Rev. Proc. 2025-09 provides a safe harbor under which a manufacturer, producer, or importer may identify the applicable sales of a designated drug made during a day described in section 5000D(b) by using a safe harbor percentage. It also provides such safe harbor percentage. A manufacturer, producer, or importer may use the safe harbor and safe harbor percentage provided in this revenue procedure until the proposed regulations are finalized or other guidance is published in the Internal Revenue Bulletin or the Federal Register.

WILL BE IN IRB: 2025-4 DATED: January 21, 2025