| (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.
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