21 U.S.C. § 826a — Attorney General report on drug shortages
submitted 14 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 148 words · no verdicts yet
The Attorney General must report yearly to Congress on drug shortages, starting six months after July 9, 2012. The report must cover requests, denials, and review times under section 826(h). It must also describe DEA-FDA coordination and name controlled-substance drugs the Secretary finds in shortage.
The Attorney General must send a report on drug* shortages to two congressional committees. They are the House Committee on Energy and Commerce, and the Senate Committee on the Judiciary.
The first report was due within six months of July 9, 2012. After that, the Attorney General must send this report every year.
The report must cover three things. First, it must count the requests received under section 826(h) and state* their average review time. It must also count how many were granted and denied, giving the reason for each denial. Second, it must describe how the Drug Enforcement Administration* and the Food and Drug Administration work together to prevent or fix drug shortages. Third, it must name drugs containing a controlled substance* covered by section 826 that the Secretary has determined are currently in shortage.
facts
Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug* shortages that—
identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial;
describes the coordination between the Drug Enforcement Administration* and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and
identifies drugs containing a controlled substance* subject to section 826 of this title when such a drug is determined by the Secretary to be in shortage.
Source credit: (Pub. L. 112–144, title X, § 1006, July 9, 2012, 126 Stat. 1105.)
- 2012Enacted · Pub. L. 112-144 · 126 Stat. 1105
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