La. Admin. Code tit. 46 § XXXIV-303

Current through Register Vol. 50, No. 9, September 20, 2024

Section XXXIV-303 - Required Information

A. The board requires the following from each applicant as part of the initial licensing procedure and as part of any renewal or reinstatement of such license:

1. the company name, physical distribution address, business address, and the name and contact information of the person for the facility or physical location of the applicant;

2. all trade or business names used by the applicant;

3. the mailing address, and the name and contact information of the person for regulatory compliance used by the applicant;

4. the type of ownership or form of business operation used by the applicant (i.e., partnership, corporation, or sole proprietorship); if other than a natural person, the type of entity and the name of the state where formed;

5. the names of the owners of the applicant including the percentage of interest owned;

6. the name and contact information of the person appointed as the designated responsible party;

7. the names and titles of the directors and officers of the applicant;

8. a list of every state or territory, other than Louisiana, where the applicant holds a current license for wholesale drug or device distribution;

9. any other information which the board may require to determine qualification for obtaining, renewing, or reinstating a license.

B. Changes in any information with regard to, but not limited to, contact persons for the facility or physical location, the owners of the licensee including the percentage of interest owned, the person appointed as the designated responsible party, the directors and officers of the licensee, or the regulatory contact person shall be submitted in writing to the board within 60 days after such changes become effective. Failure to do so may result in disciplinary action being taken against the licensee.

1. Any licensee changing their physical location is required to submit an application for location change at least 30 days prior to such change of location. Failure to do so may result in disciplinary action being taken against the licensee.

C. A license shall be valid only for the person or the facility or physical location for which it is issued. Licenses are not transferable for change of location or change of ownership of the facility or physical location licensed by the board. Any such change shall require the submission of an application and fee for, and the issuance of, a new license by the board and the termination of the existing license.

D. Drug or device distributors with a place of business physically located in Louisiana must notify the board, in writing, within three business days of discovery of, or being in a position to have acquired such knowledge of, any theft or diversion of drugs or devices.

E. Drug or device distributors with a place of business physically located in Louisiana must notify the board, in writing, within 24 hours of discovery of, or being in a position to have acquired such knowledge of, any contraband, counterfeit, or misbranded drugs or devices in their possession whether actual or constructive.

La. Admin. Code tit. 46, § XXXIV-303

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 29:1480 (August 2003), LR 30:1481 (July 2004), LR 32:397 (March 2006), LR 35:1539 (August 2009), LR 36:1246 (June 2010), amended by the Department of Health, Board of Drug and Device Distributors, LR 42:2184 (December 2016).

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