Current through Register Vol. 50, No. 3, March 20, 2024
A. The board shall
consider the following factors in issuing an initial license, the renewal of an
existing license, or reinstatement of a license to a person to engage in the
distribution of drugs and devices:
1. any
convictions of the applicant or designated responsible party under any federal,
state, or local laws relating to drug samples, drug or device distribution,
retail drug dispensing, or distribution of controlled substances;
2. any felony convictions of the applicant or
designated responsible party under federal, state, or local laws;
3. the applicant's past experience in the
manufacture or distribution of drugs or devices, including controlled
substances;
4. the furnishing by
the applicant of false or fraudulent information to the board;
5. suspension or revocation by federal,
state, or local government of any license currently or previously held by the
applicant, including a license to distribute or manufacture any drug or device,
including controlled substances;
6.
compliance with the licensing requirements under any previously granted
licenses;
7. compliance with the
requirements to maintain and/or make available to the state licensing
authorities or to federal, state, or local law enforcement officials those
records required to be maintained by drug or device distributors;
8. any other factors that the board considers
relevant to and consistent with its function to protect public health and
safety;
9. failure to timely comply
with a request made by the board shall result in the termination of an
application for license or renewal. The applicant may apply for reinstatement
if timely done and in accordance with the requirements for reinstatement, as
well as timely complying with the request made by the board.
B. The board shall request all
criminal history records information necessary to discover any information
relating to the above factors for all new license applicants physically located
in Louisiana. Criminal history records information shall only be requested for
those licensees of previously issued licenses if they have appointed a new
designated responsible party or if they have transferred an ownership interest
of more than 10 percent to another owner.
C. The board shall deny a license to an
applicant if it determines that the issuing of such a license would not be in
the interest of public health, safety or welfare.
D. The designated responsible party must have
knowledge of the policies and procedures pertaining to operations of the
applicant or licensed drug or device distribution facility.
1. A designated responsible party must meet
the following requirements:
a. be at least 21
years of age;
b. have at least two
years of full-time employment history with either a pharmacy, legend drug or
device distributor, or medical gas distributor in a capacity related to the
retail drug dispensing, distribution, and recordkeeping of legend drugs or
devices; or other similar qualifications as deemed acceptable by the
board;
c. be employed by the
applicant or drug or device distributor in a full-time position;
d. be actively involved in and aware of the
actual daily operation of the wholesale drug or device distributor;
e. be physically present at the facility of
the applicant or drug or device distributor during regular business hours,
except when absence of the designated responsible party is authorized,
including, but not limited to, sick leave and vacation leave;
f. serve in the capacity of a designated
responsible party for only one applicant or drug or device distributor at a
time, except where more than one licensed drug or device distributor is
co-located in the same facility;
g.
not have any felony convictions under federal, state, or local law relating to
drug or device distribution, retail drug dispensing, or distribution of
controlled substances.
AUTHORITY NOTE:
Promulgated in accordance with R.S.
37:3461-3482.
