The Civic Node

Federal Register — Established Aggregate Production Quotas for Schedule I and II Controlled Substances for 2026

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Summary

Primary-source Federal Register final order (91 FR 287, document 2025-24277) establishing the 2026 aggregate production quotas (APQs) for Schedule I and II controlled substances and assessments of annual needs (AAN) for List I chemicals. Effective January 5, 2026. This is the annual DEA regulatory action that determines the legal ceiling on how much Adderall, Vyvanse, Ritalin, and other ADHD medications can be produced in the United States. The proposed version was published November 28, 2025; comments closed December 15, 2025.

Key Points

  • Effective date: January 5, 2026
  • Citation: 91 FR 287; Federal Register document 2025-24277
  • Legal authority: Section 306 of the Controlled Substances Act (21 U.S.C. 826)
  • Delegation: Attorney General → DEA Administrator (per 28 CFR 0.100)
  • Purpose: Quotas “represent those quantities of schedule I and II controlled substances and the list I chemicals…that may be manufactured in the United States in 2026 in order to provide for the estimated medical, scientific, research, and industrial needs of the U.S., lawful export requirements, and the establishment and maintenance of reserve stocks”
  • Rulemaking timeline: Proposed notice published November 28, 2025; comment period closed December 15, 2025; final order effective January 5, 2026
  • Contact: Heather Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, DEA (571-776-3882)

Newsletter Angles

  • The primary regulatory mechanism of the ADHD shortage lives here: Every year the DEA issues this one document that caps production of Schedule I and II substances. It’s one of the most consequential documents nobody reads — it determines whether ADHD patients can get their medication.
  • The rulemaking process is a chokepoint within a chokepoint: Public comment period runs about two weeks (Nov 28 – Dec 15). Most affected patients don’t know it’s happening. Manufacturers who depend on favorable quota allocations are the primary commenters. This is how regulatory capture operates in plain sight.
  • The “estimated medical needs” language is the legal pivot point: The statute says quotas must be set at levels “necessary to meet the estimated medical, scientific, and research needs of the United States.” Vermont Law Review and other analysts have argued the DEA’s methodology for estimating medical need is opaque and diversion-biased. This is the statutory lever any litigation strategy would pull.
  • The 2026 APQ as the latest data point: For any Chokepoint Control piece that wants to show the mechanism in action, citing the specific Federal Register document gives regulatory-grade authority. It’s not speculation about how quotas work — it’s the actual 2026 quotas.

Entities Mentioned

Concepts Mentioned

Quotes

“The 2026 aggregate production quotas (APQ) and assessment of annual needs (AAN) represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine that may be manufactured in the United States in 2026 in order to provide for the estimated medical, scientific, research, and industrial needs of the U.S., lawful export requirements, and the establishment and maintenance of reserve stocks.” — DEA Final Order, 91 FR 287

Notes

This is pure primary-source regulatory text — authoritative for any claim about DEA quota authority but not analytically rich on its own. The value is in citing the specific 2026 APQ as the latest instance of the mechanism. Writers should pair this with the Vermont Law Review piece (reform proposals) and the Reason piece (Ascent case) for a fuller picture of the regulatory framework in action. The specific numerical quotas for amphetamine, d-amphetamine, lisdexamfetamine, and methylphenidate are in the full document; the excerpt read covers only the legal authority and background sections.

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