The Pulse online service will provide free resources to enable pharmacy to meet drug traceability rules.
By Nov. 27, all participants in the US pharmaceutical supply chain—manufacturers, wholesaler/distributors and dispensers, among others—are obliged to comply with the 2013 Drug Supply Chain Security Act (DSCSA). DSCSA, enforced by FDA, creates an interoperable electronic system for tracking pharmaceutical packages at the unit level, from point of manufacture to point of dispensing. Most major pharma companies and distributors have been working steadily toward this goal, but many observers have noted that the ability of small pharmacies, which might lack an internal IT resource, are far behind meeting the looming deadline. In December 2022, for example, the American Pharmacists Association wrote FDA requesting “enforcement discretion” (i.e., a delay) in DSCSA compliance for pharmacies with staffs of 25 or less.
Now, the National Association of Boards of Pharmacy (NABP) is stepping in with an online resource, branded as Punilse, to help these pharmacies. Pulse “will provide access to user-friendly tools and a comprehensive network of verified relationships, enabling consistent communication with trusted trading partners of all sizes across the supply chain,” says NABP. It will also include educational programs and tools to help those who utilize the platform prepare for DSCSA compliance, further enabling supply chain success. The project is expected to go live this summer, and NABP has started up a pilot to test its performance.
Al Carter, NABP’s executive director, tells Pharmaceutical Commerce that Pulse participation will be free to any state-registered pharmacy (NABP membership is not required). A valuable part of the service is access to a list of authorized trading partners (i.e., distributors)—for which a fee will be required—but verifying product and supporting tracing requests will be cost-free. State regulators will be able to initiate tracing requests, but Carter says that data access will be limited only to those specific requests. (Opening up a significant fraction of pharmaceutical trade to government oversight has been a constant worry of the pharma industry throughout the evolution of DSCSA.)
Although the program will start with a focus on pharmacies only, Carter says that eventually clinics, doctors’ offices, and other points of drug dispensing will eventually be able to participate as well.