Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter Y - REGULATIONS TO PROHIBIT THE SALE OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE GROUP ALKALOIDS; AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN PRODUCTS CONTAINING EPHEDRINE
Section 229.464 - Regulations to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine
Current through Reg. 49, No. 38; September 20, 2024
(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: