PREPROPOSAL STATEMENT OF INQUIRY
DEPARTMENT OF HEALTH
[Filed April 30, 1997, 3:52 p.m.]
Subject of Possible Rule Making: Sales requiring prescriptions--Ephedrine restrictions. This rule identifies ephedrine as a legend drug. The rule also provides a listing of ephedrine-combination products that have obtained an exemption to be sold over-the-counter. Manufacturers of legitimate ephedrine-combination products can obtain an exemption from prescription only status by submitting a request and supporting documentation to the board. The proposed amendment updates the listing by removing products that are no longer distributed in Washington state.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.450.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The rule is necessary to curtail the illicit sale of ephedrine products in the state of Washington. In addition to the abuse of ephedrine, ephedrine is being used in the illicit production of methamphetamines. The proposed changes will update the listing of products that have received an exemption from the prescription only status and can be sold over-the-counter. Several of the products contained within the listing are no longer manufactured. Distributors of over-the-counter medications and law enforcement agencies rely on the listing of products to determine the prescription status of a product.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: None.
Process for Developing New Rule: Negotiated rule making, the board will send written notification of the board's intent to amend rule to all manufacturers of ephedrine-combination products sold in Washington state. In addition, the proposed rule amendment will be discussed at public meetings and with law enforcement agencies.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Lisa Salmi, P.O. Box 47863, Olympia, WA 98504, (360) 753-6834, FAX (360) 586-4359. The board will hold public meetings to receive comment on proposed rule amendment.
April 21, 1997
Donald H. Williams