201 KAR 16:550 - Authorization for animal control agencies to apply for a restricted controlled substances certificate from DEA
RELATES TO: KRS 217.177(1), (4), 321.207, 321.351
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.207(1) permits the Kentucky Board of Veterinary Examiners to authorize an animal control agency to apply for a registration certificate by the United States Drug Enforcement Administration (DEA) to euthanize animals. KRS 321.207(2) requires the 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(3) and 321.240(5) authorize the board to promulgate administrative regulations to implement KRS Chapter 321. This administrative regulation establishes the application, renewal, and reinstatement requirements for certification as an animal control agency, and the requirements for board inspections at certified animal control agencies.
Section 1. Definitions.
(1) "Animal shelter" means a public agency or
private humane society, society for the prevention of cruelty to animals,
animal protection shelter or control agency, or other facility that provides
shelter and care for homeless, stray, unwanted, or injured animals.
(2) "Certified Animal Control Agency" means
an animal shelter that is certified under the provisions of KRS Chapter 321 and
201 KAR Chapter 16.
(3) "Designated
On-site Manager" means a person who registers with the board to assume
responsibility for the ordering, management, use, and disposal of controlled
substances at a board-certified animal control agency.
Section 2. Application and Renewal
Requirements.
(1) The applicant animal shelter
shall apply to the board for authorization as established by
KRS
321.207.
(2) A complete application to the board shall
include the following components:
(a) A
completed Application for Certification as an Animal Control Agency form or
online equivalent form, including all required attachments;
(b) Identification of the agency designated
on-site manager;
(c) A complete and
current list of all individuals performing euthanasia or related activities at
the animal shelter, whether or not each individual holds a credential from the
board; and
(d) Payment of the fee
in accordance with
201 KAR 16:514.
(3) Prior to the board's issuance
of the animal control agency certificate, the applicant shall undergo an
inspection of the facility by the board, its inspector, or other designee of
the board in accordance with Section 5 of this administrative
regulation.
(4) Following board
application approval, the applicant shall apply to DEA for registration as a
practitioner and designate "animal shelter" on the appropriate DEA
form.
(5) A certified animal
control agency shall submit to inspection by a board representative at any
time, with or without advanced notice.
(6) A certified animal control agency shall
identify a designated on-site manager in accordance with
201 KAR 16:552.
(a) The agency shall notify the board in
writing within ten (10) days of any change in the designated on-site manager of
the animal shelter by submitting a completed Request for a New Designated
On-site Manager form or online equivalent form, including all required
attachments.
(b) The designated
on-site manager shall be responsible for complying with all state and federal
laws related to the ordering, purchase, storage, tracking, management, and
disposal of the drugs obtained under the DEA controlled substances
registration.
(7)
Background checks. The board may conduct a national or jurisdictional level
background check on each designated on-site manager. The check shall be
processed by a board approved background check provider, and may include a copy
of the designated on-site manager's fingerprints captured at a board approved
location. The board may accept the results of an employment background check
from the county office in lieu of a state or federal background check if the
background check results are not more than six (6) months old from the date of
application. The board may reject background checks that do not have an
official seal or watermark, or that are more than ninety (90) days old. The
board may impose additional requirements as a condition of certification for
the animal control agency or deny certification following the board's review of
findings from a background check.
Section 3. Renewal Requirements for a
Certified Animal Control Agency.
(1) A
board-certified animal control agency shall renew the board certification
annually in accordance with
201 KAR 16:572.
(2) Failure to renew the certificate for an
animal control agency shall result in the following actions by the board:
(a) The animal control agency certificate
shall be moved to expired status;
(b) Each "active" status certified animal
euthanasia specialist under the employment of the expired certified animal
control agency shall be moved to "inactive" status;
(c) The DEA shall be notified of the lapse in
certification; and
(d) The board
shall conduct a closeout inspection within six (6) months of the date of
expiration to ensure that the controlled substances and other drugs on-site are
properly disposed of. An animal shelter with an expired certificate shall
continue to maintain the drugs in accordance with
201 KAR 16:552, and the Kentucky
Veterinary Medicine Practice Act (KRS Chapter 321), and 201 KAR Chapter 16,
until the drugs are transferred in accordance with state and federal laws, or
disposed of in accordance with
201 KAR 16:552, Section
7.
Section 4.
Reinstatement Requirements for Animal Control Agencies.
(1) An animal control agency with an expired
certificate shall have five (5) years to reinstate their certificate by
submitting a completed Reinstatement Application for Animal Control Agencies
form or online equivalent form, including all required attachments and payment
of the application fee pursuant to
201 KAR 16:514.
(2) The animal control agency shall undergo
inspection by an authorized representative of the board in accordance with
Section 5(3) of this administrative regulation prior to the reinstatement of a
certificate.
(3) After five (5)
years, the agency shall not be able to reinstate and shall be required to apply
for a new certificate in accordance with this administrative regulation and
201 KAR 16:572.
Section 5. Inspection
Requirements.
(1) A certified animal control
agency shall be subject to inspection by the board, its investigator, or a
board representative.
(2) An
inspection may occur at any time, with or without advance notice. The
designated on-site manager shall make themselves available to provide access
and information during the inspection.
(3) An inspection shall be required:
(a) Prior to the approval of a new
Application for Certification as an Animal Control Agency;
(b) Prior to the approval of a Reinstatement
Application for Animal Control Agencies, if the last inspection was completed
more than twelve (12) months prior to the date of the application;
(c) Periodically on a schedule set by the
board, not more routinely than every ten (10) months, and at least once every
two (2) years;
(d) As needed due to
staff turnover at the animal control agency;
(e) Under suspicion of probable cause for
violation of KRS Chapter 321; and
(f) Following the expiration, termination,
suspension, or surrender of the certificate.
