La. Admin. Code tit. 46 § XCI-301

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

Section XCI-301 - Licensing, Renewal and Reinstatement Requirements

A. The board shall issue sub-types for distributors of legend drug and legend device licenses as follows:

1. standard distributors;

2. wholesale distributors; and

3. third-party logistics provider distributors.

B. Every drug or device distributor shall submit an initial application for a new license on a form furnished by the board and accompanied by the initial license fee.

1. The board shall require a separate license for each facility or physical location directly or indirectly owned or operated by the same business entity or for a parent entity with divisions, subdivisions, subsidiaries, and/or affiliate companies when operations are conducted at more than one location and there exists joint ownership and control among all the entities.

2. Parent entity must license all divisions, subdivisions, subsidiaries, and/or affiliate companies owned by the parent company that sell and/or ship legend drugs or devices in or into Louisiana.

C. All new licenses issued by the board shall expire on December 31 of the calendar year issued.

D. A license shall be renewed annually by timely submitting an application and the license renewal fee.

E. Each application for the renewal of the license must be made between October 1 and December 31 of each year on a paper or electronic form provided by the board.

1. If a license is not renewed on or before the expiration date, a person may apply for reinstatement of the expired license within one year by submitting an application, the license renewal fee, and the license reinstatement fee.

2. If a license is expired beyond one year, a person may apply for reinstatement of the expired license by submitting an application, the initial license fee, the license reinstatement fee, and if applicable, the initial inspection fee.

3. A person may not lawfully operate as a drug or device distributor in Louisiana until the expired license has been reinstated.

F. Licenses renewed annually between October 1 and December 31 shall expire on December 31 of the following calendar year.

G. Each license issued hereunder shall be displayed by the licensee in a conspicuous place at the licensed facility or physical location.

H. Out-of-state drug or device distributors licensed by the board must have on file at all times with the board a current copy of a valid certificate of registration or license for drug or device distribution as issued by the appropriate regulatory board or agency of the state in which the facility or physical location licensed with the board is located or registration or license as issued by the appropriate federal agency when applicable.

1. If the state in which the facility licensed with the board is located does not require the facility to be registered or licensed as a drug or device distributor and the facility or physical location is registered or licensed in the state in which it is located as a manufacturer of drugs or devices, a current copy of the valid manufacturer registration or license must be submitted to and maintained with the board.

2. If the state in which the facility or physical location licensed with the board is located does not require the facility or physical location to be registered or licensed as a drug or device distributor and/or the facility or physical location is not a registered/licensed manufacturing facility and the state in which the facility or physical location is located does not require any registration or licensure of the facility or physical location, a letter from the appropriate state regulatory board or agency must be submitted to the board confirming such fact.

a. If the state in which the facility or physical location is located does not require any registration or licensure for distribution or manufacturing but a federal agency does require and issues registration or licensure to the facility or physical location licensed by this board, a copy of the federal registration or license must be submitted.

3. If the facility or physical location licensed with the board does not physically distribute and/or manufacture the drugs or devices that it owns or holds title to and/or the facility or physical location licensed with the board contracts with a third-party logistics provider for distribution of the drugs or devices and the state in which the facility or physical location licensed by the board is located does not require any registration or licensure of the facility or physical location, a letter from the appropriate state regulatory board or agency confirming this fact and a current copy of the valid registration or license from the state in which the third-party logistics provider facility is located must be submitted to the board.

a. if the state in which the third-party logistics provider facility or physical location is located does not require any registration or licensure for third-party logistics providers but a federal agency does require and issues registration or licensure to the third-party logistics provider facility or physical location licensed by this board, a copy of the federal registration or license must be submitted.

I. An initial application for a new license is valid for 180 days after receipt by the board and must be completed within this time frame.

1. If the application is not completed, the application becomes void and any application fee(s) paid is forfeited by the applicant and is non-refundable.

2. After the 180 days have expired, a new application for a license will be required to be submitted by the applicant to include payment of another license application fee.

J. Requests for voluntary cancellation of a license made by a licensee must be made in writing and must include information such as, but not limited to, the date the request is effective and the reason for the voluntary cancellation of the license.

1. If the request for voluntary cancellation is made before the license has expired, the original unexpired license certificate must be returned to the board and no refund of any portion of the license fee(s) paid will be made by the board.

K. If a licensed in-state drug or device distributor has an additional off-site storage facility, the off-site storage facility may operate under the current drug or device distribution license held by the licensee as long as the off-site storage facility is in compliance with §309. A.1 of this Part and has temperature monitoring and an alarm system and the off-site storage facility does not physically receive or distribute legend drugs or devices from its location.

L. A license shall not be issued by the board for any drug or device distributor to operate from or out of a dwelling, building, or property zoned as residential.

M. A license issued to a drug or device distributor will be revoked after 180 days from the date of issuance if an inspection and disciplinary hearing reveal a lack of legitimate business activity as per recordkeeping requirements of §311. B of this Part or a violation of any provisions of this Title.

La. Admin. Code tit. 46, § XCI-301

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 32:396 (March 2006), LR 34:875 (May 2008), LR 35:1538 (August 2009), LR 36:322 (February 2010), LR 39:2758 (October 2013), Amended by the Department of Health, Board of Drug and Device Distributors LR 422183 (12/1/2016), Amended by the Department of Health, Board of Drug and Device Distributors LR 42:2183 (December 2016), repromulgated LR 4349 (1/1/2017).

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