1. (a) License fee.

   1. (1) All applicants for a device distributor license or a renewal license shall pay a licensing fee. All fees are nonrefundable. Licenses are issued for one or two-year terms as determined by the department. A license shall only be issued when all past due fees and delinquency fees are paid. License fees are based on gross annual device sales as follows:

      1. (A) For a distributor with gross annual device sales of $0 - $499,999.99:

         1. (i) $200 for a one-year license; or
         2. (ii) $400 for a two-year license.

      2. (B) For a distributor with gross annual device sales of $500,000 - $9,999,999.99:

         1. (i) $450 for a one-year license; or
         2. (ii) $900 for a two-year license.

      3. (C) For a distributor with gross annual device sales greater than or equal to $10 million:

         1. (i) $700 for a one-year license; or
         2. (ii) $1,400 for a two-year license.

   2. (2) A device distributor who is required to be licensed under this section and who is also required to be licensed as a wholesale drug distributor under §229.252(a)(1) of this title (relating to Licensing Fee and Procedures) or as a wholesale food distributor under §229.182(a)(3) of this title (relating to Licensing Fee and Procedures) shall pay a combined licensure fee for each place of business. All fees are nonrefundable. Licenses are issued for one or two-year terms as determined by the department. The licensing fee is based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices) as follows:

      1. (A) For each place of business having combined gross annual sales of $0 - $199,999.99;

         1. (i) $200 for a one-year license; or
         2. (ii) $400 for a two-year license.

      2. (B) For each place of business having combined gross annual sales of $200,000 - $499,999.99;

         1. (i) $300 for a one-year license; or
         2. (ii) $600 for a two-year license.

      3. (C) For each place of business having combined gross annual sales of $500,000 - $999,999.99;

         1. (i) $400 for a one-year license; or
         2. (ii) $800 for a two-year license.

      4. (D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99;

         1. (i) $500 for a one-year license; or
         2. (ii) $1,000 for a two-year license.

      5. (E) For each place of business having combined gross annual sales greater than or equal to $10 million;

         1. (i) $750 for a one-year license; or
         2. (ii) $1,500 for a two-year license.

   3. (3) All applicants for a device manufacturer license or renewal license shall pay a licensing fee. All fees are nonrefundable. Licenses are issued for one or two-year terms as determined by the department. License fees are based on the gross annual device sales as follows:

      1. (A) For a manufacturer with gross annual device sales of $0 - $499,999.99;

         1. (i) $200 for a one-year license; or
         2. (ii) $400 for a two-year license.

      2. (B) For a manufacturer with gross annual device sales of $500,000 - $9,999,999.99;

         1. (i) $900 for a one-year license; or
         2. (ii) $1,800 for a two-year license; and

      3. (C) For a manufacturer with gross annual device sales greater than or equal to $10 million;

         1. (i) $1,500 for a one-year license; or
         2. (ii) $3,000 for a two-year license.
2. (b) Texas Online. Applicants may submit applications and renewal applications for a license under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.

3. (c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is:

   1. (1) 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 types of device distribution or manufacturing:

      1. (A) the manufacture or distribution of radiation machines which are devices; or
      2. (B) the manufacture or distribution of devices which contain radioactive materials; or
   2. (2) 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.
4. (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.