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Drug Manufacturers and Distributors

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.


Update on Hurricane Harvey Waivers for DSHS License Holders

On August 23, 2017, the Office of the Governor issued a disaster proclamation in response to Hurricane Harvey and temporarily suspended the statutes and rules pertaining to professional and business licenses or certification renewal applications. During the suspension, DSHS extended license expiration dates for professionals and businesses in the affected counties and waived the late fees for those who submitted renewal applications.

On December 17, 2018, the Office of the Governor terminated the suspension of the DSHS statutes and rules related to the Hurricane Harvey disaster.

Effective March 1, 2019, DSHS will no longer extend license expiration dates or waive late fees for any licensed professionals or businesses in the following counties: 

Angelina, Aransas, Atascosa, Austin, Bastrop, Bee, Bexar, Brazoria, Brazos, Burleson, Caldwell, Calhoun, Cameron, Chambers, Colorado, Comal, DeWitt, Fayette, Fort Bend, Galveston, Goliad, Gonzales, Grimes, Guadalupe, Hardin, Harris, Jackson, Jasper, Jefferson, Jim Wells, Karnes, Kerr, Kleberg, Lavaca, Lee, Leon, Liberty, Live Oak, Madison, Matagorda, Milam, Montgomery, Newton, Nueces, Orange, Polk, Refugio, Sabine, San Augustine, San Jacinto, San Patricio, Trinity, Tyler, Victoria, Walker, Waller, Washington, Wharton, Willacy, and Wilson.

What this Means for License Holders in these counties:

To avoid a late fee, you will need to submit your license or certification renewal application with the required fees along with any required supplemental documentation, in accordance with the applicable requirements for your license or certification type by February 28, 2019.  

Late fees will be assessed on applications postmarked on or after March 1, 2019.

The current status of a license may also be verified online.


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.

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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.

Last updated January 15, 2019