| (a) General. Except as provided by §229.245 of
this subchapter (relating to Exemption), a person may not engage in
the wholesale distribution of nonprescription drugs in Texas unless
the person has a valid license from the department for each place
of business.
(b) Out-of-state place of business. Except as provided
by §229.245 of this subchapter, a person who engages in the wholesale
distribution of nonprescription drugs from outside this state may
only engage in the wholesale distribution of nonprescription drugs
within this state if the person holds a license as required under
subsection (a) of this section.
(c) Combination product. If the United States Food
and Drug Administration determines, with respect to a product that
is a combination of a nonprescription drug and a device, that the
primary mode of action of the product is as a nonprescription drug,
the wholesale distributor must obtain a license as described in this
section.
(d) Proof of licensure. The license holder must show
proof of licensure in a format readily available at each place of
business.
(e) New place of business. Each person acquiring or
establishing a place of business for wholesale distribution of nonprescription
drugs after the effective date of this subchapter must obtain a license
before beginning operation.
(f) Two or more places of business. A wholesale distributor
of nonprescription drugs must obtain a license for each place of business.
(g) Pre-licensing inspection. The applicant must cooperate
with any pre-licensing inspection by the department of the applicant's
place of business. The department may accept reports from authorities
in other jurisdictions to determine the extent of compliance with
the minimum standards in this subchapter for applicants located out-of-state.
(h) 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 nonprescription drugs who meets the requirements
in this subchapter and pays all license fees under §229.249 of
this subchapter (relating to Licensure Fees).
(i) Transfer of license. Licenses are not transferable.
(j) License term. Unless the license is amended as
provided in subsection (k) of this section, or suspended or revoked
as provided in §229.250 of this subchapter (relating to Refusal,
Cancellation, Suspension, or Revocation of a License), the license
is valid for two years.
(k) 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 requires submission of an application
as outlined in §229.247 of this subchapter (relating to Licensing
Procedures) and submission of fees as outlined in §229.249 of
this subchapter.
(l) Renewal of license.
(1) The license application as outlined in §229.247
of this subchapter and nonrefundable licensing fees as outlined in §229.249
of this subchapter for each place of business must be submitted to
the department before the expiration date of the current license.
(2) A person who files a renewal application after
the expiration date must pay an additional $100 delinquency fee.
(3) A person who fails to submit a renewal application
before the current license expires and continues operations is subject
to enforcement and penalty provisions in §229.252 of this subchapter
(relating to Enforcement and Penalties), and the refusal, cancellation,
suspension, and revocation provisions in §229.250 of this subchapter.
(4) A renewal license must only be issued when all
past due administrative penalties, license fees, and delinquency fees
are paid.
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