WSR 16-02-016 PROPOSED RULES DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed December 28, 2015, 11:46 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 15-17-077.
Title of Rule and Other Identifying Information: WAC 246-887-040 Designation of nonnarcotic stimulant drugs for purposes of RCW 69.50.402 (1)(c) and 246-887-045 Prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants, proposing adding Lisdexamfetamine to the list of Schedule II nonnarcotic stimulants for purposes of RCW 69.50.402 (1)(c) and adding binge eating disorder (BED) in adults to the list of disease states or conditions for which Schedule II nonnarcotics can be prescribed, dispensed, or administered.
Hearing Location(s): Highline Community College, Mt. Constance Conference Room, 2400 South 240th Street, Des Moines, WA 98198, on March 3, 2016, at 9:30 a.m.
Date of Intended Adoption: March 3, 2016.
Submit Written Comments to: Doreen Beebe, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2260, by February 29, 2016.
Assistance for Persons with Disabilities: Contact Doreen Beebe by February 24, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: WAC 246-887-040 and 246-887-045, the pharmacy quality assurance commission (commission) is proposing to add Lisdexamfetamine (also known by the brand name Vyvanse) to the list of Schedule II nonnarcotic stimulants for purposes of RCW 69.50.402 (1)(c). The commission is also proposing to add BED in adults to the list of disease states or conditions for which Schedule II nonnarcotic stimulants can be prescribed, dispensed, or administered for those specific Schedule II nonnarcotic stimulants that have been specifically approved by the FDA for such disease state or condition. By adding Lisdexamfetamine to the list of designated nonnarcotic stimulants and BED to the list of approved disease states or conditions, practitioners will be able to use Lisdexamfetamine to treat BED in adults.
Reasons Supporting Proposal: RCW 69.50.402 (1)(c)(ii) restricts the use of Schedule II nonnarcotic stimulants to only those disease states or conditions listed in statute. It also states that the commission, in consultation with the medical quality assurance commission and the board of osteopathic medicine and surgery, may designate additional disease states and conditions for which practitioners may prescribe Schedule II nonnarcotic stimulants. Thus, to allow practitioners to prescribe Lisdexamfetamine, the commission must add Lisdexamfetamine and BED in adults to the rules.
Statute Being Implemented: RCW 69.50.402.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington state pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting: Doreen Beebe, 111 Israel Road S.E., Tumwater, WA 98504-7852, (360) 236-4834; Implementation and Enforcement: Lisa Hodgson, 111 Israel Road S.E., Tumwater, WA 98504-7852, (360) 236-2927.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Doreen Beebe, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504, phone (360) 236-4834, fax (360) 236-2260, e-mail doreen.beebe@doh.wa.gov.
December 23, 2015
A. J. Linngi, R.Ph., Chair
Pharmacy Quality Assurance Commission
AMENDATORY SECTION (Amending WSR 92-04-029, filed 1/28/92, effective 2/29/92)
WAC 246-887-040 Designation of nonnarcotic stimulant drugs for purposes of RCW 69.50.402 (1)(c).
The ((board of)) pharmacy quality assurance commission hereby designates, the following Schedule II controlled substances as nonnarcotic stimulants for purposes of RCW 69.50.402 (((a)(3) [69.50.402 (1)(c)])) (1)(c):
(1) Amphetamine sulfate in any of its generic forms.
(2) Dextroamphetamine sulfate in any of its generic forms and under the following brand names:
(a) Dexedrine (SKF);
(b) Dexedrine spansules (SKF).
(3) Dextroamphetamine HCL in any of its generic forms.
(4) Dextroamphetamine tannate in any of its generic forms.
(5) Methamphetamine HCL (Desoxyephedrine HCL) in any of its generic forms and under the following brand name:
Desoxyn (Abbott).
(6) Amphetamine complex in any of its generic forms and under the following brand names:
(a) Biphetamine 12 1/2 (Pennwalt);
(b) Biphetamine 20 (Pennwalt).
(7) Combined amphetamines sold under the following brand names:
Obetrol-10 and 20 (Obetrol).
(8) Phenmetrazine HCL in any of its generic forms and under the following brand name:
(((a))) Preludin (Boehringer-Ingelheim).
(9) Methylphenidate HCL in any of its generic forms and under the following brand name:
(((a))) Ritalin (Ciba).
(10) Lisdexamfetamine in any of its generic forms and under the following brand name:
Vyvanse.
AMENDATORY SECTION (Amending WSR 03-04-045, filed 1/28/03, effective 2/28/03)
WAC 246-887-045 Prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants.
The Schedule II stimulants listed in WAC 246-887-040 may be prescribed, dispensed, or administered to patients for the following disease states or conditions:
(2) Multiple sclerosis; and
(3) Moderate to severe binge eating disorder in adults.
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