21 U.S.C. § 826 — Production quotas for controlled substances

(a)(1) Each year the Attorney General must determine the total amount and set production^* quotas for each basic class of schedule I and II controlled substances and for ephedrine, pseudoephedrine, and phenylpropanolamine. The amounts must cover estimated United States medical, scientific, research, and industrial needs, lawful exports, and reserve stocks. Quotas generally state^* amounts of basic classes, not individual dosage forms. (2) To help avoid overproduction, shortages, or diversion, the Attorney General may instead set an aggregate or individual production quota, or a regulated procurement quota, in dosage-form terms.

(b) The Attorney General must limit or reduce manufacturers' individual quotas enough to keep their total from exceeding the annual amount under (a). Each manufacturer's quota must be reduced in the same proportion. If a registrant made more than its revised quota before the reduction was issued, the excess comes out of its next year's quota.

(c) By December 1 each year, after a registered manufacturer^* applies, the Attorney General must set its quota for the classes and chemicals it seeks to make, subject to (a) and (b). The Attorney General must consider the manufacturer's expected disposal, inventory, and other needs, current disposal rate, national disposal trend in the prior year, production cycle and inventory, raw-material availability, yield and stability problems, emergencies such as strikes and fires, and other factors.

(d) On application, the Attorney General must set a quota for a registrant that did not manufacture^* the class or listed chemicals in one or more earlier calendar years, subject to (a) and (b). The Attorney General must consider reasonably expected current-year needs and relevant factors from (c).

(e) During the year, a registrant that applied for or received a quota may ask for an increase to meet remaining-year disposal, inventory, and other needs. The Attorney General must consider events since the original application that may require faster production and may consider any unused amount by which the (a) determination exceeds all registrants' quotas.

(f) No registration or quota is required for quantities of a schedule I or II substance or listed chemical^* that necessarily and incidentally result from a registered manufacturing process for another covered substance or chemical. The Attorney General may restrict retention and disposal of those incidental products by rule.

(g) Each reference to ephedrine, pseudoephedrine, or phenylpropanolamine includes its salts, optical isomers, and salts of optical isomers.

(h)(1) Within 30 days after receiving a qualifying request, the Attorney General must review it and either increase aggregate and individual quotas for a shortage drug^* and its ingredients to the requested level when necessary, or give a written explanation when that level is unnecessary. The Secretary must post that explanation on the Food and Drug Administration website. (2) A qualifying request concerns a schedule II controlled substance^* on the section 356e shortage list and is submitted by its manufacturer.

(i)(1) For fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone, called a “covered controlled substance” here, the Attorney General must estimate United States diversion when setting a production or procurement quota. The estimate must consider reliable information selected with the Health and Human Services Secretary about overdose deaths, abuse, and overall public-health effects, and may use other reliable information. After the estimate, the Attorney General must make appropriate reductions from the quota that would otherwise have been set. (2) If the approved aggregate quota is higher than the prior year's, the final order must, after consultation with the Secretary, explain why the public-health benefits clearly outweigh the consequences of more product being available for sale and possible diversion. Within one year after October 24, 2018, and yearly afterward, the Attorney General must report to the listed Senate and House committees anonymized counts of manufacturers receiving individual quotas and of those receiving a higher quota than the previous year. (3) Within one year after that date, the Attorney General must report to Congress how quota decisions will account for changes in accepted medical use and how the Attorney General will work with the Secretary on appropriate anonymous estimates of covered substances submitted to approved collection receptacles, mail-back programs, and take-back events. This section does not define “covered controlled substance.”