Section
1. Definitions.
(1) "Endogenous"
means a substance that is naturally produced by the healthy body.
(2) "Exogenous" means a substance that is not
naturally produced by the healthy body.
(3) "Out of competition testing" means all
testing other than:
(a) Pre-race TCO2 testing;
and
(b) Post-race testing at a
licensed association under the jurisdiction of the commission.
(4) "Sample" means that portion of
a specimen subjected to testing by the commission laboratory.
(5) "Sampling" means the act of collecting a
specimen from a horse.
(6)
"Specimen" means blood, urine, or other biologic matter taken or drawn from a
horse for testing.
Section
2. Prohibited Substances and Practices.
(1) All substances identified in this
administrative regulation shall be prohibited unless specifically permitted. A
positive finding by the commission laboratory of a substance prohibited by this
administrative regulation in a specimen taken from a horse designated for
testing by a commission veterinarian or his designee shall be prima facie
evidence that a violation has occurred. Any reference to substances in this
section does not alter the requirements for testing concentrations in race day
samples established in
810
KAR 8:010 and
810
KAR 8:050.
(2) Any pharmacological substance not
addressed by this administrative regulation and without current approval by the
U.S. Food and Drug Administration for human or veterinary use shall be
prohibited at all times without prior approval of the commission. If a
veterinarian seeks approval to use a pharmacological substance not currently
approved by the U.S. Food and Drug Administration, the commission or its
designee may consult with the Association of Racing Commissioners
International, the Racing and Medication Testing Consortium, or their
successors to determine whether to authorize use of the substance.
(3) Therapeutic substances not otherwise
prohibited by this administrative regulation may be used if the substances:
(a) Are currently approved for human or
veterinary use by the U.S. Food and Drug Administration; and
(b) Are prescribed and administered in the
context of a valid veterinarian-client-patient relationship.
(4) Compounded medications not
otherwise prohibited by this administrative regulation may be used if the
medications:
(a) Are permitted by federal law
or the law of the state where the horse is located when the compounded
medication is administered; and
(b)
Are prescribed and administered in the context of a valid
veterinarian-client-patient relationship.
(5)
(a)
Except as provided in paragraph (b) of this subsection, the following Anabolic
Androgenic Steroids (AAS) shall be prohibited:
1. Exogenous AAS, such as: 1-androstenediol
(5[ALPHA]-androst-1-ene-3[BETA],17[BETA]-diol); 1-androstenedione
(5[ALPHA]-androst-1-ene-3,17-dione); bolandiol
(estr-4-ene-3[BETA],17[BETA]-diol); bolasterone; boldenone; boldione
(androsta-1,4-diene-3,17-dione); calusterone; clostebol danazol
(oxazolopregna-4-en-20-yn-17[ALPHA]-ol); dehydrochlormethyltestosterone
(4-chloro-17[BETA]-hydroxy-17[ALPHA]-methylandrosta-1,4-dien-3-one);
desoxymethyltestosterone (17[ALPHA]-ethyl-5[ALPHA]-androst-2-en-17[BETA]-ol);
drostanolone; ethylestrenol (19-norpregna-4-en-17[ALPHA]-ol); fluoxymesterone;
formebolone; furazabol
(17[ALPHA]-methyloxadiazolo-5[ALPHA]-androstan-17[BETA]-ol); gestrinone;
