WSR 97-09-063

DEPARTMENT OF HEALTH

(Board of Pharmacy)

[Filed April 21, 1997, 2:13 p.m.]

notice of intent to adopt federal scheduling order--placement of remifentanil into schedule ii

The Washington State Board of Pharmacy intends to adopt the November 5, 1996, action of the Drug Enforcement Administration (DEA) to place remifentanil in Schedule II of the state Uniform Controlled Substances Act:

WAC 246-887-140 Schedule II. The board finds that the following substances have a high potential for abuse and have currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions and that the abuse of the following substances may lead to severe psychic or psychological dependence. The board, therefore, places each of the following substances in Schedule II.

(a) The drugs and other substances listed in this section, by whatever official name, common or usual name, chemical name, or brand name designated, are included in Schedule II.

(b) Substances. (Vegetable origin or chemical synthesis.) Unless specifically excepted, any of the following substances, except those listed in other schedules, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis:

(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine, naloxone, and naltrexone, and their respective salts, but including the following:

(i) Raw opium;

(ii) Opium extracts;

(iii) Opium fluid;

(iv) Powdered opium;

(v) Granulated opium;

(vi) Tincture of opium;

(vii) Codeine;

(viii) Ethylmorphine;

(ix) Etorphine hydrochloride;

(x) Hydrocodone;

(xi) Hydromorphone;

(xii) Metopon;

(xiii) Morphine;

(xiv) Oxycodone;

(xv) Oxymorphone; and

(xvi) Thebaine.

(2) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b)(1) of this section, but not including the isoquinoline alkaloids of opium.

(3) Opium poppy and poppy straw.

(4) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions which do not contain cocaine or ecgonine.

(5) Methylbenzoylecgonine (cocaine--its salts, optical isomers, and salts of optical isomers).

(6) Concentrate of poppy straw (The crude extract of poppy straw in either liquid, solid, or powder form which contains the phenanthrine alkaloids of the opium poppy.)

(c) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:

(1) Alfentanil;

(2) Alphaprodine;

(3) Anileridine;

(4) Bezitramide;

(5) Bulk dextropropoxyphene (nondosage forms);

(6) Carfentanil;

(7) Dihydrocodeine;

(8) Diphenoxylate;

(9) Fentanyl;

(10) Isomethadone;

(11) Levo-alphacetylmethadol - also known as levo-alpha-acetylmethadol, levomethadyl acetate or LAAM;

(12) Levomethorphan;

(13) Levorphanol;

(14) Metazocine;

(15) Methadone;

(16) Methadone--Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane;

(17) Moramide--Intermediate, 2-methyl-3-morpholino-1,1-diphenylpropane-carboxylic acid;

(18) Pethidine (meperidine);

(19) Pethidine--Intermediate--A,4-cyano-1-methyl-4-phenylpiperidine;

(20) Pethidine--Intermediate--B,ethyl-4-phenylpiperidine-4-carboxylate;

(21) Pethidine--Intermediate--C,1-methyl-4-phenylpiperidine-4-carboxylic acid;

(22) Phenazocine;

(23) Piminodine;

(24) Racemethorphan;

(25) Remifentanil;

(26) Racemorphan;

(26) (27) Sufentanil.

Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.

RCW 69.50.201 (2)(e) allows the board to directly adopt DEA scheduling orders without the need for the issuance of a Notice of Proposed Rule under chapter 34.05 RCW. This board will use the expedited rule process allowed for under RCW 69.50.201 provided no objection is made to the board's adoption of the scheduling order.

The proposed rule will be adopted by the Board of Pharmacy on June 27, 1997, at the board's regularly scheduled meeting if no objection to the rule is received.

Written comments and/or objections to the rule may be submitted to Donald H. Williams, Executive Director, Washington State Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863 or FAX (360) 586-4359.

The board will accept comments up to June 1, 1997.

Donald H. Williams

Executive Director

Legislature Code Reviser

Register

Washington State Code Reviser's Office