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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 §229.440Refusal, Cancellation, Suspension, or Revocation of License

(a) The commissioner may refuse an application or may suspend or revoke a license if the applicant or licensee:

  (1) has been convicted of a felony or misdemeanor that involves moral turpitude;

  (2) is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

  (3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

  (4) is an association, partnership, or corporation and the managing officer has been convicted in state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

  (5) has violated any of the provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or these sections;

  (6) has failed to pay a license fee or a renewal fee for a license; or

  (7) has obtained or attempted to obtain a license by fraud or deception.

(b) The commissioner may refuse an application for a license or may suspend or revoke a license if the commissioner determines from evidence presented during a hearing that the applicant or licensee:

  (1) has violated the Health and Safety Code, §431.021(l)(3), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

  (2) has violated the Health and Safety Code, Chapter 481 (Texas Controlled Substance Act), or the Health and Safety Code, Chapter 483 (Dangerous Drugs Act); or

  (3) has violated the rules of the director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain.

(c) The department may, after providing opportunity for hearing, refuse to license a distributor or manufacturer of devices, or may suspend or revoke a license for violations of the requirements in these sections or for any of the reasons described in the Act.

(d) Any hearings for the refusal, revocation or suspension of a license are governed by §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).

(e) A license issued under these sections shall be returned to the department if the device distributor's or manufacturer's place of business:

  (1) ceases business or otherwise ceases operation on a permanent basis;

  (2) relocates; or

  (3) changes name or ownership. For a corporation, an ownership change is deemed to have occurred, resulting in the necessity to return the license to the department, when 5.0% or more of the share of stock of a corporation is transferred from one person to another.


Source Note: The provisions of this §229.440 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective January 1, 2005, 29 TexReg 11983

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