QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.

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.” .