Systech announced recently that it joined the National Association of Boards of Pharmacy (NABP) Interoperable Partner Program, Pulse by NABP. This is important news as both Systech and NABP want to ensure that pharmacies and dispensers are ready for DSCSA (Drug Supply Chain Security Act) compliance this November. Though a stabilization period has been granted by the FDA, the November 27, 2023 date is still the legal target for the industry. 

How will DSCSA Work in practice? 

DSCSA is ultimately a system of systems, with each major stakeholder needing slightly different capabilities to address their requirements for compliance. Manufacturers serialize individual products, aggregate them into cases and pallets, and ship physically and send serialized transaction information (TI) and transaction statements (TS) data to wholesalers. Wholesalers must receive the shipping information (TI/TS) and create TI/TS data for order shipment onto dispensers. Finally, dispensers must be able to receive the TI/TS information and verify the serialized products received match the digital record that was sent. This data exchange is the foundational backbone of the DSCSA regulation. Without proper data exchange and storage of the TI/TS information, the rest of the requirements will be almost impossible to achieve. 

While this is a simplified explanation, it sheds light on the tasks that major players must undertake. Pharmacies face new challenges due to data connections and on-site verification best practices. Although the regulations do not mandate pharmacies to verify every incoming product, neglecting to do so might lead to problems later.    

The Pulse Interoperable Partner Program provides a way for the industry to interact and collaborate with regulators and other trading partners through a set of tools that complement proven traceability systems like Systech’s UniTrace. This collaboration empowers Dispensers and other supply chain trading partners to streamline their operations and processes that otherwise would become cumbersome and time-consuming. The program covers some of the less mature requirements of the DSCSA regulation and expands and streamlines processes like ATP (Authorized Trading Partners) and master location data. 

A platform for Dispensers, Pulse by NABP is already integrated with Systech’s UniTrace platform for Verification Router Service (VRS) and is currently used by Systech’s manufacturer customers. This integration will simplify the product verification process for the dispenser community and allow for electronic documentation of their product investigations through the UniTrace platform. While there are other vendors in production within the NABP VRS network (previously Mediledger), Systech is the only one in production and participating in the PIPP program from NABP. This partnership will enable Systech to expand its product offerings. 

Some of the most significant benefits pharmacies will see are the simplification of operations, automation and electronic record keeping of product investigations, tracing requests and verification of ATP status and reducing the amount of work and paperwork needed to complete such tasks. Pharmacy operations are already impacted by the need to verify and reconcile product serial numbers when medicines are received without using a holistic system like Systech UniTrace. They do not need another major commitment of time and effort just for compliance. 

As the dispenser community leverages the DSCSA stabilization window granted by the FDA, working with Pulse and Systech will enable all the connections to be made and testing to be completed in time for enforcement in 2024.