United States

Regulation name: The Drug Supply Chain Security Act

November 27, 2013
DSCSA enacted
November 27, 2014
Third-party logistics providers (3PLs) must report licensure information to FDA annually
November 27, 2015
Manufacturers must print lot numbers on packaging
November 27, 2017
Manufacturers must serialize and verify products
November 27, 2018
Repackagers must serialize products
September 23, 2019
FDA delays enforcement of saleable returns requirement for wholesalers
November 27, 2019
Wholesalers/distributors can only receive and distribute serialized products
August 25, 2023
FDA announces extended stabilization period, postponing enforcement for one year
November 27, 2024
Full interoperable electronic unit-level traceability for all stakeholders
Serialization status: Active
Country population: 334,9 mln people
Market coding requirements: GTIN、Serial Number、Batch Nr、Expiration Date、US NDC Code (only human readable)
Aggregation requirement: Yes
Governmental reporting requirement: No
Track & Trace requirement: Yes

Official governing body: FDA(https://www.fda.gov/)

Required transactions&reporting

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