WSR 03-03-096

EXPEDITED RULES

DEPARTMENT OF HEALTH


[ Filed January 17, 2003, 3:31 p.m. ]

Title of Rule: WAC 246-887-165 Adding Xyrem to Schedule III of the Uniform Controlled Substances Act.

Purpose: The proposed rule will add Xyrem to Schedule III of the Uniform Controlled Substances Act. This action is taken to be consistent with federal rules.

Statutory Authority for Adoption: RCW 69.50.201, 18.64.005.

Statute Being Implemented: RCW 69.50.201.

Summary: The main active ingredient in the drug Xyrem is Gamma-hydroxybutyric acid (GHB). GHB is currently a Schedule I controlled substance. The proposed rule will place the drug Xyrem in Schedule III of the Uniform Controlled Substances Act based upon the approval of the FDA. All other forms of GHB will remain in Schedule I of the Uniform Controlled Substances Act.

Reasons Supporting Proposal: The Food and Drug Administration recently approved Xyrem for use in the treatment of cataplexy associated with narcolepsy. GHB-containing drugs approved by the FDA can be placed in Schedule III of the Uniform Controlled Substances Act.

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

Name of Proponent: Department of Health, Board of Pharmacy, governmental.

Rule is necessary because of federal law, C.F.R. 13235.

Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rule will add Xyrem to Schedule III of the Uniform Controlled Substances Act. The proposal will allow for the legitimate medical use of Xyrem. Xyrem will now be available in the state of Washington for the treatment of cataplexy associated with narcolepsy. The proposed rule addresses a public health concern, the treatment of cataplexy.

Proposal Changes the Following Existing Rules: Adopts WAC 246-887-165 adding Xyrem to Schedule III of the Uniform Controlled Substances Act.

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 THE USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Lisa Salmi, Lisa.Salmi@doh.wa.gov, Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863 , AND RECEIVED BY March 24, 2003.


January 6, 2003

D. H. Williams

Executive Director

OTS-6090.1


NEW SECTION
WAC 246-887-165   Adding Xyrem to Schedule III.   The Washington state board of pharmacy finds that Xyrem, sodium oxybate, Gamma-hydroxybutyric (GHB), is approved for medical use by the Food and Drug Administration and hereby places that substance in Schedule III.

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