WSR 14-23-040 EXPEDITED RULES DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed November 12, 2014, 12:24 p.m.]
Title of Rule and Other Identifying Information: Chapter 246-886 WAC, Animal control—Legend drugs and controlled substances and WAC 246-887-220 through 246-887-290, Uniform Controlled Substances Act—Chemical capture programs. Amend the name of the regulatory authority and move designated rules sections from chapter 246-887 WAC to new sections in chapter 246-886 WAC related to chemical capture programs.
NOTICE
THIS RULE IS BEING PROPOSED UNDER AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Doreen E. Beebe, Department of Health, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852, AND RECEIVED BY January 19, 2015.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposal is to amend sections of rule to update the name of the regulatory authority from the board of pharmacy to the pharmacy quality assurance commission to implement HB 1609 (2013). The rule is also amended to consolidate WAC 246-887-220 through 246-887-290 as new WAC 246-886-150, 246-886-160, 246-886-170, 246-886-190, 246-886-200, 246-886-210, 246-886-220, and 246-886-230 without material change. Consolidating the requirements under one chapter will simplify access to requirements by those who must comply. WAC 246-887-220 through 246-887-290 are proposed for repeal.
Reasons Supporting Proposal: The rule clarifies requirements for those who must comply and the public by placing standards for legend drugs and controlled substances under one chapter.
The expedited rule-making process is appropriate because the proposed rules incorporate Washington state statue [statute] and administrative rules without material change, per RCW 34.05.353 (1)(b).
Statutory Authority for Adoption: RCW 18.64.005, 69.50.320, and 69.41.080.
Statute Being Implemented: HB 1609 (chapter 19, Laws of 2013), RCW 18.64.005, 69.50.320, and 69.41.080.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting: Doreen Beebe, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4834; Implementation and Enforcement: Chris Humberson, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4853.
November 10, 2014
Chris P. Barry, R.Ph., Chair
Pharmacy Quality Assurance Commission
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-010 Definitions.
The following definitions apply throughout this chapter unless the context clearly indicates otherwise:
(1) "Animal control agency" means any agency authorized by law to euthanize or destroy animals; to sedate animals prior to euthanasia or to engage in chemical capture of animals.
(2) "Approved legend drugs" means any legend drug approved by the ((board)) commission for use by registered humane societies or animal control agencies for the sole purpose of sedating animals prior to euthanasia, when necessary, and for use in chemical capture programs.
(3) (("Board" means the Washington state board of pharmacy.
(4))) "Chemical capture programs" means wildlife management programs registered under RCW 69.50.320 and 69.41.080 to use approved legend drugs and controlled substance for chemical capture. Chemical capture includes immobilization of individual animals in order for the animals to be moved, treated, examined, or for other legitimate purposes.
(4) "Commission" means the Washington state pharmacy quality assurance commission.
(5) "Controlled substances" means a drug, substance, or immediate precursor in Schedule I through V of Article II of chapter 69.50 RCW and Schedule I through V of chapter 246-887 WAC.
(6) "Humane society" means a nonprofit organization, association, or corporation, the primary purpose of which is to prevent cruelty to animals, place unwanted animals in homes, provide other services relating to "lost and found" pets, and provide animal care education to the public, as well as sponsoring a neutering program to control the animal population.
(7) "Legend drugs" means any drugs which are required by state law or regulation of the state ((board of)) pharmacy quality assurance commission to be dispensed on prescription only or are restricted to use by practitioners only.
(8) "Registered entity" means any humane society or animal control agency registered under RCW 69.50.310.
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-020 Registration.
(1) Humane societies and animal control agencies registered with the ((board)) commission under RCW 69.50.310 may purchase, possess, and administer sodium pentobarbital and approved legend drugs as provided in RCW 69.41.080.
(2) To apply for registration a humane society or animal control agency shall submit to the ((board)) commission a completed application for registration on forms provided by the ((board)) commission.
(3) A registered humane society or animal control agency shall:
(a) Employ at least one individual who has completed a training program described in WAC 246-886-040;
(b) Designate a responsible person as defined in WAC 246-886-060;
(c) Maintain written policies and procedures available for inspection by the ((board)) commission that includes processes to:
(i) Require completion of approved training as defined in WAC 246-886-040 by each of the agency's agents or personnel who possess, and administer approved legend drugs or sodium pentobarbital, prior to being approved to administer such drugs;
(ii) Establish a system for the secure storage of all drugs to prevent access by unauthorized personnel to guard against theft and diversion;
(iii) Establish a system for accountability of access, use, and stocking of drug inventory;
(iv) Ensure the proper disposal of all drugs in compliance with state and federal laws and rules; and
(v) Establish a method to investigate and report the theft, loss, or diversion of approved legend drugs and sodium pentobarbital, in compliance with state and federal laws and rules.
