N.Y. Comp. Codes R. & Regs. tit. 10 § 80.134

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.134 - Authorization for the purchase, possession and dispensing of ketamine hydrochloride only to anesthetize animals for euthanasia, and of sodium pentobarbital to euthanize animals

(a) Except where different meanings are specified expressly, the terms in this section shall have the following meanings:

(1) An incorporated society for the prevention of cruelty to animals (society) shall include any incorporated humane society or society for the prevention of cruelty to animals having facilities for the care and eventual disposition of animals, within the State.

(2) Municipal animal control facility (facility) shall include any pound or shelter maintained by or under contract or agreement with any county, city, town or village within the State.

(3) Solution shall mean:

(i) a premixed solution of sodium pentobarbital, manufactured only and specifically for the euthanasia of animals, which contains such other ingredients as to place such solution within schedule III of the Controlled Substances Act (article 33, Public Health Law);

(ii) schedule II sodium pentobarbital; and

(iii) ketamine hydrochloride only for the purpose of anesthetizing animals for euthanasia.

(4) An agent is a person or persons other than a licensed veterinarian appointed by the incorporated society or municipal animal control facility, and duly registered with the department, authorized to purchase, possess and dispense:

(i) ketamine hydrochloride only to anesthetize animals for euthanasia; and

(ii) sodium pentobarbital to euthanize animals.

(5) A registered individual is a person certified and registered pursuant to subdivision (f) of this section.

(b) No society, facility or its agent shall purchase, possess, dispense or cause to be administered, a controlled substance within this State without first registering with the department.

(c) A society or facility and its agents shall also register with the Federal Drug Enforcement Administration (DEA) in the controlled substance schedule provided for under this Part.

(d) Any society or facility may register an agent to purchase, possess and dispense a controlled substance, by application to the department.

(1) The department shall issue such registration unless the commissioner finds that the application should be denied by reason of false statements in the application, conviction of a felony relating to controlled substances, suspension, revocation or denial of the applicant's Federal DEA registration, failure to provide adequate safeguards against diversion of the solution, or other good and sufficient reason such as conviction for a violent felony or a felony related to theft, an administrative determination that article 33 of the Public Health Law or provisions of this Part were violated, conviction for a misdemeanor relating to controlled substances, or any conviction under the Agriculture and Markets Law relating to the treatment of animals.

(2) Such registration shall be valid for a period of three years from the date of issuance and may be suspended or revoked upon a finding by the commissioner that the society, facility, agent or certified personnel have violated the provisions of this section, or any other requirement of this Part or article 33 or any other State law or regulation relating to the proper care of animals by societies or facilities.

(3) Any society or facility registering an agent shall immediately notify the department of any change in the employment or contractual relationship with the designated agent.

(4) Such registration shall be valid only at the registered location.

(e)

(1) Registered agents of societies or facilities may dispense solution for the euthanasia of animals only to registered individuals certified by the department to administer such a solution; or to a licensed and properly registered veterinarian and only for on-premises use.

(2) Solution may be dispensed for use off the premises only where the animal to be euthanized is injured or transport of such animal to the society or facility is not practical.

(f) Registration and certification of individuals to administer solution for euthanasia of animals.

(1) No person other than a licensed veterinarian shall receive a controlled substance from a duly authorized agent of a society or facility to euthanize animals unless the person is certified and registered with the department.

(2) To obtain a certification and registration from the department in order to administer a solution to euthanize animals, the applicant must:

(i) be 21 years of age or older;

(ii) hold a bachelor or associate degree in animal health sciences or related field; and

(iii) obtain a written certification from two licensed veterinarians or one licensed veterinarian and one licensed animal health technician in which the veterinarians or technicians state that they have observed the proficient use, by the applicant, of injections for the euthanasia of animals.

(3) Any person who meets the minimum qualifications stated in subparagraphs (2)(i) and (iii) of this subdivision, but who lacks the required bachelor or associate degrees, may obtain certification and registration from the department if such person has two years' experience in animal care including euthanasia of dogs and cats.

(4) The department shall issue such registration and certification unless the commissioner finds that the application should be denied by reason of false statements in the application, the applicant's conviction of a felony relating to controlled substances or for other good and sufficient reason.

