TD 9544 (REG-112805-10) - Branded Prescription Drugs

Section 9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148 (124 Stat. 119 (2010)), as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010 (HCERA), Public Law 111-152 (124 Stat. 1029 (2010)) imposes an annual fee on manufacturers and importers of branded prescription drugs that have gross receipts of over $5 million from the sales of these drugs to certain government programs (covered entity/covered entities). The previously approved final regulations supersede temporary regulations and describe how the IRS will administer the branded prescription drug fee. Section 51.7T(b) of the temporary regulations provides that the IRS will send each covered entity notification of its preliminary fee calculation by May 15 of the fee year. If a covered entity chooses to dispute the IRS' preliminary fee calculation, the covered entity must follow the procedures for submitting an error report that are established in §51.8T.

The latest form for TD 9544 (REG-112805-10) - Branded Prescription Drugs expires 2022-02-28 and can be found here.