4-hydroxytestosterone (4,17[BETA]-dihydroxyandrost-4-en-3-one); mestanolone;
mesterolone; metandienone
(17[BETA]-hydroxy-17[ALPHA]-methylandrosta-1,4-dien-3-one); metenolone;
methandriol; methasterone (17[BETA]-hydroxy-2[ALPHA],
17[ALPHA]-dimethyl-5[ALPHA]-androstan-3-one); methyldienolone
(17[BETA]-hydroxy-17[ALPHA]- methylestra-4,9-dien-3-one); methyl-1-testosterone
(17[BETA]-hydroxy-17[ALPHA]-methyl-5[ALPHA]-androst-1 -en-3-one); m
ethylnortestosterone (17[BETA]-hydroxy-17[ALPHA]-methylestr-4-en-3-one);
methyltestosterone; metribolone (methyltrienolone,
17[BETA]-hydroxy-17[ALPHA]-methylestra-4,9,11-trien-3-one); mibolerone;
nandrolone; 19-norandrostenedione (estr-4-ene-3,17-dione); norboletone;
norclostebol; norethandrolone; oxabolone; oxandrolone; oxymesterone;
oxymetholone; prostanozol (17[BETA]--1'H pyrazolo-5[ALPHA]-androstane);
quinbolone; stanozolol; stenbolone; 1-testosterone
(17[BETA]-hydroxy-5[ALPHA]-androst-1-en-3-one); tetrahydrogestrinone
(17-hydroxy-18a-homo-19-nor-17[ALPHA] pregna-4,9,11-trien-3-one); and
trenbolone (17[BETA]-hydroxyestr-4,9,11-trien-3-one); and
2. Endogenous AAS or their synthetic esters
if administered exogenously: androstenediol
(androst-5-ene-3[BETA],17[BETA]-diol); androstenedione
(androst-4-ene-3,17-dione); dihydrotestosterone
(17[BETA]-hydroxy-5[ALPHA]-androstan-3-one); prasterone
(dehydroepiandrosterone, DHEA, 3[BETA]-hydroxyandrost-5-en-17-one);
testosterone; and their metabolites and isomers, including but not limited to:
5[ALPHA]-androstane-3[ALPHA],17[ALPHA]-diol;
5[ALPHA]-androstane-3[ALPHA],17[BETA]-diol;
5[ALPHA]-androstane-3[BETA],17[ALPHA]-diol;
5[ALPHA]-androstane-3[BETA],17[BETA]-diol; 5[BETA]-androstane-3[ALPHA],
17[BETA]-diol, androst-4-ene-3[ALPHA],17[ALPHA]-diol;
androst-4-ene-3[ALPHA],17[BETA]-diol; androst-4-ene-3[BETA],17[ALPHA]-diol;
androst-5-ene-3[ALPHA],17[ALPHA]-diol; androst-5-ene-3[ALPHA],17[BETA]-diol;
androst-5-ene-3[BETA],17[ALPHA]-diol; 4-androstenediol
(androst-4-ene-3[BETA],17[BETA]-diol); 5-androstenedione
(androst-5-ene-3,17-dione); androsterone
(3[BETA]-hydroxy-5[ALPHA]-androstan-17-one); epi-dihydrotestosterone;
epitestosterone; etiocholanolone; 7[ALPHA]-hydroxy-DHEA; 7[BETA]-hydroxy- DHEA;
7-keto-DHEA; 19-norandrosterone; 19-noretiocholanolone.
(b) Anabolic steroids may be used out of
competition if:
1. The anabolic steroid is
currently approved for human or veterinary use by the U.S. Food and Drug
Administration;
2. The
administration is:
a. Performed pursuant to a
valid veterinary prescription;
b.
Entered into the horse's medical record by the administering veterinarian; and
c. Reported by the administering veterinarian to the commission no later than
twenty-four (24) hours after administration or dispensing of the
medication;
3. The
record is made available upon request for inspection by the commission or its
designee; and
4. The horse is
placed on the Veterinarian's List for six (6) months after the last
administration of an anabolic steroid or agent.
(6)
(a)
Except as provided in paragraph (b) of this subsection, the following anabolic
agents shall be prohibited:
1.
Clenbuterol;
2. Selective androgen
receptor modulators (SARMs);
3.
Ractopamine;
4. Tibolone;
5. Zeranol; and
6. Zilpaterol.
(b) Clenbuterol may be administered if the
treatment is:
1. Pursuant to a valid
veterinary prescription;
2.
