United States of America (USA)

v. 19 – Q3 2021

Market Executive Summary In the USA, the federal law called the Drug Supply Chain Security Act (DSCSA) requires tracing (by lot) and verification (by serialization) of certain prescription drug products. Required is a Product Identifier, uniquely identifying packages and homogenous cases with 4 data elements in both machine and human readable format. Trading partners have different requirements as related to their respective roles in the supply chain.

The FDA released a new guidance titled, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Guidance for Industry, on October 22nd, 2020. https://www.fda.gov/media/131005/download

COVID-19 Update:

  • Publication/News: The FDA published a guidance titled, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency, April 30, 2020. https://www.fda.gov/media/137478/download
  • Impact: the FDA is providing allowances for exemption and exclusion from certain DSCSA requirements, but only for affected products and certain supply chain activities, which are directly impacted by the COVID-19 public health emergency and meet emergency medical needs.

June 2021 update:
On June 3rd the FDA released four guidance documents with new or updated recommendations regarding compliance with the US Drug Supply Chain Security Act. The documents and links to the guidance documents are listed below:

Key Dates
  • November 27, 2023: Fully interoperable, electronic system for tracing including Product Identifiers
  • 3-Year enforcement delay bringing new enforcement date to November 27th 2023. Enforcement delay is ONLY for verifying suspect and illegitimate products, not including the requirement for ensuring a product is encoded with a product identifier.
  • November 27, 2020: Dispensers cannot accept product without Product Identifiers affixed; Dispensers must verify PI of suspect and illegitimate product.
  • Addition 3-year Enforcement Delay to the Sept 2019 1-Year delay bringing the new enforcement date to November 27th 2023.
  • November 27, 2019: (saleable returns verification enforcement discretion to 2020) Wholesale distributors cannot accept product without Product Identifiers affixed; wholesale distributors cannot resell returns with verification of Product Identifiers.
  • November 27, 2018: Repackagers – 4 element Product Identifier required on product entering the supply chain
  • November 27, 2017: (enforcement discretion to 2018) Manufacturers – 4 element Product Identifier required on product entering the supply chain
  • July 1, 2015: (adding dispensers to January 1 requirement)
  • January 1, 2015: (all trading partners except dispensers) Authorized trading partners only; T3 required to be passed with each transaction

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