WSR 08-20-127

EXPEDITED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed October 1, 2008, 8:51 a.m. ]

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

NOTICE

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 THIS USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Doreen Beebe, Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863 , AND RECEIVED BY December 1, 2008.


Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed amendment removes the 2002 edition of the Drug Topics Red Book and updates the reference to the 2008 edition. The amendment to the rule will clarify the expectation that pharmacists use current references when identifying drugs requiring a prescription as determined by the Food and Drug Administration. The rule also updates the department of health's address.

Reasons Supporting Proposal: The Drug Topics Red Book is identified as the resource for federally classified legend drugs. It is essential for pharmacists to have access to current product (drugs) information to assist practitioners and their patients in making informed decisions about medications.

Expedited rule making is appropriate for rules that "correct typographical errors, makes address or name changes, or clarify language of the rule without changing its effect" under RCW 34.05.352 [34.05.353] (1)(c).

Statutory Authority for Adoption: RCW 18.64.005.

Statute Being Implemented: RCW 69.41.075.

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

Name of Proponent: Washington department of health, board of pharmacy, governmental.

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

August 7, 2008

Doreen E. Beebe

Program Manager

OTS-9630.4


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)) 2008 edition of the Drug Topics Red Book. For the period May 31, 2008, through June 1, 2009, the board adopts the 2008 edition of the 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, interested persons must submit a written request and payment of ((seventy-six dollars)) one hundred six dollars and fifty cents for each copy to the board.

(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