Drug Supply Chain Security Act news and more

It was an eventful and informative HDA DMC (Distribution Management Conference) last week in Tampa, FL!Aside from some incredible networking and seeing old friends and new, we learned a lot on the latest things DSCSA. Here is our top 10 things we learned in 2025 HDA DMC:

We are honored to share that Mark will speak at a the March 5th ASCM-Central Jersey Forum March 5, 20256:15-715pm Eastern

2024 was a big year for DSCSA and we expect 2025 to be bigger. As the DSCSA exemption deadlines approach, Ten Count Consulting is here to guide stakeholders toward readiness and interoperability, ensuring a secure and efficient pharmaceutical supply chain.

In Ten Count Consulting's 2024 DSCSA reflection, the rise of counterfeit Ozempic emerged as the most impactful story, underscoring the urgent need for supply chain security. Katherine Eban's investigative report in Vanity Fair exposed how global demand and supply shortages allowed counterfeit versions of this critical diabetes and weight loss medication to enter markets, endangering patient safety. This crisis highlights the vital role of the Drug Supply Chain Security Act (DSCSA) in preventing counterfeit drugs through product serialization and authorized trading partner verification. At Ten Count Consulting, this story reaffirms our commitment to helping clients achieve full DSCSA compliance to protect patients and strengthen the pharmaceutical supply chain.

State regulators play a pivotal role in the successful implementation of the Drug Supply Chain Security Act (DSCSA) by ensuring compliance, enforcement, and industry collaboration to protect the drug supply chain. Their responsibilities have expanded to include verifying product authenticity, managing trading partner compliance, and engaging in education and enforcement initiatives. The National Association of Boards of Pharmacy (NABP) has facilitated this collaboration through pilots, monthly calls, and platforms like Pulse for product verification. Notable milestones include the first regulator product verification request conducted by Ohio’s Board of Pharmacy and Louisiana’s DSCSA readiness survey. Industry events and educational resources, such as NABP’s guides, have further strengthened the partnership between regulators and stakeholders. This growing collaboration is essential for achieving DSCSA’s goals of a secure, transparent, and safe pharmaceutical supply chain.

In a pivotal move to support the pharmaceutical supply chain, the FDA has granted an exemption to trading partners who are working to establish electronic data connections with their immediate partners under DSCSA. This exemption applies to manufacturers, repackagers, wholesale distributors, and dispensers, offering them more time to meet enhanced drug distribution security requirements. The DSCSA deadline varies by partner type: manufacturers and repackagers must comply by May 2025, wholesale distributors by August 2025, and larger dispensers by November 2025. Staying informed about the applicable DSCSA deadline is essential for regulatory compliance.. This decision provides trading partners with a much-needed opportunity to address data exchange challenges while ensuring continued DSCSA compliance and preventing disruptions in the supply chain.

The September 2024 FDA-industry listening sessions highlighted both significant progress and ongoing challenges in implementing the DSCSA’s enhanced drug distribution security requirements. While stakeholders had advanced in exchanging serialized transaction data, issues with data reliability and managing diverse WEEs posed risks to supply chain stability. Industry leaders urged the FDA for regulatory flexibility to focus on system improvements, exception handling, and partner engagement.

The surge in counterfeit drugs, particularly weight loss medications like Ozempic and Wegovy, highlights the urgent need for the full implementation of the Drug Supply Chain Security Act (DSCSA). Despite being enacted in 2013 to secure the pharmaceutical supply chain, the conditions that led to its creation have worsened, with bad actors exploiting online marketplaces to distribute dangerous, unregulated drugs. Recent seizures by U.S. Customs and Border Protection (CBP) underscore the growing threat to public health. Full DSCSA implementation is essential to prevent, detect, and respond to counterfeit, stolen, and contaminated medications and keep them from reaching consumers.

In 2024, Ten Count Consulting closely observed significant developments in DSCSA implementation, with a focus on exception handling as trading partners worked to align with the FDA’s stabilization period goals. Distributors advanced their processes for managing serialized products, and discrepancies between physical products and digital data became more apparent. This blog post explores effective exception-handling strategies rooted in industry guidelines, pilot studies, and collaborative discussions. Key practices include risk-based processes, thorough documentation, and strong communication with trading partners. As organizations prepare for 2025, Ten Count Consulting emphasizes the need for resilient systems and offers guidance to help clients navigate the complexities of DSCSA compliance.

