DEA production quotas and drug shortages

On Aug. 1, 2023, the heads of FDA and the Drug Enforcement Administration published an open letter addressed "Dear Americans." It said that in 2022, makers of amphetamine products had "only sold approximately 70 percent of their allotted quota for the year," leaving "approximately 1 billion more doses that they could have produced but did not make or ship," according to the joint letter¹.

Their letter came nearly a year into a shortage of mixed amphetamine salts tablets, which FDA first posted on Oct. 12, 2022, and which was still listed as current on Nov. 3, 2026, according to GxRadar's shortage tracker. It named two causes: a manufacturing delay at one drug maker that began in the fall of 2022, and record prescribing, with stimulant dispensing up 45.5 percent from 2012 to 2021. And it pointed to a control that applies to only a small set of medicines, DEA's yearly limit on how much of each Schedule II substance may be produced.

This piece explains how those limits work, how they connect to FDA's shortage list, and what DEA's own Federal Register notices show about stimulant quotas from 2023 to 2026. It does not cover prices. Questions about a specific prescription belong with the prescriber or pharmacist.

Three kinds of quota

The Controlled Substances Act tells the Attorney General to set production quotas for each basic class of Schedule I and II substance, sized 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," under 21 U.S.C. 826(a)². The job is delegated to DEA's administrator.

DEA's rules in 21 CFR part 1303³ define three types. An aggregate production quota is the total quantity of a substance that all manufacturers combined may produce in a calendar year. An individual manufacturing quota is the most a registered bulk manufacturer, the firm making the active ingredient, may make. A procurement quota is the most a manufacturer may buy to turn into finished tablets, capsules or injections. Quotas are stated in grams of anhydrous acid or base.

In setting the aggregate figure, the administrator must weigh the factors listed in 21 CFR 1303.11⁴: sales over the current and two preceding years, inventories, the procurement quotas manufacturers have requested, the extent of diversion, information from FDA, CDC, CMS and the states, and "potential disruptions to production." For five opioids (fentanyl, oxycodone, hydrocodone, oxymorphone and hydromorphone), a 2023 rule requires DEA to estimate diversion and cut quotas to account for it, according to the final rule⁵.

The quota calendar

DEA's 2023 quota rule, effective Nov. 29, 2023, also moved several deadlines later in the year. DEA said in the rule that it "frequently misses" the old ones.

Sources: 21 CFR part 1303³; 88 FR 60117⁵ (Aug. 31, 2023).

The rules also limit stockpiles. A bulk manufacturer whose inventory of a substance exceeds 55 percent of its estimated net disposal for the year (roughly, what it expects to distribute) has its manufacturing quota suspended until the inventory falls. Procurement quotas are suspended above 50 percent, or 65 percent for liquid injectables, under the part 1303³ inventory sections.

Where the shortage list comes in

Congress tied quotas to FDA's shortage list in 2012. Under section 826(h)², when a manufacturer asks for more quota for a Schedule II drug that is on FDA's list, DEA has 30 days to either raise the aggregate and individual quotas "to the level requested" or give a written explanation, which FDA must post online. The trigger is the manufacturer's request. FDA's list only makes the request eligible. Our piece on why FDA's list is smaller than ASHP's explains why that list, and not the larger one, is the one the law uses.

FDA and DEA also coordinate outside that clock. FDA's 2025 report to Congress¹⁵ said its shortage staff contacted DEA on 30 occasions that year about potential shortages, under a memorandum of understanding between the agencies. The report cited one result: after an FDA letter in July 2024 about lisdexamfetamine, DEA granted an increase in September 2024.

What the stimulant notices show

Each adjustment is published as a final order after a manufacturer's request. The 2023 and 2024 orders also began with a letter from FDA; in the 2025 orders, DEA said it had reviewed FDA's shortage list itself. In all four, DEA wrote that it was "not possible to increase the APQ within the Congressionally-mandated 30-day period" under its usual procedures, so the order was "published without opportunity for comment and made effective immediately."

In the methylphenidate order of Oct. 3, 2023⁶, DEA said FDA wrote on Aug. 10 that it had added methylphenidate extended-release tablets to the shortage list on July 26, and that a manufacturer asked for more quota on Sept. 14. In the lisdexamfetamine order of Sept. 5, 2024⁷, FDA's July 12 letter said "shortage of an active ingredient" was the reason for the shortage of all marketed generic lisdexamfetamine capsules and chewable tablets. Because some makers produce lisdexamfetamine from d-amphetamine, DEA raised that quota too. A Sept. 19, 2025 order⁸ raised both again, noting that bulk makers had started 2025 below the 40 percent inventory allowance. An Oct. 2, 2025 order⁹ raised d-amphetamine and methylphenidate for sale, in part to support work toward FDA approval of new ingredient processes and new products.

Sources: DEA established quotas for 2023¹⁰, 2024¹¹ and 2026¹³, and the four adjustment orders linked above. DEA publishes the figures in grams; GxRadar converted them to kilograms and rounded. The "for conversion" d-amphetamine quota covers material made into another substance, such as lisdexamfetamine, per the 2024 order.

Why a higher ceiling does not end a shortage

A quota is a ceiling. The joint letter said plainly that "the FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug." What the agencies did instead was ask manufacturers that would not increase production to give back their unused 2023 quota. The rules allow that. Under the part 1303 abandonment sections, DEA may hand surrendered quota to other manufacturers "in proportion to their respective quotas."

Outside researchers say the system is hard to see into. A 2025 study¹⁶ of University of Utah shortage data counted 26 shortages of the stimulants it grouped as amphetamine derivatives, methylphenidate included, from 2001 through 2023, with seven each in 2012, 2013, 2015 and 2023, and found that 58 percent of manufacturers gave no reason. The authors wrote that how much quota DEA gives each manufacturer is not public, "nor are the total amounts manufactured."

Stimulants are not the only Schedule II drugs on FDA's list. Of the 69 current shortages on Nov. 3, 2026, 11 involved Schedule II substances: five stimulant entries (mixed amphetamine salts tablets, lisdexamfetamine capsules and chewable tablets, and two extended-release methylphenidate products) and six injectable opioids (fentanyl, hydromorphone, meperidine, morphine, remifentanil and sufentanil), according to GxRadar's count of openFDA shortage data¹⁷. The opioid injections are sterile products with their own manufacturing constraints, discussed in why sterile injectables dominate shortage lists. FDA lists their reasons as "Other," "Demand increase" or nothing at all; quotas are not among the statute's seven reason categories. For what to ask when a pharmacy cannot fill a controlled-substance prescription, see our back-order guide.

What to watch

DEA proposed a rewrite of its quota application rules on May 20, 2026. It said the changes are needed "to increase visibility into the controlled substance supply chain by providing DEA with more detailed information allowing the agency to react more precisely in preventing drug shortages," according to the proposed rule¹⁴. Comments closed July 20, 2026, and no final rule had appeared by early November.

DEA's quota calendar has also slipped. The 2026 quotas were proposed on Nov. 28, 2025¹² and set on Jan. 5, 2026¹³, months after the Sept. 1 date in DEA's own rule. As of Nov. 4, 2026, the Federal Register had published no proposed quotas for 2027. GxRadar's guides to FDA's shortage database and how long shortages last track the stimulant entries in the meantime.