PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 977
‘‘(i) in a therapeutic category in which the approved racemic drug has been approved; or ‘‘(ii) for which any other enantiomer of the racemic drug has been approved. ‘‘(2) LIMITATION.— ‘‘(A) NO APPROVAL IN CERTAIN THERAPEUTIC CATEGORIES.—Until the date that is 10 years after the date of approval of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph, the Secretary shall not approve such non-racemic drug for any condition of use in the therapeutic category in which the racemic drug has been approved. ‘‘(B) LABELING.—If applicable, the labeling of a nonracemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug. ‘‘(3) DEFINITION.— ‘‘(A) IN GENERAL.—For purposes of this subsection, the term ‘therapeutic category’ means a therapeutic category identified in the list developed by the United States Pharmacopeia pursuant to section 1860D–4(b)(3)(C)(ii) of the Social Security Act and as in effect on the date of the enactment of this subsection. ‘‘(B) PUBLICATION BY SECRETARY.—The Secretary shall publish the list described in subparagraph (A) and may amend such list by regulation. ‘‘(4) AVAILABILITY.—The election referred to in paragraph (1) may be made only in an application that is submitted to the Secretary after the date of the enactment of this subsection and before October 1, 2012.’’.
Deadline.
SEC. 1114. REPORT.
dkrause on GSDDPC44 with PUBLAW
Not later than January 1, 2012, the Comptroller General of the United States shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that examines whether and how this subtitle has— (1) encouraged the development of new antibiotics and other drugs; and
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