Patient safety and GS1 Healthcare

Regulation of prescription drugs

Counterfeit drugs have become an increasing global threat over the last few decades and more and more regulatory authorities, including Argentina, Brazil, India, South Korea, Saudi Arabia and the EU, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain.

The U.S. Drug Quality and Security Act (DQSA)

The Drug Quality and Security Act (DQSA) was signed into law on 27 November 2013. It outlines critical steps to build an electronic, interoperable system for identification and traceability of prescription drugs as they are distributed in the U.S.. The new law supersedes any states requirements. The requirements are phased in over a period of 10 years by providing a migratory path from lot traceability to serialisation to item-level traceability, and are split into three main phases:

  • April 2015: paper or electronic chain of ownership (CoO).  Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies beginning 1 July 2015) in the drug supply chain will provide information about a drug and who handled it each time it is sold in the U.S. market
  • November 2017: serialisation
  • November 2023: full track-and-trace down to item level

The new system will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls.

EU Falsified Medicines Directive

One of the key objectives of the European Directive on the prevention of the entry into the legal supply chain of falsified medicinal products is to ensure product integrity and authentication of medicines (ie. safety features and product serialisation).

It will encompass a harmonised unique identifier across Europe.

For more detailed information on requirements around the world : visit our Public Policy Database