Data / Federal rules / 2026-10128
Revision of Applications for Manufacturing and Procurement Quotas
The Drug Enforcement Administration published this proposed rule in the Federal Register on May 20, 2026. Comments closed on July 20, 2026.
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What the agency says
The Drug Enforcement Administration (DEA) proposes to revise existing regulations relating to the management of quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA- registered manufacturers. This rule is being proposed to: restructure DEA's manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported; and revise the applications for individual manufacturing and procurement quota. The changes are necessary to increase visibility into the controlled substance supply chain by providing DEA with more detailed information allowing the agency to react more precisely in preventing drug shortages; and to ensure that enough of the schedule I and II controlled substances and three list I chemicals can be manufactured to meet estimated scientific, medical, lawful export, and inventory needs. This rule also contains revisions to use gender neutral language and other non-substantive revisions.
Key facts
- Document number
- 2026-10128
- Type
- Proposed rule
- Action
- Notice of proposed rulemaking
- Agency
- Justice Department; Drug Enforcement Administration
- Published
- May 20, 2026
- Comments due
- July 20, 2026
- Dates
- Comments must be received by July 20, 2026. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
- Docket
- Docket No. DEA-1278
- Regulation ID (RIN)
- 1117-AB86
- Code of Federal Regulations
- 21 CFR 1303; 21 CFR 1315
- Topics
- Administrative practice and procedure; Chemicals; Drug traffic control; Imports; Reporting and recordkeeping requirements
- Significant
- Yes, under Executive Order 12866
- Pages
- 14
Other documents from the Drug Enforcement Administration
Everything from the Drug Enforcement Administration · Rules on administrative practice and procedure · Rules on chemicals · Rules on drug traffic control · Published in May 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.