Section 71 IAC 8-6-2 - Prohibited practicesAuthority: IC 4-31-3-9
Affected: IC 4-31
Sec. 2.
(a) The possession or use, or both, of a drug, substance, or medication, specified in subdivisions (1) through (12), on the premises of a facility under the jurisdiction of the commission is prohibited. The following drugs or substances include those for 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: (9) Aminiomidazole carboxamide ribonucleotide (AICAR).(10) My-inositol trispyprophosphate (ITPP).(11) Equine growth hormone.(b) The use of extracorporeal shock wave therapy (ESWT) or radial pulse wave therapy (RPWT) shall not be permitted unless the following conditions are met: (1) Any treated horse shall not be permitted to race or breeze for a minimum of ten (10) days following treatment and will be placed on the veterinarian's list for ten (10) days.(2) A list of horses that have received ESWT treatment within the last ten (10) days shall be posted in the race office and be accessible to drivers and horsemen during normal business hours and be made available to other regulatory jurisdictions.(3) The use of ESWT or RPWT machines shall be limited to practicing veterinarians.(4) Any ESWT or RPWT machines on the association grounds must be registered with and approved by the commission or its designee before use.(5) All ESWT or RPWT treatments must be reported to the official veterinarian and the presiding judge on the prescribed form not later than the time prescribed by the official veterinarian.(6) The trainer shall report all ESWT or RPWT treatments to the official veterinarian and the presiding judge within twenty-four (24) hours of treatment.(7) A horse that receives any such treatment without full compliance with this section and similar rules in any other jurisdiction in which the horse was treated shall be placed on the judge's list.(8) Any person participating in the use of ESWT or RPWT or the possession of ESWT or RPWT machines, or both, in violation of this rule shall be considered to have committed a prohibited practice and is subject to a Class A penalty.(c) The possession or use, or both, 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" means any substance, food or nonfood, that is used to treat, cure, mitigate, or prevent a disease and any nonfood substance that is intended to affect the structure or function of the animal. The term includes any substance administered by injection, other than vaccines licensed by the United States Department of Agriculture (USDA).(d) While on the premises of a facility under the jurisdiction of the commission, veterinarians may only possess drugs, including compounds described 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 in 888 IAC 1.1-5-1(2).(e) Notwithstanding subsection (c), veterinarians may possess compounded drugs with the restrictions listed in subdivisions (1) through (4). Compounding includes any manipulation of a drug beyond that stipulated on the drug label, including, but not limited to, mixing, diluting, concentrating, or creating oral suspensions or injectable solutions as follows: (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.(4) Compounded drugs must be in containers that meet the prescription labeling requirements in subsections (i) and (j). Combining two (2) or more substances with pharmacologic effect constitutes the development of a new drug. This may only be done in accordance with state and local laws and must contain FDA approved medications, if available.(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 that 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 in this subsection 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 that sets forth the following: (1) Name and address of the veterinarian.(2) Name and address of the client.(4) Date of prescription or dispensing of drug, or both.(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.(8) Any necessary cautionary statements.(k) Any drug or medication which is used or kept on association grounds and which, by federal or state law, requires a prescription, must have been validly prescribed by a duly licensed veterinarian and be in compliance with the applicable state statutes. All such allowable medications must have a prescription label which is securely attached and clearly ascribed to show the following:(1) the name of the product;(2) the name, address, and telephone number of the veterinarian prescribing or dispensing the product;(3) the name of each patient (horse) for whom the product is intended or prescribed;(4) the doses, dosage, duration of treatment, and expiration date of the prescribed or dispensed product; and(5) the name of the person (trainer) to whom the product was dispensed.(l) The practice, administration, or application of a treatment, procedure, therapy, or method identified in this subsection, 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 that 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 #08-191E 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-071110100ERAEmergency rule filed 3/2/2021, 3:10 p.m.: 20210310-IR-071210076ERAEmergency rule filed 4/20/2023, 3:09 p.m.: 20230426-IR-071230297ERAReadopted filed 4/20/2023, 3:49 p.m.: 20230517-IR-071230071RFAReadopted filed 8/3/2023, 12:49 p.m.: 20230830-IR-071230428RFA