Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In 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.
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