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Frequently Asked Questions

Compliance for the DSCSA is not optional for supply chain participants and process development for manufacturers, repackagers, wholesalers, and dispensers should have already begun.  Non-compliant supply chain participants are at risk for fines and could face possible prison sentences as drugs not labeled correctly are considered misbranded.

The Drug Supply Chain Security Act (DSCASA) is a 2013 law to identify and quarantine suspect (potentially illegitimate) drugs within the US pharmaceutical supply chain. Many of the details and ramifications of the law are still uncertain. The difficulty for Pharmacies to implement compliance measures is compounded by a lack of awareness of DSCSA requirements and education on federal supply chain compliance regulations. Changing data formats (e.g. ASN and now EPCIS), mixtures of serialized and non-serialized products in the supply chain, requirements of volumes of data, and short (24 hour) response times place a heavy burden on pharmacists who already have a full plate. Creating and maintaining DSCSA compliance measures requires subject matter expertise in design, implementation, and maintenance of compliance systems, ASN, and other data repositories. As new requirements are being planned and implemented over the coming years, the burden to stay knowledgeable and current is overwhelming. Final implementation is scheduled for November 27, 2023 with requirements for dispensers to participate in an interoperable database to document drugs received and/or shipped to the pharmacy. The comprehensive requirements for DSCSA compliance still remain to be fully articulated by the FDA in their guidance documentation.

The Global Trade Item Number (GTIN) is the globally unique GS1 identification number used to identify “trade items” (i.e., products and services that may be priced, ordered or invoiced at any point in the supply chain). GTINs are assigned by the brand owner of the product, and are used to identify products as they move through the global supply chain to the hospital or consumer/patient. The GTIN is used to uniquely identify a product at each packaging level (e.g., a bottle of 30 tablets; a case of 100 bottles of tablets, etc.).

The National Drug Code is a 10-digit identification number established by the U.S. Food and Drug Administration (FDA) to identify drugs in accordance with Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. p360. The NDC is used by the manufacturer or relabeler to electronically submit registration and drug listing information to the FDA. The NDC consists of 3 segments which specify the drug product’s labeler, trade product and package size. Each NDC code uniquely identifies a specific drug having a particular dosage form, strength, and package size.

The GTIN differs from the NDC in two ways: The GTIN is used to identify all types of trade items, including drugs, medical devices, consumer products outside of the healthcare sector, and non-consumer trade items across all sectors. The GTIN is used for trade items around the world. The NDC is only used to identify drugs, and only drugs subject to U.S. FDA regulation. The GTIN uniquely identifies not only the individual sale unit of packaging, but also higher level groupings such as homogeneous cases, homogeneous pallets, etc. So, for example, a 30-tablet bottle of Drug XYZ will have one GTIN, and a 12-bottle case of the same drug will have a different GTIN. The NDC only identifies the drug itself, and does not distinguish between the individual sale unit and higher level groupings.

Drug trade items that have an NDC can be given a GTIN that embeds the NDC.
This is a best practice.
For an individual sale unit, the NDC is embedded in a GTIN-12 by combining the following elements in left-to-right order:

  •     The digit “3”
  •     The 10-digit NDC
  •     A check digit, computed from the previous 11 digits according to the GS1 check digit calculator.