United States Regulatory Compliance

General Overview

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.

Barcode Requirements

  National Drug Code (NDC) or a Global Trade Item Number (GTIN)

  Serial number

  Expiry date

  Batch/ Lot number

DSCSA 2023 Timeline

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

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