1. (a) License fee.

   1. (1) All device distributors in Texas shall obtain a license annually with the Texas Department of Health (department). Except as provided for in paragraph (2) of this subsection, device distributors shall pay a licensure fee for each place of business operated as follows:

      1. (A) $200 per distributor having gross annual device sales of $0-$499,999.99;
      2. (B) $450 per distributor having gross annual device sales of $500,000-$9,999,999.99; and
      3. (C) $700 per distributor having gross annual device sales greater than or equal to $10 million.

   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. The licensure fee shall be based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices) as follows:

      1. (A) $200 for each place of business having combined gross annual sales of $0-$199,999.99;
      2. (B) $300 for each place of business having combined gross annual sales of $200,000-$499,999.99;
      3. (C) $400 for each place of business having combined gross annual sales of $500,000-$999,999.99;
      4. (D) $500 for each place of business having combined gross annual sales of $1 million-$9,999,999.99; and
      5. (E) $750 for each place of business having combined gross annual sales greater than or equal to $10 million.

   3. (3) All device manufacturers in Texas shall obtain a license annually with the department and shall pay a licensure fee for each place of business operated as follows:

      1. (A) $200 per manufacturer having gross annual device sales of $0-$499,999.99;
      2. (B) $900 per manufacturer having gross annual device sales of $500,000-$9,999,999.99; and
      3. (C) $1,500 per manufacturer having gross annual device sales greater than or equal to $10 million.

2. (b) Exemption from licensure fees. A person is exempt from the licensure 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.
3. (c) Sale of food, drugs, or devices. The provisions of this section regarding the sale of food, drugs, or devices shall be considered to include the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct 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.