| August 08, 2022 | By
Although considerable progress has been made by trading partners in implementing the pharmaceutical tracking systems requested in the Drug Supply Chain Security Act (DSCSA) there is still work to be done to ensure a smooth transition when these systems go live next November, said experts who recently spoke with Regulatory focus.
Trading partners, for example, should start testing and piloting data exchanges now to resolve any issues quickly, and manufacturers in particular should pay close attention to the accuracy of data exchanged to avoid rejection of good products. which are not counterfeit. .
For its part, the United States Food and Drug Administration (FDA) must clarify whether web portals will be allowed for data exchanges, especially for small businesses that do not have the resources to build tracing systems. . The agency also needs to finalize its proposed rule on licensing standards for third-party logistics providers (3PLs).
Experts also discussed what supply chain business partners need to do to prepare for the next November deadline when these systems go live, and efforts being made to ensure a smooth transition. Effective November 27, 2023, the DSCSA requires manufacturers, wholesalers, distributors, and dispensers to exchange serialized product information and culminates the last major step in the implementation of the law.
Perry Fri, executive vice president of industry relations for the Healthcare Distribution Alliance (HDA), said the industry has made “extraordinary progress” in recent years in implementing DSCSA.
“I can’t sit here and guarantee that 100% of everything will work on November 27, 2023, but I’m confident the huge amount of industry will be there.”
Fri said the FDA’s release of draft standards guidance recommending the use of GS1’s Electronic Product Code Information Services (EPCIS) standard to convey information through the supply chain was an important development. to facilitate the development of DSCSA. The guidelines were released in July. (RELATED: FDA releases two critical DSCSA draft guidelinesRegulatory guidance July 5, 2022)
Fri said FDA approval is important because wholesalers and distributors expect to complete EPICS data exchange pilots with manufacturers this year, and all of 2023 will be dedicated to completing exchange of data with pharmacists.
Eric Marshall, executive director of the DSCSA Governance Partnership (CEO), also applauded the approval of EPCIS in the FDA guidelines. “The industry encouraged this kind of endorsement [of EPICS] for a while.” PDG is a consortium of 70 business partners and technical experts and is an FDA public-private partnership defining the data architecture for product tracking.
PDG is developing four additional chapters of a blueprint to help industry put in place the electronic systems needed to comply with the DSCSA. Marshall said the group aims to have those chapters ready for release this fall. They will join the first chapter of the master plan, which was released in July 2021. (RELATED: Industry Consortium Releases Blueprint for DSCSA Tracking SystemsRegulatory guidance July 16, 2021)
Big problem if no test
David Mason, regional serialization manager for Novartis, said it was essential that manufacturers start testing their systems and exchanging data now with their trading partners to resolve any data issues quickly.
“From what I hear, if you’re a manufacturer or a wholesaler and you haven’t started ‘testing data exchange’ you’re in big trouble, you’re at risk of not getting there .”
He added “you can’t just turn on the switch in November”.
Data management is crucial
Mason stressed the importance of having a robust data management system to ensure that all data going down and back through the supply chain is correct and errors are caught early on. “I would tell you that [this issue] will create problems with products moving through the supply chain if we don’t set the bar high.
If there are any issues or issues with barcodes or labels “you can’t scan the product and you can’t move the product”.
Recognizing the importance of data accuracy, Novartis hired a data analyst four years ago whose sole job is to manage data and ensure there is 100% reconciliation with packaging and serial numbers of products moving through the supply chain.
“Many companies don’t understand data integrity. They don’t keep their data properly…and that creates a lot of problems downstream.
Problems arise when there are aggregation errors, using the wrong GS-1 Global Location Number (GLN), or when barcodes do not match the EPCIS message.
Even Novartis, which has been trading data with a CMO for three years, “still sees issues with data and data maintenance.”
FDA must authorize portals for data exchange
One area of uncertainty is whether the FDA will allow small businesses, such as distributors, to use secure web portals to access data instead of forcing them to create tracing systems, Mason said. The draft guidance on data exchange standards, while recommending EPCIS as the data standard, does not specify whether trading partners can use portals for data exchange.
“We need this portal solution. The last directive didn’t clarify, it endorsed EPCIS, which I have to admit was a huge step and we appreciated that. But we need to go back and clarify that we also need a portal solution.
The portal is a website provided by the manufacturers or sellers of the drug to its business partners who purchase the product, which provides access to information on drug transactions.
Mason said many business partners, especially smaller distributors or companies that aren’t a large drugstore chain, such as Walgreens, CVS or Krogers, will need these portals.
“You have over 60,000 trading partners in the US supply chain and most of them aren’t sophisticated enough or don’t have the capital or the infrastructure to build systems to collect this data. They need us to develop portal solutions where they can pull the data,” he said.
FDA to finalize 3PL rule
Fri at HDA said the FDA also needs to finalize its licensing rule on wholesalers and third-party logistics providers (3PLs). A proposed rule was published in February (RELATED: FDA releases long-awaited licensing rules for drug distributors and 3PLsRegulatory guidance February 3, 2022)
“The proposed 3PL rule has some good points, but it would be good to finalize them,” Fri said.
The DSCSA requires that pharmaceutical manufacturers only accept pharmaceutical products from “authorized business partners” or parties duly authorized or registered to receive or transfer products. Authorized business partners include manufacturers, remanufacturers, distributors, wholesalers, and 3PLs.
No on/off switch
Marshall said implementing DSCSA will be an iterative process, rather than a snap change. “Because it is a system of interoperable systems, 2023 will be the beginning, not the end; it will not be a switch that will be activated in November,” he said.
Mason said it’s unrealistic to expect the DSCSA implementation to go smoothly and have all supply chain trading partners have these systems up and running by next November. He said, for example, that there were still implementation problems with the EU’s Falsified Medicines (FMD) Act, which has been in force since 2011.
“If you look at Europe…they still have gaps and they’re still working on issues,” Mason said.
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