RESOLUTION NO: 119-2-23
TITLE: Drug Supply Chain Security Act Education and Compliance Assessment
ACTION: PASS
WHEREAS, suspect products, as defined by Title II Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA), pose a significant risk to patient safety; andWHEREAS, suspect products, as defined by Title II Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA), pose a significant risk to patient safety; and
WHEREAS, since 2013, DSCSA has been implemented by United States Food and Drug Administration in several stages, and the final stage, which includes additional traceability requirements, must be implemented by November 2023; and
WHEREAS, currently, several NABP programs assess compliance with both Title I and Title II of DQSA; and
WHEREAS, NABP is developing an interoperability network (Pulse by NABP™) to assist supply chain partners with the additional traceability requirements and ensure that boards of pharmacy and other regulators have access to necessary information to investigate suspect products;
THEREFORE BE IT RESOLVED that NABP continue educating its member boards of pharmacy about upcoming DSCSA requirements and develop tools to assist its member boards of pharmacy to further educate licensees and patients about these requirements; and
BE IT FURTHER RESOLVED that NABP continue assessing pharmacy compliance with DSCSA requirements, including modifying the Multistate Pharmacy Inspection Blueprint Program’s Inspection Blueprint to assess compliance with the traceability requirements; and
BE IT FURTHER RESOLVED that NABP also develop an Inspection Blueprint for Wholesale Distributors and Third-Party Logistics Providers; and
BE IT FURTHER RESOLVED that NABP collaborate with the boards of pharmacy to increase utilization of Pulse by NABP, by state regulators and prescription drug supply chain stakeholders.
(Resolution passed at the 119th Annual Meeting in Nashville, TN.)
1“Suspect product. –The term ‘suspect product’ means a product for which there is reason to believe that such product – (A) is potentially counterfeit, diverted, or stolen; (B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is potentially the subject of a fraudulent transaction; or (D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.” Available from https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act. Accessed September 29, 2022.