DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

[Filed May 20, 2020, 10:36 a.m., effective May 20, 2020, 10:36 a.m.]

Effective Date of Rule: Immediately upon filing.

Purpose: WAC 246-887-180 Schedule V, the pharmacy quality assurance commission (commission) has adopted and [an] emergency rule to remove Epidiolex from the list of Schedule V controlled substances. The commission received a petition on April 7, 2020, to deschedule Epidiolex in WAC 246-887-180. Epidiolex is an FDA-approved cannabidiol with less than 0.3% tetrahydrocannabinal (THC) and was therefore exempted from the Controlled Substances Act by the 2018 Agricultural Improvement Act. The commission held a business meeting on April 24, 2020, and voted to approve this petition and amend its rule, WAC 246-887-180 Schedule V, to remove Epidiolex from the list of schedule V controlled substance to align with federal law.

Citation of Rules Affected by this Order: Amending WAC 246-887-180.

Statutory Authority for Adoption: RCW 18.64.005, 69.50.201.

Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.

Reasons for this Finding: The immediate amendment of these existing rules is necessary for the preservation of public health, safety, and general welfare. Epidiolex is an FDA-approved cannabidiol with less than 0.3% THC, used to help treat some seizure disorders. The 2018 Agricultural Improvement Act amended the Controlled Substances Act and declassified hemp products with less than 0.3% THC from Schedule I; however, Epidiolex was placed on Schedule V until April 2020 when the United States drug enforcement agency announced that it would be descheduled as a federally controlled substance. This emergency rule updates Washington rule to align with the federal decision. Emergency rules are necessary to reduce burdens on practitioners prescribing Epidiolex and allow patients easier access to the care they need. This rule may also help reduce pressure on the health system during the coronavirus 2019 disease (COVID-19) pandemic. Observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest. The commission will begin a permanent rule-making process following these emergency rules as soon as the COVID-19 response allows.

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

Date Adopted: May 20, 2020.

Tim Lynch, PharmD, MS

AMENDATORY SECTION(Amending WSR 19-06-068, filed 3/5/19, effective 4/5/19)

WAC 246-887-180Schedule V.

The pharmacy quality assurance commission (commission) finds that the following substances have low potential for abuse relative to substances in Schedule IV under RCW 69.50.210 and WAC 246-887-170 and have currently accepted medical use in treatment in the United States and that the substances have limited physical dependence or psychological dependence liability relative to the substance in Schedule IV. In addition to the substances listed in RCW 69.50.212, 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 V.

Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:

(1) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide); also referred to as BRV; UCB-34714; Briviact;

(2) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-carbamic acid ethyl ester].

(((3) Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols, also known as Epidiolex.))

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.