DSCSA 2024 Ten-Count Number 2: State Regulators Are Engaging
Ten Count Consulting reflects on 2024 with our list of top DSCSA moments and stories from 2024.
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State Regulators Engaging in DSCSA
As we move closer to the full operational implementation of the Drug Supply Chain Security Act (DSCSA), one thing is clear: achieving the law's ambitious goals will not be possible without the active participation of state regulators. While the federal government and industry stakeholders have laid the foundation, state regulators are a linchpin in ensuring that DSCSA’s requirements are enforced and upheld across the entire supply chain. Their involvement is crucial for safeguarding the safety, security, and transparency of the drug supply chain.
From verifying product authenticity to ensuring compliance with traceability and all other DSCSA requirements, state regulators are vital in translating federal or state laws into actionable practices on the ground. Their growing role in education, enforcement, and coordination will be pivotal in preventing harmful or counterfeit drugs from reaching patients and ensuring the DSCSA’s objectives are met.
State Regulators: Expanding into Enforcement
State regulators have long been integral to maintaining public health and safety. However, their role is now expanding to include the enforcement of DSCSA provisions. States are taking proactive steps to ensure the law is fully implemented at the local level. For example, in 2024, the National Association of Boards of Pharmacy (NABP) is leading the way in fostering collaboration between state regulators. Through pilots, explorations of tracing, initiating verification tools, and monthly calls, NABP helps ensure all states are on the same page as we approach full DSCSA implementation. Pulse by NABP Regulator Site
Additionally, states are begining to implement polcies and inspection practices that include DSCSA requirements. One example was the Louisiana Board of Drug and Device Distributors conducting a survey to assess DSCSA readiness along with a coordinated effort to check the readiness of product verification. RAPS Article
NABP State Regulator Pilots: Shaping the Future of DSCSA
Over the past few years, NABP has played a key role in shaping how state regulators approach drug traceability. Through its State Regulator Tracing Pilots, NABP provided valuable insights that have helped develop draft product tracing messaging and encourage industry efforts to ensure ability to support state regulators. These pilots, including the 2024 and 2022 reports, were instrumental in ensuring that regulations evolve alongside industry practices.
The collaboration between NABP, trade groups, GS1, and industry has been crucial in drafting important DSCSA frameworks. As we move forward, the lessons learned from these pilots will serve as an important foundation for widespread DSCSA compliance.
Verification: A Powerful DSCSA Tool
Verification is one of the most critical tools in DSCSA, and in 2024, we saw the first instances of state regulators utilizing connections to the industry-built and HDA-supported Verification Router Service (VRS) to initiate product verification requests. At the American Society of Pharmacy Law’s Annual Conference, the State of Ohio Board of Pharmacy, conducted the first-ever regulator product verification request through Pulse by NABP, part of the VRS system. Other states, such as Louisiana, have also initiated verification requests that utilized the VRS.
Currently, a pilot is underway to bring further state regulators into the verification systems, with plans for broader adoption in the near future. NABP remains a key player in this effort, hosting monthly calls for regulators to align their verification efforts with the Pulse by NABP system.
A Growing Collaboration: State Regulator and Industry Panels
Collaboration between state regulators and industry players is essential to the success of DSCSA. Events like the Healthcare Distribution Alliance’s (HDA) Distribution Management Conference and Traceability Seminar, as well as NABP’s Q4 Manufacturer/State Regulator Webinar, have provided valuable platforms for discussion. These forums allow state regulators to share insights, learn from industry leaders, and get real-time feedback on how the law is being implemented in the field.
By discussing the latest developments, challenges, and opportunities in DSCSA enforcement, these panels are helping foster an environment of collaboration that will be critical in the coming years.
Industry Tools for State Regulators and the Dispensers They Regulate
Several industry organizations came together to initiate and managed a common page of links to relevant DSCSA laws, guidance, standards, tools, webinars and more. The site is https://dscsa.pharmacy/resources and is managed by APhA, ASHP, HDA, NABP, NCPA, PDG, and PDSA with regular updates.
NABP has released a comprehensive blog and guide. The guide has been shared by many state boards and offers a detailed overview of what dispensers must do to achieve DSCSA compliance. It also highlights how regulators can support compliance efforts, strengthening the enforcement of DSCSA provisions.
Moving Forward: Collaboration is Key
As state regulators continue to take an active role in DSCSA enforcement, it’s evident that successful implementation of the law will require strong collaboration across all levels of government and industry. By sharing insights, participating in pilot programs, and aligning their efforts with industry standards, state regulators are playing a vital role in creating a more secure, transparent, and trustworthy drug supply chain.
The List Revealed So Far:
Number 9: FDA 483s Issued for DSCSA Requirements
Number 8: Two-Year Exemption for Small Dispensers
Number 7: DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting
Number 6: DSCSA Exception Handling: Building Resilient Processes for 2025 and Beyond
Number 5: Counterfeit Drug Threats in the US Supply Chain
Number 4: PDG-FDA-Industry Listening Sessions
Number 3: FDA Grants Exemption to Connected Trading Partners
Stay tuned to our blog as we share the remaining highlight of 2024
Number 1
