Wholesale Drug Distributors in Texas

Wholesale drug distributors operating in Texas must hold a valid license from the Texas Department of State Health Services for each place of business before engaging in prescription drug distribution. Both in-state and out-of-state distributors shipping into Texas are subject to licensing requirements under Chapter 431 of the Texas Health and Safety Code and Title 25 of the Texas Administrative Code.

The following entities require a Texas wholesale drug distributor license:

Applicants must submit the following documentation:

The designated representative must meet all of the following qualifications:

1. Obtain application form from DSHS (form outlined in 25 TAC Section 229.425)

2. Complete application with all required documentation for each place of business

3. Secure surety bond ($100,000) or approved equivalent security instrument

4. Submit application package to DSHS with licensing fees based on gross annual drug sales

5. Cooperate with pre-licensing inspection if DSHS schedules facility review

6. Receive license approval and display proof of licensure at each place of business in a format readily available to the public

Out-of-state persons engaging in wholesale distribution of prescription drugs into Texas from locations outside the state must hold a valid Texas wholesale drug distributor license using the same requirements as in-state distributors.