Current through Reg. 49, No. 38; September 20, 2024
(a) General. Except as provided in §
229.423 of this subchapter (relating to Exemptions), a person
may not engage in the wholesale distribution of prescription drugs in Texas, as defined in §229.421(30)
- (31) of this subchapter (relating to Definitions), unless the person has a valid license from the
commissioner of the department for each place of business.
(b)
Out-of-state place of business.
(1) Except as provided by §
229.423 of this subchapter, a person who engages in the
wholesale distribution of prescription drugs from outside this state may only engage in the wholesale
distribution of prescription drugs in this state if the person holds a license as required in subsection (a)
of this section.
(2) The department may accept reports from
authorities in other jurisdictions to determine the extent of compliance with the Texas Food, Drug, and
Cosmetic Act, Health and Safety Code, Chapter 431 and this subchapter.
(3) The department may issue a license to a person who engages in the
wholesale distribution of prescription drugs outside this state to engage in the wholesale distribution of
prescription drugs in this state if, after an examination of the reports of the person's compliance history
and current compliance record, the department determines the person is in compliance with the Act and this
subchapter.
(4) The department considers each license application
and any related documents or reports filed by or in connection with a person who wishes to engage in the
wholesale distribution of prescription drugs in this state on an individual basis.
(c) Combination product. If the United States Food and Drug Administration
determines, with respect to a product that is a combination of a prescription drug and a device, the primary
mode of action of the product is as a prescription drug, a wholesale distributor of such a product is subject
to licensure as described in this section.
(d) Applicant
qualifications. To qualify for the issuance or renewal of a wholesale distributor license under this
subchapter, the designated representative of an applicant or license holder must:
(1) be at least 21 years of age;
(2) have been employed full-time for at least three years by a pharmacy or
a wholesale distributor in a capacity related to the dispensing or distributing of prescription drugs,
including recordkeeping for the dispensing or distributing of prescription drugs;
(3) be employed by the applicant full-time in a managerial-level
position;
(4) be actively involved in and aware of the actual
daily operation of the wholesale distributor;
(5) be physically
present at the applicant's place of business during regular business hours, except when the absence of the
designated representative is authorized, including sick leave and vacation leave;
(6) serve as a designated representative for only one applicant at any one
time, except in a circumstance, as the department determines reasonable, in which more than one licensed
wholesale distributor is co-located in the same place of business at the same address and the wholesale
distributors are members of an affiliated group, as defined by the Internal Revenue Code of 1986,
26 USC §
1504;
(7) not have been
convicted of a violation of any federal, state, or local laws relating to wholesale or retail prescription
drug distribution or the distribution of controlled substances; and
(8) not have been convicted of a felony under a federal, state, or local
law.
(e) Proof of licensure. The license holder must
show proof of licensure in a format readily available to the public and at each place of business.
(f) New place of business. Each person acquiring or establishing a place of
business for the purpose of wholesale distribution of prescription drugs must apply to the department for a
license of such business before beginning operation.
(g) Two or
more places of business. If the wholesale distributor of prescription drugs operates more than one place of
business, the wholesale distributor of prescription drugs must license each place of business
separately.
(h) Pre-licensing inspection. The applicant must
cooperate with any pre-licensing inspection by the department of the applicant's place of business.
(i) Issuance of license. In accordance with §
229.281 of this chapter (relating to Processing License/Permit
Applications Relating to Food and Drug Operations), the department may license a wholesale distributor of
prescription drugs who meets the requirements of this subchapter and pays all license fees under §
229.427 of this subchapter (relating to Licensure
Fees).
(j) Transfer of license. Licenses are not transferable
from one person to another or from one place of business to another.
(k) License term. Unless the license is amended as provided in subsection
(l) of this section or suspended or revoked as provided in §
229.428 of this subchapter (relating to Refusal, Cancellation,
Suspension, or Revocation of License), the license is valid for two years.
(l) Amendment of license. A license that is amended, including a change of
name, or a notification of a change in the location of a licensed place of business will require submission
of an application as outlined in §
229.425 of this subchapter (relating to Licensing Procedures)
and submission of fees as outlined in §
229.427 of this subchapter.
(m) Renewal of license.
(1) The license
application as outlined in §
229.425 of this subchapter and nonrefundable licensing fees as
outlined in §
229.427 of this subchapter for each place of business must be
submitted to the department not later than the 30th day after the date the wholesale distributor receives a
renewal notification form from the department. A person who files a renewal application after the expiration
date must pay an additional $100 as a delinquency fee.
(2) A
license holder who fails to submit a renewal application before the current licensure expiration date and
continues operations may be subject to the enforcement and penalty provisions in §
229.430 of this subchapter (relating to Enforcement and
Penalties), and the refusal, cancellation, suspension, and revocation provisions in §
229.428 of this subchapter.
(3) A renewal license is only issued when all past due license fees and
delinquency fees are paid.
(n) Bond.
(1) A wholesale distributor applying for or renewing a license must submit,
payable to this state, a bond or other equivalent security acceptable to the department, including an
irrevocable letter of credit or a deposit in a trust account or financial institution, in the amount of
$100,000.
(2) The bond or equivalent security submitted under
paragraph (1) of this subsection must secure payment of any fines or penalties imposed by the department or
imposed in connection with an enforcement action by the attorney general, any fees or other enforcement
costs, including attorney's fees payable to the attorney general, and any other fees and costs incurred by
this state related to that license holder, authorized under the laws of this state and not paid by the
license holder before the 30th day after the date a fine, penalty, fee, or cost is assessed.
(3) The department or this state may make a claim against a bond or
security submitted under paragraph (1) of this subsection before the first anniversary of the date a license
expires or is revoked under this subchapter.
(4) The department
must deposit the bonds and equivalent securities received under this section in a separate account.
(5) A pharmacy warehouse not engaged in wholesale distribution is exempt
from the bond requirement under paragraph (1) of this subsection.
(6) A single bond is sufficient to cover all places of business operated by
a wholesale distributor in this state.
