IRS Issues Guidance on Annual Fee Imposed on Branded Prescription Drugs

Aug 24, 2011   
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On August 15, 2011, the U.S. Department of Treasury and Internal Revenue Service (IRS) issued temporary regulations (T.D. 9544) and proposed regulations (REG-112805-10) regarding the annual fee imposed on certain branded prescription drugs. The prescription drug fee was enacted by section 9008(a) of Patient Protection and Affordable Care Act (PPACA). The $2.5 billion excise tax is an aggregate annual fee imposed on branded prescription drug manufacturers and importers with gross receipts over $5 million from sales to specified government programs. Please see our previous report here for more information regarding the prescription drug fee and the PPACA.

The temporary and proposed regulations describe the rules and actions of the prescription drug fee to be taken before the annual September 30th due date. The regulations are generally consistent with previous IRS guidance documents regarding the prescription drug fee. The regulations provide guidance regarding:

  • A general overview of the fee rules
  • An explanation of terms used in implementing the fee
  • A description of the information requested from covered entities and provided by specified government programs
  • A description of how the fee and subsequent adjustments are calculated
  • Rules relating to the notice of preliminary fee calculation, dispute resolution process, and notification of final fee calculation
  • An explanation of how to pay the fee, how the fee is treated for tax purposes, and how to make refund claims

See the official release of the documents in the August 18th Federal Register here and here. The Department of Treasury and the IRS are seeking public comment until November 16, 2011. The attorneys at Fuerst Ittleman, PL are knowledgeable in both tax and food and drug law. If you have questions regarding the prescription drug excise tax, please contact us at