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A COMPREHENSIVE GUIDE TO THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)
What You Need to Know
A Comprehensive Guide to the Drug Supply Chain Security Act (DSCSA)
George Gketsios
Senior Manager – Solution Consulting
Introduction:
The pharmaceutical industry is a lucrative yet highly regulated field, especially concerning drug supply.
In this comprehensive guide, we delve into the Drug Supply Chain Security Act (DSCSA), a federal law signed in 2013 to bolster drug supply chain security. We cover its significance, implementation phases, the importance of 3T documentation, reasons for aggregation, and exemptions under this act.
What is the Drug Supply Chain Security Act (DSCSA)?
The DSCSA is a crucial federal law enacted in 2013, designed to enhance the security of the pharmaceutical supply chain.
By establishing a comprehensive tracking and tracing system, it enables monitoring prescription drugs from manufacturers to end-users. The collaboration of stakeholders such as manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers is essential for its success.
DSCSA's Final Implementation Phase:
Scheduled to take effect on November 27, 2023, the final implementation phase demands that all participants in the pharmaceutical supply chain have systems in place to trace prescription drugs at the package level.
This entails ensuring each package has a unique identifier, which must be updated as it progresses through the supply chain.
Understanding 3T Documentation:
Critical to DSCSA compliance, 3T documentation comprises Transaction Information, Transaction History, and Transaction Statement. These standardized pieces of information accompany every prescription drug transfer within the supply chain. Transaction Information includes product details, strength, dosage form, package size, and the National Drug Code (NDC) number.
Transaction History encompasses all product transactions, while the Transaction Statement confirms the product’s legitimacy and non-counterfeit status.
The Importance of Aggregation:
Aggregation, the process of combining identical products into larger units, plays a vital role in DSCSA adherence. For packaged products or multi-product kits, aggregation facilitates the tracking and tracing of each unit with unique identification numbers. This process streamlines tracking and updating identifiers, making the monitoring of prescription drugs more efficient.
Exemptions Under DSCSA Requirements:
While the DSCSA encompasses most prescription drugs, some exemptions apply. Compounding pharmacies preparing drugs for individual patients based on prescriptions and over-the-counter drugs not in prescription form are exempt from the Act’s provisions.
Conclusion:
The Drug Supply Chain Security Act (DSCSA) is a pivotal piece of legislation aimed at enhancing the pharmaceutical supply chain’s security. As a production manager in the pharmaceutical industry, understanding the DSCSA is essential to ensure compliance with the law. This guide equips you with the necessary knowledge to take the right steps and ensure your organization’s full compliance with the Act.
Stay informed, be prepared, and uphold the integrity of the drug supply chain.
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