Reported by the administering veterinarian to the commission no later than 24
hours after administration or dispensing of the medication; and
(7) The following substances shall be
prohibited:
(a) Erythropoiesis-Stimulating
Agents (ESAs), such as darbepoetin (dEPO); erythropoietins (EPO); EPO-Fc;
EPOmimetic peptides (EMP), e.g., CNTO 530 and peginesatide; and
methoxypolyethylene glycol-epoetin beta (CERA);
(b) Non-erythropoietic EPO-Receptor agonists,
such as ARA-290, asialo EPO and carbamylated EPO; and
(c) Hypoxia-inducible factor (HIF)
stabilizers, such as cobalt (if detected at concentrations in excess of the
threshold prescribed in
810
KAR 8:010, Section 2(4)(b)), and roxadustat (FG-4592);
and HIF activators, (e.g., argon, xenon).
(8)
(a)
Except as provided in paragraph (b) of this subsection, Chorionic Gonadotropin
(CG) and Luteinizing Hormone (LH) and their releasing factors, shall be
prohibited in male horses.
(b)
Chorionic Gonadatropin (CG) and Luteinizing Hormone (LH) may be used in male
horses if:
1. The treatment is pursuant to a
valid veterinary prescription; and
2. The administering veterinarian files a
treatment plan with the commission prior to administering the
medication.
(9)
(a)
Except as provided in paragraph (b) of this subsection, Corticotrophin
releasing factors and corticotrophin releasing hormones (CCRH) shall be
prohibited.
(b)
Adrenocorticotrophic Hormone (ACTH) may be used if the treatment is:
1. Pursuant to a valid veterinary
prescription; and
2. Reported by
the administering veterinarian to the commission no later than twenty-four (24)
hours after administration or dispensing of the medication by the
veterinarian.
(c) Growth
Hormone (GH); Growth Hormone Releasing Hormone (GHRH); CJC-1295, sermorelin and
tesamorelin; Growth Hormone Secretagogues (GHS); anamorelin; ipamorelin;
GH-Releasing Peptides (GHRPs); alexamorelin; GHRP-6; hexarelin; and pralmorelin
(GHRP-2) shall be prohibited.
(d)
Venoms and toxins from sources, such as snails, snakes, frogs, and bees and
their synthetic analogues, such as ziconotide, shall be prohibited.
(e) Growth factors, such as Fibroblast Growth
Factors (FGFs), Hepatocyte Growth Factor (HGF), Insulin-like Growth Factor-1
(IGF-1) and its analogues, Mechano Growth Factors (MGFs), Platelet-Derived
Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF) and any other
growth factor affecting muscle, tendon or ligament protein
synthesis/degradation, vascularization, energy utilization, regenerative
capacity or fiber type switching shall be prohibited.
(10) Platelet rich plasma (PRP) and
autologous conditioned plasma (IRAP) may be used if the treatment is:
(a) Pursuant to a valid veterinary
prescription; and
(b) Reported to
the commission's representative at the time of sampling if administered within
the preceding twenty-four (24) hours.
(11) All beta-2 agonists, such as all optical
isomers (i.e., d- and l-) where relevant, shall be prohibited.
(12) Clenbuterol and albuterol may be used if
the treatment is:
(a) Pursuant to a valid
veterinary prescription;
(b)
Reported by the administering veterinarian to the commission no later than
twenty-four (24) hours after administration or dispensing of the medication by
the veterinarian; and
(13)
(a)
Except as established in paragraphs (b) and (c) of this subsection, hormone and
metabolic modulators shall be prohibited such as:
1. Aromatase inhibitors, such as
aminoglutethimide, anastrozole, androsta-1,4,6-triene-3,17-dione
(androstatrienedione), 4-androstene-3,6,17 trione (6-oxo), exemestane,
formestane, letrozole, testolactone;
2. Selective estrogen receptor modulators
(SERMs), such as raloxifene, tamoxifen, toremifene;
3. Other anti-estrogenic substances, such as
clomiphene, cyclofenil, fulvestrant;
4. Agents modifying myostatin function(s),
such as myostatin inhibitors;
5.
