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 229.246 - Licensure Requirements

Current through Reg. 49, No. 28; July 12, 2024
(a) General.
				  Except as provided by §
										229.245 of
				  this title (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 title, 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 in 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, a wholesale distributor of
				  such a product is subject to licensure as described in this section.
(d) Display of license. The license shall be
				  displayed in an open public area at each place of business.
(e) New place of business. Each person
				  acquiring or establishing a place of business for the purpose of wholesale
				  distribution of nonprescription drugs after the effective date of these
				  sections shall apply to the department for a license of such business prior to
				  beginning operation.
(f) Two or
				  more places of business. If the wholesale distributor of nonprescription drugs
				  operates more than one place of business, the wholesale distributor of
				  nonprescription drugs shall license each place of business
				  separately.
(g) Pre-licensing
				  inspection. The applicant shall 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 these sections for applicants located
				  out-of-state.
(h) Issuance of
				  license. In accordance with §
										229.281
				  of this title (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 of these sections, and pays
				  all license fees in compliance with §
										229.249
				  of this title (relating to Licensure Fees).
(i) Transfer of license. Licenses shall not
				  be transferable from one person to another or from one place of business to
				  another.
(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 title (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, ownership, or a notification of a change
				  in the location of a licensed place of business will require submission of an
				  application as outlined in §
										229.247 of
				  this title (relating to Licensing Procedures) and submission of fees as
				  outlined in §
										229.249
				  of this title.
(l) Renewal of
				  license.
(1) The license application as
				  outlined in §
											229.247 of
				  this title and nonrefundable licensing fees as outlined in §
											229.249
				  of this title for each place of business shall be submitted to the department
				  prior to the expiration date of the current license. A person who files a
				  renewal application after the expiration date must pay an additional $100 as a
				  delinquency fee.
(2) A licensee who
				  fails to submit a renewal application prior to the current licensure expiration
				  date and continues operations may be subject to the enforcement and penalty
				  provisions in §
											229.252
				  of this title (relating to Enforcement and Penalties), and/or the refusal,
				  cancellation, suspension and revocation provisions in §
											229.250
				  of this title.
(3) A renewal
				  license shall only be issued when all past due license fees and delinquency
				  fees are paid.