201 KAR 16:550 - Authorization for animal control agencies to apply for a restricted controlled substances certificate from DEA

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

201 KAR 16:550
46 Ky.R. 1735, 2468, 2611; eff. 6-30-2020.

STATUTORY AUTHORITY: KRS 321.207(1), (2), 321.235(3), 321.240(5)

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