Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.250 - Refusal, Cancellation, Suspension, or Revocation of License

Universal Citation: 25 TX Admin Code § 229.250

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

(a) The department may refuse an application for a wholesale distributor of nonprescription 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 the 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 the 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), concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(6) has violated the Controlled Substance Act, Texas Health and Safety Code Chapter 481, or the 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 maintain;

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

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

(10) 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 nonprescription 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 must remain 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 § 229.247 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 § 229.247 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, requiring return of 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.

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