The Drug Supply Chain Security Act: A Case for Better Implementation and Awareness

Armond Marcarian

The Drug Supply Chain Security Act (DSCSA) serves as a critical safeguard for the pharmaceutical supply chain, aiming to ensure that all prescription drugs can be traced from their origin to the consumer. Enacted in 2013, the DSCSA is a federal law that requires the pharmaceutical industry to implement systems to trace the distribution of prescription drugs.

Central to this Act are the Pedigree Requirements outlined in Section 503(e)(1)(A). These requirements mandate that each prescription drug be accompanied by a detailed pedigree, which documents every prior sale, purchase, or trade, including transaction dates and the names and addresses of all parties involved in the chain of distribution. This meticulous documentation is essential for preventing counterfeit medications from entering the supply chain and protecting public health.

However, several Medi-Cal administrative appeals currently being defended by Marcarian Law Firm shed light on significant shortcomings in the dissemination of information regarding the DSCSA to pharmacy professionals. The cases involve retail pharmacies and their pharmacists who are facing legal actions stemming from audits conducted by the California Department of Healthcare Services related to alleged noncompliance with the DSCSA.

As the legal landscape surrounding the DSCSA continues to evolve, Marcarian Law Firm remains at the forefront, actively monitoring these developments and engaging in discussions about effective regulatory compliance. Our mission is to bridge the gap between legal requirements and practical implementation, ensuring that dedicated healthcare professionals have the support they need to adhere to laws designed to protect public health.

The integrity of our healthcare system hinges on clear communication and equitable treatment for those who tirelessly serve their communities, and we are proud to play a pivotal role in shaping the future of healthcare regulation.

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