25 Tex. Admin. Code § 229.439 – Licensure Fees

(a) License fee.
1. (1) A person must obtain a license from the department before operating or conducting business as a device distributor. All applicants for a device distributor license or a renewal license must pay a non-refundable licensing fee. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.
  1. (A) For a distributor with gross annual device sales of $0 - $499,999.99, the fees are:
    1. (i) $552 for a two-year license;
    2. (ii) $552 for a two-year license for a change of ownership; and
    3. (iii) $276 for a license amended during the current licensure period for minor changes.
  2. (B) For a distributor with gross annual device sales of $500,000 - $9,999,999.99, the fees are:
    1. (i) $1,296 for a two-year license;
    2. (ii) $1,296 for a two-year license for a change of ownership; and
    3. (iii) $648 for a license amended during the current licensure period for minor changes.
  3. (C) For a distributor with gross annual device sales greater than or equal to $10 million, the fees are:
    1. (i) $2,016 for a two-year license;
    2. (ii) $2,016 for a two-year license for a change of ownership; and
    3. (iii) $1,008 for a license amended during the current licensure period for minor changes.
2. (2) If a person who is required to be licensed as a device distributor under this section is also required to be licensed as a wholesale drug distributor under §229.246(a) of this chapter (relating to Licensure Requirements) or a wholesale food distributor under §229.182(a)(3) of this chapter (relating to Licensing/Registration Fee and Procedures), the person must pay a combined non-refundable fee for each place of business. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.
  1. (A) For each place of business having combined gross annual sales of $0 - $199,999.99, the fees are:
    1. (i) $598 for a two-year license;
    2. (ii) $598 for a two-year license for a change of ownership; and
    3. (iii) $299 for a license amended during the current licensure period for minor changes.
  2. (B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:
    1. (i) $897 for a two-year license;
    2. (ii) $897 for a two-year license for a change of ownership; and
    3. (iii) $449 for a license amended during the current licensure period for minor changes.
  3. (C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:
    1. (i) $1,248 for a two-year license;
    2. (ii) $1,248 for a two-year license for a change of ownership; and
    3. (iii) $624 for a license amended during the current licensure period for minor changes.
  4. (D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:
    1. (i) $1,560 for a two-year license;
    2. (ii) $1,560 for a two-year license for a change of ownership; and
    3. (iii) $780 for a license amended during the current licensure period for minor changes.
  5. (E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:
    1. (i) $2,340 for a two-year license;
    2. (ii) $2,340 for a two-year license for a change of ownership; and
    3. (iii) $1,170 for a license amended during the current licensure period for minor changes.
3. (3) A person must first obtain a license from the department to operate and conduct business as a device manufacturer in Texas. All applicants for a device manufacturer license or renewal license must pay a nonrefundable licensing fee. The department issues licenses for two-year terms and will only issue a license when all past due fees are paid. License fees are based on gross annual device sales.
  1. (A) For a manufacturer with gross annual device sales of $0 - $499,999.99, the fees are:
    1. (i) $552 for a two-year license;
    2. (ii) $552 for a two-year license for a change of ownership; and
    3. (iii) $276 for a license amended during the current licensure period for minor changes.
  2. (B) For a manufacturer with gross annual device sales of $500,000 - $9,999,999.99, the fees are:
    1. (i) $2,592 for a two-year license;
    2. (ii) $2,592 for a two-year license for a change of ownership; and
    3. (iii) $1,296 for a license amended during the current licensure period for minor changes.
  3. (C) For a manufacturer with gross annual device sales greater than or equal to $10 million, the fees are:
    1. (i) $4,320 for a two-year license;
    2. (ii) $4,320 for a two-year license for a change of ownership; and
    3. (iii) $2,160 for a license amended during the current licensure period for minor changes.
(b) Texas.gov. Applicants may submit initial and renewal license applications electronically through www.texas.gov. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs of processing applications and renewals through the website.
(c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person:
1. (1) is licensed under §289.252 of this title (relating to Licensing of Radioactive Material) or registered under §289.226 of this title (relating to Registration of Radiation Machine Use and Services) and engages only in the following activities:
  1. (A) manufacturing or distributing of radiation machines that are devices; or
  2. (B) manufacturing or distributing of devices that contain radioactive materials; or
2. (2) is a charitable organization, as described in the Internal Revenue Code of 1986 §501(c)(3), or a nonprofit affiliate of one, where permitted by law.
(d) Sale of food, drugs, or devices. This section includes the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any of the regulated articles for sale; the sale, dispensing, and giving of any regulated article; and supplying or applying of any regulated articles in the operation of any food, drug, or device place of business.

Source Note:The provisions of this §229.439 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective March 12, 1997, 22 TexReg 2438; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective February 1, 2006, 31 TexReg 501; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147.