EXPEDITED RULES
(Board of Pharmacy)
Title of Rule: WAC 246-883-020 Identification of legend drugs for purposes of chapter 69.41 RCW.
Purpose: The proposed amendment identifies the 2002 edition of the American Druggist Red Book as the official listing of legend drugs in the state of Washington.
Statutory Authority for Adoption: RCW 69.41.075, 18.64.005(7).
Statute Being Implemented: RCW 69.41.075.
Summary: RCW 69.41.075 mandates that the Board of Pharmacy identify those drugs that can only be sold on prescription or are restricted to use by practitioners. The law allows the board to use a commercial publication for the purpose of identifying the drugs. The board has adopted the American Druggist Red Book as the official source of legend drugs in the state of Washington. The proposed change will update the rule by listing the latest edition of the Red Book, the 2002 edition.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: D. H. Williams, 1300 Quince Street S.E., Olympia, WA 98504-7863, (360) 236-4828.
Name of Proponent: Department of Health, Washington State Board of Pharmacy, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: RCW 69.41.075 mandates that the Board of Pharmacy identify those drugs that can only be sold on prescription or are restricted to use by practitioners. The law allows the board to use a commercial publication for the purpose of identifying the drugs. The board has adopted the American Druggist Red Book as the official source of legend drugs in the state of Washington. The proposed change will update the rule by listing the latest edition of the Red Book, the 2002 edition.
Proposal Changes the Following Existing Rules: The proposed
change will update the rule by listing the latest edition of the
American Druggist Red Book, the 2002 edition.
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 THE USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Lisa Salmi, Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, fax (360) 586-4359, e-mail Lisa.Salmi@doh.wa.gov , AND RECEIVED BY May 20, 2002.
January 22, 2002
D. H. Williams
Executive Director
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.]