DEA Proposes Expanding Definition of 3,4-MDP-2-P Methyl Glycidic Acid (PMK Glycidic Acid) as a List I Chemical

What this means for your practice

This proposed rule by the DEA, while targeting a specific precursor chemical not directly utilized in typical telehealth, medspa, dental, or chiropractic practices, is significant for all healthcare businesses operating within the DEA's regulatory purview. It underscores the agency's proactive approach to preventing the diversion of chemicals used in the illicit manufacture of controlled substances. For TrueEval clients, this action serves as a crucial reminder of the DEA's broad authority under the Controlled Substances Act (CSA) and its continuous efforts to close potential loopholes in chemical control. While your practice may not directly handle List I chemicals, understanding the DEA's vigilance in regulating precursors is essential for maintaining a comprehensive view of federal controlled substance compliance. It signals a broader trend where the DEA will expand definitions and regulations to prevent diversion, which could indirectly affect the supply chain for various healthcare-related substances or highlight areas of future regulatory focus. Healthcare operators should stay informed about such regulatory expansions as they reflect the evolving landscape of drug control and enforcement.

Washington, D.C. — The Drug Enforcement Administration (DEA) has published a Notice of Proposed Rulemaking in the Federal Register, signaling its intent to broaden the definition of 3,4-MDP-2-P methyl glycidic acid (also known as PMK glycidic acid) as a List I chemical under the Controlled Substances Act (CSA). This proposed amendment, outlined in 21 CFR Part 1310, is a strategic move by the DEA to enhance its ability to control chemicals critical to the illicit manufacture of controlled substances.

Overview of the Proposed Rule

Currently, the DEA classifies 3,4-MDP-2-P methyl glycidic acid as a List I chemical, with its listing encompassing its salts, optical and geometric isomers, and salts of isomers. The agency's proposal seeks to expand this definition significantly. Under the new proposed listing, the chemical would include:

• 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid)
• Its esters, not listed elsewhere in the CSA
• Its optical and geometric isomers
• Its salts
• Salts of its optical and geometric isomers
• Salts of its esters, not listed elsewhere in the CSA
• Any combination thereof, whenever the existence of such is possible.

The DEA's rationale behind this modification is to prevent circumvention of existing controls by illicit manufacturers who may exploit unlisted forms of the chemical, such as its esters, to produce controlled substances. By explicitly including these derivatives, the DEA aims to strengthen the regulatory framework surrounding this crucial precursor.

Legal Authority and Context

The Controlled Substances Act (CSA) grants the Attorney General the authority to designate chemicals as List I chemicals through regulation. This authority has been delegated to the Administrator of the DEA. A List I chemical is specifically defined as "a chemical that is used in manufacturing a controlled substance in violation of [the CSA] and is important to the manufacture of the controlled substances." The current comprehensive list of all listed chemicals is found in 21 CFR 1310.02.

This proposed rule demonstrates the DEA's ongoing commitment to disrupting the supply chain of illicit drugs by targeting essential precursor chemicals. By proactively adjusting its definitions, the agency aims to stay ahead of illicit manufacturing practices and maintain the integrity of the controlled substances regulatory scheme.

Public Comment Period

The DEA encourages public participation in this rulemaking process. Interested parties, including chemical manufacturers, distributors, and other stakeholders, are invited to submit comments on the proposed rule. Comments must be submitted electronically or postmarked on or before September 2, 2026. Electronic submissions are strongly encouraged through the Federal eRulemaking Portal at https://www.regulations.gov, referencing "Docket No. DEA-1427.

Commenters are advised that all submissions are considered part of the public record. Those wishing to submit confidential or proprietary business information must follow specific instructions provided by the DEA, including submitting two copies, one clearly marked "CONTAINS CONFIDENTIAL INFORMATION" and another redacted copy marked "TO BE PUBLICLY POSTED." This ensures that sensitive information is reviewed while maintaining transparency for public inspection.

Implications for Regulatory Compliance

While this proposed rule directly impacts chemical manufacturers and distributors dealing with 3,4-MDP-2-P methyl glycidic acid, it serves as a broader indicator of the DEA's rigorous enforcement posture. All entities regulated under the CSA, including healthcare providers, should note the agency's continuous efforts to update and expand its regulatory controls. Staying informed about such changes is critical for maintaining a robust compliance program and understanding the evolving landscape of drug control and diversion prevention.

Key Facts

| Detail | Value | |---|---| | Agency | Drug Enforcement Administration (DEA), Department of Justice | | Action | Notice of Proposed Rulemaking | | CFR Part Affected | 21 CFR Part 1310 | | Docket Number | DEA-1427 | | Comment Deadline | September 2, 2026 | | Proposed Change | To include esters of 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) in its definition as a List I chemical. |

Frequently Asked Questions

What is the DEA proposing to change about 3,4-MDP-2-P methyl glycidic acid?

The DEA is proposing to modify the listing of 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) as a List I chemical to include its esters, not listed elsewhere in the Controlled Substances Act (CSA), along with its existing components like salts, optical and geometric isomers.

What is a 'List I chemical' according to the CSA?

A 'List I chemical' is defined as a chemical that is used in manufacturing a controlled substance in violation of the CSA and is important to the manufacture of controlled substances.

How can I submit comments on this proposed rule?

Comments can be submitted electronically through the Federal eRulemaking Portal at https://www.regulations.gov, referencing 'Docket No. DEA-1427'. Paper comments can also be mailed to the Drug Enforcement Administration at the address provided in the notice.

What is the deadline for submitting comments?

Comments must be submitted electronically or postmarked on or before September 2, 2026.

Will my comments be made public?

Yes, all comments received are considered part of the public record and will be made available for public inspection online at https://www.regulations.gov, unless reasonable cause is given. Specific instructions are provided for submitting confidential or proprietary business information.

Source: DEA — Proposed Rule: Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical · 2026-08-03