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/)

Depands on your use case