The Internal Revenue Service has published final regulations that provide guidance on the annual fee imposed by the Affordable Care Act on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The regulations describe the rules related to the fee, including how it is computed and how it is paid. The document also withdraws the Branded Prescription Drug Fee temporary regulations published August 18, 2011, and contains new temporary regulations regarding the definition of “controlled group” that apply beginning on January 1, 2015. The text of the temporary regulations also serves as the text of proposed regulations. Comments on the proposed regulations and requests for a public hearing must be received by October 27, 2014. Finally, the IRS also has issued Notice 2014-42, which provides additional guidance on the fee for 2015 and subsequent years.