On July 20, 2017, FDA announced its intent to establish a pilot project program under the Drug Supply Chain Security Act (DSCSA) to assist in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the U.S. Under this voluntary program, FDA will work with stakeholder to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. This Federal Register (FR) notice describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate.
Additional information on this pilot project program:
- As part of the DSCSA, FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.
- Based on the information gathered at the FDA public workshop held April 5-6, 2016 and from the comments submitted to the public docket for the workshop, FDA has identified several potential issues to examine, and evaluation methods to use, in pilot projects established under the DSCSA Pilot Project Program. These potential issues and evaluation methods are summarized in Table 1 within the Federal Register Notice.
- The program will be designed to explore issues related to utilizing 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.
- Particular program goals include assessing the ability of supply chain members to: Satisfy the requirements of section 582 of the FD&C Act; identify, manage, and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively; and demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain, in addition to identifying the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing and verification purposes.
- FDA expects that participants will propose the design and execution of their pilot project in their submission to FDA.
- FDA encourages supply chain members to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, the pilot project(s) should focus on the requirements for package level tracing and verification that go into effect in 2023.
- FDA is particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors.
- FDA will issue a final program report which will be publically available on FDA’s website. This report will include the names and industry sector(s) of the pilot project participant(s); the pilot project’s objectives and evaluation methods; the duration of the pilot project; and the key findings and lessons learned from the pilot project.
More information on the logistics related to this pilot project program, including progress reports, final report, and meetings with FDA, can be found in the Federal Register Notice. Responses to the Docket will be accepted through September 18, 2017.