Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.435 - Licensure Requirements

Current through Reg. 49, No. 28; July 12, 2024
(a) General.
				  Except as provided by §
										229.434 of
				  this title (relating to Exemptions), a person may not engage in the
				  distribution or manufacture of devices in Texas unless the person has a valid
				  license from the Commissioner of the Department of State Health Services
				  (commissioner) for each place of business.
(b) Display of license. The license shall be
				  displayed in an open public area at each place of business.
(c) Existing place of business. Each person
				  involved in the distribution or manufacture of devices in Texas on the
				  effective date of these sections must apply for a device distributor
				  manufacturer license no later than 60 days following the effective date of
				  these sections.
(d) New place of
				  business. Each person acquiring or establishing a place of business for the
				  purpose of device distribution or manufacturing after the effective date of
				  these sections shall apply to the Department of State Health Services
				  (department) for a license of such business prior to beginning
				  operation.
(e) Two or more places
				  of business. If the device distributor or manufacturer operates more than one
				  place of business, the device distributor or manufacturer shall license each
				  place of business separately.
(f)
				  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 distributor or
				  manufacturer of devices who meets the requirements of these sections, and pays
				  all fees in compliance with §
										229.439
				  of this title (relating to Licensing Fees).
(g) Transfer of license. Licenses shall not
				  be transferable from one person to another or from one place of business to
				  another.
(h) License term. Unless
				  the license is amended as provided in subsection (j) of this section or revoked
				  or suspended as provided in §
										229.440
				  of this title (relating to Refusal, Cancellation, Suspension, or Revocation of
				  a License), the license is valid for two years.
(i) Renewal of license.
(1) The license application as outlined in
				  §
											229.436(b)
				  of this title (relating to Licensing Procedures) and nonrefundable licensing
				  fees as outlined in §
											229.439
				  of this title (relating to Licensing Fees) 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 §
											229.443
				  of this title (relating to Enforcement and Penalties), and/or the revocation
				  and suspension provisions in §
											229.440
				  of this title.
(3) A renewal
				  license shall only be issued when all past due fees and delinquency fees are
				  paid.