Sec. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE
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## SEC. 1005 QUOTAS APPLICABLE TO DRUGS IN SHORTAGE Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended by adding at the end the following: > > ### “(h) > > > ####
(1)> > Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall— > > > ##### “(A) > > complete review of such request; and > > > ##### “(B) > > > ######
(i)> > as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled substance and any ingredient therein to the level requested; or > > > ###### “(ii) > > if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide a written response detailing the basis for the Attorney General’s determination. > > The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration. > > > #### “(2) > > A request is described in this paragraph if— > > > ##### “(A) > > the request pertains to a controlled substance on the list of drugs in shortage maintained under section 506E of the Federal Food, Drug, and Cosmetic Act; > > > ##### “(B) > > the request is submitted by the manufacturer of the controlled substance; and > > > ##### “(C) > > the controlled substance is in schedule II.” > .
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Sec. 1005
QUOTAS APPLICABLE TO DRUGS IN SHORTAGE
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