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

Universal Citation: 25 TX Admin Code ยง 229.246

Current through Reg. 49, No. 38; September 20, 2024

(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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