United States

v. 1.5 – 12/20/17

Serialization Model Track and Trace
Governing Body United States FDA
Compliance Date Multiple phases

  • Transaction History, Transaction Information, and Transaction Statement: January 1, 2015 – Must be provided, captured, and maintained with each change of ownership.
  • Manufacturer to Product Identifier:
    November 27, 2017
  • Repackagers serialize product, associate and verify SNI: November 27, 2018
  • Wholesalers receive and ship serialized product. Wholesalers verify SNI,
    including returns: November 27, 2019
  • Dispensers receive and ship serialized product. Dispensers verify SNI:
    November 27, 2020
  • Interoperable Track and Trace System, package (item-leve) traceability, unit-level traceability with aggregation and inference: November 27, 2023
FDA Draft Guidance: Compliance Dates
  • Under the DSCSA – FDA deferred enforcement for one year on the manufacturers’ requirement to apply product identifiers. There are no other implied “extensions”, including repackagers required to affix product identifiers for any product they introduce to the supply chain starting November 27, 2018
  • The FDA will not take enforcement action for verification not using product identifier for products introduced into commerce before November 26, 2018
  • There is no extension on the requirement to provide T3 (Transaction Information, Transaction History, and Transaction Statement) in electronic form starting November 27, 2017
FDA Draft Guidance: Grandfathering Policy
  • The grandfathering policy states that a package or homogenous case of product is “in the pharmaceutical supply chain” if it was packaged by the product’s manufacturer or repackager before November 27, 2018
  • Any product packaged before November 27, 2018 is thereby exempted from product identifier requirements including the affixing of the product identifier to the package
  • Subsequently, any verification requirements (of product identifier for either investigation of suspect product, or for saleable returns) are exempted for any product that does not have a product identifier affixed
  • Transaction statement can serve as proof of exemption for downstream trading partners if manufacturers are requested to provide packaging date information
Randomization Requirements No
Aggregation Requirements Not required by DSCSA before 2023; however, it is advised based on wholesaler requests and to adequately verify product identifiers of suspect product before 2023.
Data Submission Requirements There are currently no requirements in place. The DSCSA states that there will be a fully interoperable system in place by November 27, 2023; however, the FDA has not yet disclosed the structure or requirements for this system.
Saleable Unit Data Carrier GS1 Data Matrix encoded with the Standardized Numerical Identifier (SNI), Lot, and Expiry Date
Saleable Unit HRI GTIN, Serial Number, Lot, and Expiry Date
Shipping Case Data Carrier GS1 Data Matrix or Linear Barcode
Shipping Case HRI Standardized Numeric Identifier (SNI), Lot, and Expiry Date
Logistics Unit Data Carrier Not specified–assume SSCC18 based on HDA recommendation and to facilitate aggregation to pallet and logistics unit
Logistics Unit HRI Not specified–assume HDA recommended format
Additional Notes