Starting in November 2017, all pharmaceutical companies selling prescription drug products in the United States are required to serialize each individual, salable drug unit. DSCSA has established an eight-year timetable between 2015 and 2023 for step-by-step implementation.
In 2019, the Food and Drug Administration (FDA) officially launched their Pilot Program for DSCSA 2023, which is intended to assist members of the pharmaceutical distribution supply chain in the development of an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.
In 2021 FDA released four long-awaited DSCSA guidance documents – Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.
National Drug Code (NDC) or a Global Trade Item Number (GTIN)
Batch/ Lot number
2017 – Manufacturers affix product identifiers
2018 – Repackagers affix products identifiers
2019 – Wholesale distributors only accept product identifiers
2020 – Dispensers only accept product identifiers
2023 – Unit-level traceability