DEA Raises ADHD Stimulant Production Limits for the Third Straight Fall as Shortages Persist
A Nov. 10 order lifts this year's quotas for amphetamine by up to 40 percent and methylphenidate by 19 percent. The 2027 proposal keeps them high, and comments close Dec. 10.
Idea in Brief
The News
The Drug Enforcement Administration raised its 2026 production quotas for d-amphetamine, d,l-amphetamine, methylphenidate and hydromorphone in a final order published Nov. 10, and proposed 2027 quotas the same day.
Our Numbers
By our comparison of DEA notices, the four main ADHD stimulants can be made in 84 percent more volume under the 2027 proposal than under the quotas DEA set for 2023.
The Move
Expect shortages to ease slowly, not at once: 73 amphetamine salt tablet listings are still in FDA's shortage database. Comments on 2027 close Dec. 10 and the telemedicine flexibilities end Dec. 31.
The Drug Enforcement Administration has raised the 2026 production limits for the main amphetamine and methylphenidate ingredients for the third fall in a row. A final order published Nov. 10, 2026 increases this year's aggregate production quota for d-amphetamine (for sale) by 40 percent, d,l-amphetamine by 31 percent, methylphenidate (for sale) by 19 percent and hydromorphone by 21 percent, effective immediately.
The same day, DEA published its proposed quotas for 2027, which keep all four stimulants at or above the new 2026 levels. Comments are due Dec. 10. For prescribers the practical question is when tablets reach pharmacies, and the documents suggest the answer is gradually.
What did DEA change on Nov. 10?
The order, signed Nov. 4 by DEA Administrator Terrance C. Cole, answers manufacturer requests made under a shortage provision of the Controlled Substances Act, 21 U.S.C. 826(h). That section requires DEA to finish reviewing a quota request within 30 days when the drug is on the Food and Drug Administration's shortage list. DEA says it skipped its usual comment period to meet that clock.
The requests themselves came in July and August. One hydromorphone manufacturer asked on July 24. Methylphenidate makers asked on July 31, Aug. 1 and Aug. 20. Two d,l-amphetamine manufacturers asked on Aug. 14 and Aug. 24, and a d-amphetamine maker on Aug. 14. By our count, publication came 78 to 109 days after those dates. The order does not say when each review was completed.
DEA's stated reasons are numbers from FDA. In July, FDA predicted that 2026 domestic medical need would rise 23.6 percent for d,l-amphetamine, 23.7 percent for d-amphetamine and 23.4 percent for methylphenidate compared with what was observed in 2025, and 20.9 percent for hydromorphone. DEA also cites a 173 percent rise this year in d,l-amphetamine quota approved for product development, which manufacturers use to make validation batches for new drug applications. For methylphenidate, it notes International Narcotics Control Board figures showing global stocks fell from 91.6 tons in 2023 to 80.6 tons in 2024.
Hydromorphone is the one opioid in the order, and its reasons are different. Multiple manufacturers reported shortages of hydromorphone hydrochloride injection to FDA, citing increased demand or manufacturing delays. DEA also found that one bulk manufacturer plans to export far more this year, putting 2026 hydromorphone exports 142 percent above 2025. For hospital teams that rely on injectable hydromorphone, the order is the first increase to this year's ceiling.
Lisdexamfetamine is missing from the Nov. 10 order but not from the agenda. The 2027 notice says DEA "recently proposed" higher 2026 quotas for lisdexamfetamine and methylphenidate and is carrying the same figures into 2027. For lisdexamfetamine, that is 62,833 kilograms, 22.5 percent above the quota DEA set for 2026 in January.
Our five-year quota table
To see how far the ceilings have moved, we pulled the established quotas from DEA's notices for 2023, 2024 and 2026, the Nov. 10 adjustment and the 2027 proposal. DEA published its 2025 table as an image, so we cite the 2025 mid-year adjustments in the text rather than the table.
| Substance | 2023 | 2024 | 2026 (Jan.) | 2026 (Nov. 10) | 2027 proposed | Change |
|---|---|---|---|---|---|---|
| d-Amphetamine (for sale) | 21,200 | 21,200 | 26,450 | 37,108 | 38,486 | +81.5% |
| d,l-Amphetamine | 21,200 | 21,200 | 24,234 | 31,655 | 32,903 | +55.2% |
| Lisdexamfetamine | 26,500 | 26,500 | 51,291 | no change | 62,833 | +137.1% |
| Methylphenidate (for sale) | 41,800 | 53,283 | 58,283 | 69,503 | 69,503 | +66.3% |
| Hydromorphone | 1,994 | 1,952 | 1,949 | 2,357 | 2,356 | +18.1% |
| Oxycodone (for sale) | 53,841 | 53,658 | 50,238 | no change | 49,830 | -7.4% |
| Hydrocodone (for sale) | 27,240 | 27,144 | 26,978 | no change | 26,842 | -1.5% |
Taken together, the four stimulants can be manufactured in 203,724 kilograms under the 2027 proposal against 110,700 kilograms in DEA's 2023 quotas, an increase of 84 percent by our arithmetic. Lisdexamfetamine has climbed fastest. DEA raised it mid-year on Sept. 5, 2024 (to 32,736 kilograms) and on Sept. 19, 2025 (to 39,908 kilograms), and an Oct. 2, 2025 order lifted d-amphetamine and methylphenidate. This month's order is the third autumn in a row of stimulant increases.
