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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER XLICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
RULE §229.434Exemptions

(a) A person is exempt from licensing under §229.435 of this title (relating to Licensure Requirements) if the person engages only in the following types of device distribution:

  (1) intracompany sales;

  (2) distribution from a place of business located outside the State of Texas; or

  (3) the sale, purchase, or trade of a distressed or reconditioned device by a salvage broker or a salvage operator licensed under §229.605 of this title (relating to Licensing Requirements and Procedures).

(b) A person is exempt from licensing under §229.435 of this title if the person holds a registration certificate issued under Occupations Code, Chapter 266, and engages only in conduct within the scope of that registration.

(c) This section does not exempt a person from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Texas Dangerous Drug Act, Health and Safety Code, Chapter 483; or the rules adopted to administer and enforce those chapters.


Source Note: The provisions of this §229.434 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; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective November 23, 2014, 39 TexReg 9018

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