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-040 Training of personnel.
(1) Personnel of a registered humane society or animal control agency may administer approved legend drugs and sodium pentobarbital if the individual:
(a) Has been approved by the registered entity to administer these drugs; and
(b) Has completed a ((board-approved)) commission approved training program or training that is substantially equivalent.
(2) Application for approval of a training program must be submitted to the ((board)) commission prior to the initiation of training.
(3) A training program must:
(a) Use a manual approved by the ((board)) commission;
(b) Be at least four hours in length;
(c) Be taught by a licensed veterinarian or by a person who has completed an approved training program taught by a licensed veterinarian;
(d) Require both didactic and practical training in the use of both approved legend drugs and sodium pentobarbital;
(e) Require a passing score of no less than seventy-five percent on a final examination; and
(f) Include, but not be limited to, the following topics:
(i) Anatomy and physiology:
(A) Methods of euthanasia;
(B) Routes of drug administration;
(C) Use of sedatives;
(D) Drug dosing;
(E) Use of restraints; and
(F) Process and verification of death;
(ii) Pharmacology of the drugs;
(iii) Indications, contraindications, and adverse effects;
(iv) Human hazards;
(v) Disposal of medical waste (needles, syringes, etc.);
(vi) Recordkeeping and security requirements; and
(vii) Applicable federal and state laws and rules.
(4) Training programs shall retain a list of persons who have successfully completed the program for a minimum of two years.
(5) The ((board)) commission shall maintain a registry of approved training programs and manuals. Interested persons may request a copy of the registry by contacting the ((board)) commission.
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-080 Recordkeeping and reports.
(1) A registered humane society or animal control agency must use a bound logbook with consecutively numbered pages to record the receipt, use, and disposition of approved legend drugs and sodium pentobarbital. Only one drug may be recorded on any single page.
(2) The logbook must have sufficient detail to allow an audit of the drug usage to be performed and must include:
(a) Date and time of administration;
(b) Route of administration;
(c) Identification number or other identifier assigned to the animal;
(d) Estimated weight of the animal;
(e) Estimated age and breed of the animal;
(f) Name of drug used;
(g) Dose of drug administered;
(h) Amount of drug wasted; and
(i) Initials of the primary person administering the drug.
(3) The logbook may omit subsections (2)(b), (d), and (e) of this section if the information is recorded in other records cross-referenced by the animal identification number or other assigned identifier.
(4) Personnel of the registered entity shall document any errors or discrepancies in the drug inventory in the logbook. He or she shall report the findings to the responsible supervisor for investigation.
(5) The registered entity shall report any unresolved discrepancies in writing to the ((board)) commission within seven days, and to the federal Drug Enforcement Administration if the loss includes a controlled substance.
(6) The designated individual, as defined in WAC 246-886-060, shall perform a physical inventory or count of approved legend drugs and sodium pentobarbital every six months. The physical inventory must be reconciled with the logbook.
(7) The supervisor or designated individual shall destroy legend drugs that are unfit for use due to contamination or having passed its expiration date. A second member of the staff shall witness drugs that are destroyed or wasted. The records of the destruction of drugs are documented in the logbook with the date of the event and signatures of the individuals involved.
(8) A registered entity shall return all unwanted or unused sodium pentobarbital to the manufacturer or destroy them in accordance with the rules and requirements of the ((board)) commission, the federal Drug Enforcement Administration, and the department of ecology.
(9) A registered entity shall maintain a written list of all authorized personnel who have demonstrated the qualifications to possess and administer approved legend drugs, and sodium pentobarbital.
(10) All records of the registered entity must be available for inspection by the ((board)) commission or any officer who is authorized to enforce this chapter.
(11) The registered entity shall maintain the logbook and other related records for a minimum of two years.
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-100 Violations.
The ((board)) commission may suspend or revoke a registration issued under chapter 69.50 RCW if the ((board)) commission determines that any agent or employee of a registered humane society or animal control agency has purchased, possessed, or administered legend drugs in violation of RCW 69.41.080 or 69.50.310, or this chapter or has otherwise demonstrated inadequate knowledge in the administration of legend drugs. The ((board's)) commission's revocation or suspension of a registration would restrict the registered entity's ability to use both approved legend drugs and sodium pentobarbital.
NEW SECTION
WAC 246-886-150 Chemical capture programs.
