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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER OLICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.246Licensure Requirements

(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.


Source Note: The provisions of this §229.246 adopted to be effective February 1, 2007, 32 TexReg 315

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