(5) Such registration and certification shall be valid for a period of three years from the date of issuance and may be suspended or revoked upon a finding by the commissioner that the registered individual has violated the provisions of this Part, article 33 or any other State law or regulation relating to the proper care of animals, or is not competent to administer solution in the euthanasia of animals by injection.

(g) Renewal of registrations. Registrations issued under this section shall be renewed by the department upon receipt of a completed renewal application which includes proof of attendance at a department-sponsored or -approved course in the safe and effective use of a solution in the euthanasia of animals.

(h) Safeguarding of solution. Agents shall safeguard the solution in compliance with the standards for safeguarding controlled substances set out in section 80.6(a) and (b) of this Part.

(i) Minimum security standards for a society, facility and its agents.

(1) The solution must be stocked in a securely locked cabinet of substantial construction. The cabinet shall be stationary and made of steel or other approved metal and of sufficient size to store the stock of solution.

(2) The cabinet shall be limited to the storage of the solution, needles and syringes and solution records.

(j) Recordkeeping requirements.

(1) Agents shall keep records of all solution purchased, dispensed and administered.

(2) All purchase records, including a copy of the invoice, shall be kept in a separate file and filed by date received.

(3) A separate record of solution activities and transactions in the form of a running inventory shall be maintained and include the following:

(i) the name of the drug (by brand name);

(ii) the name of the manufacturer, lot number, NDC number;

(iii) the strength of the drug in milligrams (mg) per milliliter (ml);

(iv) the total amount of drug received in milliliters;

(v) the name, address and DEA registration number of the supplier of the drug;

(vi) the date the solution was received;

(vii) the signature of the person receiving the solution;

(viii) the date of any transaction or activity, the amount of the solution dispensed at each dispensing;

(ix) the signature of the agent who dispensed the solution;

(x) the signature of the registered individual administering the solution; and

(xi) the remaining amount of drug on hand.

(4) Any unused solution must be returned to the agent. The agent must record the date, the amount returned, the signatures of the agent and the registered individual returning the drug, and the amount on hand after such transaction.

(5) A separate record shall be maintained of all losses with a brief statement describing the incident and signed by the agent and a witness.

(6)

(i) Agents shall cause the registered individual and any contracting practitioner to receive a work card or medical record sheet when dispensing the solution and such record shall be returned to the agent upon completion of each workday.

(ii) The work card or medical report sheet shall contain information to properly identify each animal to whom the solution is administered. For each female with litter, utilize only one record or card.

(iii) The registered individual euthanizing such animal shall document on such record the date of the administration of the drug, the amount of the drug used and the registered individual's signature.

(7) All records pertaining to the solution shall be kept on the premises of the society or facility for a period of five years and shall be available readily and produced promptly for inspection by authorized representatives of the commissioner.

(k) Quarterly reports. Within 10 days of the end of each quarter of each year, the society or facility shall submit a report to the department signed by an officer or official and the agent and include the following:

(1) the name, address and phone number of the society or facility;

(2) the agent's name, bureau registration number, DEA registration number;

(3) the total amount of solution received from suppliers;

(4) the total amount of solution dispensed to personnel;

(5) the total amount of solution returned from personnel;

(6) the total amount of solution lost for any reason;

(7) the total amount of solution on hand at the end of the quarter;

(8) an actual physical inventory count of solution on hand; and

(9) the total number of animals euthanized by species.

(l) All agents and registered individuals are under continuing duty to report immediately to the department any loss, theft or diversion of solution from the society or facility.

(m) Certification or registration by the department under this section does not authorize the use of medicated darts in a handgun.

(n) Registered individuals may administer solution for euthanasia of animals only when in the employ of a registered society or facility and only when solution is obtained from the registered agent of such society or facility.

(o) An agent of a society or facility may also obtain registration and certification to administer the solution as defined in paragraph (f)(2) of this section. However, the same individual may not act as both the agent dispensing and the registered individual administering in the same facility at the same time.

(p) Agents of an incorporated society or a facility are responsible for the proper safeguarding and handling of hypodermic syringes and needles and must comply with section 80.133(h)-(j) of this Part. All needles and syringes shall be stored in compliance with subdivision (i) of this section.

(q) The agent of a society or facility is not relieved of his responsibilities to detect or correct any diversion or mishandling of any solution by a delegation of responsibility.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.134