Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 1 - GENERAL PROVISIONS › Subpart C - Legend Drugs and Controlled Substances › Section 246-945-031 - Ephedrine prescription restrictions

Current through Register Vol. 24-14, July 15, 2024
(1) The commission, under
					 RCW
					 69.41.075, 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:
TRADE NAME
EPHEDRINE CONTENT
1. AMESAC capsule (Russ)
25 mg. ephedrine HCL
2. AZMA AID tablet (Various, e.g., Purepac)
24 mg. ephedrine HCL
3. BRONC-EASE PLUS (Natur-Pharma)
25 mg. ephedrine HCL
4. BRONCHODILATOR AND EXPECTORANT (PDK Labs)
25 mg. ephedrine HCL
5. BRONITIN tablet (Whitehall)
24 mg. ephedrine HCL
6. BRONKAID tablet (Breon)
24 mg. ephedrine sulfate
7. BRONKOLIXER (Sterling Winthrop)
12 mg. ephedrine
8. BRONKOTABS tablet (Breon)
24 mg. ephedrine sulfate
9. EFEDRON nasal jelly (Hyrex)
0.6% ephedrine HCL in 20 g.
10. MINI THINS asthma relief (BDI Pharmaceuticals)
25 mg. ephedrine
11. PAZO HEMORRHOID suppository (Bristol-Meyers)
3.86 mg. ephedrine sulfate
12. PAZO HEMORRHOID ointment (Bristol-Meyers)
0.2% ephedrine sulfate
13. PRIMATENE tablet (Whitehall)
24 mg. ephedrine HCL
14. PRIMATENE M tablet (Whitehall)
24 mg. ephedrine HCL
15. PRIMATENE P tablet (Whitehall)
24 mg. ephedrine HCL
16. QUELIDRINE (Abbott)
5 mg. ephedrine HCL
17. TEDRAL tablet (Parke-Davis)
24 mg. ephedrine HCL
18. THEODRINE tablet (Rugby)
25 mg. ephedrine HCL
19. VATRONOL nose drops (Vicks Health Care)
0.5% ephedrine sulfate
(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 commission 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 commission with the
					 formulation of any such product;
(b) Provides the commission 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 commission's approval to
					 market such product.