Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said. So, the pharmaceutical companies then pushed to get their 505(b)(2) drugs declared sole source,” Soefje said. “If This went into effect in January 2022.”
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