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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 §229.442Advertising

(a) An advertisement of a device shall be deemed to be false if it is false or misleading in any particular.

(b) An advertisement of a device is false if the advertisement represents that the device affects:

  (1) infectious and parasitic diseases;

  (2) neoplasms;

  (3) endocrine, nutritional, and metabolic diseases and immunity disorders;

  (4) diseases of blood and blood-forming organs;

  (5) mental disorders;

  (6) diseases of the nervous system and sense organs;

  (7) diseases of the circulatory system;

  (8) diseases of the respiratory system;

  (9) diseases of the digestive system;

  (10) diseases of the genitourinary system;

  (11) complications of pregnancy, childbirth, and the puerperium;

  (12) diseases of the skin and subcutaneous tissue;

  (13) diseases of the musculoskeletal system and connective tissue;

  (14) congenital anomalies;

  (15) certain conditions originating in the perinatal period;

  (16) symptoms, signs, and ill-defined conditions; or

  (17) injury and poisoning.

(c) Subsection (b) of this section does not apply to an advertisement of a device if the advertisement does not violate the Act, §431.182(a), and is disseminated:

  (1) to the public for self-medication and is consistent with the labeling claims permitted by the United States Food and Drug Administration (FDA);

  (2) only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or

  (3) only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.

(d) This section does not indicate that self-medication for a disease, other than a disease listed under subsection (b) of this section, is safe and effective.


Source Note: The provisions of this §229.442 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective January 1, 2005, 29 TexReg 11983

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