A Shift in Policy? DEA Finally Raises Quotas for Amphetamine, Methylphenidate, and Hydromorphone
By Hunter DeKoninck
Published: November 10, 2026
On November 10, 2026, DEA published a final order raising the 2026 aggregate production quotas (APQ) for four Schedule II substances: d,l-amphetamine, d-amphetamine (for sale), methylphenidate (for sale), and hydromorphone. The order, Adjustment to the 2026 Aggregate Production Quota, 91 Fed. Reg. 72564 (Docket No. DEA-1568M), is effective immediately.
After years of flat or shrinking quotas for several of the drugs, these increases for 2026 are large. DEA also published its proposed 2027 quotas the same day, and they hold the higher levels. Below is a summary of the changes, along with the percentage change for each drug to highlight how large the adjustments are:
Substance | Prior 2026 APQ | Adjusted 2026 APQ | Change |
d,l-amphetamine | 24,234,443 | 31,654,915 | +30.6% |
d-amphetamine (for sale) | 26,450,000 | 37,108,041 | +40.3% |
Methylphenidate (for sale) | 58,283,000 | 69,502,651 | +19.3% |
Hydromorphone | 1,949,378 | 2,356,798 | +20.9% |
Why DEA Acted Without Comment
In issuing this final order, DEA acted under 21 U.S.C. § 826(h), which requires DEA to review a manufacturer’s quota request within 30 days when the drug is on FDA’s shortage list and to raise the quota to the requested level if an increase is necessary to address the shortage. DEA said it could not satisfy the 30-day clock and the comment procedures in 21 C.F.R. § 1303.13, so the order issued without notice and comment.
DEA’s stated rationale for the increases is demand. DEA’s move appears to be in response to FDA’s demand projections and shortage listings, rather than an admission that earlier quotas were too low. FDA projected 2026 domestic medical need to rise over 2025 by 23.6% for d,l-amphetamine, 23.7% for d-amphetamine, 23.4% for methylphenidate, and 20.9% for hydromorphone. DEA also cited sharply higher quota use for product development (up 173% for d,l-amphetamine and 32% for d-amphetamine year to date), a projected 142% jump in hydromorphone exports from one bulk manufacturer, and declining global methylphenidate stocks.
Notably, for amphetamine, DEA said sufficient quota had already been granted to meet patient needs and that the increase was necessary to build reserve stocks to start next year.
How This Compares to Prior Years
The chart below shows each drug’s initial and year-end quota from 2020 through 2026, plus the 2027 proposal. Three patterns stand out:
Amphetamine quotas sat at 21.2 million grams each for years (from 2021 through 2024 for d-amphetamine and through 2025 for d,l-amphetamine) before the recent increases.
Methylphenidate quotas were cut from 57.4 million grams in 2021 to 41.8 million for 2022, then later raised to 53.3 million in 2023 and again raised to 58.3 million in 2025. Today’s new 69.5 million quota is about 66% above the 2022 level.
Hydromorphone has trended the other way, falling from 3.5 million grams at the end of 2020 to about 1.95 million, so even after this increase it sits far below 2020’s quota.
What It Means for the Industry
Manufacturers - This is more room to produce and rebuild reserve stocks heading into 2027.
Distributors and Pharmacies - Relief will not be immediate. A quota is a ceiling rather than a delivery, and this one took effect with fewer than two months left in the year; DEA itself framed the amphetamine increase as reserve-building.
My Read
In my view, the more interesting question is whether these increases may signal a broader shift in DEA’s views toward quotas and stimulant supply. I read it as a pivot from restraint (i.e. a law enforcement-minded approach that was concerned with restricting available supply) to responsiveness (i.e. a regulatory-minded approach that gives more weight to public demand, FDA’s forecasts and the industry’s stated needs), with three caveats.
First, the pivot did not start today. The 2023 methylphenidate increase of about 27% and the 2025 d-amphetamine and methylphenidate adjustments came first, and this order is the broadest yet. The same-day 2027 proposal, which keeps methylphenidate and hydromorphone flat at the new level and raises d,l-amphetamine and d-amphetamine by about 4%, suggests DEA views these levels as the new baseline rather than a one-time fix, though proposed numbers can change.
Second, the order leans on FDA demand forecasts and shortage-list data rather than any change in DEA’s stated view of diversion risk.
Third, DEA’s own statement that amphetamine quota was already sufficient for patient needs is a reminder that quota may not be the only cause of the shortages. The practical test will be whether pharmacies see steadier supply in 2027, and whether DEA’s tolerance for higher production holds if diversion or enforcement concerns re-emerge.
This post is for general informational purposes and does not constitute legal advice. Consult counsel regarding your specific compliance obligations.
