HLT-44-07-00032-P Ketamine Hydrocloride and Schedule II Sodium Pentobarbital

10/31/07 N.Y. St. Reg. HLT-44-07-00032-P

NEW YORK STATE REGISTER

VOLUME XXIX, ISSUE 44

October 31, 2007

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-44-07-00032-P

Ketamine Hydrocloride and Schedule II Sodium Pentobarbital

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed action:

This is a consensus rule making to amend sections 80.2, 80.132 and 80.134 of Title 10 NYCRR.

Statutory authority:

Public Health Law, sections 3308(2) and 3305(1)(d)

Subject:

Use of ketamine hydrochloride and schedule II sodium pentobarbital by animal control facilities.

Purpose:

To allow the use of ketamine hydrochloride and schedule II sodium pentobarbital for anesthesia and euthanasia purposes by animal control facilities.

Text of proposed rule:

The title of Section 80.134 in the Table of Contents is amended to read as follows:

80.134 Authorization for the purchase, possession and dispensing of ketamine hydrochloride to anesthetize animals and/or sodium pentobarbital to euthanize animals.

Section 80.2 is hereby amended to read as follows:

80.2 Exemptions. (a) Pursuant to section 3305 of the Public Health Law, the provisions of this Part restricting the possession of controlled substances shall not apply to:

(1) common carriers or warehousemen while engaged in lawfully transporting or storing such substances or to any employee of the same acting within the scope of his employment;

(2) public officers or their employees in the lawful performance of their official duties requiring possession of controlled substances;

(3) temporary incidental possession by employees or agents of persons lawfully entitled to possession or by persons whose possession is for the purpose of aiding public officers in performing their official duties;

(4) a person in the employ of the United States government, its territories, districts or insular governments by reason of his official duties;

(5) a master of a ship or a person in charge of any aircraft upon which a physician is not regularly employed; or

(6) a duly authorized agent of an incorporated society for the prevention of cruelty to animals or a municipal animal control facility for the limited purpose of purchasing, possessing and dispensing [sodium pentobarbital] to registered and certified personnel, ketamine hydrochloride to anesthetize animals and/or sodium pentobarbital to euthanize animals.

(b) The provisions of article 33 with respect to the payment of fees and costs shall not apply to the State of New York or any political subdivision thereof or any agency or instrumentality of either.

(c) The following exemptions are granted to the possession and use of schedule III or IV substances as part of an industrial process or manufacture of substances other than drugs: None.

Section 80.132 is hereby amended to read as follows:

80.132 Hypodermic syringes and needles; designation of persons or classes of persons.

(a) The following persons or classes of persons may obtain hypodermic syringes and hypodermic needles without prescription for use within the scope of their professions or activities:

(1) physicians;

(2) dentists;

(3) veterinarians;

(4) undertakers;

(5) nurses;

(6) podiatrists;

(7) registered pharmacists;

(8) hospitals;

(9) sanitariums;

(10) clinical laboratories;

(11) medical institutions;

(12) manufacturers or dealers in medical, pharmaceutical, surgical or dental supplies or their agents;

(13) resident physicians or interns of hospitals, sanitariums or other medical institutions;

(14) a duly authorized agent of an incorporated society for the prevention of cruelty to animals or a municipal animal control facility for the limited purpose of purchasing, possessing and dispensing to registered and certified personnel ketamine hydrochloride to anesthetize and/or sodium pentobarbital [to registered and certified personnel] to euthanize animals;

(15) persons engaged in an agricultural activity, provided that the manufacturer, distributor or supplier of the hypodermic syringe or hypodermic needle or of any product pre-packaged in a hypodermic syringe has an established needle and syringe return program in compliance with any applicable law;

(i) for purposes of this section, agricultural activity shall mean the production of food for human consumption and fiber through crops, livestock and livestock products.

(16) an advanced life support agency; and

(17) persons certified by the New York State Department of Environmental Conservation as wildlife rehabilitators. Wildlife rehabilitators 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 section 80.133(g) of this Part;

(18) licensed respiratory therapists and licensed respiratory therapy technicians;

(19) certified home health agencies, licensed home care services agencies and long term home health care programs approved under Article 36 of the Public Health Law; and

(20) certified hospices licensed under Article 40 of the Public Health Law.

Section 80.134 is hereby amended to read as follows:

80.134 Authorization for the purchase, possession and dispensing ketamine hydrochloride to anesthetize animals and/or 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; or

(iii) ketamine hydrochloride.

