Tenn. Comp. R. & Regs. 1140-09-.03 - MINIMUM QUALIFICATIONS

(1) The board shall consider, at a minimum, the following factors in reviewing an application for a license as a manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor:

(a) Any convictions of the applicant under any federal, state, or local laws relating to drug samples or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state, or local laws;

(c) The applicant's past experience in the manufacturing or distribution of prescription drugs and prescription devices, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with manufacturing or distribution;

(e) Suspension or revocation 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, prescription drugs and prescription devices;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with requirements to maintain and/or make available to the board or to federal, state, or local law enforcement officials those records required federal, state or local laws; and

(h) Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

(2) 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.

(3) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

Notes

Tenn. Comp. R. & Regs. 1140-09-.03

Original rule filed January 7, 1992 effective February 21, 1992. Repeal and new rule filed May 11, 1999, effective July 25, 1998. Emergency rules filed January 31, 2014 expired effective July 31, 2014. The rules reverted to their previous status. Amendment filed July 11, 2014; effective October 9, 2014. Amendment filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404, 63-10-404 (2), (6), (8), (14), (18), (37), 63-10-304, 63-10-305, 63-10-306, 63-10-504, and 63-10-504(b)(1).