The US Food and Drug Administration (FDA) has announced its intent to establish a pilot-project program under the Drug Supply Chain Security Act (the DSCSA Pilot Project Program) to assist in development of an electronic, interoperable system that will identify and trace prescription drugs as these drug are distributed within the US. The DSCSA was signed into law in November 2013 and outlined steps to build this system by 2023. Its purpose is to reduce diversion of drugs distributed domestically as well as help reduce the influx of counterfeit drugs from foreign sources.
Under the DSCSA Pilot Project Program, the FDA said it will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program will be voluntary and will be open to pharmaceutical distribution supply-chain members. The FDA said it will be particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors, which include manufacturers, repackagers, wholesale distributors, and dispensers.
The FDA says that program will be designed to explore issues related to using 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 the FDA. The FDA says that pilot project is designed to allow the industry to identify and evaluate the most efficient systems for their unique operational systems.
The FDA says that the pilot project(s) should focus on the requirements for package-level tracing and verification that go into effect in 2023. “Such pilot projects will be more useful than pilot projects dedicated to lot-level tracing,” said the agency in its Federal Register notice. If there are adequate pilot project submissions, the FDA said it may establish more than one pilot project to accomplish the goals of the DSCSA Pilot Project Program
In a notice in the July 20, 2017 edition of the Federal Register, the FDA further describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate. FDA is soliciting comments through September 18, 2017 on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Management and Budget (OMB) for approval. FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information.
Separately, the FDA announced three upcoming public meetings on enhanced drug-distribution security under the DSCSA for August 23, 2017, December 5 and 6, 2017, and February 28, 2018.
These public meetings will focus on the following topics for discussion:
- What supply-chain security should look like in 2023
- What is needed for enhanced drug distribution security
- What is needed for electronic interoperability
- Standards for product tracing
- Data-architecture options for an electronic interoperable system
- The management and maintenance of product-tracing data
- The use of aggregation and inference for enhanced product tracing and verification
- Building capacity for a unit-level system for product tracing and verification.
Source: FDA (pilot program) and FDA (public meetings)