Regulatory Brief

 Propofol


Formal title: Docket Number [DEA-338] Schedules of Controlled Substances: Placement of Propofol Into Schedule IV

The Drug Enforcement Agency (DEA) has announced its proposed rulemaking on the placement of Propofol into Schedule IV of the Controlled Substances Act (CSA).

Brief Description:

The Drug Enforcement Agency (DEA) has proposed to place the substance propofol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action would impose the regulatory controls and criminal sanctions of schedule IV on those who handle propofol and products containing propofol.

AVMA Response:

The AVMA recognizes DEA's determination that healthcare providers are at risk of abusing propofol and that scheduling of propofol is one means by which such abuse can be curtailed. The AVMA acknowledged that propofol must be utilized with care and diligence in clinical medicine and research, to help avoid adverse events in veterinary patients as well as possible abuse situations.

The AVMA understands the importance of controlling the use of any drug with high abuse potential. The AVMA also has concerns that adding propofol as a Schedule IV controlled substance may result in decreased use of this important anesthetic by some veterinarians because of the burdens associated with registration, record keeping, and waste disposal in accordance with DEA rules. Due to the very short time interval before propofol becomes unusable after opening a vial and the partial amount of the drug typically used in a veterinary setting, some unusable product often remains in the vial after veterinary use. The AVMA is concerned that under DEA rules, veterinarians might no longer be allowed to dispose of any unused propofol into an absorbent substance for incineration or disposal as solid waste (see AVMA's Best Management Practices for Pharmaceutical Disposal). Therefore, if propofol becomes a Schedule IV controlled substance, the AVMA believes that it is important for the DEA to have a pre-defined process set in place that would allow for convenient disposal of wasted propofol on an ongoing basis, possibly similar to procedures referred to in CFR Title 21, section 1307.21, paragraph (c).

The AVMA continues to be committed to educating our members to ensure they have current knowledge of DEA rules. The AVMA welcomes the opportunity to serve as a resource to the DEA on this and other important matters associated with controlled substances, including mobile practitioner needs for portable DEA registration numbers.

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