The Drug Enforcement Administration (DEA) has released three public inspection documents ahead of their official publication in the Federal Register on October 2, 2025. These upcoming rules address technical corrections, production quota adjustments, and a major modernization of the Controlled Substances Ordering System (CSOS). Here’s a preview of what’s coming:
Technical Correction to DEA Registration Payment Methods
Docket No. DEA-1111
Scheduled Publication Date: October 2, 2025
Public Inspection Document
Overview:
This final rule removes outdated references to paper payments (checks and money orders) for DEA registration applications and renewals. All payments must now be made online via secure electronic methods.
Why It Matters:
- Clarifies that only online payments are accepted.
- Aligns regulatory text with DEA’s 222 rule requiring online submissions.
- Eliminates confusion for registrants.
Adjustment to 2025 Production Quotas for d-Amphetamine and Methylphenidate
Docket No. DEA-1413M
Scheduled Publication Date: October 2, 2025
Public Inspection Document
Overview:
DEA is increasing the 2025 aggregate production quotas (APQs) for two Schedule II substances—d-amphetamine and methylphenidate—due to reported shortages and increased demand.
New Quotas:
- d-Amphetamine (for sale): 26,450,000g (up from 21,200,000g)
- Methylphenidate (for sale): 58,283,000g (up from 53,283,000g)
Why It Matters:
- Addresses domestic shortages flagged by FDA.
- Supports product development and global demand.
- Ensures adequate supply for legitimate medical use.
CSOS Modernization: Mandatory Online Enrollment
Docket No. DEA-732
Scheduled Publication Date: October 2, 2025
Public Inspection Document
Overview:
DEA is modernizing the Controlled Substances Ordering System (CSOS) by requiring all enrollment applications and supporting materials to be submitted online via the Diversion Control Division’s secure portal.
Key Changes:
- Eliminates paper enrollment forms (DEA Forms 251–254).
- Uses Login.gov for identity verification.
- Streamlines roles and approval workflows.
- Enhances security and efficiency.
Why It Matters:
- Saves registrants over $11 million annually in labor and processing costs.
- Reduces call center demand and delays.
- Supports bulk enrollment and future scalability.
Final Note
These rules are currently available for public inspection and will be officially published in the Federal Register on October 2, 2025. They reflect DEA’s continued efforts to modernize operations, respond to public health needs, and streamline regulatory compliance.
If you need further information please reach out to Brinks DEA Consulting.