WSR 05-14-157

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed July 6, 2005, 9:36 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 03-15-103.

Title of Rule and Other Identifying Information: Chapter 246-887 WAC, regulations implementing the Uniform Controlled Substances Act -- Chemical capture programs (CCP). The 2003 legislature recognized that the Washington Department of Fish and Wildlife (WDFW) has a need for controlled substances in chemical capture programs in order to accomplish wildlife management goals and to protect the public health. This legislation allows WDFW biologists and officers to purchase, possess, and administer controlled substances for use in CCP. The Department of Health (DOH) was given the authority to issue a limited registration to WDFW to carry out chemical capture with controlled substances. The proposed rules establish requirements for registration, drug storage, training, records and reports, lists controlled substances approved for use, and describes disciplinary actions for violating the rule. This proposal creates new sections WAC 246-887-220, 246-887-230, 246-887-240, 246-887-250, 246-887-260, 246-887-270, 246-887-280, and 246-887-290.

Hearing Location(s): CenterPoint Corporate Park, Creekside Building #3, 2nd Floor, 20435 72nd Avenue South, Kent, WA 98032, on August 10, 2005, at 10:00 a.m.

Date of Intended Adoption: August 10, 2005.

Submit Written Comments to: Lisa Salmi, P.O. Box 47863, Olympia, WA 98504-7863, e-mail Lisa.Salmi@doh.wa.gov or www3.doh.wa.gov/policyreview/default.asp, fax (360) 586-4359, by August 1, 2005.

Assistance for Persons with Disabilities: Contact Lisa Salmi by August 1, 2005, TTY (800) 833-6388 or (711) for relay.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will add new sections to chapter 246-887 WAC, regulations implementing the Uniform Controlled Substances Act. The proposed rule amendments implement legislation to allow WDFW biologists and officers to purchase, possess, and administer approved controlled substances for CCP. CCP typically capture, relocate, study, and monitor wildlife populations. The proposed rule sets standards that must be followed for controlled substance use in CCP.

The proposed rule amendments will allow appropriately trained WDFW personnel to use the most effective drug available to handle nuisance, injured, and dangerous wildlife. It is anticipated that the proposed rule will protect public health and safety by allowing WDFW biologists and officers to use the most effective drug and to promote the health of fish and wildlife.

Reasons Supporting Proposal: The proposed rule will promote public health and safety and promote the health of fish and wildlife species in the state by allowing WDFW biologists and officers access to the most effective drugs available to carry out chemical capture.

Statutory Authority for Adoption: RCW 69.50.320, 18.64.005.

Statute Being Implemented: RCW 69.50.320.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington State Department of Fish and Wildlife, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Steven M. Saxe, P.O. Box 47863, Olympia, WA 98504-7863, (360) 236-4825.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule does not impact small businesses. The proposed rule only affects the Washington State Department of Fish and Wildlife.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Lisa Salmi, Department of Health, Washington State Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, phone (360) 236-4828, fax (360) 586-4359, e-mail Lisa.Salmi@doh.wa.gov.

June 7, 2005

Steven Saxe

Executive Director

OTS-6722.2


NEW SECTION
WAC 246-887-220   Chemical capture programs.   Purpose. Wildlife management programs often require the use of controlled substances for chemical capture programs. The purpose of these rules is to set requirements for the use of controlled substances 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.

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NEW SECTION
WAC 246-887-230   Registration requirements.   (1) The department of fish and wildlife may apply to the board for a limited registration under chapter 69.50 RCW (Controlled Substance 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 board. The department of fish and wildlife shall notify the board 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 board in writing of the name of the designated individual.

(4) Controlled substances obtained under this limited registration shall be for veterinary use only.

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NEW SECTION
WAC 246-887-240   Authorized individuals.   To be eligible to possess and/or administer controlled substances, 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.

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NEW SECTION
WAC 246-887-250   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 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 board. Any amendments or deletions to the policies and procedures must be approved by the board prior to implementation.

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NEW SECTION
WAC 246-887-260   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 emergency field use. The emergency 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 emergency field supply shall be recorded in a bound logbook with sequentially numbered pages.

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NEW SECTION
WAC 246-887-270   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 board 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 six 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 board of pharmacy 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 board, the Drug Enforcement Administration, and the department of ecology.

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NEW SECTION
WAC 246-887-280   Approved controlled substances.   (1) The following controlled substances are hereby designated as approved controlled substances for use by officers and biologists of the department of fish and wildlife for chemical capture programs:

(a) Ketamine;

(b) Tiletamine and zolazepam (Telazol);

(c) Diazepam (Valium);

(d) Carfentanil (Wildnil); and

(e) Diprenorphine.

(2) Other controlled substances as approved by rule of the board after consultation with the department of fish and wildlife.

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NEW SECTION
WAC 246-887-290   Controlled substances registration disciplinary actions.   In addition to any criminal or civil liabilities that may occur, the board 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.

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Washington State Code Reviser's Office