As we step into 2025, Ten Count Consulting looks back on the milestones of 2024 with our DSCSA 2024 Ten Count. A highlight from the year was the PDG-FDA Joint Public Meeting in June, where over 800 stakeholders convened to evaluate the DSCSA stabilization period. Significant advancements in serialized data exchange and data quality were noted, yet challenges remain for less-engaged trading partners, particularly smaller dispensers. The meeting emphasized collaboration, continuous improvement, and the reality of managing imperfect data through robust, risk-based processes. As the DSCSA journey continues, Ten Count Consulting is here to guide stakeholders toward readiness and interoperability, ensuring a secure and efficient pharmaceutical supply chain. Stay tuned as we reveal more highlights from our 2024 Ten Count.

As part of our DSCSA 2024 Ten Count, Ten Count Consulting reflects on the top DSCSA developments of the year. At number 8, we explore the FDA’s pivotal decision to grant a two-year exemption for small dispensers. This exemption, issued in June 2024 and revised in July, offers dispensers with 25 or fewer full-time employees temporary relief from certain interoperability and electronic tracing requirements. However, it does not absolve them of their responsibilities to verify trading partners and ensure drug safety. The exemption acknowledges the unique challenges small dispensers face, including limited resources, financial pressures, and operational demands. Yet, the focus remains on achieving full compliance within two years.

The FDA’s issuance of 483 observations tied to DSCSA requirements marks a pivotal moment for the pharmaceutical supply chain as full compliance with the law becomes mandatory. These observations highlight the FDA’s focus on enforcing key DSCSA mandates, including product verification, transaction data integrity, and ensuring all trading partners are authorized. Non-compliance not only risks enforcement actions but also jeopardizes patient safety. Now more than ever, trading partners must prioritize robust systems, process optimization, and collaboration to meet regulatory expectations. Ten Count Consulting is here to help your organization navigate DSCSA requirements and ensure your operations align with the law.

As we enter 2025, Ten Count Consulting looks back at key DSCSA moments from 2024 in our DSCSA 2024 Ten Count. One standout story is the National Association of Boards of Pharmacy's (NABP) pilot exploring serial number decommissioning to combat counterfeit drugs. This pilot focused on capturing end-of-commerce events—such as dispensing, damage, or theft—to prevent counterfeiters from reusing valid serial numbers. While not currently required under DSCSA, decommissioning serial numbers could significantly enhance the detection of counterfeit drugs and safeguard patient safety. The pilot's findings show that capturing these events is feasible and could have limited past counterfeit incidents. This underscores the importance of DSCSA compliance for all stakeholders in the supply chain, with collaboration being key to protecting patients from fake medications.

Pablo Medina Joins the Ten Count Consulting Team

On October 9, 2024, the FDA announced a partial exemption from certain DSCSA requirements for trading partners who have initiated their systems and processes, including establishing electronic data connections with their immediate trading partners. The FDA’s decision was made to allow additional time for resolving issues related to data exchange, quality, and reliability, which many in the industry are still navigating.

This years HDA Traceability conference for DSCSA 2024 did not disappoint and lots of useful insights. We enjoyed a productive conference and it was great hearing from experts and catching up with peers!

Some significant confusion appears to be making landfall around contract pharmacies in the months ahead as the requirements of the DSCSA (Drug Supply Chain Security Act) come into full enforceable effect for most of the US prescription drug supply chain on November 27th, 2024. The foundation of the problems related to 340B products existed well before the passage of DSCSA in 2013 but the requirements of the law require the industry to make difficult decisions in order to understand and ensure compliance without negatively impacting drug distribution.

Be Ready for Full DSCSA November 2024 Unless You Have Partial Exemption as a Small Dispenser (Less than 25 Pharmacist/Techs)!Healthcare drug supply chain trading partners (Manufacturers, Distributors, Retail Pharmacies, and Health Systems) are being confronted with the upcoming full implementation of the Drug Supply Chain Security Act (DSCSA) and realizing that they may not be ready for full compliance by November, 27 2024 even with significant investments and best efforts. These organizations now realize that they must attempt to file for an exemption for certain components of the regulation through the FDA Waivers Exceptions and Exemptions Request (WEER) process. The application process is opaque and requires insightful DSCSA understanding with very limited resources with the technical and operational understanding to assist with drafting this submission.

