Designated drugs during noncompliance periods

There is hereby imposed on the sale by the manufacturer, producer, or importer of any designated drug during a day described in subsection (b) a tax in an amount such that the applicable percentage is equal to the ratio of— A day is described in this subsection with respect to a designated drug if it is a day during one of the following periods: The period beginning on the March 1st (or, in the case of initial price applicability year 2026, the October 2nd) immediately following the date on which such drug is included on the list published under section 1192(a) of the Social Security Act and ending on the earlier of— The period beginning on the November 2nd immediately following the March 1st described in paragraph (1) (or, in the case of initial price applicability year 2026, the August 2nd immediately following the October 2nd described in such paragraph) and ending on the earlier of— In the case of any designated drug which is a selected drug (as defined in section 1192(c) of the Social Security Act) that the Secretary of Health and Human Services has selected for renegotiation under section 1194(f) of such Act, the period beginning on the November 2nd of the year that begins 2 years prior to the first initial price applicability year of the price applicability period for which the maximum fair price established pursuant to such renegotiation applies and ending on the earlier of— A day shall not be taken into account as a day during a period described in subsection (b) if such day is also a day during the period— beginning on the first date on which— ending on the last day of February following the earlier of— For purposes of this subsection, the term “applicable agreement” means the following: An agreement under— For purposes of this section, the term “applicable percentage” means— For purposes of this section— The term “designated drug” means any negotiation-eligible drug (as defined in section 1192(d) of the Social Security Act) included on the list published under section 1192(a) of such Act which is manufactured or produced in the United States or entered into the United States for consumption, use, or warehousing. The term “United States” has the meaning given such term by section 4612(a)(4). The terms “initial price applicability year”, “price applicability period”, and “maximum fair price” have the meaning given such terms in section 1191 of the Social Security Act. Rules similar to the rules of paragraphs (2) and (4) of section 4132(c) shall apply for purposes of this section. In the case of a sale which was timed for the purpose of avoiding the tax imposed by this section, the Secretary may treat such sale as occurring during a day described in subsection (b). Rules similar to the rules of section 4662(e) (other than section 4662(e)(2)(A)(ii)(II)) shall apply for purposes of this chapter. The Secretary shall prescribe such regulations and other guidance as may be necessary to carry out this section.