This November 2023, the entire pharmaceutical supply chain—including pharmacies—will need to comply with key provisions of the United States Drug Supply Chain and Security Act (DSCSA).
With this deadline rapidly approaching, the National Association of Boards of Pharmacy’s (NABP) goal is to simplify the process of achieving DSCSA compliance for pharmacies across the US through its brand-new digital platform: Pulse by NABP™.
Understanding DSCSA
Passed by Congress in 2013, DSCSA requirements are intended to further protect the US prescription drug supply chain, ensuring patients receive safe medication.
Several key DSCSA provisions have already been enacted since being passed in 2013. In November 2023, final requirements will go into effect. While these requirements affect the entire supply chain, pharmacies will play a significant role. As the final step in the supply chain, they help ensure the ecosystem remains secure through compliance with DSCSA.
Pharmacies’ DSCSA Responsibilities Today
Pharmacies’ existing DSCSA responsibilities are to:
Conduct business only with authorized trading partners such as properly licensed and registered wholesalers permitted to ship in your state.
Receive, store, and share product tracing information at the lot level and only accept prescription drugs that have the transaction information, history, and statement.
Establish procedures to investigate and properly handle suspect or illegitimate drugs.
Key Roles and Responsibilities Expand in November
An important element of the final November 2023 milestone requires the entire supply chain to become securely and electronically interoperable. This includes the ability to enable product tracing at the saleable package or homogenous (single lot number) case level.
Some additional essential considerations for pharmacies to meet DSCSA compliance requirements in November 2023 include:
Pharmacies are the last step in the drug supply chain. As the patient-facing final defense against drug fraud, pharmacists protect consumers from bad actors. By following the DSCSA act and related FDA guidance documents, pharmacies will have done their part in keeping the supply chain ecosystem safe and compliant.
Pulse Offers Connectivity, Tools for DSCSA Compliance
NABP has developed the digital Pulse platform as a resource for pharmacies to enable continued compliance. Pulse is a digital network developed by NABP that connects organizations across the supply chain. It allows trading partners and regulators to fulfill the core mission of DSCSA by working together to identify and remove fraudulent medications from the supply chain.
Pulse’s efficient, digital platform is designed for pharmacies of all sizes. Acting as a directory for the supply chain, Pulse enables pharmacists to respond to regulator trace requests, initiate verification requests to manufacturers, and initiate and respond to trading partner trace requests. These capabilities allow Pulse to operate in the background, leaving pharmacists’ day-to-day work unchanged.
With Pulse’s intuitive adoption process, pharmacists can focus on dispensing safe medication to patients with peace of mind.
Staying Ahead of the Curve with Pulse
Pulse is launching in late summer and will give DSCSA representatives from every US pharmaceutical trading partner the ability to create a user account, setup their company profile and ensure they are accessible to state regulators and trading partners for any DSCSA related interactions.This includes the future enhancements that will provide the ability to respond to state regulator tracing requests or initiate or respond to dispenser tracing requests following business confidentiality requirements of DSCSA.
NABP is also providing educational materials on DSCSA and Pulse to ensure resources are at users’ fingertips. Pharmacies can use these to train staff on becoming and remaining DSCSA-compliant.
Visit our website to begin your DSCSA compliance journey with and learn how Pulse can save you headaches later: www.pulse.pharmacy
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.