Mofebutazone Classified as 4/B Banned Substance

In its February 20th meeting, the Racing Medication and Testing Consortium's (RMTC) Board of Directors approved a recommendation from its Scientific Advisory Committee (SAC) to designate a 4/B classification for the substance Mofebutazone.  Subsequently, the Association of Racing Commissioners International (ARCI) has approved and assigned a 4/B classification to this substance in its Uniform Classification of Foreign Substances, consistent with other NSAIDs lacking FDA approval. 

The FDA has advised the RMTC regarding other non-FDA approved drugs that possession is not permitted, nor is the compounding of a non-FDA approved substances.

It is considered a Banned Substance on the FEI Prohibited Substance List.  As it lacks FDA approval, it would be classified as a Banned (S0) Substance by HISA's Anti-Doping and Medication Control (ADMC) regulations, recently approved by the Federal Trade Commission.

S0. NON-APPROVED SUBSTANCES

Any pharmacologic substance that is not approved by any governmental regulatory health authority for human or veterinary use within the jurisdiction is prohibited. This prohibition includes drugs under pre-clinical or clinical development, discontinued drugs, and designer drugs (a synthetic analog of a drug that has been altered in a manner that may reduce its detection)....

ARCI 025-015 Prohibited Practices

(2)  Prohibited Substances and Methods:

(a)  The substances and methods listed in the annexed Prohibited List may not be used at any place or time and may not be possessed on the premises of a racing or training facility under the jurisdiction of the Commission, except as a restricted therapeutic use.

Effective May 22, 2023, a confirmed laboratory finding, possession, or distribution of Mofebutazone constitutes a Doping Violation under HISA's ADMC regulations.

In those jurisdictions that are not subject to HISA where racing commissions have adopted the Model Rules or comparable language, the possession or a confirmed laboratory finding of Mofebutazone constitutes a violation.