Be Ready for Full DSCSA November 2024 Unless You Have Partial Exemption as a Small Dispenser (Less than 25 Pharmacist/Techs)!Healthcare drug supply chain trading partners (Manufacturers, Distributors, Retail Pharmacies, and Health Systems) are being confronted with the upcoming full implementation of the Drug Supply Chain Security Act (DSCSA) and realizing that they may not be ready for full compliance by November, 27 2024 even with significant investments and best efforts. These organizations now realize that they must attempt to file for an exemption for certain components of the regulation through the FDA Waivers Exceptions and Exemptions Request (WEER) process. The application process is opaque and requires insightful DSCSA understanding with very limited resources with the technical and operational understanding to assist with drafting this submission.

FDA recommends to submit a WEE Request where needed by August 1, 2024 for potential to receive notification prior to the approaching end of the FDA Stabalization Period.We are seeing a growing number of clients in a bit of panic this week trying to determine if they should be submitting a WEE Request for extension of readiness time for DSCSA requirements beyond the approaching November 27th, 2024 end of FDA stabalization period.The short answer is "It Depends" and here are some questions to be asking to determine if you should be filing a WEER as soon as possible.

Join a workshop with two of the preeminent DSCSA consulting firms for a 2 part FDA waiver and exemption submission (also know as WEER) development consulting workshop. -Be guided through drafting the required components of submitting an exemption request based on years of DSCSA experience.-Get your organization ready to submit an application to the FDA by the recommended August 1st submission deadline.

After an insightful PDG-FDA Public meeting on June 17th/18th in Washington DC, it is clearly time for all stakeholders to understand where they are on DSCSA and ensure they are not at risk of non-compliance for the federal law and related guidance. The updates from trading partners across the supply chain including manufacturers, repackagers, distributors, dispensers and 3PLs along with inputs from the FDA, state boards of pharmacy, as well as service and solution providers painted a challenging picture in the limited months ahead. What should your company be doing in light of all of this? We step through what we learned along with some recommended next steps.

Looking back at some of the articles and blog posts we did to help outline some steps to complete your DSCSA journey.

In 2023, NABP completed a 3 month long DSCSA product tracing pilot with leading organizations from across the supply chain.Based on feedback from the pilot, the following key findings were determined as critical to enable secure electronic interoperability for DSCSA industry wide compliance.

With just 1 month until the most challenging parts of the federal DSCSA law take effect (given a 1 year "stabilization period" announced by FDA), some stakeholders are still not fully grasping the importance or level of effort required to ensure compliance.

Finding the Right Partners is Key to Making Beneficial Short and Long Term Decisions

Finding the Right Partners is Key to Making Beneficial Short and Long Term Decisions

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With less than 240 days until the final and most challenging parts of the federal DSCSA law take effect, it is easy to see many are still not grasping the importance or level of effort required to ensure compliance. It can feel a bit like the scene in a comic when everyone is waiting for a superhero to swoop in an make things better. The reality is, a DSCSA superhero isn't coming, you need to make sure you organization has the tools and partners to save itself.

With the final months of that timeline winding down, we felt it was important to share a few updated thoughts. We realize there is a significant amount of DSCSA groups and events going and we welcome any comments or additional points that peers feel are important to highlight. We appreciate the work that the FDA and other regulatory groups do on a daily basis to help keep the supply chain and patients safe and hope help provide some insights as we work with clients across the supply chain on DSCSA implementation.

In an effort to help share insights, we are starting this DSCSA 2023 for Pharmacist blog series to help provide areas you should be working on and understand why it is important your organziation.

Don't forget the last critical stepin your journey to DSCSA compliance of ensuring that your organizationspolicies, procedures and training are updated appropriately to clearly documentyour compliance. The FDA increased mentions of DSCSA in warning letters andother activities in 2022 and we expect this to continue to increase as theimportant DSCSA requirement of November 27th, 2023 approach. State Boards ofPharmacies are now becoming more aware of the law and are expected toincorporate more aspects in their inspections and activities as well.

