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In November 2013, a landmark decision was taken by Congress to strengthen the U.S. pharmaceutical supply chain. The Drug Supply Chain Security Act (DSCSA) became law, establishing regulations designed to address the issues of counterfeit, contaminated, stolen, or otherwise harmful drugs endangering public health. It was created to keep these illicit and counterfeit drugs out of the U.S. drug supply chain, protecting end users. The act outlines steps for electronically tracking and tracing prescription drugs at the packaging level.
DSCSA requirements mandate manufacturers, wholesalers, healthcare providers and pharmacies to maintain and securely share certain prescription drug data. It aims to maximize patient and public safety by preventing the distribution of incorrect or harmful drugs and to enhance the security of our country’s drug supply with a more seamless flow of data between supply chain partners. This is achieved by marrying the physical with its digital counterpart. This dual representation includes a digital version manifested though barcodes and transaction event data, coupled with the physical version bearing product identifier data in a human-readable format on the label. The primary goal of these DSCSA requirements is to support the pharmaceutical industry with inventory accuracy and establish other operational proficiencies.
In the dynamic healthcare supply chain management landscape, understanding the DSCSA requirements and developing a solid implementation plan is crucial for both trading partners and healthcare systems, whether in a consolidated pharmacy service center, warehouse or a hospital. With the November 2023 DSCSA compliance requirements now in effect and a one-year stabilization period extending to November 2024, there is a real urgency to ensure traceability and transparency in the pharmaceutical supply chain. The need for efficient and streamlined pharmacy operations and an exhaustive understanding of requirements for trading partners and health systems has never been more critical given shifting regulations and compliance requirements. Although there are some basic similarities in expectations for both, specific requirements exist separately for each distinct group and sub-groups.
Both trading partners and health systems must become familiar with the law working with their respective teams to ensure understanding occurs and communications take place both ways to confirm knowledge to build confidence in their partnership and plans. Manufacturers, repackagers, wholesale distributors and dispensers (which could include a health system) must provide product tracing information and must know how to handle suspect and illegitimate products. As authorized trading partners, health systems should confirm their counterparts’ authorization by checking the state licensure website; third-party logistics providers and wholesale distributors must report licensure annually.
Manufacturers, repackagers, wholesale distributors and dispensers must also adhere to these DSCSA requirements:
DSCSA compliance and a solid plan for all involved will soon be non-negotiable and there are numerous reasons why health systems will want to ensure every partner along the pharmaceutical supply chain is fully DSCSA ready, such as:
These interdependent expectations and requirements for DSCSA trading partners and health systems alike highlight the significant imperative for alignment in this supply chain industry evolution. It is crucial to recognize that DSCSA readiness is not just a regulatory obligation, but an essential responsibility to patient safety, the integrity of the pharmacy supply chain and the advancement of healthcare.