The Drugs and Medical Devices Group is responsible for ensuring that drug manufacturers and distributors comply with minimum licensing standards established to protect the health and safety of of the citizens of Texas. In order to accomplish this objective, inspections of prescription and over-the-counter (OTC) drug manufacturers and distributors are conducted. If voluntary compliance with the licensing standards cannot be achieved, the Group recommends regulatory actions when necessary. In addition, the Group provides technical assistance to its licensees, answers inquiries from consumers and investigates complaints involving possible violations of the state requirements for drug manufacturers and distributors.
Licensing
Businesses engaged in the manufacture or distribution of over-the-counter (OTC) drugs or prescription drugs in Texas are required to license with the Texas Department of State Health Services (DSHS). In addition, businesses located outside Texas who engage in the distribution of OTC or prescription drugs in this state must license as out-of-state distributors with DSHS. To become licensed as a drug manufacturer or distributor, please visit the licensing requirements page, which lists fee schedules and links to application forms.
Information on related licenses and certifications may be found by following the links below:
Email Updates
Sign up to receive email updates about important changes to the Drug Manufacturers and Distributors Program. This feature will serve as a tool to increase communication with license holders regarding new information added to the website.
Contact Information
For General Program Assistance
Email: Drugs and Medical Devices Group
Phone: (512) 834-6755
Fax: (512) 834-6759
For Licensing Assistance
Email: Drugs and Food Safety Licensing Group
Phone: (512) 834-6727
Fax: (512) 834-6741
Mailing addresses may be found on the contact page.