DEA Caps 2026 Drug Production: From Heroin to Sudafed Limits
Published Date: 11/28/2025
Notice
Summary
The DEA is setting limits on how much of certain controlled drugs and chemicals can be made in 2026. This affects drug makers and anyone involved in producing or using these substances. They’re asking for public comments by December 15, 2025, before finalizing the rules, which could impact production and supply next year.
Analyzed Economic Effects
7 provisions identified: 4 benefits, 2 costs, 1 mixed.
Proposed cuts to several Schedule II opioids
DEA proposes reduced 2026 aggregate production quotas for multiple Schedule II opioids — specifically codeine (for sale), morphine (for sale), fentanyl, hydrocodone (for sale), hydromorphone, oxycodone (for sale), and oxymorphone (for sale) — as reductions from their 2025 established APQ values; DEA observed an average 10.56 percent decrease in medical usage of those opioids in 2024 versus 2023.
Stimulant quotas: some kept, lisdexamfetamine raised
DEA observed a 6.74 percent increase in 2024 domestic use of Schedule II stimulants (amphetamine, methylphenidate, lisdexamfetamine) versus 2023. DEA proposes to set 2026 APQs for d-amphetamine (for sale), d,l-amphetamine, and methylphenidate at their 2025 adjusted APQ levels, and proposes to increase the lisdexamfetamine APQ from 2025 to meet an extrapolated 8.94 percent increase in domestic use and a 14.85 percent increase in export requirements for 2026; DEA also proposes a corresponding increase to d-amphetamine (for conversion) to support lisdexamfetamine manufacture.
AAN set for ephedrine, pseudoephedrine, phenylpropanolamine
DEA proposes the 2026 assessment of annual needs (AAN) for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, and states the AAN includes imports of these chemicals (but excludes imports of controlled substances for use in industrial processes).
Higher remifentanil quota for 2026
DEA proposes a higher 2026 APQ for remifentanil than the 2025 established APQ to support increasing domestic medical use (used primarily intravenously during and after surgeries) and growing export requirements, based on rising domestic usage since 2020 and export increases from 2022–2024.
Noroxymorphone quota increased for product development
DEA proposes an increased 2026 APQ for noroxymorphone (for sale) from the 2025 established APQ to accommodate a manufacturer's request to manufacture reference standards, identify unknown impurities, and conduct product development manufacturing activities.
Higher Schedule I quotas for research substances
DEA proposes higher 2026 APQs than 2025 for certain Schedule I substances — including 3,4-methylenedioxy-N-methylcathinone, 5-methoxy-N,N-dimethyltryptamine, psilocybin, and psilocyn — to support increased research and clinical trials studying potential treatments for conditions such as PTSD and depression.
All other Schedule I/II quotas proposed at zero
DEA proposes that the APQ for all other Schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero for 2026.
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