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PDFWAC 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 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, 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 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 online access. Arrangements for periodic updates or online 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 18.64.005 and 69.41.075. WSR 10-02-081, § 246-883-020, filed 1/5/10, effective 2/5/10. Statutory Authority: RCW 69.41.075 and 18.64.005(7). WSR 02-14-049, § 246-883-020, filed 6/27/02, effective 7/28/02. Statutory Authority: RCW 69.41.075, 18.64.005. WSR 00-06-078, § 246-883-020, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 69.41.075. WSR 96-21-041, § 246-883-020, filed 10/11/96, effective 11/11/96. Statutory Authority: RCW 18.64.005. WSR 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. WSR 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]. WSR 85-18-091 (Order 196), § 360-32-050, filed 9/4/85. Statutory Authority: RCW 18.64.005 and 69.41.075. WSR 83-20-053 (Order 176), § 360-32-050, filed 9/29/83. Statutory Authority: RCW 69.41.075. WSR 81-10-025 (Order 160), § 360-32-050, filed 4/28/81. Statutory Authority: 1979 1st ex. s. c 139. WSR 79-09-138 (Order 149, Resolution No. 9/79), § 360-32-050, filed 9/5/79.]
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