On November 8, 2011, the Drugs and Medical Devices Group notified firms that hold Certificates of Authority (COA) of changes in the law as a result of implementation of House Bill 1137, 82nd Texas Legislature, pertaining to over-the-counter sales of ephedrine, pseudoephedrine, and norpseudoephedrine (PSE). These changes include establishment of a real-time tracking system to prevent illegal sales of PSE products as well as new limits on the quantity of PSE products sold. For more details refer to Letter to Certificate of Authority Holders.
IMPORTANT NOTICE FOR RETAILERS OF PSEUDOEPHEDRINE AND
EPHEDRINE CONTAINING OVER-THE-COUNTER DRUGS
The Texas Department of State Health Services (DSHS) adopted 25 Texas Administrative Code (TAC), §§230.11-230.16, concerning Limitations on Sales of Products Containing Ephedrine, Pseudoephedrine, and Norpseudoephedrine, June 19, 2006.
These sections are necessary to comply with Health and Safety Code (HSC), Chapter 486, relating to the over-the-counter sales of ephedrine, pseudoephedrine, and norpseudoephedrine.
Under Chapter 486, any business establishment (other than a pharmacy licensed by the Board of Pharmacy) that wishes to engage in over-the-counter sales of products containing any quantity of ephedrine, pseudoephedrine, or norpseudoephedrine must have a Certificate of Authority (COA) from DSHS. In order to obtain a COA, a business must: file an application with DSHS; pay the required fee ($600 for two years); and agree to comply with the restrictions to access and record keeping requirements of these sections. Compliance with these sections will be verified through audits and inspections.
If you have technical questions about completing the application, please call the Food and Drug Licensing Group at (512) 834-6626.
If you have questions about the content of the rules, or need additional information, please contact the Drugs and Medical Devices Group at (512) 834-6755.
For more details refer to: Notice to Retailers (pdf 45KB)
Other Important Links related to the Pseudoephedrine Retail Certificate of Authority Program
Letter from Representative Leo Berman (pdf 30KB)
Partial List of Products Subject to the Law and Products That Are Exempt (pdf 43KB)
McNeil products (ex. Tylenol, Motrin) containing pseudoephedrine (MS-Word 34KB)