• Contact this ProgramSearch this Program
    Customer Surveys

    Please let us know how we are doing by completing our customer service survey.


Licensing Requirements for Drug Manufacturers and Distributors


Table of Contents


Drug Manufacturers

Drug manufacturers may apply for a license by completing and returning a license application form. Licenses are valid for 2 years unless amended, suspended or revoked. For assistance in completing applications, call (512) 834-6727.

“Manufacturer” means a person who manufactures, prepares, propagates, compounds, processes, packages, or repackages drugs, or a person who changes the container, wrapper, or labeling of any drug package. A person licensed or approved by the United States Food and Drug Administration to engage in the manufacture of drugs consistent with the federal agency's definition of "manufacturer" under the agency's regulations and guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293). The term does not include a pharmacist engaged in compounding that is done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging that is done in accordance with Occupations Code, §562.154.

Fee Schedule for In-State Manufacturers of Prescription Drugs

Fees for In-State Manufacturers of Prescription Drugs - Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $1,080 for each place of business
$200,000 - $19,999,999.99 $1,755 for each place of business
$20,000,000 or more $2,295 for each place of business
Fees for In-State Manufacturers of Prescription Drugs - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $540 for each place of business
$200,000 - $19,999,999.99 $877 for each place of business
$20,000,000 or more $1,147 for each place of business

Fee Schedule for In-State Manufacturers of Nonprescription Drugs

Fees for In-State Wholesale Distributors of Nonprescription Drugs Who Are Manufacturers - Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $1,040 for each place of business
$200,000 - $19,999,999.99 $1,690 for each place of business
$20,000,000 or more $2,210 for each place of business
Fees for In-State Wholesale Distributors of Nonprescription Drugs Who Are Manufacturers - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $520 for each place of business
$200,000 - $19,999,999.99 $845 for each place of business
$20,000,000 or more $1,105 for each place of business

Drug Distributors

Drug distributors may apply for a license by completing and returning a license application form. Licenses are valid for 2 years unless amended, suspended or revoked. For assistance in completing applications, call (512) 834-6727.

“Distributor” means a person engaged in the wholesale distribution of prescription drugs, including, but not limited to, a distributor, wholesaler, own-label distributor, private-label distributor, jobber, broker, manufacturer warehouse, distributor warehouse, or other warehouse, manufacturer's exclusive distributor, authorized distributor of record, independent wholesale drug trader, specialty wholesale distributor, third-party logistics provider, retail pharmacy that conducts wholesale distribution, and a pharmacy warehouse that conducts wholesale distribution.

Fee Schedule for In-State Distributors of Prescription Drugs

Fees for In-State Wholesale Distributors of Prescription Drugs - Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
Medical Gas ONLY Distributors $0 - $20,000.00 $675 for each place of business
$0 - $199,999.99 $1,080 for each place of business
$200,000 - $19,999,999.99 $1,755 for each place of business
$20,000,000 or more $2,295 for each place of business
Fees for In-State Wholesale Distributors of Prescription Drugs - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
Medical Gas ONLY Distributors $0 - $20,000.00 $337 for each place of business
$0 - $199,999.99 $540 for each place of business
$200,000 - $19,999,999.99 $877 for each place of business
$20,000,000 or more $1,147 for each place of business

Fee Schedule for In-State Distributors of Nonprescription Drugs

Fees for In-State Wholesale Distributors of Nonprescription Drugs - Initial / Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $1,040 for each place of business
$200,000 - $19,999,999.99 $1,690 for each place of business
$20,000,000 or more $2,210 for each place of business
Fees for In-State Wholesale Distributors of Nonprescription Drugs - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $520 for each place of business
$200,000 - $19,999,999.99 $845 for each place of business
$20,000,000 or more $1,105 for each place of business

Fee Schedule for Out-Of-State Distributors of Prescription Drugs

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

Fees for Out-Of-State Wholesale Distributors of Prescription Drugs - Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
Medical Gas ONLY Distributors $0 - $20,000.00 $675 for each place of business
$0 - $199,999.99 $1,080 for each place of business
$200,000 - $19,999,999.99 $1,755 for each place of business
$20,000,000 or more $2,295 for each place of business
Fees for Out-Of-State Wholesale Distributors of Prescription Drugs - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
Medical Gas ONLY Distributors $0 - $20,000.00 $337 for each place of business
$0 - $199,999.99 $540 for each place of business
$200,000 - $19,999,999.99 $877 for each place of business
$20,000,000 or more $1,147 for each place of business

Fee Schedule for Out-Of-State Distributors of Nonprescription Drugs

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

Fees for Out-Of-State Wholesale Distributors of Nonprescription Drugs - Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $19,999,999.99 $1,300 for each place of business
$20,000,000 or more $1,950 for each place of business
Fees for Out-Of-State Wholesale Distributors of Nonprescription Drugs - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $19,999,999.99 $650 for each place of business
$20,000,000 or more $975 for each place of business

Multiple Products

You may be eligible for a Multiple Products License if your firm distributes two or more of the following products: Food, Nonprescription Drugs, Compressed Medical Gases, and/or Medical Devices. A separate license is required if you are distributing Prescription Drugs (other than Compressed Medical Gases).

Fee Schedule for Distributors of Multiple Products (Including Medical Gases)

Note: License fees are based on COMBINED gross annual sales of food, drugs, and/or devices at each licensed place of business.

Fees for Distributors of Multiple Products (Including Medical Gases)- Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $540 for each place of business
$200,000 - $499,999.99 $810 for each place of business
$500,000 - $999.999.99 $1,080 for each place of business
$1,000,000 - $9,999,999.99 $1,350 for each place of business
$10,000,000 $2,025 for each place of business
Fees for Distributors of Multiple Products (Including Medical Gases) - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $270 for each place of business
$200,000 - $499,999.99 $405 for each place of business
$500,000 - $999.999.99 $540 for each place of business
$1,000,000 - $9,999,999.99 $675 for each place of business
$10,000,000 $1,012 for each place of business

Fee Schedule for Distributors of Multiple Products (Nonprescription Drugs)

Note: License fees are based on COMBINED gross annual sales of food, drugs, and/or devices at each licensed place of business.

Fees for Distributors of Multiple Products (Nonprescription Drugs)- Initial/Renewal License or Change of Ownership
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $520 for each place of business
$200,000 - $499,999.99 $780 for each place of business
$500,000 - $999.999.99 $1,040 for each place of business
$1,000,000 - $9,999,999.99 $1,300 for each place of business
$10,000,000 $1,950 for each place of business
Fees for Distributors of Multiple Products (Nonprescription Drugs) - Minor Amendments (Name, Address)
Gross Annual Drug Sales Licensing Fees
$0 - $199,999.99 $260 for each place of business
$200,000 - $499,999.99 $390 for each place of business
$500,000 - $999.999.99 $520 for each place of business
$1,000,000 - $9,999,999.99 $650 for each place of business
$10,000,000 $975 for each place of business

Late Fees

A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.


Exemptions from Licensing Fees

A Drug manufacturer or distributor may be exempt from licensing fees if they are a charitable organization, as described in the Internal Revenue Code of 1986, §501(c)(3), or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.

Last updated September 2, 2015