La. Admin. Code tit. 46 § XXXIV-305

Current through Register Vol. 50, No. 11, November 20, 2024

Section XXXIV-305 - Qualifications

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.

La. Admin. Code tit. 46, § XXXIV-305

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 32:398 (March 2006), LR 35:1539 (August 2009), LR 39:2758 (October 2013), amended by the Department of Health, Board of Drug and Device Distributors, LR 42:2185 (December 2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.