FDA launches pilot programme to track and trace US supply chain

The FDA has launched a pilot programme designed to ensure greater accountability in the US drug supply chain.

The new pilot project will test innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the US.

The system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.

“As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain,” said FDA Commissioner Scott Gottlieb.

“We recognise that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply.”

The FDA states that the programme is “intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by 2023”.

The Drug Supply Chain Security Act (DSCSA) was signed in November 2013 and outlines critical steps to build an electronic interoperable system by November 2023, that will identify and trace certain prescription drugs as they are distributed within the United States.

“The 2023 system has the potential to reduce diversion of drugs distributed domestically as well as help deter counterfeit drugs from entering the supply chain. The pilot programme will be designed to explore issues related to utilising the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA,” states the Agency.

Eligible entities are invited to apply to participate in the programme.