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Wholesalers continue to worry about manufacturer commitment to timely compliance
The seventh edition of a serialization readiness survey, conducted annually by the Healthcare Distribution Alliance (HDA), finds that 32% of manufacturers are sending at least some serialized data to their distributors, while 62% of surveyed distributors are capable of receiving and processing these data. Meanwhile, dispensers (i.e., pharmacies) continue not to understand their responsibilities to accept the serial data and investigate suspicious products, according to distributor responses to the survey.
All these participants in the US pharma supply chain—manufacturers, wholesaler/distributors, pharmacies (and even third-party logistics providers and others) are obligated to be able to exchange serial product data with their trading partners, and to validate those data to prevent suspect, diverted, or illegitimate product from entering the supply chain, by November 2023, under the 2013 Drug Supply Chain Security Act (DSCSA). Today, essentially all pharma products regulated under DSCSA have a 2D barcode that gives a unique identifier to each item-level package (this was a DSCSA requirement back in 2015). In the past year, FDA issued guidance that recommended that all this data exchange be performed by using the EPCIS standard of the GS1 US organization, but the requirement to actually exchange item-level data only goes into force in 2023.
“The [survey] data show the industry is making progress, but also prompt us to ask what the operational impact to the supply chain will be come Nov. 28, 2023, if manufacturers continue to defer their serialization investments well into the final year of DSCSA implementation,” said Perry Fri, EVP of HDA. “Likewise, dispenser education remains a priority as the FDA has indicated it will not grant further enforcement discretion in 2023.”
Another pressurepoint of DSCSA for wholesalers is the aggregation/inference topic: the ability to receive a case of multiple items (each with its own product code) but to infer those codes only from the code affixed to the case (a so-called parent-child relationship). Wholesalers need to be able to process incoming cases smoothly and quickly, but that depends on manufacturers’ willingness to invest in aggregation equipment. The survey finds that nearly 58% of manufacturers are aggregating data for all SKUs (up from 45% last year). An additional 6% plan to aggregate data for all SKUs for each unit to a case by the end of this year.
The survey was conducted by an independent third party for HDA during the past summer. The full survey is available at no cost from HDA’s website (https://www.hda.org/~/media/pdfs/center/2022-serialization-survey.ashx). This year, the survey was sponsored by LSPediA, 3Keys GmbH, and HealthFirst.