New Network Provides Regulators, Industry With Tool to Further Protect Drug Supply Chain
MOUNT PROSPECT, IL – The National Association of Boards of Pharmacy® (NABP®) announced today that it is entering the final phase of development for its new network to facilitate supply chain interoperability. The network will provide a means for state regulators and trading partners to investigate and remove suspect or illegitimate medications from the legitimate supply chain. NABP was exploring how to address the Drug Supply Chain Security Act’s (DSCSA’s) upcoming interoperability requirements. The Association began working on the network after stakeholders from across the industry requested assistance identifying and addressing gaps in interoperability among all sectors and state regulators.
Passed by Congress in 2013, the requirements in DSCSA are intended to further protect the United States prescription drug supply chain, and the patients who use it, from substandard or falsified medications. The law has already triggered several implementation milestones since its passage, but several important provisions will go into effect in November 2023.
As the pharmaceutical supply chain prepares to comply with the November 2023 requirements, state regulatory authorities are preparing to support implementation of the law. A key requirement that NABP’s DSCSA network addresses is the requirement to electronically track and make available prescription drugs’ ownership transaction records. While participation is voluntary, the network will serve as a critical information sharing tool to help state regulators and trading partners ensure the legitimacy of prescription medications via electronic interoperability.
“The state boards of pharmacy play a critical role in protecting our nation’s drug supply. When the requirements of DSCSA are fully implemented in November 2023, it will be necessary for regulators to have an efficient means of communicating with manufacturers, wholesale distributors, pharmacies, and other dispensers. NABP’s DSCSA network will provide the secure, efficient, and uniform means for state regulators and trading partners to efficiently investigate and remove suspect or illegitimate medications from the legitimate supply chain,” says NABP President Reginald B. “Reggie” Dilliard, DPh.
While the US prescription drug supply is among the most secure in the world, counterfeit drugs can still make their way to patients. In fact, in early 2022, more than $230 million in counterfeit/adulterated HIV medications were distributed nationwide, demonstrating the need for the implementation of DSCSA’s 2023 requirements. Just as important is the need for tools that will support industry and regulators’ ability to adhere to the requirements.
The foundational platform will be provided at no cost to states or members of the supply chain. The network has been designed with collaborative input from all sectors of the supply chain, including small dispensers and state regulators.
NABP’s research on the DSCSA network began in fall 2021 with collaboration with state regulators to develop use cases, followed by a pilot program with stakeholders from across the industry in summer 2022. Testing with key stakeholders, including large and small dispensers, wholesalers, and manufacturers, is planned for early 2023. The network is expected to fully launch in mid-2023.