Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
321.181,
321.207,
321.235,
321.351
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
321.207(1) requires the
Kentucky Board of Veterinary Examiners to authorize an animal control agency,
that it determines to be qualified, to apply for a registration certificate by
the United States Drug Enforcement Administration (DEA) to procure, manage, and
dispose of controlled substances which are authorized by the board for use in
animal sedation and euthanasia.
KRS
321.207(2) requires an
applicant agency to comply with administrative regulations that establish
standards for the proper storage and handling of the drugs the board has
authorized for use, and other provisions that may be necessary to ensure that
the drugs are used safely and solely for the purpose of euthanizing animals.
KRS
321.235(1)(a) and (b)
require the board to promulgate administrative regulations to implement KRS
Chapter 321. KRS
321.235(2)(b) 3. authorizes
the board to establish standards in veterinary medicine, medical records, and
other matters pertaining to veterinarians, veterinary technicians, animal
control agencies, animal euthanasia specialists, designated on-site mangers,
allied animal health professionals, veterinary facilities, AAHP facilities,
veterinarian managers, AAHP managers, registered responsible parties, or
unlicensed persons. This administrative regulation establishes the duties for
the animal control agency designated on-site manager, standards for proper drug
storage, and drugs that may be used by certified animal control agencies and
the certified animal euthanasia specialists they employ.
Section 1. Definitions.
(1) "Dispose" means to destroy or
transfer.
(2) "Manage" means to
administer, dispense, or inventory.
(3) "Procure" means to order, purchase, or
receive.
Section 2.
Responsibilities of a Certified Animal Control Agency. A certified animal
control agency shall:
(1) Ensure staff shall
comply with all requirements of KRS Chapter 321 and 201 KAR Chapter
16;
(2) Identify an agency
designated on-site manager and ensure the person complies with the requirements
in Section 3 of this administrative regulation;
(3) Report any change to the designated
on-site manager in writing to the board within ten (10) business days by
submitting a completed Request for a New Designated On-site Manager form or
online equivalent form, including all required attachments;
(4) Notify the board in writing within ten
(10) business days following the termination or severance of employment of a
certified animal euthanasia specialist in order that the certificate of the
animal euthanasia specialist may be moved to inactive status;
(5) Ensure that the United States Drug
Enforcement Administration (DEA) Controlled Substances Registration is kept in
active status if there are controlled substances in the possession of the
animal control agency;
(6) Submit
to inspection by a board representative at any time, with or without advanced
notice in accordance with
201 KAR 16:550, Section 5;
and
(7) Report to the board and to
DEA within twenty-four (24) hours any suspected diversion of controlled
substances or theft of controlled substances.
Section 3. Responsibilities of a Designated
On-site Manager.
(1) The designated on-site
manager shall be responsible for reviewing educational materials provided by
the board and submitting a responsive answer sheet for review by the board. A
board inspector or representative shall periodically review educational
materials with the designated on-site manager.
(2) The designated on-site manager shall:
(a) Ensure proper controls are in place in
accordance with all state and federal laws for all controlled substances and
other drugs at the animal control agency;
(b) Ensure drugs for euthanasia and drugs
used for sedation prior to euthanasia shall be limited to the substances
identified in Section 4 of this administrative regulation;
(c) Ensure all employees authorized to
conduct animal euthanasia at the certified animal control agency are trained
and certified in accordance with the requirements of
201 KAR 16:560 and
201 KAR 16:562, unless the
employee is a board-licensed veterinarian or board-licensed veterinary
technician;
(d) Ensure all animal
euthanasia specialists who conduct euthanasia at the certified animal control
agency maintain an active certificate with the board;
(e) Notify the board in writing within ten
(10) business days following the termination of a certified animal euthanasia
specialist so the certificate of the animal euthanasia specialist may be taken
out of active status;
(f) Develop
and maintain standard operating procedures in writing for carcass disposal in
accordance with all state and local laws and ordinances;
(g) Ensure that a designated area is provided
for animal euthanasia activities, and that the area is kept clean and orderly,
and is maintained as a safe workspace;
(h) Ensure that drugs ordered under DEA
Registration held by any person or entity other than the certified animal
control agency are kept in separate secure storage pursuant to
KRS
321.207(8); and
(i) Be responsive and cooperative to the
board's request for access and information to the certified animal control
agency.
(3) The
designated on-site manager shall ensure that the animal euthanasia process
shall be conducted within the restrictions set forth in this subsection.
(a) Euthanasia shall only be conducted upon
animals owned by the certified animal control agency, except in cases of
emergency care as defined by
KRS
321.181(33).
1. Transfer of ownership or a temporary
contract shall not be used for the purpose of circumventing this
subsection.
2. Wildlife shall be
redirected to one (1) of the following:
a. A
board-licensed veterinarian;
b. A
Certified Wildlife Rehabilitator authorized to operate pursuant to
301 KAR 2:075;
c. A Commercial Nuisance Wildlife Control
Operator authorized to operate pursuant to
301 KAR 3:120;
d. A Captive Wildlife Holder authorized to
operate pursuant to
301 KAR 2:081;
e. A Wildlife Transporter authorized to
operate pursuant to
301 KAR 2:082;
f. KDFWR wildlife biologist; or
g. KDFWR conservation officer.
(b) Euthanasia shall
only be conducted upon the premises of the certified animal control agency,
except in cases of emergency care as defined by
KRS
321.181(33).