Activators of the AMP-activated protein kinase (AMPK), such as
5-Aminoimidazole-4-carboxamide ribonucleotide (AICAR); and Peroxisome
Proliferator Activated Receptor δ (PPARδ) agonists such as GW
1516;
6. Insulins;
7. Trimetazidine; and
8. Thyroxine, and thyroid modulators/hormones
such as T4 (tetraiodothyronine/thyroxine), T3 (triiodothyronine), or
combinations thereof.
(b) Thyroxine (T4) may be used:
1. The treatment is pursuant to a valid
veterinary prescription; and
2. A
treatment report is filed in writing or electronically with the commission
within twenty-four (24) hours of the administration or dispensing of the
medication by the veterinarian.
(c) Altrenogest may be used in fillies and
mares if the treatment is pursuant to a valid veterinary prescription.
Altrenogest may be used is permitted in intact males if the treatment is:
1. Pursuant to a valid veterinary
prescription; and
2. The
administering veterinarian files a treatment plan with the commission prior to
administering the medication.
(14)
(a)
Except as provided in paragraphs (b) and (c) of this subsection, diuretics
shall be prohibited, such as acetazolamide, amiloride, bumetanide, canrenone,
chlorthalidone, ethacrynic acid, indapamide, metolazone, spironolactone,
thiazides, such as bendroflumethiazide, chlorothiazide, hydrochlorothiazide,
torsemide, triamterene, vasopressin receptor antagonists or vaptans, such as
tolvaptan.
(b) Furosemide and
trichlormethiazide may be used out of competition if the treatment is:
1. Pursuant to a valid veterinary
prescription; and
2. Reported at
the time of sampling if administered within the preceding twenty-four (24)
hours.
(c) Other
diuretics, including those established in paragraph (a) of this subsection, may
be administered in an emergency if the treatment is:
1. Pursuant to a valid veterinary
prescription; and
2. Reported to
the commission within twenty-four (24) hours of administration.
(15) Masking agents,
such as desmopressin, plasma expanders (such as glycerol; intravenous
administration of albumin, dextran, and hydroxyethyl starch), and probenecid,
shall be prohibited.
(16) The
administration or reintroduction of any quantity of autologous, allogenic
(homologous) or heterologous blood or red blood cell products of any origin
into the circulatory system shall be prohibited.
(17) Artificially enhancing the uptake,
transport or delivery of oxygen, with perfluorochemicals, efaproxiral (RSR13),
hemoglobin products, hemoglobin-based blood substitutes, and microencapsulated
hemoglobin products (excluding supplemental oxygen) shall be
prohibited.
(18)
(a) Except as provided in paragraph (b) of
this subsection, any form of intravascular manipulation of the blood or blood
components by physical or chemical means shall be prohibited.
(b) The use of a hyperbaric oxygen chamber
shall not be a violation of this administrative regulation.
(19) Polymers of nucleic acids or
nucleic acid analogues shall not be transferred unless prior approval is
requested and received from the commission or its designee.
(20) The use of normal or genetically
modified hematopoietic cells shall be prohibited.
(21) Mesenchymal stem cells may be used for
treatment of musculoskeletal disorders, if the treatment is:
(a) Entered by the veterinarian in the
horse's medical record, which record shall be made available to a designee of
the commission upon request;
(b)
Pursuant to a valid veterinary prescription; and
(c) Reported to the commission's
representative at the time of sampling.
Section 3. Out-of-Competition Testing.
