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Drugs and Medical Devices Group

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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


Medical Device Manufacturers and Distributors

The Drugs and Medical Devices Group is responsible for ensuring that medical device manufacturers and distributors comply with minimum licensing standards established to protect the health and safety of the citizens of Texas. In order to accomplish this objective, inspections of medical device 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 medical device manufacturers and distributors.

Applications and Forms

For assistance with licensing, please call (512) 834-6727

Online Licensing Options

Medical device manufacturers and distributors may use the Regulatory Services Online Licensing System to apply for new (initial) licenses or to renew existing licenses.

At this time, we are unable to process applications online for minor amendment changes to a license, such as name or address changes. Multiple product licenses may not be obtained or renewed using the online licensing system.

Device Manufacturers

Device Distributors


Tattoo and Body Piercing Studios

The Drugs and Medical Devices Group is responsible for ensuring that tattoo and body piercing studios, including temporary locations, comply with minimum licensing standards established to protect the health and safety of the citizens of Texas. In order to accomplish this objective, inspections of studios and temporary locations 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 operating tattoo and body piercing studios.

Licensing

We require any business that is engaged in tattooing (i.e., the practice of producing an indelible mark or figure on the human body by scarring or inserting pigments under the skin using needles, scalpels, or other related equipment) or body piercing (i.e., the practice of creating an opening in a person's body, other than the individual's earlobe, to insert jewelry or another decoration) to be licensed with the Department of State Health Services. In addition, we require temporary locations at which tattooing or body piercing is performed for not more than seven days in conjunction with a single event or celebration to be licensed with the Department.

Applications and Forms

For assistance with applications and forms, please call: (512) 834-6727


Online Licensing

The Department of State Health Services is pleased to offer current and prospective licensees the opportunity to apply for licenses online using the Regulatory Services Online Licensing System.

Who May Apply or Renew Online

Tattoo and body piercing studios seeing initial licensure, license renewals, or temporary event licenses may use the online licensing system. At this time, we are unable to process minor amendment changes (such as name or address), nor are we able to renew temporary event licenses online.


Tattoo Studio License Applications


Body Piercing Studio License Application


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.

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.

Applications and Forms

For assistance with licensing, please call (512) 834-6727

Drug Manufacturers

Nonprescription Drugs License Applications

Prescription Drugs License Applications

Drug Distributors

Nonprescription Drugs License Applications

Prescription Drugs License Applications

Out of State Nonprescription Drugs License Applications

Out of State Prescription Drugs License Applications

Last Updated May 13, 2016

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