Revision of Applications for Manufacturing and Procurement Quotas
Abstract
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.
Federal Register Source
This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.
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Frequently Asked Questions
What is the 2026-10128 Federal Register document?
Document 2026-10128 is a Proposed Rule published by the Department of Justice in the Federal Register on May 20, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/05/20/2026-10128/revision-of-applications-for-manufacturing-and-procurement-quotas.
Is document 2026-10128 an economically significant rule?
No. Document 2026-10128 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.