Current through Register Vol. 35, No. 18, September 24, 2024
A. The board shall prohibit a person from receiving or maintaining repackager licensure if the person:
(1) has been convicted of any felony for conduct relating to manufacturing or distribution, any felony violation of Subsection (i) or (k) of section 301, or any felony violation of Section 1365 of title 18, United States Code, relating to product tampering; or
(2) has engaged in a pattern of violating the requirements of this section, or state requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.
B. The board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage as a repackager within the state:
(1) any conviction of the applicant under any federal, state or local laws relating to drug manufacture, samples, wholesale or retail drug distribution, or distribution of controlled substances;
(2) any felony convictions of the applicant under federal, state or local law;
(3) the applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;
(4) the furnishing by the applicant of false or fraudulent material in any application;
(5) suspension, revocation or any other sanction by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;
(6) compliance with regulatory and licensing requirements under previously granted licenses, if any;
(7) compliance with requirements to maintain or make available to the board or to federal, state, or local law enforcement officials those records required under this part; and
(8) any findings by the board that the applicant has violated or been disciplined or subject to administrative action by a regulatory or licensing agency in any state for violating and federal, state, or local laws relating to drug or device wholesale distribution;
(9) any other factors or qualifications the board considers relevant to and consistent with the public health and safety.
C. The applicant shall provide and attest to a statement providing a complete disclosure of any past criminal convictions and violations of the state and federal laws regarding drugs or devices or an affirmation and attestation that the applicant has not been involved in, or convicted of, any criminal or prohibited acts.
D. The board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest. Public interest considerations shall be based upon factors and qualifications that are directly related to the protection of the public health and safety.
