Texas Department of State Health Services - Drug and Medical Devices Group


Please Note

We are a service company that can help you file with the Texas Department of State Health Services - Drug and Medical Devices Group. We are not associated with this nor any other government agency. We offer paid services and software to help you file. You are not required to purchase our service to file - you may file directly with this agency without using our service.


Contact Information

Phone: 512-834-6755
Fax: 512-834-6759

Web: Home Name search
Email: DMD.regulatory@dshs.texas.gov

Licenses

We track the following licenses with the Texas Department of State Health Services - Drug and Medical Devices Group in order to provide compliance services to our clients. As a client, you see this and other reference data in License Manager in-line with your licenses.

A laptop placed on a desk with our License Manager software on display

Texas Device Distributor License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Notes:

Entities applying for this license must have a physical address within the state of Texas.

Registered Agent (Special Agency) Required?Yes

Initial Registration

Form:

Device Distributor Application

Filing Method:

Mail or online.

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $494 per facility for gross annual device sales of less than $500,000
  • $1,112 per facility for gross annual device sales of at least $500,000 but less than $10,000,000
  • $1,730 per facility for gross annual device sales of $10,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Required Attachments:
  • List of officers and directors/partners including address, driver's license number, and date of birth

Registration Renewal

Form:

Device Distributor Application (Renewal)

Filing Method:

Mail or online.

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $494 per facility for gross annual device sales of less than $500,000
  • $1,112 per facility for gross annual device sales of at least $500,000 but less than $10,000,000
  • $1,730 per facility for gross annual device sales of $10,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

Required Attachments:
  • List of officers and directors/partners including address, driver's license number, and date of birth

Texas Device Manufacturer License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Notes:

Entities applying for this license must have a physical address within the state of Texas.

Registered Agent (Special Agency) Required?Yes

Initial Registration

Form:

Device Manufacturer Application

Filing Method:

Mail or online.

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $494 per facility for gross annual device sales of less than $500,000
  • $2,225 per facility for gross annual device sales of at least $500,000 but less than $10,000,000
  • $3,708 per facility for gross annual device sales of $10,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

Device Manufacturer Application (Renewal)

Filing Method:

Mail or online.

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $494 per facility for gross annual device sales of less than $500,000
  • $2,225 per facility for gross annual device sales of at least $500,000 but less than $10,000,000
  • $3,708 per facility for gross annual device sales of $10,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

Texas In-State Manufacturer of Nonprescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Registered Agent (Special Agency) Required?Yes

Initial Registration

Form:

In-State Wholesale Distributors of Nonprescription Drugs who are Manufacturers Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $1,040 per location for gross annual drug sales of less than $200,000
  • $1,690 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,210 per location for gross annual drug sales of $20,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

In-State Wholesale Distributors of Nonprescription Drugs who are Manufacturers Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $1,040 per location for gross annual drug sales of less than $200,000
  • $1,690 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,210 per location for gross annual drug sales of $20,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

Texas In-State Manufacturer of Prescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Registered Agent (Special Agency) Required?Yes

Initial Registration

Form:

In-State Manufacture of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $1,080 per location for gross annual drug sales of less than $200,000
  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,295 per location for gross annual drug sales of $20,000,000 or more
     

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

In-State Manufacture of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $1,080 per location for gross annual drug sales of less than $200,000
  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,295 per location for gross annual drug sales of $20,000,000 or more
     
    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)
Due:

Biennially by the date of issuance.

Texas In-State Wholesale Distributors of Nonprescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group

Initial Registration

Form:

In-State Wholesale Distributors of Nonprescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

$1,040 per location for gross annual drug sales of less than $200,000
$1,690 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
$2,210 per location for gross annual drug sales of $20,000,000 or more
 
A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

In-State Wholesale Distributors of Nonprescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $1,040 per location for gross annual drug sales of less than $200,000
  • $1,690 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,210 per location for gross annual drug sales of $20,000,000 or more
     
    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)
Due:

Biennially by the date of issuance.

Texas In-State Wholesale Distributors of Prescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group

Initial Registration

Form:

In-State Wholesale Distributors of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $675 per location for medical gas only distributors with less than $20,000 in gross annual drug sales
  • $1,080 per location for gross annual drug sales of less than $200,000
  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,295 per location for gross annual drug sales of $20,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

In-State Wholesale Distributors of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $675 per location for medical gas only distributors with less than $20,000 in gross annual drug sales
  • $1,080 per location for gross annual drug sales of less than $200,000
  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,295 per location for gross annual drug sales of $20,000,000 or more

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

Texas Multiple Product (Including Medical Gases) Nonprescription Drug License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Notes:

Entities applying for this license must have a physical address within the state of Texas.

