1140-09-.03
Minimum Qualifications
Cite as Tenn. Comp. R. & Regs. 1140-09-.03
(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;
MANUFACTURERS, OUTSOURCING FACILITIES, OXYGEN SUPPLIERS AND
CHAPTER 1140-09
WHOLESALERS/DISTRIBUTORS
(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 by 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.