Purpose. Wildlife management programs often require the use of controlled substances and legend drugs for chemical capture programs. The purpose of these rules is to set requirements for the use of controlled substances and approved legend drugs in department of fish and wildlife chemical capture programs. Chemical capture includes immobilization of individual animals in order for the animals to be moved, treated, examined, or other legitimate purpose.
NEW SECTION
WAC 246-886-160 Registration requirements.
(1) The department of fish and wildlife may apply to the commission for a limited registration under chapter 69.50 RCW (Uniform Controlled Substances Act) to purchase, possess, and administer controlled substances for use in chemical capture programs.
(2) Each department of fish and wildlife field office that stores controlled substances must register with the commission. The department of fish and wildlife shall notify the commission in writing of the names of individuals who are authorized to possess and administer controlled substances.
(3) In addition, the department of fish and wildlife shall designate one individual at each field office who shall be responsible for the ordering, possession, safe storage, and utilization of controlled substances. The department of fish and wildlife shall notify the commission in writing of the name of the designated individual.
(4) Controlled substances obtained under this limited registration shall be for veterinary use only.
NEW SECTION
WAC 246-886-170 Authorized individuals.
To be eligible to possess and/or administer controlled substances and approved legend drugs, individuals must successfully complete an approved training program. The following individuals are authorized to possess and administer controlled substances:
(1) Department of fish and wildlife officers;
(2) Department of fish and wildlife biologists; and
(3) Department of fish and wildlife veterinarians.
NEW SECTION
WAC 246-886-190 Controlled substances training.
The department of fish and wildlife shall establish written policies and procedures to ensure that officers and biologists who administer controlled substances and approved legend drugs have received sufficient training. The training shall include, at a minimum, the safe handling and administration of controlled substances and the potential hazards. Officers and biologists must be able to demonstrate adequate knowledge of the potential hazards and proper techniques to be used in administering controlled substances.
The written policies and procedures shall be approved by the commission. Any amendments or deletions to the policies and procedures must be approved by the commission prior to implementation.
NEW SECTION
WAC 246-886-200 Storage requirements.
Each registered location shall store the controlled substances in a securely locked, substantially constructed cabinet. Keys to the storage area shall be restricted to those persons authorized by the department of fish and wildlife to possess and administer the drugs.
Schedule II controlled substances shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
In addition to field offices, the department of fish and wildlife may allow officers, biologists, and veterinarians to possess a supply of controlled substances for use in the field. The field supply shall be stored in a locked metal box securely attached to a vehicle. The designated officer, biologist, or veterinarian shall be responsible to ensure that the controlled substances are accounted for at all times. All receipts and use of controlled substances from the field supply shall be recorded in a bound logbook with sequentially numbered pages.
NEW SECTION
WAC 246-886-210 Controlled substances records and reports.
(1) The department of fish and wildlife shall be responsible for maintaining all records and submitting all reports required by federal or state law or regulation.
(2) A bound logbook with sequentially numbered pages shall be kept documenting the receipt and disposition of all controlled substances. In addition, all receipts and invoices shall be maintained for a period of two years.
(3) All records shall be available for inspection by the commission or any officer who is authorized to enforce this chapter.
(4) A physical inventory of approved controlled substances shall be performed, reconciled, and documented every twelve months. The inventory shall be signed and dated by the designated individual.
(5) Any discrepancy in the actual inventory of approved controlled substances shall be documented and reported immediately to the responsible supervisor who shall investigate the discrepancy. Any discrepancy that has not been corrected within seven days shall be reported in writing to the commission and the Drug Enforcement Administration (DEA).
(6) Unwanted or unused controlled substances shall be returned to the manufacturer or destroyed in accordance with the rules and requirements of the commission, the Drug Enforcement Administration, and the department of ecology.
NEW SECTION
WAC 246-886-220 Approved controlled substances.
The following controlled substances are approved for use by officers and biologists of the department of fish and wildlife for chemical capture programs:
(1) Butorphanol;
(2) Diazepam (Valium);
(3) Diprenorphine;
(4) Carfentanil (Wildnil);
(5) Fentanyl;
(6) Ketamine;
(7) Midazolam; and
(8) Tiletamine and zolazepam (Telazol).
NEW SECTION
WAC 246-886-230 Controlled substances registration disciplinary actions.
In addition to any criminal or civil liabilities that may occur, the commission may suspend or revoke a registration upon determination that the person administering controlled substances has not demonstrated adequate knowledge of the potential hazards and proper techniques to be used in administering controlled substances.
REPEALER
The following sections of the Washington Administrative Code are repealed:
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