WSR 09-22-083

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed November 3, 2009, 3:08 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 09-15-061.

Title of Rule and Other Identifying Information: WAC 246-883-020 Identification of legend drugs for purposes of chapter 69.41 RCW.

Hearing Location(s): Green River Community College, 12401 S.E. 320th Street, Lindbloom Student Center, 1st Floor, Glacier Room, Auburn, WA 98092-3622, on December 10, 2009, at 9:00 a.m.

Date of Intended Adoption: December 10, 2009.

Submit Written Comments to: Doreen E. Beebe, Washington State Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by December 4, 2009.

Assistance for Persons with Disabilities: Contact Doreen E. Beebe by December 7, 2009, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposal is to provide an up-to-date reference in rule to the 2009 edition of the commercial pharmaceutical publication, Drug Topics Red Book (Red Book) per RCW 69.41.075. The Red Book is the reference used by the state board of pharmacy (board) to identify federally-classified drugs. The proposal also corrects the address for the board of pharmacy administrative office, and provides a more efficient way to obtain the Red Book through the board.

Reasons Supporting Proposal: The board is charged with classifying drugs as legend or prescription only. It is necessary that the board use current references when classifying drugs in rule. The Red Book is an industry-recognized resource for healthcare professionals with the latest information on prescription and over-the-counter products. The reference includes drug package information: Dosage forms, route of administration, etc. The proposal also amends language to provide a more efficient way to obtain the book. Access to a current and trusted drug information resource will help ensure safe and optimal use of drugs.

Statutory Authority for Adoption: RCW 18.64.005 and 69.41.075.

Statute Being Implemented: RCW 69.41.075.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state board of pharmacy, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Doreen E. Beebe, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4834; and Enforcement: Grant Chester, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4817.

No small business economic impact statement has been prepared under chapter 19.85 RCW. A small business economic impact statement was not prepared. The proposed rule would not impose more than minor costs on businesses in an industry.

A cost-benefit analysis is not required under RCW 34.05.328. The board has determined this rule does not qualify as a significant rule under RCW 34.05.328 (5)(c)(iii).

November 3, 2009

Susan Teil Boyer

Executive Director

State Board of Pharmacy

OTS-9630.7


AMENDATORY SECTION(Amending WSR 02-14-049, filed 6/27/02, effective 7/28/02)

WAC 246-883-020   Identification of legend drugs for purposes of chapter 69.41 RCW.   (1) In accordance with chapter 69.41 RCW, the board of pharmacy finds that those drugs which have been determined by the Food and Drug Administration, under the Federal Food, Drug and Cosmetic Act, to require a prescription under federal law should also be classified as legend drugs under state law because of their toxicity or potential for harmful effect, the methods of their use and the collateral safeguards necessary to their use, indicate that they are only safe for use under the supervision of a practitioner.

(2) For the purposes of chapter 69.41 RCW, legend drugs are drugs which have been designated as legend drugs under federal law and are listed as such in the ((2002)) 2009 edition of the Drug Topics Red Book. Copies of the list of legend drugs as contained in the Drug Topics Red Book are available for public inspection at the headquarters office of the State Board of Pharmacy, ((1300 Quince Street)) 310 Israel Road S.E., P.O. BOX 47863, Olympia, Washington 98504-7863. To obtain copies of this list from the department, interested persons must submit a written request, indicating which format they wish to receive, and payment of ((seventy-six dollars for each copy to the board)) the actual cost of the text or CD, including shipping and handling charges from the publisher. Requestors may also contact the publisher directly to obtain copies. The department takes no responsibility for periodic updates or on-line access. Arrangements for periodic updates or on-line access must be made directly with the publisher.

(3) There may be changes in the marketing status of drugs after the publication of the above reference. Upon application of a manufacturer or distributor, the board may grant authority for the over the counter distribution of certain drugs which had been designated as legend drugs in this reference. These determinations will be made after public hearing and will be published as an amendment to this chapter.

[Statutory Authority: RCW 69.41.075 and 18.64.005(7). 02-14-049, 246-883-020, filed 6/27/02, effective 7/28/02. Statutory Authority: RCW 69.41.075, 18.64.005. 00-06-078, 246-883-020, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 69.41.075. 96-21-041, 246-883-020, filed 10/11/96, effective 11/11/96. Statutory Authority: RCW 18.64.005. 92-09-070 (Order 264B), 246-883-020, filed 4/14/92, effective 5/15/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as 246-883-020, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005 and 69.44.075 [69.41.075]. 85-18-091 (Order 196), 360-32-050, filed 9/4/85. Statutory Authority: RCW 18.64.005 and 69.41.075. 83-20-053 (Order 176), 360-32-050, filed 9/29/83. Statutory Authority: RCW 69.41.075. 81-10-025 (Order 160), 360-32-050, filed 4/28/81. Statutory Authority: 1979 1st ex. s. c 139. 79-09-138 (Order 149, Resolution No. 9/79), 360-32-050, filed 9/5/79.]

Washington State Code Reviser's Office