(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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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; amended to be effective September 18, 2024, 49 TexReg 7327 |