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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11526, Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Starting July 9, 2026, new rules make it easier for doctors and pharmacies to provide medicine that helps people recover from opioid addiction. These changes affect healthcare providers by expanding who can give medication-assisted treatment and how pharmacies can deliver these medicines. The goal? Faster, safer access to treatment with clear rules that save time and support recovery.
2026-10128, Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2025-05007, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
Starting December 31, 2025, veterans can get buprenorphine treatment and follow-up care through telemedicine, making it easier to access help for opioid use disorder without leaving home. This change affects veterans using VA health services and aims to improve treatment access while the government reviews feedback and policies. No new costs are mentioned, but the delay gives agencies time to ensure the rules work well.
2025-02793, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
The government is giving veterans easier access to buprenorphine treatment through telemedicine, letting them get care remotely. This change affects veterans using VA health services and aims to make treatment smoother and more convenient. The new rules were supposed to start February 18, 2025, but now they’ll kick in on March 21, 2025, while the government gathers public feedback.
2026-20226, By Grace Inc. Counseling Services; Decision and Order
By Grace Inc. Counseling Services in Baltimore faced losing its DEA license because it didn’t keep good records and lied about its owner’s past drug conviction. After a hearing, the DEA decided to revoke their registration, meaning they can’t legally handle controlled substances anymore. This affects the clinic’s ability to operate and could impact patients relying on their services.
2026-20227, St. Michael's Pharmacy; Decision and Order
St. Michael's Pharmacy in Texas had its DEA license suspended and is facing revocation because it kept filling risky drug prescriptions without fixing obvious warning signs of abuse. This affects the pharmacy’s ability to legally handle controlled substances and could impact patients relying on it. The pharmacy must now deal with these serious legal actions, which started in late 2025 and could lead to permanent closure or fines.
Previous / Next Documents
Previous: 2025-21508, Sunshine Act Meetings: Notice of Meeting Held With Less Than Seven Days Advance Notice
The FDIC held a public meeting with less than seven days' notice to discuss important banking rules and updates for 2026. This affects banks, especially community and big global ones, by adjusting rules on capital and advertising. No new costs were announced, but the timing means banks need to stay sharp and ready for changes soon.
Next: 2025-21510, Privacy Act of 1974; System of Records
The Commodity Futures Trading Commission is updating how it shares certain personal records to better protect your info and prevent fraud. Starting December 29, 2025, they’ll share some data with the Treasury and can respond faster if there’s a data breach. If you’re involved with the CFTC, these changes help keep your info safer without costing you a dime.