Federal Register #DEA-1278

DEA Proposed Rule: Quota Application Revisions for Controlled Substances and Chemicals

The Drug Enforcement Administration (DEA), under the Department of Justice, is proposing regulatory changes affecting the management of quotas for Schedule I and II controlled substances and List I chemicals. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - Products/Services Impacted: - Schedule I and II controlled substances - List I chemicals: ephedrine, pseudoephedrine, phenylpropanolamine - Key Regulatory Changes: - Restructures quota regulations for clarity and consistency - Introduces use-specific subcategories for quotas (domestic sale, export) - Revises application procedures for manufacturing and procurement quotas - Requires DEA-registered manufacturers to submit detailed production cycle and supplier data - Mandates online submission of DEA Form 250 and DEA Form 189 for quota applications - Incorporates gender-neutral language and other non-substantive updates - Notable Requirements: - Enhanced data submission to improve supply chain visibility and prevent drug shortages - Revised application deadlines and more granular quota tracking - Affected Parties: - All DEA-registered manufacturers, packagers, and labelers of the specified substances and chemicals - No specific OEMs, vendors, part numbers, or quantities are listed in this rulemaking proposal.

Description

The Drug Enforcement Administration (DEA) proposes to revise existing regulations related to the management of quotas for Schedule I and II controlled substances and List I chemicals, including ephedrine, pseudoephedrine, and phenylpropanolamine. The revisions aim to improve clarity, consistency, and transparency in the manufacturing and procurement process, enhance DEA's ability to prevent drug shortages, and increase visibility into the controlled substance supply chain. The rule includes restructuring quota regulations, clarifying use-specific subcategories for domestic sale and export, revising application procedures, and incorporating gender-neutral language and other non-substantive changes. Comments on the proposed rule are due by July 20, 2026.

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