§ 826. Production quotas for controlled substances

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1970

   Controlled Substances Act

   Pub. L. 91–513 title II § 306 · 84 Stat. 1236

   Enacted · 21 U.S.C. § 826

   Pub. L. 91–513, title II, § 306, Oct. 27, 1970, 84 Stat. 1257

   Source evidence

   Code source credit
   Pub. L. 91–513, title II, § 306, Oct. 27, 1970, 84 Stat. 1257

   Enacted provision · exact public law section
   Sec. 306. quotas applicable to certain substances (a) The Attorney General shall determine the total quantity Production quota. and establish production quotas for each basic class of controlled substance in schedules I and II to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance. (b) The Attorney General shall limit or reduce individual production quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II shall be revised in the same proportion as the 1 imitation or reduction of the aggregate of the quotas. However, if any registrant, lie fore the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year. (c) On or before July 1 of each year, upon application therefor by Manufacturing quota. a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II that, the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manufacturer’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the manufacturer’s current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer’s production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors. (d) The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance, during one or more preceding calendar years. In fixing such quota, the Attorney General shall take into account the registrant’s reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in subsection (c) of this section as may be relevant. (e) At any time during the year any registrant who has applied Quota, increase. for or received a manufacturing quota for a basic class of controlled substance in schedule I or II may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences since (he filing of the registrant’s initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate of the quotas of all registrants under this section. (f) Notwithstanding any other provisions of this title, no registration Controlled substances, incidental production. or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance with respect to which its manufacturer Restrictions. is duly registered under this title. The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances.

2. 1976

   Fiscal Year Adjustment Act

   Pub. L. 94–273 § 3(16) · 90 Stat. 375

   Substituted · 21 U.S.C. § 826(c)

   Pub. L. 94–273 substituted “October” for “July”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 94–273 substituted “October” for “July”.

   Enacted provision · exact public law section
   (16) section 306(c) of the Controlled Substances Act (21 U.S.C. 826(c));

3. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(1) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(a)

   Pub. L. 109–177, § 713(1), inserted “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for each basic class of controlled substance in schedules I and II”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 109–177, § 713(1), inserted “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for each basic class of controlled substance in schedules I and II”.

   Enacted provision · exact public law section
   (1) in subsection (a), by inserting “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for each basic class of controlled substance in schedules I and II”;

4. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(2) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(b)

   Pub. L. 109–177, § 713(2), inserted “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for each basic class of controlled substance in schedule I or II”

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 109–177, § 713(2), inserted “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for each basic class of controlled substance in schedule I or II”.

   Enacted provision · exact public law section
   (2) in subsection (b), by inserting “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for each basic class of controlled substance in schedule I or II”;

5. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(3) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(c)

   Pub. L. 109–177, § 713(3), inserted “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for the basic classes of controlled substances in schedules I and II”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 109–177, § 713(3), inserted “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for the basic classes of controlled substances in schedules I and II”.

   Enacted provision · exact public law section
   (3) in subsection (c), in the first sentence, by inserting “and for ephedrine, pseudoephedrine, and phenylpropanolamine” after “for the basic classes of controlled substances in schedules I and II”;

6. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(4) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(d)

   Pub. L. 109–177, § 713(4), inserted “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “that basic class of controlled substance”

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 109–177, § 713(4), inserted “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “that basic class of controlled substance”.

   Enacted provision · exact public law section
   (4) in subsection (d), by inserting “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “that basic class of controlled substance”;

7. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(5) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(e)

   Pub. L. 109–177, § 713(5), inserted “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for a basic class of controlled substance in schedule I or II”

   Source evidence

   Code amendment note
   Subsec. (e). Pub. L. 109–177, § 713(5), inserted “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for a basic class of controlled substance in schedule I or II”.

   Enacted provision · exact public law section
   (5) in subsection (e), by inserting “or for ephedrine, pseudoephedrine, or phenylpropanolamine” after “for a basic class of controlled substance in schedule I or II”;

8. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(6) · 120 Stat. 192

   Inserted · 21 U.S.C. § 826(f)

   Pub. L. 109–177, § 713(6), inserted “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “controlled substances in schedules I and II”, “or of ephedrine, pseudoephedrine, or phenylpropanolamine” after “the manufacture of a controlled substance”, and “or chemicals” after “such incidentally produced substances”

   Source evidence

   Code amendment note
   Subsec. (f). Pub. L. 109–177, § 713(6), inserted “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “controlled substances in schedules I and II”, “or of ephedrine, pseudoephedrine, or phenylpropanolamine” after “the manufacture of a controlled substance”, and “or chemicals” after “such incidentally produced substances”.

