Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.425 - Licensing Procedures

Universal Citation: 25 TX Admin Code ยง 229.425

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

(a) License application forms. License application forms may be obtained from the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756, or online at www.dshs.texas.gov.

(b) Contents of license application. The application for licensure as a wholesale distributor of prescription drugs must be signed and verified, submitted on a license application form furnished by the department, and contain the following information:

(1) the name, full business address, and telephone number of the applicant;

(2) all trade or business names under which the business is conducted;

(3) the address, telephone number, and name of a contact person for each of the applicant's places of business;

(4) the type of business entity:
(A) if a person, the name of the person;

(B) if the business is a sole proprietorship, the name of the proprietor;

(C) if the business is a partnership, the name of the partnership and each of the partners; or

(D) if the business is a corporation, the name of the corporation, the place of incorporation, and the name and title of each corporate office and director;

(5) the name, date of birth, residence address, telephone number, and any information necessary to complete a criminal history record check on a designated representative of each place of business;

(6) a list of all licenses and permits issued to the applicant by any other state under which the applicant is permitted to purchase or possess prescription drugs;

(7) the name of the manager, if different from the designated representative, for each place of business;

(8) a list of categories which must be marked and adhered to in the determination and paying of the fee; and

(9) a statement verified by the applicant's signature acknowledging the applicant read, understood, and agrees to abide by the provisions of this subchapter and those of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code Chapter 431.

(c) Designated representatives.

(1) For each person who is a designated representative of each place of business, the applicant must provide the following to the department:
(A) the person's places of residence for the past seven years;

(B) the person's date and place of birth;

(C) the person's occupations, positions of employment, and offices held during the past seven years;

(D) the business name and address of any business, corporation, or other organization in which the person held an office under subsection (b)(4) of this section or in which the person conducted an occupation or held a position of employment;

(E) a statement of whether, during the preceding seven years, the person was the subject of a proceeding to revoke a license or a criminal proceeding and the nature and disposition of the proceeding;

(F) a statement of whether, during the preceding seven years, the person has been enjoined, either temporarily or permanently, by a court from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, including the details concerning the event;

(G) a written description of any involvement by the person as an officer or director with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven years, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which the businesses were named as a party;

(H) a description of any misdemeanor or felony offense for which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere;

(I) a description of any criminal conviction of the person under appeal, a copy of the notice of appeal for that criminal offense, and a copy of the final written order of an appeal not later than the 15th day after the date of the appeal's disposition; and

(J) a photograph of the person taken not earlier than 180 days before the date the application was submitted.

(2) The information submitted under paragraph (1) of this subsection must be attested to under oath.

(d) Criminal history. The department will obtain an applicant's criminal history record information and may forward the fingerprints to the Federal Bureau of Investigation for a federal criminal history check.

(e) Renewal license application. The renewal application for licensure as a wholesale distributor of prescription drugs must be made on a license application form furnished by the department. Not later than the 30th day after the date the wholesale distributor receives the form, the wholesale distributor must identify and state under oath to the department any change in or correction to the information.

(f) Replacement license. In the event a current and valid license is lost, stolen, or destroyed, the license holder must request a replacement license from the department by submitting an application and non-refundable fee as outlined in § 229.427 of this subchapter (relating to Licensing Fees). A replacement license is only issued if the lost, stolen, or destroyed license was current and valid at the time of the request, and no changes in business name, location, or ownership have occurred.

(g) Texas.gov. Applicants may submit initial and renewal license applications under this subchapter electronically through texas.gov. The department is authorized to collect fees, in amounts determined by § 229.427(a) of this subchapter to recover costs associated with application and renewal application processing through texas.gov.

(h) Bond. Applicants will submit a bond in a manner prescribed by the department.

Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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