FDA official: Agency will not extend 2023 DSCSA interoperability deadline

Regulatory NewsRegulatory News | 11 August 2021 |  By 

The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by the November 2023 deadline set by the Drug Supply Chain Security Act (DSCSA), with no plans to extend the deadline for manufacturers to comply with these requirements.
So asserted Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research, who discussed DSCSA implementation at a 9 August webinar sponsored by the Healthcare Distribution Alliance. A good part of her remarks addressed the third and last piece of DSCSA calling for trading partners to have such systems in place; this provision of the law is considered the most intricate and difficult piece to develop and implement.
In June, FDA released its electronic tracking guidance. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus, 4 June 2021)
Verbois told attendees that the agency is busy at work in developing a framework for interoperability. “We recognize that there are a number of important issues associated with the enhanced systems and the architecture and the system attributes. We have been working within the agency to understand the interplay between the elements that are necessary to build a system.”
Verbois also asserted that while the US has “one of the safest supply chains in the world,” DSCSA is still needed to counter the 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, had been discovered at three pharmacies. “HIV patients that receive a counterfeit are at risk of treatment failure,” she asserted.

Earlier this month Gilead warned that tampered and counterfeit versions of its HIV drugs Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir alafenamide) were in found "in circulation within US drug distribution networks."
Deadline will not be extended
In response to a question at the end, Verbois said there are no plans to extend the 2023 deadline for enforcing the interoperability requirements.
“It is FDA’s goal that we not extend the November deadline for interoperability ... We have been working at a full tilt to make sure that we can make our goal of an interoperable system by 2023," she said.
When asked whether the agency will be providing more information and clarity on the June enhanced systems guidance, Verbois said that she “cannot give more details” other than what is already in the document.
She noted, however, that the agency was able to accommodate industry requests allowing more time to comment on the draft guidance. (RELATED: Updated: FDA grants industry 30-day extension to comment on track and trace guidance, Regulatory Focus, 2 August 2021)
Rulemaking coming soon
In other areas, Verbois said that FDA will “very soon” be issuing a proposed rulemaking on licensing requirements for wholesalers and third-party logistics providers. She declined to provide a specific date.
“Please know that we are working really hard within the agency to move that forward … we are committed to ensuring that this part of DSCSA is implemented. We feel it is a very important part of DSCSA.”
FDA has been late in issuing these licensing regulations, which were supposed to be in place by November 2015. Such regulations need to be in place before wholesale distributors and third party logistics providers take possession of products; the law mandates that pharmaceutical manufacturers only accept drug products from “authorized trading partners” or parties that are properly licensed or registered to receive or transfer products.


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