Manufacturers Not Ready for November DSCSA Deadline, Study Finds

Regulatory NewsRegulatory News | 18 October 2018 |  By 

A new study found that pharmaceutical manufacturers are woefully behind in meeting a 27 November deadline, as nearly 80% of pharmaceutical packages still do not have a readable barcode with all four required data elements necessary to meet the requirements of the Drug Supply Chain Security Act (DSCSA).
The study, from AmerisourceBergen, Cardinal Health and McKesson Pharmaceutical, which represent about 90% of pharmaceutical distribution in the US, examined package and homogenous case level barcodes in their distribution facilities in May 2018 to gain a better understanding of the progress made in implementing DSCSA serialization requirements.
When AmerisourceBergen and McKesson scanned all of their on-hand package (lowest saleable unit) barcodes in their distribution centers, they found that only 20.7%, compared with 6.6% in 2017, of packages carried a readable 2D data matrix barcode with all four required data elements, including National Drug Code, serial number, lot number and expiration date, the study found.
Meanwhile, Cardinal Health evaluated homogeneous case-level barcodes on pharmaceutical products, scanning 15,708 barcodes on 6,481 cases, and found just 15.1% of homogeneous cases were marked with the 2D barcode and four data elements.
Peter Sturtevant, senior director of industry development at GS1 US, explained to Focus that he would be shocked if manufacturers were 100% compliant with the DSCSA requirements by the deadline, though those that do not meet the requirements could be fined. He also said he thought by next May, if the study is conducted again, there would be noticeable improvements in terms of companies meeting the requirements.
“I don’t think they [FDA] want to come down very hard on industry,” he added. “They want to see industry is moving actively and positively in implementing the law.”
Additional issues identified by the study include poor barcode placement, a lack of alignment when UPC-A and 2D barcodes are both required on the same package, serialization adherence, improper coding and inconsistent expiration date formats. 
As far as what suppliers can do, AmerisourceBergen, Cardinal Health, and McKesson recommended that they refer to and implement GS1 Standards for barcode guidance with size, placement, encoding and more, to improve quality.
All three wholesalers are also offering implementation assistance, including sample barcode testing, educational sessions and individualized support.


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