24:6B-28 Adherence to written policies, procedures by wholesale distributors.
19. a. A wholesale distributor shall establish, maintain and adhere to written policies and procedures for the receipt, security, storage, inventory, transport, shipping and distribution of prescription drugs, including policies and procedures for: identifying, recording and reporting losses or thefts; correcting all errors and inaccuracies in inventories; and implementing and maintaining a continuous quality improvement system.
b.Pursuant to subsection a. of this section, a wholesale distributor shall establish procedures:
(1)for handling recalls and withdrawals of prescription drugs;
(2)to prepare for and protect against any crisis that affects the security or operation of any facility;
(3)for segregating, returning and destroying prescription drugs, and providing all necessary documentation;
(4)for disposal and destruction of containers, labels and packaging to ensure that they cannot be used in counterfeiting activities, which procedures shall require retention of all necessary documentation for at least three years, and appropriate witnessing of the destruction of any labels, packaging, immediate containers or containers in accordance with federal and State requirements;
(5)for investigating and reporting significant inventory discrepancies to the department;
(6)for reporting criminal or suspected criminal activities involving the inventory of prescription drugs to the department within five business days of discovery and for reporting suspected criminal activities involving prescription drugs that are also controlled substances to the department; and
(7)for satisfying authentication requirements required by section 14 of this act.
L.2005,c.206,s.19.
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Last modified: October 11, 2016