The Drug Supply Chain Security Act (DSCSA) represents a pivotal milestone in the pharmaceutical industry, aimed at safeguarding the integrity of the drug supply chain in the United States. As the healthcare sector evolves and the complexities of drug distribution increase, understanding the terminology associated with the DSCSA becomes crucial for stakeholders across the board. In this glossary, we will explore the key terms and concepts essential for achieving DSCSA compliance. Whether you're a healthcare professional, or a pharmaceutical distributor or retailer, this glossary will be your indispensable resource for navigating the intricacies of DSCSA compliance.
DSCSA Serialization
The DSCSA is a piece of U.S. legislation enacted to enhance the security and integrity of the pharmaceutical supply chain. One of its main goals is to protect consumers from counterfeit, stolen, contaminated or otherwise harmful prescription drugs. "Serialization" refers to the requirement under DSCSA to assign a unique identifier (usually a serial number) to individual drug packages, allowing them to be tracked and traced through the supply chain.
NDC
The National Drug Code (NDC) is a unique identifier assigned by the FDA to each medication sold in the U.S., playing a crucial role in DSCSA compliance. NDC aids in product identification, distinguishing specific drugs, strengths and package sizes. Under DSCSA, the NDC serves as a foundational element in the serialization and traceability processes, ensuring product authenticity, tracking and security throughout the pharmaceutical supply chain.
EPCIS
Electronic Product Code Information Services (EPCIS) is a GS1 standard that enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain. Within DSCSA, EPCIS facilitates the capture and communication of serialized product transaction data, ensuring traceability and verification of pharmaceutical products. It provides a standardized format for sharing information, helping stakeholders verify drug legitimacy, identify counterfeit or compromised items, and enhance the overall security and transparency of the drug supply chain. By using EPCIS, manufacturers, wholesalers and dispensers can achieve DSCSA compliance, ensuring patient safety and product integrity throughout the pharmaceutical supply lifecycle.
Product Master Data
Product Master Data refers to the foundational and consistent set of attributes, specifications and information about a pharmaceutical product. This includes details like Global Trade Item Number (GTIN), product description, strength, dosage form and packaging hierarchy. To maintain DSCSA compliance, maintaining accurate Product Master Data is crucial, as it ensures that serialized product identifiers and their associated information are standardized and consistent throughout the supply chain. This foundational data is essential for tracking, verification and authentication of pharmaceutical products as they move from manufacturers to end users. In the context of DSCSA's aim to enhance transparency, traceability and security within the pharmaceutical supply chain, Product Master Data serves as a reliable reference point, ensuring clarity and consistency in product identification and related processes.
GTIN
The Global Trade Item Number (GTIN) is a unique identifier developed by GS1 for trade items. Under DSCSA, drug manufacturers and repackagers must use identifiers like GTIN on product packages to enhance traceability within the U.S. pharmaceutical supply chain. This identifier aids in ensuring transparency, tracking products and verifying authenticity. GTINs assist in quickly identifying and removing counterfeit or compromised products, thereby safeguarding the drug supply chain and ensuring patient safety.
SGTIN
The Serialized Global Trade Item Number (SGTIN) is an extension of the standard GTIN with a unique serial number. The inclusion of this serial number allows for individual item-level identification, making it possible to track and trace each specific instance of a product. Under DSCSA, manufacturers and repackagers are required to serialize drug packages. The SGTIN provides a standardized format for this serialization, ensuring every package of medication has a distinct identifier. This enables precise tracking, verification and authentication of pharmaceutical products throughout the supply chain, from production to the end consumer. The use of SGTINs is central to DSCSA's goal of enhancing the security, transparency and safety of the U.S. pharmaceutical distribution system.
SSCC
The Serial Shipping Container Code (SSCC) is a unique 18-digit number used by GS1 to identify individual shipping containers or logistic units, such as pallets or cartons, containing pharmaceutical products. Under DSCSA, the SSCC is crucial for higher-level aggregation and offers traceability for batches or lots of serialized products as they move through the supply chain. When a case or pallet of medicines is shipped, the SSCC provides a standardized way to link the individual serialized items (often identified by SGTINs) inside the container to the container itself. This hierarchical relationship simplifies logistics, ensures consistency in tracking and aids in verifying the authenticity and origin of products, supporting DSCSA's objective of ensuring drug supply chain security and patient safety.