(1) Any horse eligible to race in Kentucky
shall be subject to testing without advance notice for the substances specified
in Section 2 of this administrative regulation. A horse shall be presumed
eligible to race in Kentucky if:
(a) It is
under the care, custody, or control of a trainer licensed by the
commission;
(b) It is owned by an
owner licensed by the commission;
(c) It is nominated to a race at an
association licensed pursuant to
KRS
230.300;
(d) It has raced at an association licensed
pursuant to
KRS
230.300 within the previous twelve (12)
calendar months;
(e) It is stabled
on the grounds of an association licensed pursuant to
KRS
230.300 or a training facility subject to the
jurisdiction of the commission; or
(f) It is nominated to participate in the
Kentucky Thoroughbred Development Fund, the Kentucky Standardbred Development
Fund, or the Kentucky quarter horse, paint horse, Appaloosa and Arabian
Development Fund.
(2) A
horse subject to testing under subsection (1) of this section may be designated
for testing by the executive director, the chief state steward, chief judge, or
their respective designee.
(3) An
owner, trainer, or any authorized designee shall fully cooperate with the
commission veterinarian, or his or her designee, by:
(a) Locating and identifying any horse
designated for out-of-competition testing;
(b) Making the horse available for the
collection of the specimen at a place designated by the commission
veterinarian, or his or her designee; and
(c) Observing the collection of the specimen.
1. If the owner, trainer or their authorized
designee, is not available to observe the collection of the specimen, the
collection shall be deferred until the trainer, owner, or their authorized
designee becomes reasonably available, but the collection shall occur no later
than six (6) hours after notice of intent to collect a specimen from a horse is
issued by the commission veterinarian or his or her designee.
2. If the collection does not occur within
the time provided for in this subsection, any horse that is designated for
testing may be barred from racing in Kentucky and placed on the veterinarian's
list, pursuant to
810
KAR 8:010, Section 18, and the steward's list or
judges' list, for a period of 180 days and the owner and trainer of the horse
may be subject to the penalties described in Section 8 of this administrative
regulation.
(4) Responsible persons.
(a) The trainer of the horse shall be
responsible for the condition of a horse sampled for an out-of-competition test
while on the grounds of a licensed training facility or racetrack.
(b) If the horse is sampled while not on the
grounds of a licensed training facility or racetrack, the owner shall be
presumed to be the responsible person unless the owner can establish, by
substantial evidence, that another licensed person had accepted the
responsibility for the care, custody, and control of the horse, making that
person the responsible person.
(c)
If a horse sampled for an out-of-competition test was claimed, sold, or
otherwise transferred during the time the substance giving rise to the positive
test may have been administered, then the commission shall investigate to
determine, by a preponderance of the evidence, the identity of the responsible
person at the time the substance may have been administered.
(d) If the commission cannot determine a
responsible person, then the commission may deem the owner responsible and may
place the horse on the veterinarian's list for as long as is necessary to
protect the integrity of racing.
(e) If a horse designated for testing is
sampled at a location not under the jurisdiction of the commission, the trainer
or his designee may declare at the time of sampling any reportable substances
that have been administered to the horse but have not previously been disclosed
to the commission.
Section
4. Specimen Collection.
(1) A
specimen shall be collected from any horse designated by the executive
director, the chief state steward, the presiding judge, or their designee,
whether the horse is located in Kentucky or in another jurisdiction.
(2) If a designated horse is located in
another jurisdiction, the executive director or commission veterinarian may
select a veterinarian from that jurisdiction's racing commission or regulatory
entity to collect the specimen.
(3)
At a licensed association or training facility under the jurisdiction of the
commission, the commission veterinarian, or his or her designee, may collect a
specimen from a horse designated for testing at any time.
(4) At a location other than the grounds of a
licensed association or a training facility under the jurisdiction of the
commission, the commission veterinarian, or his or her designee, shall collect
the specimen between the hours of 7 a.m. and 6 p.m., prevailing time, and shall
notify orally or in writing the owner, trainer, or their designee before
arriving to collect the specimen.
