By: Capelo H.B. No. 3121
A BILL TO BE ENTITLED
AN ACT
relating to making ephedrine and plant materials containing
ephedrine alkaloids Schedule V controlled substances.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The Commissioner shall, under his authority
pursuant to Health and Safety Code Title 6, Chapter 481, the Texas
Controlled Substances Act, section 481.032, Schedules, add to
Schedule V stimulants, ephedrine. Such addition shall include the
following requirements:
(2) Ephedrine, including plant materials that are
processed containing naturally occurring ephedrine alkaloids.
Excluded are the following formulations:
(a) Solid dosage forms that combine active
ingredients in the following ranges for each recommended dose:
ephedrine, its salts, isomers or salts of isomers not to exceed 12.5
milligrams (mg) combined with at least 200 mg of guiafenesin;
ephedrine, its salts, isomers or salts of isomers not to exceed 25
mg combined with at least 400 mg guiafenesin;
(b) Liquid oral dosage forms that combine active
ingredients in the following ranges for each 5 milliliter (ml)
dose: dextromethorphan HBr (not more than 10 mg), chlorpheniramine
maleate (not more than 2 mg), ephedrine HCl (not more than 5 mg),
phenylephrine (not more than 5 mg), ammonium chloride (not more
than 40 mg), ipecac fluidextract (not more than 0.005 ml);
(c) Anorectal preparations containing less than
5.0% ephedrine;
(d) Nasal decongestant preparations containing
0.5% or less ephedrine; and
(e) Any ephedrine-containing drug product that
is marketed pursuant to an approved new drug application under the
Federal Food, Drug, and Cosmetic Act.
SECTION 2. This Act takes effect September 1, 2003. The
Commissioner shall adopt rules to implement this Act by January 31,
2004.