WSR 02-14-049

PERMANENT RULES

DEPARTMENT OF HEALTH


(Pharmacy Board)

[ Filed June 27, 2002, 8:30 a.m. ]

Date of Adoption: May 21, 2002.

Purpose: Update an existing rule to designate the 2002 edition of the American Druggist Red Book as the official listing of legend drugs in the state of Washington.

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

Statutory Authority for Adoption: RCW 69.41.075.

Other Authority: RCW 18.64.005(7).

Adopted under notice filed as WSR 02-07-086 on March 19, 2002.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.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

May 21, 2002

Donna Dockter

Chair

OTS-5327.2


AMENDATORY SECTION(Amending WSR 00-06-078, filed 3/1/00, effective 4/1/00)

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)) 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 ((for the reasons that)) because of their toxicity or ((other potentiality)) potential for harmful effect, the methods of their use and the collateral safeguards necessary to their use, indicate that they are ((not)) only safe for use ((except)) under the supervision of a practitioner.

(2) ((The board of pharmacy hereby specifically identifies as legend drugs,)) For the purposes of chapter 69.41 RCW, ((those)) legend drugs are 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)) 2002 edition of the Drug Topics Red Book. Copies of the list of legend drugs as contained in the Drug Topics Red Book ((shall be)) are 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.)) To obtain copies of this list, interested persons must submit a written request and payment of seventy-six dollars 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. ((Such)) These determinations will be made after public hearing and will be published as an amendment to this chapter.

[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