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.

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Texas In-State Manufacturer 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 who are Manufacturers Initial/Renewal License Application

Agency Fee:

$1,040 for facilities with less than $200k in gross annual drug sales, $1,690 for facilities with between $200k and $20M in gross annual drug sales, or $2,210 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,040 for facilities with less than $200k in gross annual drug sales, $1,690 for facilities with between $200k and $20M in gross annual drug sales, or $2,210 for facilities with more than $20M in gross annual drug sales.

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

Initial Registration

Form:

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

Agency Fee:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

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:

$1,040 for facilities with less than $200k in gross annual drug sales, $1,690 for facilities with between $200k and $20M in gross annual drug sales, or $2,210 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,040 for facilities with less than $200k in gross annual drug sales, $1,690 for facilities with between $200k and $20M in gross annual drug sales, or $2,210 for facilities with more than $20M in gross annual drug sales.

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:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

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

Initial Registration

Form:

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

Agency Fee:

$540 for facilities with less than $200k in combined gross annual sales, $810 for facilities with between $200k and $500k in combined gross annual sales, $1,080 for facilities with between $500k and $1M in combined gross annual sales, $1,350 for facilities with between $1M and $10M in combined gross annual sales, $2,025 for facilities with more than $10M in combined gross annual sales.

Registration Renewal

Form:

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

Agency Fee:

$540 for facilities with less than $200k in combined gross annual sales, $810 for facilities with between $200k and $500k in combined gross annual sales, $1,080 for facilities with between $500k and $1M in combined gross annual sales, $1,350 for facilities with between $1M and $10M in combined gross annual sales, $2,025 for facilities with more than $10M in combined gross annual sales.

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

Initial Registration

Form:

Multiple Product Nonprescription Drug Initial/Renewal License Application

Agency Fee:

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

Registration Renewal

Form:

Multiple Product Nonprescription Drug Initial/Renewal License Application

Agency Fee:

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

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:

$1,300 for facilities with less than $20M in gross annual drug sales, $1,950 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,300 for facilities with less than $20M in gross annual drug sales, $1,950 for facilities with more than $20M in gross annual drug sales.

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:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

Registration Renewal

Form:

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

Agency Fee:

$1,080 for facilities with less than $200k in gross annual drug sales, $1,755 for facilities with between $200k and $20M in gross annual drug sales, or $2,295 for facilities with more than $20M in gross annual drug sales.

Due:

Biennially by the date of issuance.

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