Effective Date of Rule: Thirty-one days after filing.

     Purpose: WAC 246-883-020 Identification of legend drugs for purposes of chapter 69.41 RCW, the purpose of the rule is to update the commercial pharmaceutical publication referenced in the rule to the 2009 edition of the Drug Topics Red Book. In addition, the rule provides direction on ordering the publication from the board of pharmacy and corrects the address for the administrative office.

     Citation of Existing Rules Affected by this Order: Amending WAC 246-883-020.

     Statutory Authority for Adoption: RCW 18.64.005.

     Other Authority: RCW 69.41.075.

      Adopted under notice filed as WSR 09-22-083 on November 3, 2009.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 1, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.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: December 10, 2009.

Gary G. Harris, Chair

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.]

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