Texas Healthcare and Pharmaceutical Licensing

Community Pharmacy Compounding Sterile Preparations (Class A-S) License Application

$459 license fee + $25 per pharmacy balance/scale.

Online

$456 license fee + $25 per pharmacy balance/scale.

Biennially by the end of the registration anniversary month.

Device Distributor Application

Mail or online.

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)

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

Device Distributor Application (Renewal)

Mail or online.

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)

Biennially by the date of issuance.

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

Device Manufacturer Application

Mail or online.

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)

Device Manufacturer Application (Renewal)

Mail or online.

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)

Biennially by the date of issuance.

Freestanding Emergency Medical Care Center Pharmacy (Class F) License Application

$459 license fee + $25 per pharmacy balance/scale.

Online

$456 license fee + $25 per pharmacy balance/scale.

Biennially by the end of the registration anniversary month.

Online

$1,750

Online

$1,750

Biennially

Hospital Pharmacy Engaged in Compounding Sterile Preparations (Class C-S) License Application

$459 license fee + $25 per pharmacy balance/scale.

Online

$456 license fee + $25 per pharmacy balance/scale.

Biennially by the end of the registration anniversary month.

Hospital/Ambulatory Surgical Center Pharmacy (Class C) License Application

$459 license fee + $25 per pharmacy balance/scale.

Online

$456 license fee + $25 per pharmacy balance/scale.

Biennially by the end of the registration anniversary month.

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

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)

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

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)

Biennially by the date of issuance.

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

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)

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

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)

Biennially by the date of issuance.

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

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)

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

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)

Biennially by the date of issuance.

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

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)

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

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)

Biennially by the date of issuance.

Limited Prescription Deliver Pharmacy (Class H) License Application

$459

Online

$456

Biennially by the end of the registration anniversary month.

Online

$599

Providers who have already paid the Medicare Enrollment application fee or the Medicaid Enrollment fee for another state may be exempt from paying the application fee.

Online

$599

Every 3 or 5 years depending on the type of services provided.

Online

$599

Providers who have already paid the Medicare Enrollment application fee or the Medicaid Enrollment fee for another state may be exempt from paying the application fee.

Online

$599

Every 3 or 5 years depending on the type of services provided.

Online

$599

Providers who have already paid the Medicare Enrollment application fee or the Medicaid Enrollment fee for another state may be exempt from paying the application fee.

Online

$599

Every 3 or 5 years depending on the type of services provided.

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

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)

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

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)

Biennially by the date of issuance.

Multiple Product Nonprescription Drug Initial/Renewal License Application

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)

Multiple Product Nonprescription Drug Initial/Renewal License Application

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)

Biennially by the date of issuance.

Non-Resident Pharmacy (Class E) License Application

Mail to: 

Texas State Board of Pharmacy
333 Guadalupe Street Suite 3-500
Austin, TX 78701

$459

• According to Texas Occupations Code § 565.0551, the Executive Director of the Texas State Board of Pharmacy may require a license holder to submit a surety bond to the board. 
• Applications can be paid with a Check or Money Order
• The TSBP may request additional documentation to confirm or substantiate information submitted on the application. 
• Due to the high volume of applications received, the Board is unable to confirm the receipt of the application. Instead, consider using a mail courier with tracking notifications and/or delivery receipts to confirm the receipt of the application. The receiving Licensing Specialist will send the pharmacy an email to the email address provided on the application to notify if there are any deficiencies or if the application is considered complete at the time it is reviewed. This initial review process can take 1-2 weeks.

• The Name of the Pharmacy Owner is the Legal Name of the Pharmacy. This name should be the name of the direct owner legally responsible for the operation of the pharmacy, and it must match any and all
  Secretary of State and IRS filings.
  • The Business Name of the Pharmacy is the name to be listed on all pharmacy signage, licenses from other regulatory agencies, advertisements, etc
  • Ownership Information, Pharmacy Name, and the Pharmacy Address must match the information listed on the Resident Pharmacy License.
• For each owner, provide: 
  • Ownership Information Form (LIC-004)
  • Verification of the Owner’s FEIN from the IRS
  • Certificate of Formation/Application of Registration from Texas Secretary of State
    • For Foreign Entities ONLY: Formation Documents from Jurisdiction of Formation
  • Verification of Franchise Tax Account Status from Texas Comptroller
• Sworn Disclosure Statement (LIC-005) for each applicant OR  submit one of the following:
  • Page 1 of the company’s 10-K SEC Filing
  • Statement for Wholly Owned Retail Grocery Store Chain
• Submit Managing Officer Forms for each officer (LIC-021). “Managing Officers" are defined as the top four executive officers, including the corporate officer in charge of pharmacy operations, who are designated by the partnership or corporation to be jointly responsible for the legal operation of the pharmacy. For each, include: 
  • Name of the office
  • Copy of the officer's photo ID
    • Acceptable Photo IDs are: Current Driver’s License, State-Issued Identification Card, or US Passport. 
  • Verification of SSN
    • - Submit a copy of the individual’s Social Security Card OR a copy of the individual’s W2 or Paystub, that shows the full SSN and Name of the individual, with all financial information redacted
• Lease Agreement or Proof of Property Ownership 
  •  Submit either a Lease Agreement or Proof of Property Ownership, if the pharmacy owner is not leasing the space but owns the premises. 
  • If the owner of the pharmacy also owns the premises and is NOT leasing the space, submit either ONE of the following for proof of property ownership
• Inspection Report
  • Attach a copy of the most recent pharmacy inspection report dated no more than two years prior to the date of this application. The inspection must have been conducted by the regulatory or licensing agency of the resident state AFTER the pharmacy was in operation for a minimum of 30 days. 
• Written Letter(s) of License Verification for Pharmacy and Pharmacist-in-Charge
  • Submit written verification from the resident Board of Pharmacy that verifies the licenses of the BOTH the Pharmacist-in-Charge and the Pharmacy. Copies of the license will NOT fulfill this requirement. 
• Description of Services
  • Attach a detailed written description of services that the pharmacy plans to offer Texas Residents upon licensure. 
• Letter of Credit Worthiness Document from a licensed Drug Distributor and/or Manufacturer 
  •  Submit a letter from the pharmacy’s primary pharmaceutical wholesaler that verifies the pharmacy applicant’s creditworthiness. The letter must come from a licensed wholesaler and it must be for the specific pharmacy and/or for the pharmacy owner
• Verification of an ACTIVE Franchise Tax Account Status from the Texas Comptroller, if entity is also registered with Texas. Provide documentation from the Texas Comptroller that shows the entity has an ACTIVE Franchise Tax Account Status.
• Organizational Chart: Provide an organizational chart that shows multi-levels of ownership and relation to the pharmacy

Online

$456

Biennially by the end of the registration anniversary month.

Non-Resident Pharmacy Compounding Sterile Preparations (Class E-S)

$459

Online

$456

Biennially by the end of the registration anniversary month.

Nuclear Pharmacy (Class B) License Application

$459 license fee + $25 per pharmacy balance/scale.

Online

$456 license fee + $25 per pharmacy balance/scale.

Biennially by the end of the registration anniversary month.

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

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)

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

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)

Biennially by the date of issuance.

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

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)

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

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)

Biennially by the date of issuance.

Pseudoephedrine Retail Certificate of Authority

$600

Pseudoephedrine Retail Certificate of Authority (Renewal)

$600

Biennially by the date of issuance.