N.M. Admin. Code § 16.19.8.10

Current through Register Vol. 35, No. 19, October 8, 2024

Section 16.19.8.10 - MINIMUM QUALIFICATIONS

A. The board shall prohibit a person from receiving or maintaining licensure for wholesale distribution if the person:

(1) has been convicted of any felony for conduct relating to wholesale 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 in wholesale distribution of prescription drugs within the state:

(1) any conviction of the applicant under any federal, state or local laws relating to drug 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 16.19.8 NMAC; and

(8) any findings by the board that the applicant has violated or been disciplined, or the subject of administrative action or other sanction, 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 board shall consider the results of a criminal and financial background check and fingerprinting of the applicant, and designated representative to determine if an applicant or others associated with the ownership, management or operations of the wholesale distributor have committed criminal acts that would constitute grounds for denial of licensure. Manufacturers licensed by the FDA in accordance with Section 510 of the Federal Act shall be exempt from criminal and financial background checks.

D. 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.

E. 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.

F. Request for an alternative reduced wholesale license fee: The board shall collect the full license fee as set by the board unless the board determines that collection of the license fee would be inconsistent with the public interest. The applicant/petitioner shall provide the board with any information necessary to make that determination including:

(1) business/organization profit status under federal and state code;

(2) impact on the health and safety of New Mexico citizens;

(3) volume of distribution in New Mexico;

(4) sole source of dangerous drugs; and

(5) financial hardship for applicant/registrant.

N.M. Admin. Code § 16.19.8.10

16.19.8.10 NMAC - Rp, 16.19.8.10 NMAC, 12-02-09, Adopted by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017