§ 25-26-14-16 — Distributor qualifications; criminal history and financial background check

Indiana § 25-26-14-16

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 14: Wholesale Legend Drug Distributors and Third Party

Text

(a) In reviewing, for purposes of licensure
or renewal of a license under this chapter, the qualifications of persons
who engage in wholesale distribution of legend drugs in Indiana, the
board shall consider the following factors:
(1) A finding by the board that the applicant has:
(A) violated a law; or
(B) been disciplined by a regulatory agency for violating a law;
related to drug distribution in any state.
(2) A criminal conviction of the applicant.
(3) The applicant's past experience in the manufacture or
distribution of legend drugs, including controlled substances.
(4) The furnishing by the applicant of false or fraudulent material
in any application made in connection with drug manufacturing
or distribution.
(5) Suspension or revocation of any license held by the applicant
or the applicant's owner or the imposition of sanctions against the
applicant or the applicant's owner by the federal or a state or local
government for the manufacture or distribution of any drugs,
including controlled substances.
(6) Compliance with licensing requirements under previously
granted licenses.
(7) Compliance with requirements to maintain and make available
to the board or to federal, state, or local law enforcement officials
those records required under this chapter.
(8) Any other factors or qualifications the board considers
relevant to the public health and safety, including whether the
granting of the license would not be in the public interest.
(b) In reviewing an application for licensure or renewal of a license
under this chapter, the board shall consider the results of criminal
history and financial background checks for:
(1) the designated representative or the most senior individual
responsible for facility operations, purchasing, and inventory
control;
(2) the supervisor or the designated representative or the most
senior individual under subdivision (1); and
(3) principals and owners with more than a ten percent (10%)
interest in the wholesale drug distributor, if the wholesale drug
distributor is a nonpublicly held company.
(c) The criminal history and financial background checks conducted
under subsection (b) must:
(1) be conducted at the applicant's expense;
(2) include a criminal history for all current and previous states of
residence of the applicant;
(3) include the criminal history in the federal district where the
applicant currently resides;
(4) include information from the previous seven (7) years; and
(5) be approved by the board.
(d) An applicant shall provide and attest to:
(1) an affirmation that the applicant has not been involved in or
convicted of any criminal or prohibited acts; or
(2) a statement providing a complete disclosure of the applicant's
past criminal convictions and violations of state and federal laws;
regarding drugs.

Legislative History

As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.50; P.L.98-2006, SEC.18.