PROPOSED RULES
(Board of Pharmacy)
Original Notice.
Exempt from preproposal statement of inquiry under RCW 34.05.310(4).
Title of Rule: Identification of legend drugs.
Purpose: To identify by rule which drugs have been determined by the United States Food and Drug Administration to require a prescription.
Other Identifying Information: WAC 246-883-020.
Statutory Authority for Adoption: RCW 69.41.075, chapter 18.64 RCW.
Statute Being Implemented: RCW 69.41.075.
Summary: The proposed amendment will update the reference used to identify the drugs that require a prescription in the state of Washington.
Reasons Supporting Proposal: To have an accurate and current list of drugs requiring a prescription.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Don Williams, 1300 Quince Street S.E., Olympia, WA 98504, (360) 236-4828.
Name of Proponent: Department of Health, Board of Pharmacy, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: This change will update the reference used to determine the list of drugs which require a prescription in Washington state. The change is necessary so the state will have an accurate and current list of drugs requiring a prescription. The list of drugs is determined by the United States Food and Drug Administration. The rule change will reference the most current source of the list of drugs, the 1999 Drug Topics Red Book.
Proposal Changes the Following Existing Rules: Identifies the official listing of prescription drugs in Washington state to be the 1999 Drug Topics Red Book.
No small business economic impact statement has been prepared under chapter 19.85 RCW. RCW 19.85.025(3) states that a small business economic impact statement is not required for this type of rule.
RCW 34.05.328 does not apply to this rule adoption. RCW 34.05.328 (5)(b)(iii) states that this section does not apply to rules adopting a national consensus code.
Hearing Location: Tacoma Sheraton Inn, 1320 Broadway Plaza, Tacoma, WA, on October 22, 1999, at 10:00 a.m.
Assistance for Persons with Disabilities: Contact Lisa Salmi by October 1, 1999, TDD (800) 833-6388, or (800) 525-0127.
Submit Written Comments to: Lisa Salmi, fax (360) 586-4359, by October 10, 1999.
Date of Intended Adoption: October 22, 1999.
August 23, 1999
Donald H. Williams
Executive Director
OTS-3359.1
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 ....... 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.]