[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR205.6]
[Page 114]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG
Sec. 205.6 Minimum qualifications.
(a) The State licensing authority 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 convictions 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 laws;
(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 made in connection with drug manufacturing or
distribution;
(5) 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;
(6) Compliance with licensing requirements under previously granted
licenses, if any;
(7) Compliance with requirements to maintain and/or make available
to the State licensing authority or to Federal, State, or local law
enforcement officials those records required under this section; and
(8) Any other factors or qualifications the State licensing
authority considers relevant to and consistent with the public health
and safety.
(b) The State licensing authority 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.
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