| (a) License fee. (1) No person may operate or conduct business as a device distributor without first obtaining a license from the department. All applicants for a device distributor license or a renewal license shall pay a licensing fee. All fees are nonrefundable. Licenses are issued for two-year terms. 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. (A) For a distributor with gross annual device sales of $0 - $499,999.99, the fees are: (i) $480 for a two-year license; (ii) $480 for a two-year license that is amended due to a change of ownership; and (iii) $240 for a license that is amended during the current licensure period due to minor changes. (B) For a distributor with gross annual device sales of $500,000 - $9,999,999.99, the fees are: (i) $1,080 for a two-year license; (ii) $1,080 for a two-year license that is amended due to a change of ownership; and (iii) $540 for a license that is amended during the current licensure period due to minor changes. (C) For a distributor with gross annual device sales greater than or equal to $10 million, the fees are: (i) $1,680 for a two-year license; (ii) $1,680 for a two-year license that is amended due to a change of ownership; and (iii) $840 for a license that is amended during the current licensure period due to minor changes. (2) A person who is required to be licensed as a device distributor 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 two-year terms. A license shall only be issued when all past due fees and delinquency fees are paid. License fees are based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices). (A) For each place of business having combined gross annual sales of $0 - $199,999.99, the fees are: (i) $520 for a two-year license; (ii) $520 for a two-year license that is amended due to a change of ownership; and (iii) $260 for a license that is amended during the current licensure period due to minor changes. (B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are: (i) $780 for a two-year license; (ii) $780 for a two-year license that is amended due to a change of ownership; and (iii) $390 for a license that is amended during the current licensure period due to minor changes. (C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are: (i) $1,040 for a two-year license; (ii) $1,040 for a two-year license that is amended due to a change of ownership; and (iii) $520 for a license that is amended during the current licensure period due to minor changes. (D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are: (i) $1,300 for a two-year license; (ii) $1,300 for a two-year license that is amended due to a change of ownership; and (iii) $650 for a license that is amended during the current licensure period due to minor changes. (E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are: (i) $1,950 for a two-year license; (ii) $1,950 for a two-year license that is amended due to a change of ownership; and (iii) $975 for a license that is amended during the current licensure period due to minor changes. (3) No person may operate or conduct business as a device manufacturer in this state without first obtaining a license from the department. All applicants for a device manufacturer license or renewal license shall pay a licensing fee. All fees are nonrefundable. Licenses are issued for two-year terms. 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. (A) For a manufacturer with gross annual device sales of $0 - $499,999.99, the fees are: (i) $480 for a two-year license; (ii) $480 for a two-year license that is amended due to a change of ownership; and (iii) $240 for a license that is amended during the current licensure period due to minor changes. (B) For a manufacturer with gross annual device sales of $500,000 - $9,999,999.99, the fees are: (i) $2,160 for a two-year license; (ii) $2,160 for a two-year license that is amended due to a change of ownership; and (iii) $1,080 for a license that is amended during the current licensure period due to minor changes. (C) For a manufacturer with gross annual device sales greater than or equal to $10 million, the fees are: (i) $3,600 for a two-year license; (ii) $3,600 for a two-year license that is amended due to a change of ownership; and (iii) $1,800 for a license that is amended during the current licensure period due to minor changes. (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. (c) Exemption from licensing fees. A person is exempt from the licensing fees required by this section if the person is: (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: (A) the manufacture or distribution of radiation machines which are devices; or (B) the manufacture or distribution of devices which contain radioactive materials; or (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. (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 |
