24:6B-25 Criteria for return of prescription drug to wholesale distributor.
16. a. (1) A pharmacy, chain pharmacy distribution center or pharmacy member of an affiliated group shall return to a wholesale distributor any prescription drug that is on the specified list of susceptible products if the prescription drug:
(a)was ordered by a pharmacy or delivered to a pharmacy by a wholesale distributor in error or in excess of need;
(b)is identified by the pharmacy as such within 30 business days of receipt or pursuant to the retail agreement in place between the pharmacy and wholesale distributor;
(c)has been maintained in its original packaging;
(d)has had its integrity maintained; and
(e)is accompanied by appropriate and complete documentation and, where applicable, any necessary notations made to the certification, invoice or packing slip.
(2)The prescription drug shall be physically returned within 30 business days of notification to the wholesale distributor or as consistent with the wholesale distributor's return policy. If the prescription drug cannot be returned to the wholesale distributor, it shall be returned to the manufacturer.
b.A prescription drug manufacturer shall accept return of prescription drugs on the specified list of susceptible products that have not been returned to a wholesale distributor in accordance with the time frame specified in paragraph (2) of subsection a. of this section.
c.A wholesale distributor shall quarantine a prescription drug, container or labeling that is received outdated, damaged, deteriorated, misbranded, counterfeited, suspected of being counterfeited, adulterated, or otherwise deemed unfit for human consumption until it is returned.
d.A manufacturer or wholesale distributor who receives returned prescription drugs shall notify the department of the return.
e.A wholesale distributor shall identify a prescription drug that becomes outdated after receipt and has been opened or used, but is not adulterated, misbranded, counterfeited, or suspected of being counterfeit, and quarantine the drug until it is destroyed or returned.
f.A prescription drug that becomes outdated after receipt and has been unopened or unused, but is not adulterated, misbranded, counterfeit or suspected of being counterfeit shall be so identified and quarantined until it is destroyed or returned.
g.A wholesale distributor shall return or destroy, within 30 business days after discovery, a prescription drug that has been returned, if any condition under which it has been returned casts doubt on its safety, identity, strength, quality or purity.
h.A wholesale distributor:
(1)shall retain discovered contraband, counterfeit, or suspected counterfeit prescription drugs, evidence of criminal activity and accompanying documentation until its disposition is authorized by the department; and
(2)shall not destroy the shipping container, immediate or sealed outer or secondary container or labeling, and accompanying documentation, which is suspected of or determined to be counterfeit or fraudulent, until its disposition is authorized by the department.
L.2005,c.206,s.16.
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Last modified: October 11, 2016