(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 ketamine hydrochloride to anesthetize animals and/or 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 anesthesia and/or 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 anesthetized and/or 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 anesthesia and/or 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 anesthetize and/or euthanize [dogs and cats] 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 anesthetize and/or 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 anesthesia and/or 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 anesthesia and/or euthanasia of animals.

(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 anesthesia and/or 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 anesthesia and/or 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 anesthetizing and/or 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 anesthesia and/or 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.

Text of proposed rule and any required statements and analyses may be obtained from:

Katherine E. Ceroalo, Department of Health, Office of Regulatory Affairs, Corning Tower, Rm. 2438, Empire State Plaza, Albany, NY 12237-0097, [phone], fax: [phone], e-mail: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Consensus Rule Making Determination

STATUTORY AUTHORITY

Section 3308(2) of the Public Health Law (PHL) authorizes and empowers the Commissioner to make any regulations necessary to supplement the provisions of Article 33 of the Public Health Law in order to effectuate its purpose and intent.

PHL Section 3305(1)(d) requires the department to adopt rules and regulations providing for the registration and certification of any individual who, under the direction of the duly authorized and registered agent of an incorporated society for the prevention of cruelty to animals, or municipal animal control facility, uses ketamine hydrochloride to anesthetize animals and/or sodium pentobarbital to euthanize animals, including but not limited to dogs and cats. The section also authorizes the department to adopt rules and regulations that provide for the safe and efficient use of ketamine hydrochloride and/or sodium pentobarbital by incorporated societies for the prevention of cruelty to animals and animal control facilities.

These regulations have been drafted after discussions with such provider groups as The Humane Society of the United States, Mohawk & Hudson River Humane Society and the Central New York Society of Cruelty to Animals.

Prior to 1997, Public Health Law Section 3305 authorized animal control facilities to use sodium pentobarbital to euthanize animals and the Department of Health adopted regulations governing the use of schedule III sodium pentobarbital in these facilities. Although this statute was amended in 1997 to allow these facilities to also use ketamine hydrochloride to anesthetize animals, the regulations were never amended to reflect this change. These regulations are being promulgated to address that discrepancy and conform the regulations to the statute.

Additionally, humane societies and animal control facilities have apprised the Department that the available schedule III sodium pentobarbital formulation authorized by the existing regulations is recommended only for the euthanizing of dogs and larger animals, and that the schedule II formulation of sodium pentobarbital is preferred for more humane treatment of smaller animals. They have advised the Department that Schedule III formulation has a higher viscosity that renders it difficult to utilize for cats and other small animals, resulting in seizures, fear and pain to the animals at the time of euthanasia. In fact, the Schedule III formulation of sodium pentobarbital is not approved by the U.S. Food and Drug Administration for use with cats. Since Public Health Law § 3305(d) specifically authorizes humane societies and animal control facilities to use sodium pentobarbital to euthanize cats, as well as dogs and other animals, the current limitation in the regulations restricting such facilities to the Schedule III formulation of sodium pentobarbital is inconsistent with the purpose and language of the existing statute. Consequently, these regulations also would amend Part 80 of Title 10 of the New York Code of Rules and Regulations to conform the regulations to the statutory language and intent by including Schedule II sodium pentobarbital among the controlled substances that may be possessed and administered by humane societies and animal control facilities.

Animal shelters provide a valuable public service by treating stray, injured, aged, sick, and feral animals. While licensed veterinarians are authorized to appropriately euthanize small animals using Schedule II sodium pentobarbital, they are not regularly available to perform the euthanasia in animal shelters. Consequently, the inability of humane societies and animal control facilities to use Schedule II sodium pentobarbital to euthanize small animals creates a hardship for these facilities and the animals euthanized by them.

Since this proposal would conform Part 80 of Title 10 of the New York Code of Rules and Regulations to Public Health Law '3305 and will permit humane societies and animal control facilities to euthanize animals in a more compassionate and humane manner, no person is likely to object to the adoption of this rule as written.

Job Impact Statement

No Job Impact Statement is required. It is apparent, from the nature of the proposed amendment, that it will not have a substantial adverse impact on employees of municipal animal control facilities or employees of an incorporated society for the prevention of cruelty to animals. It implements statute authorizing animal control facilities to use ketamine hydrochloride to anesthetize animals and authorizes use of Schedule II sodium pentobarbital to euthanize small animals.