Sec. 3282. Strengthening considerations for DEA opioid quotas
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/bill/115/hr/6/eah/section-3282A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 306 of the Controlled Substances Act ( 21 U.S.C. 826 ) is amended— in subsection (a)— by inserting
(1)after
(a); in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production ; and by adding at the end the following: The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. ; in subsection (b), in the first sentence, by striking production and inserting manufacturing ; in subsection (c), by striking October and inserting December ; and by adding at the end the following: In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance ), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. In estimating diversion under this paragraph, the Attorney General— shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and may take into consideration whatever other sources of information the Attorney General determines reliable. After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States. Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance: An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year. Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— take into consideration changes in the accepted medical use of the covered controlled substances; and work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. . The Law Revision Counsel is directed to amend the heading for subsection
(b)of section 826 of title 21, United States Code, by striking and inserting production . manufacturing
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Sec. 3282
Strengthening considerations for DEA opioid quotas
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