Registered Agent (Special Agency) Required?Yes

Initial Registration

Form:

Multiple Product (Including Medical Gases) Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $520 for facilities with less than $200,000 in combined gross annual sales
  • $780 for facilities with between $200,000 and $500,000 in combined gross annual sales
  • $1,040 for facilities with between $500,000 and $1,000,000 in combined gross annual sales
  • $1,300 for facilities with between $1,000,000 and $10,000,000 in combined gross annual sales
  • $1,950 for facilities with $10,000,000 or more in combined gross annual sales.

 

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

Multiple Product (Including Medical Gases) Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all devices sales at each licensed place of business:

  • $520 for facilities with less than $200,000 in combined gross annual sales
  • $780 for facilities with between $200,000 and $500,000 in combined gross annual sales
  • $1,040 for facilities with between $500,000 and $1,000,000 in combined gross annual sales
  • $1,300 for facilities with between $1,000,000 and $10,000,000 in combined gross annual sales
  • $1,950 for facilities with $10,000,000 or more in combined gross annual sales.
     

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

Texas Multiple Product Nonprescription Drug License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group
Notes:

Entities applying for this license must have a physical address within the state of Texas.

Initial Registration

Form:

Multiple Product Nonprescription Drug Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $520 per location for gross annual drug sales of less than $200,000
  • $780 per location for gross annual drug sales of at least $200,000 but less than $500,000
  • $1,040 per location for gross annual drug sales of at least $500,000 but less than $1,000,000
  • $1,300 per location for gross annual drug sales of at least $1,000,000 but less than $10,000,000
  • $1,950 per location for gross annual drug sales of $10,000,000 or more.

 
A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

Multiple Product Nonprescription Drug Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drug sales at each licensed place of business:

  • $520 per location for gross annual drug sales of less than $200,000
  • $780 per location for gross annual drug sales of at least $200,000 but less than $500,000
  • $1,040 per location for gross annual drug sales of at least $500,000 but less than $1,000,000
  • $1,300 per location for gross annual drug sales of at least $1,000,000 but less than $10,000,000
  • $1,950 per location for gross annual drug sales of $10,000,000 or more.
     
    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)
Due:

Biennially by the date of issuance.

Texas Out-of-State Wholesale Distributors of Nonprescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group

Initial Registration

Form:

Out-of-State Wholesale Distributors of Nonprescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drugs delivered into Texas:

  • $1,300 per location for gross annual drug sales of less than $20,000,000
  • $1,950 per location for gross annual drug sales of $20,000,000 or more.
     
    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

Out-of-State Wholesale Distributors of Nonprescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drugs delivered into Texas:

  • $1,300 per location for gross annual drug sales of less than $20,000,000
  • $1,950 per location for gross annual drug sales of $20,000,000 or more.
     
    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)
Due:

Biennially by the date of issuance.

Texas Out-of-State Wholesale Distributors of Prescription Drugs License

Agency:Texas Department of State Health Services - Drug and Medical Devices Group

Initial Registration

Form:

Out-of-State Wholesale Distributors of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drugs delivered into Texas:

  • $675 per location for medical gas only distributors with less than $20,000 in gross annual drug sales

  • $1,080 per location for gross annual drug sales of less than $200,000

  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000

  • $2,295 per location for gross annual drug sales of $20,000,000 or more
     

    A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Registration Renewal

Form:

Out-of-State Wholesale Distributors of Prescription Drugs Initial/Renewal License Application

Agency Fee:

License fees are based on gross annual sales of all drugs delivered into Texas:

  • $675 per location for medical gas only distributors with less than $20,000 in gross annual drug sales
  • $1,080 per location for gross annual drug sales of less than $200,000
  • $1,755 per location for gross annual drug sales of at least $200,000 but less than $20,000,000
  • $2,295 per location for gross annual drug sales of $20,000,000 or more
     

A person is exempt from the license fees required by this section if the person is a charitable organization, as described in the Internal Revenue Code of 1986, 501(c)(3)

Due:

Biennially by the date of issuance.

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