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Although pharma manufacturers and contract packagers are ramping up their capital-equipment purchases to meet the November 2017 deadline for having item-level serialization, many aspects of the Drug Supply Chain Security Act (DSCSA) remain unresolved. Some of these are operational issues to be worked out by the supply chain party (wholesaler, freight forwarder, pharmacy warehouse); some are to be clarified with FDA guidance. (As with the longstanding Good Manufacturing Practices, or GMPs, FDA does not dictate what equipment or what steps to carry out to meet the law, but looks to the end results of whatever practices manufacturers undertake.)
Per instructions to FDA in DSCSA, the agency is to hold a series of workshops to enable it to coordinate its actions with what’s going on in industry. The second of such workshops was held in April at FDA headquarters, drawing over 100 participants, with a goal of appropriately setting up pilots to run for the next few years in anticipation of full DSCSA implementation.*
A daunting list of tasks are to be addressed by the pilot projects. FDA discussion leaders focused the workshop on these objectives:
As noted earlier, the aggregation/inference topic is one that has generated much commentary; the technology to successfully match the items in a case, with a case’s transaction history is available, but ensuring an acceptably high degree of accuracy remains an issue. “We need to use these pilot projects to test ideas and see what works, what doesn’t work, and how to make a fully electronic secure interoperable system for package level tracing. It may take several pilot projects and various iterations to figure this out,” said Ilisa Bernstein, deputy director of the Office of Compliance at FDA, in launching the April workshop.
Privately, pharma companies and wholesalers have been running serialization pilots on and off for years; at the spring HDMA Distribution Management Assn. meeting, a presentation by Johnson & Johnson and AmerisourceBergen detailed one that they have run for the past year. Results showed barcode legibility is an issue (if, for example, a pallet is encased in a plastic wrap, making the barcodes hard to read); and the ability to synchronize the arrival of product at a loading dock, with the electronically transferred transaction information, was touch-and-go.
Under HDMA auspices, another pilot, focused on product returns, is starting up now. As Matt Sample, senior director of secure supply chain at AmerisourceBergen noted, HDMA members receive 2% of units sold in the US as saleable returns; traditionally these go back into forward distribution, but after 2019, those rerouted products will need transaction documentation. And while 2% doesn’t sound like a lot, it represents 58 million units, which works out to thousands of returns daily for the distribution centers of the major wholesalers. Being able to retrieve transaction data to make these returns legally saleable will be a challenge—without electronic transaction data available, these units cannot be shipped to another retail location.
Pilot projects have, and will, occur in Europe with the Falsified Medicines Directive coming into force. There, most of the guidance is being developed by the European Medicines Verification Organization (EMVO), a consortium of the leading European pharmaceutical distribution organizations. In early 2015, that group announced the initiation of a project to develop the “European Hub” that will be a connector for national data depositories of serial data to communicate with each other.
* Presentations and selected videocasts of the workshop are available at FDA’s website: http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm