Authority: US FDA

Request Source: Regulation

Data Carrier: GS1 Data Matrix

Detail: The USA passed the Drug Quality and Safety Act (DQSA) in November 2013. The second part of the act, the Pharmaceutical Supply Chain Security Act (DSCSA), addresses supply chain security. DSCSA includes important steps towards a digital-based system for traceability of prescription drugs in the USA. In line with the requirements, the USA implements GS1 standards and the project is expected to be completed in 2024, covering the entire pharmaceutical industry. The drug traceability practice in the USA is shaped independently of the central authority. Traceability should occur under the responsibility of supply chain stakeholders.

• Batch/Lot Number – AI (10)
• Expiration Date – AI (17)
• GTIN
• Serial Number – AI (21)

Links:

https://www.fda.gov/drugs/drug-supply-chain