   Enacted provision · exact public law section
   (6) in subsection (f)— (A) by inserting “or ephedrine, pseudoephedrine, or phenylpropanolamine” after “controlled substances in schedules I and II”; (B) by inserting “or of ephedrine, pseudoephedrine, or phenylpropanolamine” after “the manufacture of a controlled substance”; and (C) by inserting “or chemicals” after “such incidentally produced substances”; and

9. 2006

   Combat Methamphetamine Epidemic Act of 2005

   Pub. L. 109–177 § 713(7) · 120 Stat. 192

   Added · 21 U.S.C. § 826(g)

   Pub. L. 109–177, § 713(7), added subsec. (g)

   Source evidence

   Code amendment note
   Subsec. (g). Pub. L. 109–177, § 713(7), added subsec. (g).

   Enacted provision · exact public law section
   (7) by adding at the end the following subsection: “(g) Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.” .

10. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 title X § 1005 · 126 Stat. 993

    Added · 21 U.S.C. § 826(h)

    Pub. L. 112–144 added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 112–144 added subsec. (h).

    Enacted provision · exact public law section
    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) Deadline. Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall— “(A) Review. 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) Determination. 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 Public information. Web posting. 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.” .

11. 2018

    Opioid Quota Reform Act

    Pub. L. 115–271 § 3282(a)(1) · 132 Stat. 3894

    1. Amended · 21 U.S.C. § 826(a)

       Pub. L. 115–271, § 3282(a)(1), designated existing provisions as par. (1)

    2. Substituted · 21 U.S.C. § 826(a)

       Pub. L. 115–271, § 3282(a)(1), substituted “Except as provided in paragraph (2), production” for “Production” in second sentence

    3. Added · 21 U.S.C. § 826(a)

       Pub. L. 115–271, § 3282(a)(1), added par. (2)

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 115–271, § 3282(a)(1), designated existing provisions as par. (1), substituted “Except as provided in paragraph (2), production” for “Production” in second sentence, and added par. (2).

    Enacted provision · exact public law section
    (1) in subsection (a)— (A) by inserting “(1)” after “(a)”; (B) in the second sentence, by striking “Production” and inserting “Except as provided in paragraph (2), production”; and (C) by adding at the end the following: “(2) 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.” ;

12. 2018

    Opioid Quota Reform Act

    Pub. L. 115–271 § 3282(a)(2) · 132 Stat. 3894

    Substituted · 21 U.S.C. § 826(b)

    Pub. L. 115–271, § 3282(a)(2), substituted “reduce individual manufacturing” for “reduce individual production”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 115–271, § 3282(a)(2), substituted “reduce individual manufacturing” for “reduce individual production”.

    Enacted provision · exact public law section
    (2) in subsection (b), in the first sentence, by striking “production” and inserting “manufacturing”;

13. 2018

    Opioid Quota Reform Act

    Pub. L. 115–271 § 3282(a)(3) · 132 Stat. 3894

    Substituted · 21 U.S.C. § 826(c)

    Pub. L. 115–271, § 3282(a)(3), substituted “December” for “October”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 115–271, § 3282(a)(3), substituted “December” for “October”.

    Enacted provision · exact public law section
    (3) in subsection (c), by striking “October” and inserting “December”; and

14. 2018

    Opioid Quota Reform Act

    Pub. L. 115–271 § 3282(a)(4) · 132 Stat. 3894

    Added · 21 U.S.C. § 826(i)

    Pub. L. 115–271, § 3282(a)(4), added subsec. (i)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 115–271, § 3282(a)(4), added subsec. (i).

    Enacted provision · exact public law section
    (4) by adding at the end the following: “(i) (1) (A) 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. “(B) In estimating diversion under this paragraph, the Attorney General— “(i) 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 “(ii) may take into consideration whatever other sources of information the Attorney General determines reliable. “(C) 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. “(2) (A) 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. “(B) 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: “(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. “(ii) 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. “(3) 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— “(A) take into consideration changes in the accepted medical use of the covered controlled substances; and “(B) 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.” .

16 of 16 references resolved to an enrolled provision