2016 New Jersey Revised Statutes
Title 24 - Food And Drugs
Section 24:6B-19 - Additional Requirements For Designated Representatives.

NJ Rev Stat § 24:6B-19 (2016) What's This?

24:6B-19 Additional requirements for designated representatives.
10. In addition to satisfying any requirements that the commissioner may establish by regulation, a designated representative shall:

a.submit an application that includes the following information:

(1)the person's date and place of birth;

(2)the person's occupations, positions of employment and offices held during the past seven years, and the principal business addresses;

(3)whether the person has been temporarily or permanently enjoined by a court of competent jurisdiction during the past four years for violating any federal or state law regulating drugs, along with the details of those events;

(4)a description of any involvement by the person with any business that manufactured, administered, prescribed, distributed or stored prescription drugs and was named as a party in a lawsuit;

(5)a photograph of the person taken within the previous 30 days;

(6)the name, business address, occupation, date and place of birth for each member of the person's immediate family who is employed by the wholesale distributor in a management or operations position or has ownership in the wholesale distribution business. As used in this paragraph, the term "member of the person's immediate family" includes the person's spouse, children, parents and siblings, and the spouses of the person's children and the person's siblings; and

(7)such other information as the commissioner deems relevant.

b.have a minimum of two years of verifiable, full-time managerial, supervisory, auditing or compliance experience with: (1) a pharmacy, wholesale distributor or drug manufacturer licensed, permitted or registered in this or another state, territory of the United States or the District of Columbia; (2) a nationally recognized drug trade association; or (3) a state or federal agency, where the person's responsibilities included record keeping, storage and shipment of prescription drugs;

c.serve as the designated representative for only one wholesale distributor location at any one time; and

d.be actively involved in and aware of the actual daily operations of the wholesale distributor. As used in this subsection, "actively involved" means being: employed full-time in a managerial position; physically present at the facility during normal business hours; and knowledgeable about all policies and procedures pertaining to the wholesale distributor's operations. A designated representative may seek assistance from qualified individuals to help ensure compliance with the provisions of this subsection.


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