A higher quota removes a ceiling. It does not put tablets on a pharmacy shelf, and the shortage list shows how slowly the second follows the first.
Clinical Pearls
- The Nov. 10 order raises the 2026 d-amphetamine (for sale) quota 40.3 percent, d,l-amphetamine 30.6 percent, methylphenidate (for sale) 19.3 percent and hydromorphone 20.9 percent.
- FDA told DEA it expects 2026 domestic medical need for amphetamine and methylphenidate to run about 23 to 24 percent above 2025.
- The 2027 proposal sets lisdexamfetamine at 62,833 kilograms, 22.5 percent above the quota DEA established for 2026 in January.
- Proposed 2027 quotas for oxycodone, hydrocodone and fentanyl equal this year's levels minus DEA's diversion estimates, by our arithmetic.
- The quota is a ceiling on manufacturing. It does not tell any one manufacturer to make more, and shortages listed with FDA can persist after it rises.
- Controlled-substance telemedicine prescribing without an in-person visit is allowed through Dec. 31, 2026, under the fourth temporary extension.
Are the shortages over?
No. We queried FDA's drug shortage data through the openFDA drug shortages interface on Nov. 12. Amphetamine mixed salts tablets still carry 73 package listings marked as a current shortage, from 11 companies: 19 listed as unavailable and 14 as limited. The oldest of those listings was first posted Aug. 15, 2023. Extended-release methylphenidate tablets and film show 38 current listings from seven companies, six unavailable. Lisdexamfetamine capsules and chewable tablets show 108 current listings from 14 companies, 33 with limited availability and none unavailable. Hydromorphone injection shows 26 current listings, eight unavailable.
Those are counts of package listings, not of patients affected, and many listings are marked available. They do show that the shortage designation has outlasted several quota increases.
What the 2027 proposal says about opioids
The opioid side of the notice moves in the other direction. FDA forecasts that medical use of schedule II opioids will fall 9.68 percent on average in 2027. DEA's proposed opioid quotas fall far less than that, and our arithmetic shows why. The proposed 2027 figures for hydrocodone (for sale) and fentanyl equal the 2026 established quotas minus DEA's diversion estimates for those drugs, to the gram, and oxycodone (for sale) matches within one gram. Hydromorphone's 2027 figure is the newly raised 2026 quota minus its 1,177-gram diversion estimate. DEA builds those estimates from state prescription monitoring data on patients meeting red-flag criteria and from theft and loss reports, as 21 U.S.C. 826(i) requires for five opioids.
For stimulants, FDA forecasts a 3.93 percent average rise in 2027 medical use, while DEA's own projection from IQVIA and export data is 6.98 percent for each amphetamine ingredient. DEA writes that FDA "raised concerns over drug shortages potentially related to the growth in telemedicine, supply chain issues, manufacturing and quality issues, and business decisions of manufacturers."
What should prescribers watch?
Two dates matter before the year ends. Comments on the 2027 quotas close Dec. 10, 2026, under Docket No. DEA-1730P at regulations.gov. Practices that track fill failures or forced switches between formulations have the kind of data DEA asks for. And the fourth temporary extension of telemedicine prescribing flexibilities for controlled substances runs through Dec. 31, 2026, 49 days from today. DEA has not published a permanent special registration rule in the Federal Register. Until it does, a practice that starts ADHD treatment by video should know which patients would need an in-person visit if the flexibilities lapse.
The quota picture is also shifting at the edges of the stimulant class. DEA placed the new ADHD drug centanafadine in schedule III rather than schedule II on Oct. 30, and today it placed the narcolepsy drug oveporexton in schedule IV. Neither is subject to aggregate production quotas, which apply only to schedules I and II. For the drugs that are, the useful step this month is practical: confirm which strengths and formulations local pharmacies can actually fill, write prescriptions that allow a generic or equivalent substitution where clinically appropriate, and file any comments by Dec. 10.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
