WSR 16-17-116
PROPOSED RULES
DEPARTMENT OF HEALTH
(Board of Pharmacy)
[Filed August 22, 2016, 3:56 p.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: WAC 246-886-180 Approved legend drugs, the pharmacy quality assurance commission (commission) is proposing to add acetylpromazine, atipamezole, azaperone, isoflurane, dexmedetomidine, tolazoline, and xylazine to the list of approved legend drugs authorized for use by agents and biologist[s] of the Washington department of fish and wildlife (WDFW) management chemical capture programs.
Hearing Location(s): Red Lion Hotel, 1225 North Wenatchee Avenue, Wenatchee, WA 98801, on September 29, 2016, at 1:40 p.m.
Date of Intended Adoption: September 29, 2016.
Submit Written Comments to: Doreen Beebe, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-2260, by September 26, 2016.
Assistance for Persons with Disabilities: Contact Doreen Beebe by September 26, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission, in consultation with WDFW, has determined that the request to add atipamezole, azaperone, isoflurane, and tolazoline to the list of approved legend drugs under WAC 246-886-180 is appropriate. As approved drugs, they are available for use by WDFW authorized agents to immobilize or capture individual animals to be moved, treated, and examined or for any other legitimate purpose. In addition, a technical correction adds acetylpromazine, dexmedetomidine, and xylazine, which were omitted from this list in 2012 when chapter 246-886 WAC, Animal controlLegend drugs and controlled substances, was restructured under WSR 12-21-118.
Reasons Supporting Proposal: Chemical capture methods should be performed using drugs that provide adequate sedation for the safety of the WDFW authorized agent and the welfare of the animal. RCW 69.41.080 authorizes the pharmacy quality assurance commission to add legend drugs to the approved list as needed. The proposed rule makes available new drug combinations and pharmaceuticals that have demonstrated through wildlife research to be more effective in certain circumstances and with certain species, such as marine mammals.
Statutory Authority for Adoption: RCW 69.41.080, 18.64.005.
Statute Being Implemented: RCW 69.41.080.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington state department of health, pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting: Doreen Beebe, P.O. Box 47852, Olympia, WA 98504-7852, (360) 236-4834; Implementation and Enforcement: Steve Saxe, RPh, FACHE, P.O. Box 47852, Olympia, WA 98504-7852, (360) 236-4853.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(b), a small business economic impact statement is not required for proposed rules that relate only to internal governmental operations and that are not subject to violation by a nongovernmental party.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(ii) exempts rules that relate only to internal governmental operations that are not subject to violation by a nongovernment [nongovernmental] party.
August 19, 2016
Tim Lynch, PharmD, MS, Chair
Pharmacy Quality Assurance Commission
AMENDATORY SECTION (Amending WSR 12-21-118, filed 10/23/12, effective 11/23/12)
WAC 246-886-180 Approved legend drugs.
The following legend drugs are designated as "approved legend drugs" for use by agents and biologists of the Washington state department of fish and wildlife chemical capture programs:
(1) ((Naltrexone)) Acetylpromazine;
(2) ((Detomidine)) Atipamezole;
(3) ((Metdetomidine; and)) Azaperone;
(4) ((Yohimbine.)) Detomidine;
(5) Dexmedetomidine;
(6) Isoflurane;
(7) Metdetomidine;
(8) Naltrexone;
(9) Tolazoline;
(10) Yohimbine; and
(11) Xylazine.