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Certification Requirements - Pseudoephedrine Retail Certificate of Authority Program

Who Must be Certified?

Under Chapter 486 of the Texas Health and Safety Code, 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.

Applying for Certification

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) 834-6727.

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, 71KB)

Last updated July 2, 2015