Pharma industry making some headway in DSCSA implementation

Regulatory NewsRegulatory News | 18 October 2022 |  By 

The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA), according to a recent survey. Yet industry needs to pick up the pace if the November 2023 deadline is to be met, said an official with the Healthcare Distribution Alliance (HDA), whose group conducted the survey.
 
The survey found that 75% of manufacturers plan to send 100% of their DSCSA-required serialized data with shipped products by 27 November 2023, the deadline to comply with the law. This is an improvement over last year’s survey, where only 45% of manufacturers were sending serialized data to their wholesale manufacturers. (RELATED: Pandemic has challenged industry’s implementation of DSCSA, Regulatory Focus 3 November 2021).
 
The HDA Research Foundation’s latest serialization readiness survey was launched in June 2022, with 48 manufacturers and 29 distributors responding, and was released at HDA’s traceability conference in Washington, DC on 13 October.
 
“The foundation’s data show the industry is making progress, but also prompt us to ask what the operational impact to the supply chain will be come November 28, 2023, if manufacturers continue to defer their serialization investments well into the final year of DSCSA implementation,” said Perry Fri, executive vice president of industry relations at HDA.
 
Respondents cited some of the key challenges impacting their ability to comply with the 2023 deadline. Manufacturers cited collaboration with trading partners (51%), governance of the interoperable system for 2023 (49%) and differences in interpretation of the law (34%) as some of the main challenges.
 
For their part, healthcare distributors noted collaboration with trading partners (90%), technical challenges (72%) and establishing standards (48%) as top concerns.
 
The survey also found that approximately 32% of manufacturers are currently sending some serialized data to distributors; with most manufacturers sending serialized data for less than 150 SKUs (45%).
 
It also showed that progress has been made with the pace of aggregation, with more manufacturers planning to aggregate stock keeping units (SKUs) by the end of this year. Fifty-eight percent of manufacturers are aggregating data for all SKUs, which is up from 45% last year. An additional 6% plan to aggregate data for all SKUs for each unit to a case by 2022. A third of manufacturers plan to aggregate by 2023.
 
Aggregation means that the unique identifiers attached to each product are uniquely serialized to higher packaging levels and is a prerequisite for manufacturers to send serialized transaction data.
 
On another front, progress has been made with respect to master data. The survey found that 52% of distributors received master data for up to 25% of products, up from 44% in 2021, while 24% received no master data, down from 35% in 2021. The most popular method used to submit master data are through spreadsheets, (59%), followed by the HDA new product form (55%) and the GS1 Global Data Synchronization Network (GDSN) at 32%.
 
Having robust master data for both verification router service (VRS) and interoperable data exchange allows DSCSA trading partners to keep track of which products are in circulation. 
 
The survey found that most manufacturers, 84%, have no concerns with meeting the requirement to process serialized saleable returns. Of the 16% who do have concerns, viability of the VRS was cited as the dominant concerns, followed by a lack of FDA guidance on the verification requirement and the inability to send aggregated data.
 
The survey also showed that 62% of distributors report they can receive serialized product. This is a slight increase from 60% last year.
 
According to distributors, dispenser knowledge of the 2023 DSCSA requirements is limited, with none of the distributors reporting that their dispenser customers “understand their responsibilities to accept products with product identifiers and to investigate suspicious products.”
 
The survey was sponsored by LSPedia, 3Keys GmbH, and HealthFirst.
 
HDA serialization survey
 

 

© 2022 Regulatory Affairs Professionals Society.

Tags: DSCSA, FDA, VRS

Discover more of what matters to you

10;20;25;30;31;33;