United States of America (USA)

v. 14 – 2020/02

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.

There have been no new developments, since September 2019, when the FDA issued a guidance document informing the public of an enforcement discretionary period for the requirement for wholesale distributors to verify the Product Identifiers of any product being returned to them intended to be returned to saleable inventory. Where initially wholesale distributors were required to perform this verification starting November 27, 2019, this latest guidance document introduced an enforcement discretionary period to November 27, 2020.

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.
Key Dates
  • January 1, 2015: (all trading partners except dispensers) Authorized trading partners only; T3 required to be passed with each transaction
  • July 1, 2015: (adding dispensers to 01 January requirement)
  • November 27, 2017: (enforcement discretion to 2018) Manufacturers – 4 element Product Identifier required on product entering the supply chain
  • November 27, 2018: Repackagers – 4 element Product Identifier required on product entering the supply chain
  • 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, 2020: Dispensers cannot accept product without Product Identifiers affixed
  • November 27, 2023: Fully interoperable, electronic system for tracing including Product Identifiers