Businesses which manufacture or distribute over-the-counter or prescription drugs must be licensed in Texas.
Drug Manufacturers & Distributors
The Drugs and Medical Devices Unit ensures drug manufacturers and distributors comply with minimum licensing standards to protect the health and safety of Texans. We inspect prescription and over-the-counter (OTC) drug manufacturers and distributors to make sure they meet these standards. When voluntary compliance with the licensing standards cannot be achieved, we recommend regulatory actions. We also provide technical assistance to licensees, answer questions from consumers and investigate complaints involving possible violations of the state requirements for drug manufacturers and distributors.
To stay up to date on changes to the Drug Manufacturers and Distributors program, sign up for our email updates.
Replacement License Document
If you lost your license, follow the steps below to print a replacement document. You will need to know your license number or ownership name.
- Visit the DSHS Online Licensing Services webpage.
- Click on the “license search” link under the “Check License Status or Search for a License” category.
- Select a search method.
- Enter the required information denoted by a red asterisk (*).
- Click the white checkbox next to “I’m not a robot” under the “Security Measures” section.
- Complete the reCaptcha/Security prompts.
- Click on the Search button.
- Click on your ownership name.
- Click the Print button on the lower right side of the screen.
Post this document in the location of your original license certificate.
If you need to update information on your license, email Foods Licensing Branch or Drug & Food Safety Licensing Branch for assistance.
This document does not extend your license expiration date. It maintains the same expiration date as the original document.
What We Do
Consult & Educate
Inspect & Enforce
Licensing & Certifications
Popular Resources
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Forms & Publications
Access licensing forms and publications for drug manufacturers and distributors.
Laws & Regulations
Stay up to date on relevant laws and regulations for drug manufacturers and distributors.
Mailing Address
Drugs and Medical Devices Unit MC 1987
Texas Department of State Health Services
P. O. Box 149347
Austin, TX 78714-9347
United States
Mailing Address
BF&VS, Food and Drug Licensing Group MC 2835
Texas Department of State Health Services
P. O. Box 149347
Austin, TX 78714-9347
United States
Phone:
737-218-7074
Contact person
Ademola Olufemi
Physical Address
We only receive special service deliveries, such as UPS or Federal Express, at this address. Do not send money to this address.
DSHS Consumer Protection Division
1100 W. 49th Street
Austin, TX 78756
United States