EXPEDITED RULES
(Pharmacy)
Title of Rule: Chapter 246-889 WAC, Pharmaceutical precursor substance control.
Purpose: The proposed amendment to the rule will add the drug, gamma-butyrolactone (GBL), to the list of precursor substances in WAC 246-889-020 to make state law consistent with federal law.
Statutory Authority for Adoption: RCW 69.43.050, 18.64.005.
Statute Being Implemented: RCW 69.43.050.
Summary: On February 18, 2000, federal legislation was enacted to control gamma-butyrolactone (GBL). As a result of this law, GBL became a list I chemical under federal law. The proposed amendment will place GBL in the listing of precursor substances to be consistent with federal law.
Reasons Supporting Proposal: GBL was being abused by high school and college students at "rave parties," by body-builders for its alleged anabolic effects, and in cases of sexual assault.
Name of Agency Personnel Responsible for Drafting and Implementation: Lisa Salmi, 1300 Quince Street S.E., P.O. Box 47863, Olympia, 98504, (360) 236-4828; and Enforcement: Donald H. Williams, 1300 Quince Street S.E., P.O. Box 47863, Olympia, 98504, (360) 236-4825.
Name of Proponent: Department of Health, Washington State Board of Pharmacy, 1300 Quince Street S.E., P.O. Box 47863, Olympia, WA 98504-7863, governmental.
Rule is necessary because of federal law, 21 C.F.R. Part 1310.
Explanation of Rule, its Purpose, and Anticipated Effects: Chapter 246-889 WAC, Pharmaceutical -- Precursor substance control, regulates the distribution of precursor drugs. Precursor drugs are those drugs that are used to manufacture controlled substances. It is necessary to control the manufacture and distribution of precursor substances to prevent, curtail, or limit the manufacturing of controlled substances. Controlled substances are those substances that have a high potential for abuse an a high degree of psychic or physical dependence. In order to protect the health and safety of the public, these drugs must be strictly regulated.
Proposal Changes the Following Existing Rules: Updates rule
to include gamma-butyrolactone (GBL) in the list of precursor
substances to be consistent with federal rules.
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 A. Salmi, Department of Health, Washington State Board of Pharmacy, 1300 Quince Street S.E., P.O. Box 47863, Olympia, WA 98504-7863 , AND RECEIVED BY July 23, 2002.
April 23, 2002
D. H. Williams
Executive Director
OTS-5642.1
AMENDATORY SECTION(Amending WSR 94-07-105, filed 3/18/94,
effective 3/18/94)
WAC 246-889-020
Precursor substance defined.
(1) For the
purpose of this chapter a precursor substance is any of the
following substances or their salts or isomers:
(a) Anthranilic acid;
(b) Barbituric acid;
(c) Chlorephedrine;
(d) Diethyl malonate;
(e) D-lysergic acid;
(f) Ephedrine;
(g) Ergotamine tartrate;
(h) Ethylamine;
(i) Ethyl malonate;
(j) Ethylephedrine;
(k) Gamma-butyrolactone (GBL);
(l) Hydriodic acid;
(((l))) (m) Lead acetate;
(((m))) (n) Malonic acid;
(((n))) (o) Methylamine;
(((o))) (p) Methylformamide;
(((p))) (q) Methylephedrine;
(((q))) (r) Methylpseudoephedrine;
(((r))) (s) N-acetylanthranilic acid;
(((s))) (t) Norpseudoephedrine;
(((t))) (u) Phenylacetic acid;
(((u))) (v) Phenylpropanolamine;
(((v))) (w) Piperidine;
(((w))) (x) Pseudoephedrine; and
(((x))) (y) Pyrrolidine.
Provided; that this definition shall not include any drug that contains ephedrine, phenylpropanolamine, or pseudoephedrine or any cosmetic if that drug or cosmetic can be lawfully sold, transferred, or furnished over-the-counter without a prescription or by a prescription under chapter 69.04 or 69.41 RCW.
(2) The board finds that the reference to methylformanide in RCW 69.43.010, was intended to refer to methylformamide and corrects that reference by deleting "methylformanide" and adding "methylformamide." This change is based upon the finding that this revision conforms to the tests set forth in RCW 69.43.010(2).
(3) Registrants should be aware that precursor substances in subsection (1)(a), (f), (k), (l), (n), (o), (p), (t), and (w) of this section are also regulated as schedule II immediate precursors pursuant to WAC 246-887-150 and all applicable rules and laws governing the distribution of schedule II controlled substances must also be complied with.
[Statutory Authority: RCW 18.65.005 and 18.64.005. 94-07-105, § 246-889-020, filed 3/18/94, effective 3/18/94. Statutory Authority: RCW 69.43.050. 92-12-035 (Order 277B), § 246-889-020, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as § 246-889-020, filed 8/30/91, effective 9/30/91. Statutory Authority: 1988 c 147 § 5. 88-14-096 (Order 218), § 360-38-010, filed 7/6/88.]