Date of Adoption: October 22, 1999.

Purpose: Designates the "Red Book" as the official resource to identify which drugs must be distributed by prescription only in Washington state.

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

Statutory Authority for Adoption: RCW 69.41.075, 18.64.005.

Adopted under notice filed as WSR 99-18-083 on August 31, 1999.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0. Effective Date of Rule: Thirty-one days after filing.

February 7, 2000

Michael Kleinberg

Board Chair

OTS-3359.2

AMENDATORY SECTION(Amending WSR 96-21-041, filed 10/11/96, effective 11/11/96)

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 hereby finds that those drugs which have been determined by the Food and Drug Administration, pursuant to the Federal Food, Drug and Cosmetic Act, to require a prescription under federal law should also be classified as legend drugs under state law for the reasons that their toxicity or other potentiality for harmful effect, the methods of their use and the collateral safeguards necessary to their use, indicate that they are not safe for use except under the supervision of a practitioner.

(2) The board of pharmacy hereby specifically identifies as legend drugs, for purposes of chapter 69.41 RCW, those drugs which have been designated as legend drugs under federal law and are listed as such in the 1995-96 edition of the American Druggist Blue Book.      For the period May 31, 1995, through June 1, 1996, the board adopts the 1995 edition of the Blue Book. For the period June 1, 1996, through May 31, 1997, the board adopts the 1996 edition of the Blue Book. For the period June 1, 1997, through May 31, 1998, the board adopts the 1997 edition of the Blue Book. Effective March 22, 2000, the board adopts the 1999 Drug Topics Red Book. Copies of the list of legend drugs as contained in the ((American Druggist Blue Book)) Drug Topics Red Book shall be available for public inspection at the headquarters office of the State Board of Pharmacy, 1300 Quince Street S.E., P.O. BOX 47863, Olympia, Washington 98504-7863.      Copies of this list shall be available from the board of pharmacy at the above address upon request made and upon payment of a fee in the amount of seventy-six dollars per copy.

(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.      Such determinations will be made after public hearing and will be published as an amendment to this chapter.

[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