PREVIOUS VERSION

The previous document that this document is based upon is available.

201 KAR 16:552.Responsibilities for certified animal control agencies; limitations on drugs.

RELATES TO:

KRS 321.181, 321.207, 321.235, 321.351

STATUTORY AUTHORITY:

KRS 321.207(1) – (3),(5)-(8), 321.235(1)(a), (b), (2)(b)3.

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 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)

(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.

HISTORY: (49 Ky.R. 1540, 1905; eff. 7-5-2023; 50 Ky.R. 416, 1304, 1476; eff. 4-2-2024.)

FILED WITH LRC: December 11, 2023

CONTACT PERSON: Michelle Shane, Executive Director, Kentucky Board of Veterinary Examiners, 107 Corporate Drive, Second Floor, Frankfort Kentucky 40601, phone (502) 782-0273, fax (502) 695-5887, email michelle.shane@ky.gov.

201 KAR 16:552.Responsibilities for certified animal control agencies; limitations on drugs.

RELATES TO:

KRS 321.181, 321.207, 321.235~~321.235(7)~~, 321.351

STATUTORY AUTHORITY:

KRS 321.207(1) – (3),(5)-(8), 321.235(1)(a), (b), (2)(b)3.~~(1), (2), 321.235(3), 321.240(5)~~

NECESSITY, FUNCTION, AND CONFORMITY:

KRS 321.207(1) requires~~permits~~ 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~~order, purchase, manage, and store~~ controlled substances which are authorized by the board for use in animal sedation and euthanasia. KRS 321.207(2) requires an~~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(1)(a) and, (b) require~~, (2)(b)3. authorizesKRS 321.235(3) and 321.240(5) authorize~~ 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" ~~in relation to drugs~~ means to destroy or transfer.

(2)

"Manage" ~~in relation to drugs~~ means to administer, dispense, or inventory.

(3)

"Procure" ~~in relation to drugs~~ means to order, purchase, or receive.

Section 2.

Responsibilities of a Certified Animal Control Agency. A certified animal control agency shall:

(1)

Ensure~~A certified animal control agency and~~ staff shall comply with all requirements of KRS Chapter 321 and 201 KAR Chapter 16;.

(2)

Identify~~A certified animal control agency shall identify~~ an agency designated on-site manager and ensure the person complies with the requirements in Section 32 of this administrative regulation;.

(3)

Report any~~Any~~ change to the designated on-site manager ~~shall be reported~~ 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)

(5)

Ensure~~A certified animal control agency shall 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)(5)

Submit~~A certified animal control agency shall 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.Section 2.

Responsibilities of a Designated On-site Manager.

(1)

(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 43 of this administrative regulation;

(c)

(d)

Ensure all animal euthanasia specialists who conduct euthanasia at the certified animal control agency maintain an active certificate with the board;

(e)

(f)

Develop~~Shall develop~~ and maintain standard operating procedures in writing for carcass disposal in accordance with all state and local laws and ordinances; ~~and~~

(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~~Shall 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)~~KRS 321.181(10)~~.

1.

Transfer of ownership or a temporary contract shall not be used for the purpose of circumventing this subsection.~~; and~~

2.

Wildlife shall be redirected to one (1) of the following:

a.

Aa board-licensed veterinarian;,

b.

A Certified Wildlife Rehabilitator authorized to operate pursuant to 301 KAR 2:075;~~, or~~

c.

A Commercial~~to a~~ 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; or

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).~~KRS 321.181(10); and~~

(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.Section 3.

Authorized~~Approved~~ 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~~the following board-approved specific drugs~~ ~~for the purpose of animal euthanasia~~. ~~The drugs approved by the board for euthanasia are:~~

(a)

~~Sodium pentobarbital; and~~

(b)

~~Sodium pentobarbital with lidocaine.~~

(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~~board-approved~~ specific drugs, or any combination thereof:~~, for the purpose of animal anesthesia or sedation prior to euthanasia.~~ ~~The drugs approved by the board for animal anesthesia or sedation prior to euthanasia are, or any combination thereof:~~

(a)

Acepromazine;

(b)

Dexmedetomidine;

(c)

Ketamine ~~(30-day supply or less)~~; 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~~approved~~ controlled substances.

(5)(4)

Expired drugs.

(a)

Expired drugs shall not be used.

(b)

Expired drugs shall be properly disposed of in accordance with Section 87 of this administrative regulation.

Section 5.Section 4.

Storage.

(1)

Board authorized~~approved~~ 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)

Aa locked storage room;, or

(b)

Other locked~~other~~ enclosure; and~~at the DEA address of record for the certified animal control agency.~~

(c)

If the safe or cabinet weighs less than 750 lbs, it~~theThe~~ ~~cabinet~~ 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~~stored~~ in a securely locked cabinet that is:,

(a)

Separate~~separate~~ from the storage location of the drugs; and,

(b)

Within~~within~~ a locked storage room; or other locked

(c)

~~Other lockedother~~ enclosure ~~at the DEA address of record for the certified animal control agency~~.

Section 6.Section 5.

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~~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.Section 6.

Records.

(1)

A certified animal control agency shall maintain records of procurement, management, and disposal~~purchases, administration~~ of board authorized~~board approved~~ euthanasia drugs and sedation drugs, as listed in Section 43 of this administrative regulation,~~, transfer, and destruction of drugs~~ for a minimum of two (2) years.

(2)

Records of administration shall, at a minimum, 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)

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~~approved~~ 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~~purchase~~ and destruction of board authorized~~approved~~ 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~~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 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.Section 7.

(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)

Section 9.Section 8.

Disciplinary Action. An animal control agency, designated on-site manager, and ~~credentialed~~ 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.Section 9.

Incorporation by Reference.

(1)

"Request for a New Designated On-site Manager", 07/2023~~12/2022~~, is incorporated by reference.

(2)

HISTORY: (49 Ky.R. 1540, 1905; eff. 7-5-2023; 50 Ky.R. 416, 1304, 1476; eff. 4-2-2024.)

FILED WITH LRC: December 11, 2023

Page Generated: 9/19/2024, 12:15:11 PM

Title 201 | Chapter 016 | Regulation 552

201 KAR 16:552.Responsibilities for certified animal control agencies; limitations on drugs.

RELATES TO:

STATUTORY AUTHORITY:

NECESSITY, FUNCTION, AND CONFORMITY:

Section 1.

(1)

(2)

(3)

Section 2.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

Section 3.

(1)

(2)

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(3)

(a)

1.

2.

a.

b.

c.

d.

e.

f.

g.

(b)

(c)

Section 4.

(1)

(2)

(a)

(b)

(c)

(d)

(3)

(4)

(5)

(a)

(b)

Section 5.

(1)

(a)

(b)

(c)

(2)

(a)

(b)

Section 6.

(1)

(a)

(b)

(c)

(2)

Section 7.

(1)

(2)

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(3)

(4)