FDA official: Agency will not extend DSCSA 2023 interoperability deadline
Posted on August 11, 2021 | By
The US Food and Drug Administration is working “hard” on implementing requirements calling on manufacturers and trading partners to put in place fully interoperable electronic tracking and traceability systems by the November deadline 2023 set by the Drug Supply Chain Security Act (DSCSA), with no plans to extend the time limit for manufacturers to comply with these requirements.
So said Leigh Verbois, director of the FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research, who discussed the implementation of the DSCSA during a webinar. August 9 sponsored by the Healthcare Distribution Alliance. Much of his remarks focused on the third and final element of the DSCSA calling on business partners to put such systems in place; this provision of the law is considered the most complex and difficult part to develop and implement.
In June, the FDA released its electronic tracking guidelines. (RELATED: FDA Details DSCSA Implementation Plans in Four Guidelines, Regulatory guidance, June 4, 2021)
Verbois told attendees the agency was busy developing an interoperability framework. “We recognize that there are a number of significant issues associated with enhanced systems, architecture and system attributes. We worked within the agency to understand the interplay between the elements needed to build a system.
Verbois also asserted that although the United States has “one of the most secure supply chains in the world,” the DSCSA is still needed to counter threats that remain in the pharmaceutical supply chain.
Last year Janssen announced that a counterfeit version of its drug Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide), which is indicated to treat HIV in adults and adolescents over 12 years old, was discovered. in three pharmacies. “HIV-positive patients who receive a counterfeit run a risk of treatment failure,” she said.
Earlier this month, Gilead warned that falsified and counterfeit versions of its anti-HIV drugs Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide) and Descovy (emtricitabine / tenofovir alafenamide) were “circulating in drug distribution channels. Americans “.
The deadline will not be extended
In response to a question at the end, Verbois said there were no plans to extend the 2023 deadline for enforcing interoperability requirements.
“The FDA’s goal is not to extend the November deadline for interoperability… We have been working at full speed to ensure that we can meet our goal of an interoperable system by 2023,” a- she declared.
When asked if the agency would provide more information and clarity on June’s improved systems guidance, Verbois said it “cannot give more details” than what is already in the document. .
She noted, however, that the agency was able to respond to industry requests by giving it more time to comment on the draft guidelines. (RELATED: Update: FDA grants industry 30-day extension to comment on tracking and traceability guidelines, Regulatory guidance, August 2, 2021)
Soon the regulations
In other areas, Verbois said the FDA will be issuing regulatory proposals “very soon” on licensing requirements for wholesalers and third-party logistics providers. She declined to give a specific date.
“Please know that we are working very hard within the agency to get things done… we are committed to ensuring that this part of the DSCSA is implemented. We think this is a very important part of DSCSA.
The FDA has been slow to release these licensing regulations, which were due to be in place by November 2015. Such regulations must be in place before wholesale distributors and third-party logistics providers take possession of the products; the law requires that pharmaceutical manufacturers only accept pharmaceuticals from “authorized business partners” or parties duly authorized or registered to receive or transfer products.
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