New Jersey-2018-A334-Introduced

An Act concerning pharmaceutical manufacturers and wholesale distributors and amending P.L.2005, c.206.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. Section 16 of P.L.2005, c.206 (C.24:6B-25) is amended to read as follows:

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; and

(c) [has been maintained in its original packaging;] (deleted by amendment, P.L. c. ) (pending before the Legislature as this bill)

(d) [has had its integrity maintained; and] (deleted by amendment, P.L. c. ) (pending before the Legislature as this bill)

(e) is accompanied by appropriate and complete documentation and, where applicable, any necessary notations made to the certification, invoice or packing slip.

(2) A pharmacy, chain pharmacy distribution center, or pharmacy member of an affiliated group may return to a wholesale distributor any prescription drug that is on the specified list of susceptible products if the prescription drug is no more than six months past its expiration date.

(3) 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c. A wholesale distributor shall quarantine a prescription drug, container or labeling that is received outdated, damaged, deteriorated, misbranded, counterfeited, suspected of being counterfeited, adulterated, or otherwise deemed unfit for human consumption until it is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;

(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.

i. A manufacturer or wholesale distributor shall permit a pharmacy, chain pharmacy distribution center, or pharmacy member of an affiliated group to return outdated drugs in both full and partial containers for up to six months after the labeled expiration date.

j. A manufacturer or wholesale distributor shall provide a pharmacy, chain pharmacy distribution center, or pharmacy member of an affiliated group a full credit or replacement for any returned outdated drugs in both full and partial containers, provided the drug is not adulterated, misbranded, or counterfeit.

(cf: P.L.2005, c.206, s.16)

2. This act shall take effect immediately.

STATEMENT

This bill permits a pharmacy, chain pharmacy distribution center, or pharmacy member of an affiliated group to return to a wholesale distributor or the pharmaceutical manufacturer certain prescription drugs if the drug is no more than six months past its expiration date. The bill requires pharmaceutical manufacturers and wholesale distributers to accept the return of the outdated drugs in both full and partial containers. Furthermore, the bill provides that the manufacturer or distributer is required to provide a pharmacy, chain pharmacy distribution center, or pharmacy member of an affiliated group with full credit or replacement for those drugs, provided the drug is not adulterated, misbranded or counterfeit.