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November 2018 serialization deadline is looming—and FDA will not provide another extension
Concurrent with the annual DSCSA Traceability seminar held by the Healthcare Distribution Alliance (Washington, DC, Oct. 15-17), the Big Three wholesalers, and the GS1 Healthcare organization, released a second survey of how much pharma product is serialized and ready for the November 27 deadline, when all products manufactured after that date are to have a 2D barcode on their label.
While there was substantial progress from a similar 2017 survey, the 2018 results are underwhelming. The organizations found that 20.7% of products are DSCSA-compliant at the unit of sale level (the 2017 figure was 6.6.%); a parallel survey of “homogeneous cases” (i.e., cases that contain the same product, which has slightly different DSCSA compliance requirements) found that 15.1% of cases were ready.
Per the 2013 Drug Supply Chain Security Act, manufacturers were to have all their saleable units serialized by November 2017; subsequently, that date got changed to 12 months later. At the HDA meeting Dr. Ilisa Bernstein, deputy director of the FDA Office of Compliance, warned industry not to expect another extension. Does this mean that the industry is going to come to a grinding halt on November 28 if its product labels are non-compliant? Not necessarily: under grandfathering rules announced by FDA, only products readied for commercial distribution after that date need to be compliant, so one industry response is to bulk up its current production, and those products will be saleable until their expiration date is reached. There is also some latitude in obtaining waivers from FDA for compliance.
“Since the majority of pharmaceutical products have a multi-year lifecycle, we don’t expect to realize the full impact of DSCSA serialization until the end of 2021,” noted Ameer Ali, a senior manager at AmerisourceBergen. “It will be a gradual process as we continue to work out issues and adjust processes to experience the benefits of complete, accurate product data.”
The survey also revealed a range of subtleties to DSCSA compliance that manufacturers will have to pay attention to. A compliant label contains four elements: NDC number, lot number, serial number and expiry date, all within a 2D barcode for units of sale, and 2D barcodes or linear barcodes for homogeneous cases. Some labels have only some of these elements, even with the 2D barcode. The survey participants also found some variations between information encoded in the 2D barcode, and linear codes (which are more easily read by retail pharmacies) that are supposed to have the same information. Problems were also noted with NDC codes (which retailers depend on) differing between the linear display and the 2D display, which could cause problems in distribution-center operations.
“With improvements in our results this year, DSCSA implementations are going in the right direction,” said Scott Mooney, VP of distribution operations at McKesson. “I expect to see the percentage gradually growing and growing. One thing is certain: All new packages after November 27, 2018, should have 2D barcodes on them.”