WSR 03-09-064

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed April 15, 2003, 9:07 a.m. ]

     Date of Adoption: March 31, 2003.

     Purpose: The rule places the prescription product, Xyrem¦, in Schedule III of the Uniform Controlled Substances Act. Xyrem¦ will now be available in the state of Washington for the treatment of cataplexy associated with narcolepsy.

     Citation of Existing Rules Affected by this Order: New section WAC 246-887-165.

     Statutory Authority for Adoption: Chapter 69.50 RCW.

     Other Authority: RCW 18.64.005.

      Adopted under notice filed as WSR 03-03-096 on January 17, 2003.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 1, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.
     Effective Date of Rule: Thirty-one days after filing.

March 31, 2003

Susan Teil Boyer

Board Chair

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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