1. (a) General. Except as provided by §229.434 of this title (relating to Exemptions), a person may not engage in the distribution or manufacture of devices in Texas unless the person has a valid license from the Commissioner of Health (commissioner) for each place of business.
2. (b) Display of license. The license shall be displayed in an open public area at each place of business.
3. (c) Existing place of business. Each person involved in the distribution or manufacture of devices in Texas on the effective date of these sections must apply for a device distributor manufacturer license no later than 60 days following the effective date of these sections.
4. (d) New place of business. Each person acquiring or establishing a place of business for the purpose of device distribution or manufacturing after the effective date of these sections shall apply to the Texas Department of Health (department) for a license of such business prior to beginning operation.
5. (e) Two or more places of business. If the device distributor or manufacturer operates more than one place of business, the device distributor or manufacturer shall license each place of business separately.
6. (f) Issuance of license. The department may license a distributor or manufacturer of devices who meets the requirements of this section and §229.441 of this title (relating to Minimum Standards for Licensure).
7. (g) Transfer of license. Licenses shall not be transferable from one person to another or from one place of business to another.
8. (h) License expiration. Unless the department revokes or suspends a license as provided in §229.440 of this title (relating to Refusal, Cancellation, Suspension, or Revocation of a License), the initial license shall be valid for one year from the date of issuance which becomes the anniversary date.

9. (i) Renewal of license.

   1. (1) Each year prior to the anniversary date, the distributor or manufacturer of devices shall renew its license following the requirements of this section and §229.436 of this title (relating to Licensing Procedures).
   2. (2) The renewal license shall be valid for one year from the anniversary date.
   3. (3) The license renewal application and fee for each place of business shall be submitted to the department 30 days prior to the expiration date of the current license in accordance with department procedures in §229.436 of this title. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.
   4. (4) Failure to submit the renewal application prior to the current licensure expiration date may subject the device distributor or manufacturer to the enforcement provisions under the Act and also to the provisions of §229.440 of this title.
10. (j) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business will require submission of an application as outlined in §229.436 of this title (relating to Licensing Procedures) and submission of fees as outlined in §229.439 of this title (relating to Licensure Fees).
11. (k) Notification of change of location of place of business. Not fewer than 30 days in advance of the change, the licensee shall notify the commissioner or the commissioner's designee in writing of the licensee's intent to change the location of a licensed place of business. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. Not more than ten days after the completion of the change of location, the licensee shall notify the commissioner or the commissioner's designee in writing to verify the change of location, the specific date of change, the new location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address. Notice will be deemed adequate if the licensee provides the intent and verification notices to the commissioner or the commissioner's designee by certified mail, return receipt requested, mailed to the Texas Department of Health, 1100 West 49th Street, Austin, Texas.
12. (l) Combination products. If the United States Food and Drug Administration determines, with respect to a product that is a combination of a drug and a device, that the primary mode of action of the product is as a device, a distributor or manufacturer of the product is subject to licensure as described in this section.

Source Note:The provisions of this §229.435 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 19, 2001, 26 TexReg 2196.