(c) All euthanized animals shall be disposed
of in accordance with the certified animal control agency's standard operating
procedures for carcass disposal.
Section 4. Authorized Drugs for Animal
Euthanasia and Anesthesia or Sedation of Animals Prior to Euthanasia.
(1) For the purpose of animal euthanasia, a
certified animal control agency shall be restricted to the purchase of only
sodium pentobarbital.
(2) For the
purpose of animal anesthesia or sedation prior to euthanasia, a certified
animal control agency shall be restricted to the purchase of only the following
board-authorized specific drugs, or any combination thereof:
(a) Acepromazine;
(b) Dexmedetomidine;
(c) Ketamine; and
(d) Xylazine.
(3) Scheduled drugs (controlled substances)
shall be limited to a thirty (30) day supply, or the smallest quantity
available for purchase if that quantity is greater than a thirty (30) day
supply.
(4) The DEA's Schedule II
order forms (titled "DEA-222") shall be used for each purchase or transfer of
board authorized controlled substances.
(5) Expired drugs.
(a) Expired drugs shall not be
used.
(b) Expired drugs shall be
properly disposed of in accordance with Section 8 of this administrative
regulation.
Section
5. Storage.
(1) Board authorized
euthanasia and sedation drugs shall be stored at the DEA address of record for
the certified animal control agency in a secure steel safe or securely locked
steel cabinet within:
(a) A locked storage
room; or
(b) Other locked
enclosure; and
(c) If the safe or
cabinet weighs less than 750 lbs, it shall be bolted securely to the floor or
wall.
(2) DEA Controlled
Substance Schedule II order forms shall be maintained at the DEA address of
record for the certified animal control agency in a securely locked cabinet
that is:
(a) Separate from the storage
location of the drugs; and
(b)
Within a locked storage room or other locked enclosure.
Section 6. Disposal of Needles and
Medical Waste.
(1) All needles in an animal
control agency shall:
(a) Not be accessible to
the public;
(b) After one (1) use,
be rendered incapable of re-use; and
(c) Be disposed of in an approved biohazard
or sharps container.
(2)
All syringes used in the process of euthanasia shall be disposed of in an
approved biohazard or sharps container.
Section 7. Records.
(1) A certified animal control agency shall
maintain records of procurement, management, and disposal of board authorized
euthanasia drugs and sedation drugs, as listed in Section 4 of this
administrative regulation, for a minimum of two (2) years.
(2) Records of administration shall, at a
minimum, include:
(a) The date of
use;
(b) Identification of the
animal;
(c) The amount of the drug
used;
(d) Any amount
wasted;
(e) The signature of the
person administering the drug;
(f)
The signature of the designated on-site manager certifying the accuracy of the
administration of board authorized euthanasia drugs and sedation drugs not less
than once per month; and
(g) The
signature of the designated on-site manager certifying to the accuracy of the
records not less than once per month, as well as on the annual
inventory.
(3) Records of
procurement and destruction of board authorized euthanasia drugs and sedation
drugs shall be maintained in a separate file from the records of administration
of those substances.
(4) The
records of procurement, management, and disposal may be audited by
representatives of the DEA or authorized designees of the board to determine
adequacy, accuracy, and validity of the recordkeeping. The board may impose
restrictions and administrative penalties on certificate holders or designated
on-site managers as a result of substandard controls or records of the
drugs.
(5) The records of purchase,
administration, transfer, and destruction of euthanasia and sedation drugs,
shall be maintained at the DEA address of record for the certified animal
control agency.
Section
8. Destruction or Disposal of Drugs. Drugs at an animal control
agency that require disposal shall be disposed of in accordance with one (1) of
the methods set forth in this section. A written receipt with appropriate
signatures shall be obtained for the methods in subsections (1) through (3) of
this section, and a record of the action taken shall be made for the method in
subsection (4) of this section. The record shall be maintained with the drug
logs at the animal control agency.
(1)
Transfer non-expired, non-controlled drugs to a licensed
veterinarian.
(2) Transfer
non-expired, controlled drugs to a DEA registered, board-licensed veterinarian
using DEA Form 222. Copies of the DEA Form 222 shall be distributed per federal
law.
(3) Surrender expired or
non-expired drugs to local law enforcement for destruction.
(4) Inject expired or non-expired drugs into
and incinerate an animal carcass in accordance with state and local rules on
incineration. Written documentation shall describe the amounts disposed of,
type of carcass, date of injection and incineration, witnesses, and any other
pertinent details.
Section
9. Disciplinary Action. An animal control agency, designated
on-site manager, and animal euthanasia specialists shall be subject to
disciplinary action pursuant to
KRS
321.235 and
321.351 for a violation of state
or federal statutes or administrative regulations.
Section 10. Incorporation by Reference.
(1) "Request for a New Designated On-site
Manager", 07/2023, is incorporated by reference.
(2) This material may be inspected, copied,
or obtained, subjected to applicable copyright law, at the Kentucky Board of
Veterinary Examiners, 107 Corporate Drive, Frankfort, Kentucky 40601, Monday
through Friday, 8:30 a.m. to 4:30 p.m. This material may also be obtained at
www.kybve.com.
STATUTORY AUTHORITY:
KRS
321.207(1) - (3),(5)-(8),
321.235(1)(a), (b), (2)(b)3.
