Drug Supply Chain Security Act news and more

Stay informed on the Drug Supply Chain Security Act with Ten Count Consulting—an industry-trusted source for DSCSA deadline and compliance updates.

Why DSCSA Training Matters Now More Than Ever April 1, 2026 Discover why DSCSA training is essential for compliance and patient safety. Learn challenges, strategies, and how Ten Count Consulting can help. Read it now

DSCSA 2025 Ten Count: Number 2 - Value Beyond Compliance Begins to Take Center Stage February 10, 2026 The value beyond compliance potential of DSCSA took a significant step forward in 2025 through the advancement of collaboration and technology. In the early years of DSCSA development, it was unclear if the supply chain could fully embrace moving away from dependency on the linear UPC barcode. 2025 showed that adoption of the 2D datamatrix had advanced for some beyond adoption and into innovation. Read it now

DSCSA 2025 Ten Count: Number 3 - Importance of a Training Strategy February 3, 2026 An often overlooked need related to making DSCSA compliance long-term sustainable is for a well-defined and managed training program. In many of the recent FDA 483 & Warning Letters, it is clear that regulators want to see well documented evidence that all associates who have roles in DSCSA are fully trained. Central to ensuring compliance is evident is the need for well managed training courses and training completion records. Read it now

DSCSA 2025 Ten Count: Number 4 - Governance and Effectiveness Check January 29, 2026 Read it now

DSCSA 2025 Ten Count: Number 5 - FDA Begins Virtual Inspections, Highlights the Importance of Inspection Readiness January 26, 2026 FDA Begins Virtual Inspections, Highlights the Importance of Inspection Readiness. As the exemptions of 2025 expired, the importance of inspection readiness moved to center stage as 2025 unfolded. Adding to the challenges was the confirmation from manufacturers that the FDA has started utilizing virtual inspections to check DSCSA readiness. Read it now

DSCSA 2025 Ten Count: Number 6 - Rise of Counterfeit and Diverted GLP 1 Medications January 19, 2026 The Importance of DSCSA Becomes Apparent As Bad Actors Move Into The High Demand GLP1 Area. 2025 started off with a letter from 38 State Attorney Generals warning of the increase instances of counterfeits and asking the FDA to take steps to help address the problem. In June, members of congress echoed the concerns and additionally asked for steps to be taken. Read it now

DSCSA 2025 Ten Count: Number 7 - The Approaching Urgency of Moving from NDC-10 to NDC-12 January 12, 2026 The next item that was hard to miss last year in the DSCSA 2024 Ten Count, list of top DSCSA moments and stories from 2025. Number 7 is the approaching NDC-12 rule finalization. On July 22, 2022 the FDA released a proposed rule to adopt a 12-digit format for National Drug Codes. This proposal came after a series of public FDA and industry meetings prior as well as a previous drafted proposal. Read it now

DSCSA 2025 Ten Count: Number 8 - FDA and State Inspection Audits, 483, and Warning Letters Increasing January 6, 2026 Number 8 on our Ten Count DSCSA 2025 countdown is FDA and State Regulatory Agencies Increase DSCSA Specific Inspections, 483s, and Warning Letters Prompting trading partners to ask if their processes, people, and systems are audit ready. Read it now

DSCSA 2025 Ten Count: Number 9- Product Verification Shows Immediate Value January 4, 2026 We continue to look back at the previous year, Ten Count Consulting rewinds to highlight what you may have missed with our DSCSA 2025 Ten Count. Ten Count Consulting's list of top DSCSA moments and stories from the year. Number 9 is the expanding adoption of product verification. Read it now

DSCSA 2025 Ten Count: Number 10- The End of Key DSCSA Exemptions December 30, 2025 As we turn the calendar to 2026 and see DSCSA becoming fully operational across the supply chain, Ten Count Consulting rewinds for the topics you may have missed with our DSCSA 2025 Ten Count. Ten Count Consulting's list of top DSCSA moments and stories from the year. The End of DSCSA Connected Trading Partner Exemptions. All but "small dispensers" must be fully compliant! Read it now

Is My Large Pharmacy Ready for the End of the Last DSCSA Exemption Period? September 9, 2025 As we fast approach the upcoming November 27th, 2025 end of the "Connected Trading Partner" exemption period for DSCSA, large pharmacies (greater than 25 pharmacists/pharmacy techs in 2024) should be moving through final preparations and into exception process readiness. The only wide exemption remaining after this November will be the small dispenser exemption which extends full readiness to November 27th, 2026 for pharmacies with fewer than 25 pharmacists/pharmacy techs. Read it now

Ten Count: HDA Traceability 2025 September 1, 2025 Top Ten Things We Learned from the HDA Traceability Conference. We were excited to participate in the 2025 HDA Traceability Forum at the Westin in Washington DC on August 4-6. It was a busy conference with lots of networking and note taking and it took us a few weeks to get our summary together. Read it now

Another FDA Warning Letter Regarding DSCSA July 14, 2025 In this post, we break down a recent FDA warning letter issued to a pharmaceutical distributor for failing to comply with the Drug Supply Chain Security Act (DSCSA). The letter highlights common gaps we continue to see in the industry, including mishandling notifications, weak suspect product procedures, and transaction data issues. Ten Count Consulting shares how we help companies identify these risks through DSCSA assessments, strengthen their compliance programs, and prepare confidently for FDA inspections. Read it now

Happy DSCSA Day Manufacturers & Repackagers! May 27, 2025 The Interoperable Requirements of DSCSA Have Arrived! A big step forward and important day for patient safety is upon us as the final broad exemption/extension for DSCSA requirements has expired for all manufacturers and repackagers of US prescription drug products that apply. All product being packaged or shipped from either manufacturers or repackagers must now include serialized product identifiers on packaging and accompanied with Transaction Statements and full saleable unit level Transaction Information. Read it now