VRS
Verification Router Service (VRS) is a technology solution that facilitates the verification of serialized product identifiers on pharmaceutical packages. This system enables stakeholders following DSCSA compliance guidelines, such as manufacturers, wholesalers and dispensers, to quickly validate a product's unique identifier against the manufacturer's data. By routing verification requests to the appropriate data holder, VRS ensures that products are genuine, helping to prevent counterfeit or compromised drugs from entering the supply chain. This plays a pivotal role in DSCSA's overarching goal of enhancing transparency, traceability and security in the pharmaceutical distribution system.
Sellable unit
A sellable unit refers to the smallest packaged form of a pharmaceutical product that is intended for sale to end users, typically patients. This unit carries a unique serialized identifier, ensuring traceability as it moves through the supply chain. The serialization of sellable units is a fundamental requirement for DSCSA compliance, enabling stakeholders like manufacturers, distributors and pharmacies to verify the authenticity and lineage of individual drug products. By ensuring each sellable unit is distinctly identified, DSCSA aims to prevent counterfeit or tampered products from reaching patients.
Non-sellable unit
A non-sellable unit refers to a pharmaceutical product or package that is not intended for direct sale to end users, typically patients. Examples might include intermediate packaging levels like cases or pallets that contain multiple sellable units. While these units are serialized for tracking within the supply chain, they aren't intended for individual retail distribution. DSCSA mandates that even non-sellable units have traceability and serialization requirements to ensure the integrity and authenticity of the entire drug supply chain, from manufacturing through distribution to dispensing.
Change of ownership
This refers to the transfer of pharmaceutical products between distinct entities or trading partners within the supply chain, such as from a manufacturer to a wholesaler, or from a wholesaler to a pharmacy. This change necessitates the transmission of transaction information, history and statements for the serialized drug products being transferred. DSCSA compliance requires the documentation and verification of these ownership changes to ensure the authenticity, traceability and integrity of drug products as they move through different hands in the pharmaceutical distribution system.
Repository
A repository refers to a centralized system or database where serialized product information is stored and managed. This repository captures, maintains and provides access to serialization data, such as unique product identifiers, transaction histories and other pertinent details. Following DSCSA compliance requirements, manufacturers, wholesalers, repackagers and dispensers are obliged to track and verify drug products throughout the supply chain. The repository facilitates this by allowing stakeholders to verify the authenticity of a product, trace its movement, and ensure it hasn't been tampered with or counterfeited. Essentially, the repository serves as a trusted source of serialized data, supporting DSCSA's goal of ensuring drug supply chain security, transparency and patient safety by offering a consolidated view of product information and transactions.
GLN
A Global Location Number (GLN) is a unique identifier, developed by GS1, that specifies locations or legal entities within the pharmaceutical supply chain, such as manufacturers or pharmacies. GLN ensures transparency and traceability by consistently identifying where a drug product has been, aiding in product verification, authenticity and compliance, thereby enhancing drug supply chain security and patient safety.
SGLN
This stands for Serialized Global Location Number (SGLN). The GLN is a unique number used by GS1 to identify a specific location, such as a warehouse, pharmacy or hospital. When "serialized", it incorporates an extension component, allowing the identification of specific locations or sub-locations within a larger facility. Under DSCSA, SGLN can play a role in providing granular visibility into the exact points within the supply chain where pharmaceutical products are stored, handled, or transacted. By leveraging SGLN, stakeholders can achieve precise tracking and verification of product movements, ensuring the product's authenticity and compliance with DSCSA mandates. It enhances traceability, providing a detailed understanding of where a drug product has been at every stage, supporting the overarching goal of ensuring drug supply chain security and patient safety.
UOM
Unit of Measure (UOM) refers to the standard quantity or dimension used to track and manage pharmaceutical products throughout the supply chain. UOM is vital for serialization as it provides consistency and clarity in how products are labeled, tracked and verified. Within the DSCSA compliance framework, accurate UOM ensures that all stakeholders — manufacturers, repackagers, wholesalers and dispensers — can effectively track and verify drug products, enhancing traceability and patient safety. Common UOMs under DSCSA might include individual items (like tablets or vials) or larger packaging units (like cartons or cases). Properly defining and utilizing UOM is foundational to ensuring the integrity of the drug supply chain as mandated by the DSCSA.
As we've explored in this glossary, DSCSA involves a multitude of terms and concepts, all aimed at ensuring the traceability, security and authenticity of pharmaceutical products from manufacturer to patient. By familiarizing yourself with these key DSCSA-related terms, you empower yourself to navigate this regulatory landscape with confidence and contribute to the ongoing effort to protect public health while maintaining DSCSA compliance.
