N.M. Admin. Code § 16.19.8.16 - MINIMUM QUALIFICATIONS

A. The board will not license a third-party logistics provider when the FDA has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and published notice thereof.

B. The board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in providing third-party logistics 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 this part; and

(8) any findings by the board that the applicant has violated or been disciplined, or the subject of administrative action, by a regulatory or licensing agency in any state for violating and federal, state, or local laws relating to drug or device 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 responsible for facility operations, to determine if an applicant or others associated with the ownership, management or operations of the third-party logistics provider have committed criminal acts that would constitute grounds for denial of licensure.

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.

Notes

N.M. Admin. Code § 16.19.8.16

Adopted by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017