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IRS issues temporary and proposed regulations for branded prescription drug fee

18 August 2011

Pharmaceutical and Biotechnology Alert

On 15 August, the Internal Revenue Service (IRS) issued identical temporary and proposed regulations to govern the branded prescription drug fee imposed on pharmaceutical manufacturers under Section 9008 of the Patient Protection and Affordable Care Act (PPACA). The proposed regulations (76 Fed. Reg. 51245) are effective 18 August and are accompanied by a notice of proposed rulemaking (76 Fed. Reg. 51310) laying out the procedure for commenting. Comments on the proposed regulations are due by 16 November, except for comments on the paperwork/information collection aspect of the proposed regulations, which are due by 17 October.



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