Wash. Admin. Code § 246-945-030

Current through Register Vol. 24-23, December 1, 2024

Section 246-945-030 - Identification of legend drugs for purposes of chapter 69.41 RCW

(1) Those drugs determined by the FDA to require a prescription under federal law should be classified as legend drugs under state law because their toxicity, potential for harmful effect, methods of use, or collateral measures necessary to their use indicate they are only safe for use under the supervision of a practitioner.

(2) The commission finds that under state law, legend drugs are those drugs designated as legend drugs under federal law, as of the date of adoption of this rule, and listed in at least one of the following publications in effect as of March 7, 2024, unless the drug is identified as an over-the-counter drug by the commission in WAC 246-945-034:

(a) The 44th Edition, including supplements, of the Approved Drug Products with Therapeutic Equivalence Evaluations "Orange Book" (available at https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book).

(b) The 2024 version, including monthly updates, of the Approved Animal Drug Products "Green Book" (available at https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book).

(c) The 2024 Purple Book: Database of FDA-Licensed Biological Products (available at https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or).

(3) Copies of the reference material listed in subsection (2) of this section are available for public inspection at the commission's office at Department of Health, Town Center 2, 111 Israel Road S.E., Tumwater, WA 98501.

(4) The commission also identifies those ephedrine products specified in WAC 246-945-031 as legend drugs under state law.

(5) There may be changes in the marketing status of drugs after the publication of the above references. Upon application of a manufacturer or distributor, the commission may grant authority for the over-the-counter distribution of certain drugs designated as legend drugs in these references. These determinations will be made after public hearing and will be published as an amendment to this chapter.

Wash. Admin. Code § 246-945-030

Adopted by WSR 20-12-072, Filed 6/1/2020, effective 7/1/2020, and 3/1/2021

Amended by WSR 24-21-069, Filed 10/11/2024, effective 11/11/2024