Section 6. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Application for Certification
as an Animal Control Agency", 12/2022;
(b) "Reinstatement Application for Animal
Control Agencies", 12/2022; and
(c)
"Request for a New Designated On-site Manager", 12/2022.
(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.
Notes
STATUTORY AUTHORITY: KRS 321.207(1), (2), 321.235(3), 321.240(5)
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
RELATES TO: KRS 217.177(6), 321.207, 321.235(7), 321.351
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.207(1) permits the Kentucky Board of Veterinary Examiners to authorize an animal control agency to apply for a registration certificate by the United States Drug Enforcement Administration (DEA) to euthanize animals. KRS 321.207(2) requires the 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(3) and 321.240(5) authorize the board to promulgate administrative regulations to implement KRS Chapter 321. This administrative regulation establishes the certification requirements, 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. General Requirements.
(1) The applicant animal control agency shall apply to the board for authorization as established by KRS 321.207.
(2) A complete application to the board shall include the following components:
(a) A completed Application for Certification as an Animal Control Agency form or online equivalent form, including all required attachments;
(b) Identification of the agency designated onsite manager;
(c) A complete and current list of all individuals preforming euthanasia activities at the animal control facility; and
(d) Payment of the fee in accordance with 201 KAR 16:514.
(3) Prior to the board's issuance of the certificate of authorization, the applicant shall undergo an inspection of the facility by the board inspector or other designee of the board.
(4) Following board application approval, the applicant shall apply to DEA for registration as a practitioner and designate "animal shelter" on the appropriate DEA form.
(5) A certified animal control agency shall submit to inspection by a board representative at any time, with or without advanced notice.
(6) A certified animal control agency shall designate an onsite manager of the shelter. The agency shall notify the board in writing within ten (10) days of any change in the onsite manager of the shelter.
(7) Background checks. The board may conduct a national or jurisdictional level background check on each designated shelter manager. The check shall be processed by a board approved background check provider, and may include a copy of the designated manager's fingerprints captured at a board approved location. The board may reject background checks that do not have an official seal or watermark, or that are more than ninety (90) days old. The board may impose additional requirements as a condition of certification for the animal control agency or deny certification following the board's review of findings from a background check.
(8) Animal control agency certificate renewal requirements.
(a) An animal control agency shall renew the board certification annually in accordance with 201 KAR 16:572.
(b) Failure to renew the certificate for an animal control agency shall result in the following actions by the board:
1. The animal control agency certificate shall be moved to expired status;
2. All certified animal euthanasia specialists under the employment of the formerly certified animal control agency shall be moved to inactive status; and
3. The DEA shall be notified of the lapse in certification.
(c)
1. An animal control agency with an expired certificate shall have five (5) years to reinstate their certificate by submitting a completed Reinstatement Application for Animal Control Agencies form or online equivalent form, including all required attachments and payment of the application fee pursuant to 201 KAR 16:514.
2. The animal control agency shall undergo inspection by an authorized representative of the board in accordance with subsection (3) of this section prior to the reinstatement of a certificate.
3. After five (5) years, the agency shall apply for a new certificate in accordance with this administrative regulation and 201 KAR 16:572.
Section 2. Approved Drugs. A certified animal control agency shall be restricted to the purchase of sodium pentobarbital and other euthanasia drugs currently approved by the American Veterinary Medical Association (AVMA) for the purpose of euthanizing animals. DEA's Schedule II order forms (titled "DEA-222") shall be used for each purchase of sodium pentobarbital or other AVMA approved euthanasia drugs.
Section 3. Records.
(1) A certified animal control agency shall maintain records of purchases and administration of sodium pentobarbital and other AVMA approved euthanasia drugs for a period of not less than two (2) years.
(2) Records of administration shall include, at a minimum, the following information:
(a) The date of use;
(b) Identification of the animal;
(c) The amount of the drug used;
(d) The signature of the person administering the drug;
(e) The signature of the onsite manager certifying the accuracy of the administration of sodium pentobarbital and other AVMA approved euthanasia drugs not less than once per month; and
(f) The signature of the onsite manager certifying to the accuracy of the records.
(3) Records of purchase and destruction of sodium pentobarbital and other AVMA approved euthanasia drugs shall be maintained in a separate file from the records of administration of those substances.
(4) The records of purchase, destruction, and administration 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 as a result of substandard controls or records of the drugs.
(5) The records of purchase, destruction, and administration shall be maintained at the location of the agency.
Section 4. Storage.
(1) Sodium pentobarbital and other AVMA approved euthanasia drugs shall be stored in a securely locked cabinet within a locked storage room or other enclosure at the certified animal control agency.
(2) Schedule II order forms shall be stored in a securely locked cabinet, separate from the storage location of the drugs, within a locked storage room or other enclosure at the certified animal control agency.
Section 5. Disposal of Needles and Medical Waste. All needles generated in the process of euthanizing animals shall be disposed of pursuant to KRS 217.177(6).
Section 6. Disciplinary Action. An animal control agency and its employees shall be subject to disciplinary action pursuant to KRS 321.235(7) and KRS 321.351 for a violation of state or federal statutes or administrative regulations.
Section 7. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Application for Certification as an Animal Control Agency", 3/2020; and
(b) "Reinstatement Application for Animal Control Agencies", 3/2020.
(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, 8:00 a.m. to 4:30 p.m. This material may also be obtained at www.kybve.com.
Notes
STATUTORY AUTHORITY: KRS 321.207(1), (2), 321.235(3), 321.240(5)