(Feb. 2, 2024) – The U.S. Drug Supply Chain Security Act requirements went into effect Nov. 27, 2023, for "authorized trading partners," including dispensing pharmacies. While the original act was enacted in 2013, final guidance was issued late in 2023. For detailed information and background, the Food and Drug Administation maintains a list of Drug Supply Chain Security Act Law and Policies. There are many vendors out there selling "solutions" for the DSCSA, which may improve pharmacy operations and tracking; however, most Kansas pharmacies should already comply with the DSCSA without these supplemental programs. For information about requirements for pharmacies, including hospital pharmacies, the following resources provide helpful guidance:
Requirements include:
- Engage in business only with licensed, registered trading partners. This can be done by checking the registration of manufacturers and repackagers; checking the licensing of wholesale distributors and third-party logistics providers; and checking the licensing of pharmacies through their respective state regulatory entity (e.g., Kansas Board of Pharmacy for Kansas pharmacies).
- Manage product tracing documentation to verify pharmaceuticals have a documented, traceable chain of custody at the package level, and to keep that documentation for six years.
- Implement a process to respond to, and manage, suspected or verified illegitimate pharmaceuticals (e.g., counterfeit) to ensure patients do not receive illegitimate products.
The Kansas Hospital Association's service organization partner, APS, is an excellent resource for members reviewing their options to ensure DSCSA compliance. For more information from APS, contact Dennis George at (913) 327-8730.
--Karen Braman