(a) Drug products containing single ingredient ephedrine, its salts, optical isomers or salts of optical isomers, are dangerous drugs as defined in the Health and Safety Code, Chapter 483, relating to Dangerous Drugs.

(b) Drug products that contain pseudoephedrine are exempt from the designation as dangerous drugs if the drug product is labeled in accordance with the U.S. Food and Drug Administration's final monograph.

(c) Any drug product containing ephedrine, its salts, optical isomers or salts of optical isomers shall not be sold, distributed, introduced into commerce, manufactured, produced, packaged, exposed, offered, possessed or held for sale, dispensed or given away in this state except as dispensed upon the prescription of a licensed practitioner.

(d) The following formulations are exempt from the designation as dangerous drugs under subsection (a) of this section, and the dispensing restrictions under subsection (c) of this section:

(1) solid dosage forms that combine active ingredients must be in the following ranges for each recommended dose: ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 12.5 milligrams (mg) combined with at least 200 mg guiafenesin; ephedrine, its salts, optical isomers or salts of optical isomers not to exceed 25 mg combined with at least 400 mg guiafenesin;

(2) 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);

(3) anorectal preparations containing less than 5.0% ephedrine;

(4) nasal decongestant preparations containing 0.5% or less ephedrine; and

(5) any ephedrine-containing drug product that is marketed pursuant to an approved new drug application under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301, et seq.

Source Note: The provisions of this §229.464 adopted to be effective November 1, 1999, 24 TexReg 4564; amended to be effective March 31, 2011, 36 TexReg 1981