FDA to hold DSCSA Public Meetings Dec 7 & 8 2022

How do I know my company is "DSCSA 2023" ready?

Special Guest speaker Mark Karhoff of Ten Count Consulting will present at the LSPediA Customer Advisory Board Meeting June 28, 2022

For pharmacies (dispensers) storing and sharing your DSCSA related data as you prepare to ensure system and processes to comply with DSCSA 2023. It is important to remember that DSCSA is primarily an "ownership change" law and generally does not include the dispensing of medicine to patients. Here is an overview of considerations for storing and sharing DSCSA related transaction data.

With the interoperability requirements of DSCSA just around the corner on November 27,2023, continue to share thoughts for the diverse and dedicated pharmacists of the United States around this important federal law. A key part of DSCSA is ensuring your organization understands the Products and Barcoding is Key to Stopping Potentially Harmful Medicine

With the interoperability requirements of DSCSA just around the corner on November 27,2023, continue to share thoughts anr the diverse and dedicated pharmacists of the United States around this important federal law. A key part of DSCSA is ensuring your organization understands the term used throughout the law known as ATP (Authorized Trading Partners).

JnJ Joins Gilead in Filing Suit Against Distribution/Dispense of Counterfeit Product. These cases further highlight the importance of the ongoing industry work to define DSCSA 2023 requirements in a way that will more effectively protect patients. The US Rx Supply Chain is only as strong as it's weakest links and clearly more preventative and proactive approaches are needed.

T-minus 21 months until DSCSA Nov 27, 2023...... It's not an unreasonable reaction to feel the panic kick in as many big questions remain but there are already things that all this work is making clear, interoperability does not work without alignment and eventual adoption. This is very easily said but much work is involved in answering:‍What is the industry aligning on to enable a secure, electronic and interoperable manner?How fast minimally is "promptly" facilitating the gathering of information in the event of potentially harmful product?How does adoption happen across an incredibly diverse ecosystem of systems?‍

We appreciate advancing open dialogue on the use of unfolding technologies such as Blockchain. Here are some recent resources along with some past information we shared on the topic.

Several Industry Organizations Collaborate to Create a DSCSA Dispenser Resource Page

The Healthcare Distribution Alliance recently released their annual survey to share "the current readiness of manufacturers and distributors to meet the Drug Supply Chain Security Act (DSCSA) requirements." The survey contains useful insights on how the industry is doing in the path towards DSCSA2023 including the challenging interoperable requirements.

The FDA has announced a public meeting to allow stakeholders to provide further feedback on the Enhanced Drug Distribution Security provisions of DSCSA.

Are you ready for DSCSA Audits?5 Steps To Ensure The Answer Is "Yes"

With the overwhelming number of events and things happening in the US Rx Supply Chain, many manufacturers to Rx dispensers are asking if the time is now to rethink RFID?

Summary of FDA DSCSA 2023 Draft Guidance Comments These notes are provided for free use without copyright and meant to summarize the comments in the documents to the best of our ability but are not a complete representation of the documents and are not intended to be legal or business advice.

FDA CDER announces a planned webinar "Enhanced Drug Distribution Security in 2023 Under the DSCSA"

Ten Count Consulting announces new website to help US Rx Supply Chain clients stay informed.

With the fast-approaching wrap-up of the DSCSA stabilization period on November 27th, 2024, there remains a significant number of industry areas that need greater clarity, communication, and adoption. While participation across segments has improved in 2024, we still have a ways to go before the benefits expected from DSCSA can be more fully realized.

We help clients review and ensure coverage for all requirements for the DSCSA roles within which they are performing business activities. We also help clients ensure they are external audit ready through well established procedures, policies and training. Understanding these pillars of DSCSA is a starting point for beginning the journey of full compliance.

What Is the True Impact of the FDA Proposed NDC Format Expansion? It is critical for the industry to fully understand the impacts of this proposed change. While cost in some areas may be less, this change impact is significantly wider than those caused by DSCSA due to the areas impacted from regulatory establishment of product through distribution/dispensing and into payment impacts.

What software do you need to be DSCSA compliant? With the fast approaching DSCSA 2023 requirments now 16 months away, many pharmacuetical stakeholders from manufacturers to dispensers are asking this question. DSCSA has been especially challenging to predict what is needed for the more complex requirements related to interoperability