WSR 24-15-076
PERMANENT RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed July 18, 2024, 7:31 a.m., effective August 18, 2024]
Effective Date of Rule: Thirty-one days after filing.
Purpose: Removing fenfluramine from the list of Schedule IV substances. The pharmacy quality assurance commission (commission) is proposing to add a new subsection to WAC 246-945-055 to delete fenfluramine from Schedule IV in accordance with RCW
69.50.201. The commission is also proposing to create new WAC 246-945-05001, to establish a list of exempted substances from RCW
69.50.204,
69.50.206,
69.50.208,
69.50.210, and
69.50.212, including fenfluramine.
Citation of Rules Affected by this Order: New WAC 246-945-05001; and amending WAC 246-945-055.
Adopted under notice filed as WSR 24-07-067 on March 15, 2024.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 1, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 1, Amended 1, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 1, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 1, Repealed 0.
Date Adopted: July 12, 2024.
Hawkins DeFrance, PharmD, Chair
Pharmacy Quality Assurance Commission
OTS-5139.1
NEW SECTION
The commission, under RCW
69.50.201, deletes the following substance listed in RCW
69.50.210 from Schedule IV in the state of Washington.
Fenfluramine. Any material, compound, mixture, or preparation containing any quantity of the following substance, including its salts, isomers, and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible: Fenfluramine.
AMENDATORY SECTION(Amending WSR 20-12-072, filed 6/1/20, effective 7/1/20)
WAC 246-945-055Schedule IV.
The commission finds that the following substances have a low potential for abuse relative to substances in Schedule III under RCW
69.50.208 and WAC 246-945-054, and have currently accepted medical use in treatment in the United States and that the abuse of the substances may lead to limited physical dependence or psychological dependence relative to the substances in Schedule III. In addition to substances listed in RCW
69.50.210, the commission places each of the following drugs and substances by whatever official name, common or usual name, chemical name, or brand name in Schedule IV.
(1) Narcotic drugs. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set in this subsection: 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers, and salts of these isomers (including tramadol).
(2) Depressants. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(a) Alfaxalone;
(b) Fospropofol;
(c) Suvorexant.
(3) Any material, compound, mixture, or preparation which contains any quantity of Lorcaserin, including its salts, isomers, and salts of such isomers, wherever the existence of such salts, isomers, and salts of isomers is possible.
(4) Stimulants. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(a) Cathine ((+) - norpseudoephedrine);
(b) SPA ((-)-1-dimethylamino-1,2-diphenylethane).
(5) Other substances. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts: Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its optical isomers) and its salts, isomers, and salts of isomers.
(6) The commission, under RCW 69.50.201, may delete substances designated as a Schedule IV controlled substance and list them in WAC 246-945-05001. Reviser's note: The brackets and enclosed material in the text of the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.