Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain.
The Significance of DSCSA and Serialization in the Pharmaceutical Supply Chain
The Drug Supply Chain Security Act (DSCSA) is a federal law enacted in 2013 to enhance the security and traceability of pharmaceutical products within the United States supply chain. Its primary objective is to safeguard patients from exposure to counterfeit, stolen, or otherwise harmful drugs.
Why Is DSCSA Compliance and Serialization Important?
Serialization represents a crucial component of DSCSA compliance, encompassing the unique identification of individual drug packages or units through assigned serial numbers. Each serialized unit is linked with vital information, including the product's National Drug Code (NDC), lot number, expiration date, and other pertinent particulars. The utilization of unique serial numbers enables efficient tracking and tracing of each drug package's progress across various supply chain entities. Transaction data, history, and statements are exchanged, enabling the establishment of drug origins and facilitating prompt tracking in the event of recalls or safety concerns.
Who is Responsible for Compliance with DSCSA?
Pharmaceutical distributors and dispensers bear the responsibility of authenticating received drug products by confirming the validity of serialized identifiers and scrutinizing the product's transaction history. This critical step ensures that the drugs being distributed are safer from counterfeiting or compromised in some way. In instances where suspected counterfeit or compromised drugs are identified, investigators can trace the drug's movement and identify potential points of supply chain integrity breaches.
Is Compliance with DSCSA Required?
The U.S. Food and Drug Administration (FDA) has provided manufacturers, distributors, and dispensers with a 10-year implementation period to fully comply with the federal regulations governing serialized unit traceability. The final deadline for complete compliance across the entire supply chain is November 27, 2023.
The FDA recently announced a 1-year reprieve, to November 27, 2024, on enforcement activities for system-wide electronic interoperable systems for tracking products through the supply chain.
The European Union's Falsified Medicines Directive (FMD), introduced in 2011 and finalized in 2019, serves as a regulatory framework sharing similar goals with the DSCSA. Its primary objective is to enhance the security of the pharmaceutical supply chain and prevent the introduction of falsified medicines. The FMD mandates the use of a unique identifier, akin to the serialization requirement in the DSCSA. Additionally, it requires distributors and dispensers to authenticate medicines by scanning the unique identifier in the European Medicines Verification System (EMVS).
What is the Purpose of DSCSA?
The FDA's DSCSA and the EU's FMD share primary objectives revolving around enhancing patient safety and safeguarding the integrity of the pharmaceutical supply chain. ProPharma, an organization committed to improving patient safety, has been a critical partner to its clients in achieving FMD compliance. We are fully prepared to support our clients in meeting their DSCSA compliance requirements and actively contribute to the broader initiative aimed at protecting patient health and safety.
DSCSA compliance and serialization play a vital role in ensuring the security and traceability of pharmaceutical products within the supply chain. By implementing serialization and adhering to the associated regulations, stakeholders can effectively track and trace drugs, verify authenticity, and effectively respond to any potential safety concerns. The collaborative efforts of organizations like ProPharma are instrumental in achieving compliance and actively contributing to the overarching goal of patient safety and well-being.
What are the Consequences of DSCSA Non-Compliance?
It is a criminal act if a company sells (intentionally or unintentional) non-serialized products. Failure to comply can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.
Partner with DSCSA Compliance and Serialization Experts
Are you ready to ensure compliance with DSCSA regulations and enhance patient safety within the pharmaceutical supply chain? Partner with ProPharma today and let us support you in meeting your serialization and compliance requirements. Join us in safeguarding patient health and contributing to a secure pharmaceutical supply chain. Contact us now for expert guidance and seamless solutions!
