§13758. Licensure
1.
Purpose; statement of intent.
The purpose of this section is to require licensure of manufacturers and wholesalers within or outside the State. The intent of the Legislature is that the board may not adopt rules regarding companies without wholesale facilities or manufacturers' facilities located in this State that are more restrictive than federal law or regulation.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
2.
Licensure, manufacturers and wholesalers.
All manufacturers and wholesalers whose products are distributed in the State in any manner must be licensed by the board.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
3.
Licensure, individuals.
An individual who is employed by a manufacturer or wholesaler that is licensed under this subchapter need not obtain licensure under this subchapter.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
4.
Form.
License forms must state:
A.
The applicant's name, address, day phone, 24-hour phone, ownership status and manufacturer or wholesaler designation;
[PL 2025, c. 544, §4 (NEW).]
B.
The applicant's United States Department of Justice, Drug Enforcement Administration registration number and the applicant's United States Food and Drug Administration registration number, as applicable, if the applicant has obtained the registration number at the time the form is executed; and
[PL 2025, c. 544, §4 (NEW).]
C.
The date the form is executed.
[PL 2025, c. 544, §4 (NEW).]
License forms must be executed by an owner or officer of the manufacturer or wholesaler, providing printed name and title.
If, at the time the form is executed, the applicant has not obtained a registration number described in paragraph B that is applicable to the applicant, the applicant shall file that registration number with the board once the registration number is obtained.
[PL 2025, c. 544, §4 (RPR).]
5.
Fees.
Each licensee shall pay a fee as set under section 13724.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
6.
Violations.
It is unlawful for manufacturers or wholesale companies to distribute prescription drugs in this State unless licensed under the provisions of this subchapter or subchapter 5.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1987, c. 861, §18 (AMD). PL 1989, c. 502, §B75 (AMD). PL 1997, c. 245, §11 (AMD). PL 2005, c. 262, §B15 (AMD). PL 2007, c. 402, Pt. DD, §28 (AMD). PL 2025, c. 544, §4 (AMD).