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Monday, January 5, 2015

Regulators to Tighten Rules on Compounded Medications


LEXINGTON, Ky. - In an effort to strengthen rules to combat the use of illegally compounded medications in racing, regulators are taking steps to ensure that commissions have adequate authority to sanction licensees who violate existing federal restrictions limiting the use of such substances.

“Commission investigators are finding that some are seeking to circumvent existing doping rules by using new drugs created by combining multiple substances in a compound,” Association of Racing Commissioners International (ARCI) President Ed Martin said.

“Existing federal rules requiring that compounded medications be dispensed only by veterinary prescription to address a specific medical need of an individual horse are being ignored by some. It is a problem that those doing this believe they won’t get caught by the feds. Racing commissions are taking steps to ensure that they can confiscate the substances and bring action against those who use or distribute these illegal compounds,” he noted.

The ARCI has given approval to a Model Rules policy that would:

·         Outlaw the possession or use of a drug, substance, or medication not specifically approved by an appropriate federal agency absent permission of the Commission or its designee.

·         Ban the possession, use, or distribution of a compounded medication on track property if there is an United States Food and Drug Administration-approved equivalent of that substance available for purchase.

·         Require that a compounded medication be dispensed only by prescription issued by a licensed veterinarian to meet the medical needs of a specific horse and for use only in that specific horse

·         Create a racing rules violation for the possession of a compounded medication not properly labeled consistent with existing federal requirements.

Adoption of the new provision augments existing efforts of racing commissions to combat illegally compounded drugs. In 2012 several southern and western U.S. state racing commissions quietly requested federal assistance in tackling this problem. Today state and federal regulatory entities are cooperating in joint efforts. Additionally, racing commissions deploy vehicle and barn searches that have been helpful in finding illegal substances.

The newly adopted policy is included in the ARCI Model Rules ARCI-011-020 and ARCI-025-020. Commissions are expected to promulgate regulations in 2015.
Action on a companion provision concerning medical labeling requirements was deferred by the ARCI pending public comment on whether a prescription for a substance should be required to be issued by a veterinarian licensed in the racing regulatory jurisdiction where the track is located. Due to the fact that many horses participate in multiple jurisdictions, questions were raised as to whether such a requirement would impose an undue burden.

Those wishing to comment on the proposed language may do so online at the ARCI website.

The ARCI acknowledges those who assisted in the development and drafting of the new model policy, particularly Dr. Lynn Hovda, Chairperson of the ARCI Regulatory Veterinarians Committee; Dr. Dionne Benson, Executive Director of the Racing Medication and Testing Consortium; Mr. Hugh Gallagher of the New York Racing Association; Dr. Mary Scollay-Ward, Equine Medical Director of the Kentucky Horse Racing Commission, and Dr. Rick Arthur of the California Horse Racing Board.

The ARCI is the only umbrella organization of the officially sanctioned governing rulemaking bodies for professional horse and greyhound racing in North America and parts of the Caribbean. The ARCI sets standards for racing regulation, medication policy, drug testing laboratories, totalizator systems, racetrack operation and security, and off-track wagering entities.

ARCI members are the only independent entitles recognized to license, enforce, and adjudicate matters pertaining to racing.