn what good barcodes are, what good data looks like, and talk through what-ifs. We, the industry leaders, have done all we can to prepare as many companies as possible.Aug. 27 is when we find out what companies actually took this seriously. … That said, I want to pause and thank our manufacturer partners that did invest, pilot, partnered and worked on this together. Thanks to our peers for the very weird frenemy relationship we formed because well. we're in this together. … Aug. 27 is the new norm., and it's here.”
References
1. Saraceno N. Top Questions Regarding the DSCSA. Pharmaceutical Commerce. August 25, 2025. Accessed August 27, 2025. https://www.pharmaceuticalcommerce.com/view/top-questions-regarding-dscsa
2. HDA Statement on DSCSA Implementation Milestone For Distributors. HDA. August 27, 2025. Accessed August 27, 2025. https://www.hda.org/newsroom/2025/august/hda-statement-on-dscsa-implementation-milestone-for-distributors/
3. Matt Sample LinkedIn post. LinkedIn. August 27, 2025. Accessed August 27, 2025. https://www.linkedin.com/feed/update/urn:li:activity:7366306790440955906/
Stay ahead in the life sciences industry with Pharmaceutical Commerce, the latest news, trends, and strategies in drug distribution, commercialization, and market access.
