Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.428 - Refusal, Cancellation, Suspension, or Revocation of License

Universal Citation: 25 TX Admin Code § 229.428

Current through Reg. 49, No. 38; September 20, 2024

(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 license holder:

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

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

(3) is an association, partnership, or corporation and the managing officer 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, Texas Health and Safety Code Chapter 431 (Act) or this subchapter;

(5) has violated the Texas 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, Texas Health and Safety Code Chapter 481, or the Texas Dangerous Drug Act, Texas 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 license holder to maintain;

(8) fails to complete a license application or submits an application containing false, misleading, or incorrect information or containing information not verifiable 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 this subchapter 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 remains in effect until the department determines the reason for the suspension no longer exists. If the suspension overlaps a renewal date, the suspended license holder must comply with the renewal procedures in § 229.425 of this subchapter (relating to Licensing Procedures); however, the department may choose not to renew the license until the department determines 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 subchapter 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 this subchapter must 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 percent 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 Texas Health and Safety Code § 431.405.

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