2016 New Jersey Revised Statutes
Title 24 - Food And Drugs
Section 24:6B-27 - Maintenance Of Document, Record Relative To Pedigree, Certification.
24:6B-27 Maintenance of document, record relative to pedigree, certification.
18. a. A person who receives or passes a pedigree or certification pursuant to this act shall maintain the document or record for three years from receipt or passing of the document or record.
b.A wholesale distributor shall:
(1)establish and maintain records of all transactions regarding the receipt, distribution or other disposition of all prescription drugs, including the dates of receipt and distribution or other disposition of the prescription drugs; and
(2)make its inventories and other records available for inspection and copying by an authorized official of any local, State or federal governmental agency for a period of three years following the creation of those records.
c.A wholesale distributor shall ensure that its records as described in this section:
(1)if kept at the inspection site or immediately retrievable by computer or other electronic means, are readily available for authorized inspection during the retention period; and
(2)if kept at a central location apart from the inspection site and not electronically retrievable, are made available for inspection within two business days of a request by an authorized official of any State or federal governmental agency charged with enforcement of the provisions of this act.
d.A wholesale distributor shall maintain an ongoing list of persons with whom it does business related to prescription drugs.
e.A wholesale distributor shall establish and maintain procedures for reporting counterfeit or suspected counterfeit prescription drugs, or counterfeiting or suspected counterfeiting activities to the department.
f.A wholesale distributor shall maintain a system for mandatory reporting to the department of significant shortages or losses of prescription drugs when diversion of prescription drugs is known or suspected.
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