What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is federal legislation passed in 2013 that creates national requirements for tracing pharmaceutical products throughout the entire supply chain by 2023. This new legislation includes provisions for product identification, tracing and enhanced verification, detection and response, notification, wholesaler licensing, and third-party logistics provider licensing.
Additional information will be added to the product to allow for the traceability of the product in the supply chain. Full implementation of DSCSA will result in standardized, unit-level traceability throughout the entire drug supply chain — from the manufacturer to the pharmacy (or provider).
What is Enhanced Verification?
Enhanced Verification refers to the compliant process by which Novartis receives requests from its Authorized Trading Partner, determines whether the product identifier provided corresponds to the product identifier imprinted by Novartis, and reports its finding to the Authorized Trading Partner.
Who may enter an Enhanced Verification Request?
An Enhanced Verification request may be initiated by an Authorized Trading Partner who has physical possession of the product which is the subject of the request. Trading Partners must have a valid state license to dispense prescription drugs in the U.S.
What should I do if I am not an Authorized Trading Partner?
- If you or the person you are acting on behalf of are currently experiencing side effects, please contact your doctor or other medical health professional.
- If you or the person you are acting on behalf of have questions about the product, packaging, or labeling, please contact your doctor or pharmacist.
- If you or the person you are acting on behalf of wish to report side effects, you may report side effects to Novartis Pharmaceuticals at 1-888-NOW-NOVA (669-6682). You may also report side effects to FDA at 1-800-FDA-1088.
- If you or the person you are acting on behalf of have any other questions regarding product verification, please contact your pharmacist.
Key Terms:
GTIN: (Global Trade Item Number) is a globally unique 14-digit number used to identify products in the supply chain. The GTIN, as well as other key product attributes, are automatically identified when a 2-D bar code is scanned.
LOT: (Lot Number) is combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.
EXP: is the product expiration date.
SN: (Serial Number) is a unique serial number that is placed on the sellable unit to identify that unit which can be verified by Novartis.
Authorized Trading Partner: Pharmaceutical trading partner that has a valid state license to dispense prescription drugs in the US.
Enhanced Verification: An Enhanced Verification Request is the compliant process by which Novartis receives requests from its Authorized Trading Partner, determines whether the product identifier provided corresponds to the product identifier imprinted by Novartis, and reports its finding to its Authorized Trading Partner.