Section 71IAC8-6-2. Prohibited practices

   (a) The possession and/or use of a drug, substance, or medication, specified below, on the premises of a facility under the jurisdiction of the commission is prohibited. These drugs or substances include those which a recognized analytical method has not been developed to detect and confirm the administration of such substance, or the use of which may endanger the health and welfare of the horse or endanger the safety of the rider, or the use of which may adversely affect the integrity of racing:

(1) Erythropoietin.

(2) Darbepoetin.

(3) Oxyglobin.

(4) Hemopure.

(5) Snake venom.

(6) Snail venom.

(7) Ractopamine.

(8) Zilpaterol.

  (b) The use of extracorporeal shock wave therapy or radial pulse wave therapy shall not be permitted unless the following conditions are met:

(1) Any treated horse shall not be permitted to race for a minimum of ten (10) days following treatment.

(2) The use of extracorporeal shock therapy or radial pulse wave therapy machines shall be limited to practicing veterinarians.

(3) Any extracorporeal shock therapy or radial pulse therapy machines on the association grounds must be registered with and approved by the commission or its designee before use.

(4) All extracorporeal shock therapy or radial pulse therapy treatments must be reported to the official veterinarian on the prescribed form not later than the time prescribed by the official veterinarian.

  (c) The possession and/or use of a drug, substance, or medication on the premises of a facility under the jurisdiction of the commission that has not been approved by the United States Food and Drug Administration (FDA) for any use (human or animal) is forbidden without prior permission of the commission. For purposes of this rule, the term "drug" is any substance, food or nonfood, that is used to treat, cure, mitigate, or prevent a disease, any nonfood substance that is intended to affect the structure or function of the animal, and includes any substance administered by injection other than vaccines licensed by the USDA.

  (d) While on the premises of a facility under the jurisdiction of the commission, veterinarians may only possess drugs, including compounds as discussed below in subsection (e), in amounts commensurate with the needs of horses with which the veterinarian has a veterinarian-client-patient relationship as that term is defined at 888 IAC 1.1-5-1(2).

  (e) Notwithstanding subsection (c), veterinarians may possess compounded drugs with the restrictions listed below. Compounding includes any manipulation of a drug beyond that stipulated on the drug label, including, but not limited to, mixing, diluting, concentrating, and/or creating oral suspensions or injectable solutions.

(1) Compounds may only be prescribed to or prepared for horses with which the veterinarian has a veterinarian-client-patient relationship;

(2) Compounded drugs may only be made from other FDA-approved drugs;

(3) Veterinarians may not possess compounds where there are FDA-approved, commercially available drugs that can appropriately treat the horse; and

(4) Compounded drugs must be in containers that meet the prescription labeling requirements in subsections (i) and (j).

  (f) The possession of any drug not approved by the FDA for distribution in the United States is prohibited, unless the veterinarian can show proof of prior authorization from the FDA Center for Veterinary Medicine that has been obtained on a single-patient basis only. The authorization must be maintained in the animal health record. A copy of the authorization must be available for immediate inspection.

  (g) Extra-label administration of drugs, including use for indication or at dosage levels, frequencies, or routes of administration other than those stated in the labeling, is permitted for FDA-approved drugs only. Extra-label use must meet the prescription labeling requirements in subsections (i) and (j).

  (h) A veterinarian shall not possess any drug that is not labeled pursuant to the requirements of subsection (i) or (j).

  (i) Drugs possessed by practicing veterinarians on the premises of a facility under the jurisdiction of the commission which have not yet been prescribed or dispensed to horses with which the veterinarian has a veterinarian-client-patient relationship must be affixed with the manufacturer's label, which must include:

(1) recommended or usual dosage;

(2) route for administration, if it is not for oral use;

(3) quantity or proportion of each active ingredient;

(4) names of inactive ingredients, if for other than oral use;

(5) an identifying lot or control number;

(6) manufacturer, packer, or distributor's name and address; and

(7) net quantity contents.

If any information as described herein is not included on the manufacturer's label, but instead is on the manufacturer's package insert, the package insert must be maintained on the veterinarian's truck.

  (j) When issuing a prescription for or dispensing a drug to a horse with which the veterinarian has a veterinarian-client-patient relationship, the veterinarian must affix or cause to be affixed a label which sets forth the following:

(1) Name and address of the veterinarian;

(2) Name and address of the client;

(3) Name of the horse;

(4) Date of prescription and/or dispensing of drug;

(5) Directions for use, including dose and duration directions, and number of refills;

(6) Name and quantity of the drug (or drug preparation, including compounds) prescribed or dispensed;

(7) For compounded drugs, the established name of each active ingredient; and

(8) Any necessary cautionary statements.

  (k) The practice, administration, or application of a treatment, procedure, therapy, or method identified below, which is performed on the premises of a facility under jurisdiction of the commission or in any horse scheduled to compete in a race under the jurisdiction of the commission and which may endanger the health and welfare of the horse or endanger the safety of the rider or driver, or the use of which may adversely affect the integrity of racing is prohibited: Intermittent hypoxic treatment by external device. (Indiana Horse Racing Commission; 71 IAC 8-6-2; emergency rule filed Feb 21, 2003, 4:15 p.m.: 26 IR 2385; emergency rule filed Jan 21, 2004, 2:30 p.m.: 27 IR 1920; emergency rule filed Mar 10, 2006, 11:00 a.m.: 29 IR 2220; emergency rule filed Mar 12, 2008, 1:53 p.m.: 20080326-IR-071080191ERA, eff Mar 11, 2008 [IC 4-22-2-37.1 establishes the effectiveness of an emergency rule upon filing with the Publisher. LSA Document #08-191(E) was filed with the Publisher March 12, 2008.]; emergency rule filed Mar 19, 2009, 11:07 a.m.: 20090401-IR-071090195ERA, eff Mar 12, 2009 [IC 4-22-2-37.1 establishes the effectiveness of an emergency rule upon filing with the Publisher. LSA Document #09-195(E) was filed with the Publisher March 19, 2009.]; emergency rule filed Mar 3, 2011, 11:50 a.m.: 20110309-IR-071110100ERA; emergency rule filed May 7, 2014, 2:27 p.m.: 20140514-IR-071140143ERA, eff May 15, 2014)