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Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward, despite multiple hurdles for regulators, manufacturers, and distributors. FDA recently announced that it would delay enforcement of requiring manufacturers to add product identifiers to drug packaging, a key step for establishing an interoperable drug tracking system by 2023 that will reduce drug diversion and the influx of counterfeit medicines into the United States.
These and other supply chain challenges will be discussed at a public meeting to be held on August 23, 2017 at FDA headquarters in Maryland and at two additional meetings scheduled for December 5–6, 2017 and February 28, 2018.
The decision to postpone full implementation of the program is explained in a draft guidance, published in June 2017, that outlines requirements for imprinting product identifiers on drug packages, as specified by the Drug Supply Chain Security Act (DSCSA) of 2013. FDA states that it will not enforce package-level identification until Nov. 26, 20018, instead of beginning Nov. 27, 2017. The delay reflects concerns of manufacturers and other trading partners about a lack of information technology systems able to handle the tracking data and difficulties for contract manufacturers to meet program requirements on time.
Meanwhile, FDA is launching a pilot program to test issues involved in establishing the long-sought interoperable electronic system for drug tracing and identification. This pilot initiative was included in DSCSA and discussed at a public workshop in April 2016. FDA hopes that large and small manufacturers, dispensers and distributors will propose projects able to evaluate product identifier management, barcode quality, system interoperability, data exchange, error handling, and methods for investigating illegitimate products. The agency will evaluate proposals and hopes to sign off on several that will run from four to six months. Each project will provide monthly progress reports and a final report with key findings and lessons learned, with an eye to helping supply chain members meet program requirements.
The three public meetings will provide opportunities for all parties to address supply chain security needs, electronic interoperability, and data exchange standards, as described in a Federal Registernotice July 20, 2017. The broader goal is to discuss what supply chain security should look like in 2023, standards for product tracing, the management of product tracing data, and building capacity for a unit-level system for product tracing and verification.
At the same time, FDA is collaborating with other regulatory authorities to devise methods for better securing the international medical product supply chain. An initiative supported by the 21-nation Asia-Pacific Economic Cooperation (APEC) has developed a Supply Chain Security Toolkit for Medical Products. The aim is to help manufacturers and distributors detect and deal with substandard and falsified drugs in Asia and other regions. The toolkit website provides resources and training materials for track and trace, internet sales, detection technology, and other issues, explains Ilisa Bernstein, deputy director of the Office Compliance in the Center for Drug Evaluation and Research (CDER). The program addresses areas of vulnerability in the medical product supply chain and recommends best practices for preventing and detecting substandard and falsified medical products before they reach consumers.