Current through Register Vol. 50, No. 3, March 20, 2024
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.
AUTHORITY NOTE:
Promulgated in accordance with R.S.
37:3461-3482.
