Section 246-883-030. Ephedrine prescription restrictions.

(1) The board of pharmacy, pursuant to RCW 69.41.075, hereby identifies ephedrine, or any of its salts in a solid or aqueous form normally intended for oral administration, in any quantity, as a legend drug subject to the restrictions of RCW 69.41.030.

(2) The following products containing ephedrine or its salts in the amount of 25 mg. or less per solid dosage unit or per 5 ml. of liquid forms in combination with other ingredients in therapeutic amounts are exempt from subsection (1) of this section:

(3) Ma Huang or other botanical products of genus ephedra used in their natural state and containing 25 mg. or less of ephedrine per recommended dosage as a preparation for human consumption are not legend drugs for the purposes of this section.

(4) Any reformulation of listed products which increases the ephedrine content to more than 25 mg. of ephedrine per solid dosage unit or per 5 ml. of liquid forms shall negate the exemption. The manufacturers of listed products shall notify the board of any reformulation which increases the ephedrine content to more than 25 mg. of ephedrine per solid dosage unit or per 5 ml. of liquid forms prior to distributing that product in the state of Washington.

(5) Manufacturers of products containing 25 mg. or less of ephedrine per solid dosage unit or per 5 ml. of liquid forms in combination with other ingredients in therapeutic amounts may gain exemption from subsection (1) of this section if, prior to the distributing of any such product in the state of Washington, the manufacturer:

(a) Provides the board with the formulation of any such product;

(b) Provides the board samples of all dosage forms in which the product is to be marketed in the packaging in which the product is to be marketed; and

(c) Receives the board's approval to market such product.

[Statutory Authority: RCW 18.64.005. WSR 94-08-100, § 246-883-030, filed 4/6/94, effective 5/7/94; WSR 93-05-046 (Order 333B), § 246-883-030, filed 2/17/93, effective 3/20/93. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-883-030, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005(11) and 69.41.075. WSR 82-06-042 (Order 165), § 360-32-055, filed 3/2/82. Statutory Authority: RCW 69.41.075. WSR 81-10-025 (Order 160), § 360-32-055, filed 4/28/81. Statutory Authority: 1979 1st ex. s. c 139. WSR 79-09-138 (Order 149, Resolution No. 9/79), § 360-32-055, filed 9/5/79.]

RCW 18.64.005. WSR 94-08-100, § 246-883-030, filed 4/6/94, effective 5/7/94; WSR 93-05-046 (Order 333B), § 246-883-030, filed 2/17/93, effective 3/20/93. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-883-030, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005(11) and 69.41.075. WSR 82-06-042 (Order 165), § 360-32-055, filed 3/2/82. Statutory Authority: RCW 69.41.075. WSR 81-10-025 (Order 160), § 360-32-055, filed 4/28/81. Statutory Authority: 1979 1st ex. s. c 139. WSR 79-09-138 (Order 149, Resolution No. 9/79), § 360-32-055, filed 9/5/79.