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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER WLICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.428Refusal, Cancellation, Suspension or Revocation of License

(a) The commissioner may refuse an application for a wholesale distributor of prescription drugs license or may suspend or revoke such 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 and/or any officer or director of a corporation has been convicted of a felony or misdemeanor that involves moral turpitude;

  (3) is an association, partnership, or corporation and the managing officer and/or any officer or director of a corporation has been convicted of a felony or misdemeanor involving 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) has violated any of the provisions of the Texas, Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or this subchapter;

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

  (6) has violated the Texas Controlled Substances Act, Health and Safety Code, Chapter 481, or the Texas Dangerous Drug Act, Health and Safety Code, Chapter 483;

  (7) 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;

  (8) fails to complete a license application or submits an application that contains false, misleading, or incorrect information or contains information that cannot be verified by the department;

  (9) has furnished false or fraudulent information in any application made in connection with drug manufacturing or distribution;

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

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

(b) The department may, after providing opportunity for hearing, refuse to license a wholesale distributor of prescription drugs, 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.

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

(d) If the department suspends a license, the suspension shall remain in effect until the department determines that the reason for the suspension no longer exists. If the suspension overlaps a renewal date, the suspended license holder shall comply with the renewal procedures in §229.425 of this title (relating to Licensing Procedures); however, the department may choose not to renew the license until the department determines that the reason for suspension no longer exists.

(e) If the department revokes or does not renew a license, a person may reapply for a license by complying with the requirements and procedures in §229.425 of this title at the time of reapplication. The department may refuse to issue a license if the reason for revocation or non-renewal continues to exist.

(f) A license issued under these sections shall be returned to the department if the person'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.

(g) The commissioner may suspend or revoke a license if the license holder no longer meets the qualification for obtaining a license under Health and Safety Code, §431.405.


Source Note: The provisions of this §229.428 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755

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