WSR 15-17-077

PREPROPOSAL STATEMENT OF INQUIRY

[Filed August 17, 2015, 12:21 p.m.]

Subject of Possible Rule Making: WAC 246-887-040 and 246-887-045, designation of nonnarcotic stimulant drugs for purposes of RCW 69.50.402 (1)(c) and prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants. The pharmacy quality assurance commission (commission) is considering amending the rules to add lisdexamfetamine (also known by the trade name Vyvanse), a Schedule II nonnarcotic stimulant for the treatment of binge eating disorder (BED).

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 69.50.402.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The federal Food and Drug Administration (FDA) approved lisdexamfetamine for treatment of BED in January 2015. Washington law includes lisdexamfetamine as a Schedule II nonnarcotic stimulant, but includes only ADHD, not BED, as an approved indication. Because lisdexamfetamine is currently the only FDA approved drug for treatment of BED, the commission is considering updating the rules to include lisdexamfetamine for treatment of BED. State law provides that the commission may designate, in consultation with the medical commission and the osteopathic board, new disease states or conditions not already included in statute for treatment by Schedule II nonnarcotic stimulant.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Federal FDA and Drug Enforcement Administration.

Process for Developing New Rule: Collaborative rule making.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. Stakeholders will be invited to provide comments on the rule amendments and to provide input throughout the rule-making process. Interested parties can sign-up to receive information, updates, or provide comments to the commission at WSPQAC@doh.wa.gov or by contacting Brittany Mahugh, Policy Analyst, Department of Health, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852.

August 17, 2015

Chris Humberson, R.Ph.

Executive Director

Pharmacy Quality

Assurance Commission