(5) A licensed association or training
facility under the jurisdiction of the commission at which a horse designated
for testing is located shall cooperate fully in the collection of the
specimen.
Section 6. Sample Storage and Testing.
(1) Any out of competition sample collected
pursuant to this administrative regulation shall be stored in a temperature
controlled unit at a secure location chosen by the commission until the sample
is submitted for testing. The samples shall be secured under conditions
established by the commission veterinarian in accordance with
810
KAR 8:010, Section 13.
(2) The commission is the owner of an out of
competition specimen.
(3) A trainer
or owner of a horse receiving notice of a report of finding from the commission
may request that a split sample corresponding to the portion of the sample
tested by the commission laboratory be sent to a split sample laboratory which
has documented its proficiency in detecting the substance associated with the
report of finding and has been approved by the commission.
(4) Split samples shall be subject to
810
KAR 8:010, Sections 12 and 13, and the chain of
custody of any split sample shall be maintained in accordance with
810
KAR 8:010, Section 14.
(5) The cost of testing a split sample,
including shipping, shall be borne by the owner or trainer requesting the
test.
Section 8. Penalty. A trainer, owner,
responsible person, or any other individual who violates this administrative
regulation shall be subject to the following penalties:
(2)
If the owner, trainer, or any authorized designee fails to cooperate or
otherwise prevents a horse from being tested, the horse designated for testing
shall be barred from racing in Kentucky and placed on the veterinarian's list,
pursuant to
810
KAR 8:010, Section 19, and the steward's list or
judges' list, for 180 days, and the individual or individuals responsible for
the failure to cooperate or prevention of the horse from being tested shall be
subject to the penalties established in subsection (4) of this
section.
(3) A horse that is barred
from racing in Kentucky and placed on the Veterinarian's List and the steward's
list, or judges' list pursuant to subsection (4)(b) or subsection (5) of this
section shall remain barred from racing and shall remain on the veterinarian's
list and the steward's list or judge's list:
(a) Upon sale or transfer of the horse to
another owner or trainer until the expiration of 180 days; and
(b) Until the horse is determined by the
commission to test negative for any substance prohibited by this administrative
regulation and is approved for racing by the commission veterinarian and the
chief state steward or presiding judge.
(4)
(a)
Willful failure to make a horse available for sampling, tampering with or
attempting to tamper in order to alter the integrity and validity of a sample,
including urine substitution or adulteration, or any other deceptive acts or
interference in the sampling process, shall be penalized as follows:
1. For a first offense, a Class A penalty as
established in
810 KAR
8:030; or
2. For a second offense, permanent license
revocation.
(b) A horse
that is not produced for out of competition testing shall be placed on the
Veterinarian's List for a minimum of 180 days.
(5) Failure to report treatment as required
by this administrative regulation shall be penalized as follows:
(a) For a first offense, a warning;
or
(b) For a second or subsequent
offense, a Class D penalty as established in
810 KAR
8:030.
(6) Upon finding a violation of this
administrative regulation, the horse in which the presence of a substance
described in Section 2 of this administrative regulation was detected shall be
barred from racing in Kentucky and placed on the veterinarian's list pursuant
to
810
KAR 8:010, Section 19, and the stewards' or judges'
list, for a period of up to 180 days and shall remain barred from racing in
Kentucky until the horse is determined by the commission to test negative for
any substance described in Section 2 of this administrative regulation and is
approved for racing by the commission veterinarian and the chief state steward
or presiding judge.
(7) Upon
finding a violation of this administrative regulation, the horse in which the
presence of a substance described in Section 2 of this administrative
regulation was detected shall remain subject to the requirements of subsection
(4) of this section:
(a) Upon sale or
transfer of the horse to another owner or trainer before the expiration of 180
days; and
(b) Until the horse is
determined by the commission to test negative for any substance described in
Section 2 of this administrative regulation and is approved for racing by the
commission veterinarian and the chief state steward or presiding
judge.