2025-24277Notice

DEA Caps Ephedrine Quotas: Enough for Pills, Not for Breaking Bad?

Published Date: 1/5/2026

Notice

Summary

The DEA set the official 2026 production limits for certain controlled drugs and chemicals like ephedrine and pseudoephedrine. These limits make sure there’s enough for medicine, research, and legal uses without overproducing. This affects drug makers and keeps the supply safe and steady starting January 5, 2026.

Analyzed Economic Effects

6 provisions identified: 6 benefits, 0 costs, 0 mixed.

Specific Gram Quotas Listed

The final order lists explicit 2026 APQs in grams for many Schedule I and II substances (for example: MDMA 12,000 g; methylone 30,000 g; psilocybin 50,000 g; psilocyn 80,000 g; delta-9-tetrahydrocannabinol 1,523,040 g; 3,4-methylenedioxyamphetamine (MDA) 12,000 g). These numeric quotas establish the maximum permitted manufacture of each named basic class of controlled substance for 2026.

2026 Production Quotas Finalized

DEA issued the final 2026 aggregate production quotas (APQs) for Schedule I and II controlled substances and the assessment of annual needs (AANs) for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The final order is effective January 5, 2026 and sets the permitted quantities that may be manufactured in the U.S. in 2026 to meet medical, research, export, and reserve stock needs.

Higher Quotas Set For Several Drugs

The Administrator established the 2026 APQs at higher levels than proposed for the following basic classes: d,l-amphetamine; d-amphetamine (for conversion); dimethyltryptamine; lisdexamfetamine; morphine (for sale); oripavine; psilocybin; and psilocyn. This final decision increases the established 2026 production limits for those named substances compared to the proposal.

List I Chemical AANs Include Imports

The assessment of annual needs (AANs) for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine includes imports of those chemicals when determining 2026 quantities. The rule specifies that imports of these chemicals are counted toward the AANs, but imports of controlled substances for use in industrial processes are not included.

APQs Do Not Impose Pharmacy Ordering Limits

DEA clarified that aggregate production quotas set a limit on total annual manufacture but do not impose ordering thresholds or limits on pharmacies purchasing controlled substances from distributors. The order states APQs are production limits and do not themselves create pharmacy purchasing limits.

Amphetamine Isomer Allocation Clarified

DEA stated it does not allocate d-amphetamine and l-amphetamine quotas in a fixed 1:1 ratio and explained that manufacturers often request d,l-amphetamine (a racemic 50:50 mixture) instead of separate isomer quotas. DEA said the established d,l-amphetamine and d-amphetamine APQs are allocated so that amphetamine mixed-salt products can be manufactured consistent with FDA approvals and Current Good Manufacturing Practices.

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Key Dates

Published Date
1/5/2026

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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