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Drug Manufacturers and Distributors


Emergency Guidance Regarding Handwashing Stations in Warehouse/Distribution/Fulfillment Centers When Under A Boil Water Notice 

In accordance with section 418.016 of the Texas Government Code, the Office of the Governor granted DSHS’s request to temporarily suspend 25 TAC § 229.224(b)(1), § 229.224(b)(2)(A), and § 229.420(a)(18) to the extent that it adopts 21 C.F.R. § 211.52, but only to the extent necessary to allow warehouse and distribution centers to continue operating while under boil-water notices, and only to the extent that such warehouse and distribution centers comply with guidance issued by DSHS regarding temporary measures that can be taken under a boil water notice to ensure public health and safety; provided, however, that to the extent federal law independently applies to any warehouse or distribution center, this suspension does not affect the applicability of the federal law and only removes the state law-based limitation.

 The Declaration is for:  Statewide

This suspension is in effect until the boil-water notice in the relevant area is lifted, unless extended or terminated earlier by the Office of the Governor, but in any event shall terminate when the February 12, 2021 disaster declaration is lifted or expires.


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:


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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 February 24, 2021