2023 New York Laws › PBH - Public Health › Article 2-A - Prescription Drugs › Title 2 - Prescription Drugs; Various Provisions › 280-B - Unused Perscription Drug Donation and Redispensing Program.

§  280-b.  Unused prescription drug donation and redispensing program.
1.  As used in this section:
(a) "Donor entity" means a manufacturer, wholesaler, or distributor of
prescription drugs; a pharmacy; or a hospital authorized  under  article
twenty-eight of this chapter.
(b)   "Recipient   entity"   means   a  manufacturer,  wholesaler,  or
distributor of prescription drugs; a pharmacy; or a hospital  authorized
under article twenty-eight of this chapter.
(c)"Third party intermediary" means a not-for-profit organization that
facilitates  the  donation  or transfer of prescription drugs under this
section but does not take possession or ownership  of  the  prescription
drugs.
(d)  "Redispense"  means  to  dispense  a  prescription  drug that was
donated and received under this section.
2. The commissioner shall make regulations governing the donation  and
redispensing of unused prescription drugs under this section.
3.  A donor entity may donate unused prescription drugs to a recipient
entity, directly or through a  third-party  intermediary,  in  a  secure
manner,   ensuring   the   privacy  of  any  individuals  for  whom  the
prescription drugs were initially dispensed or intended to be dispensed.
Prescription drugs redispensed under this section shall be inspected  by
a  pharmacist  or  other  licensed  health  care provider as provided by
regulations. The participation of  any  donor  or  recipient  entity  in
redispensing shall be voluntary.
4.  Only  prescription  drugs  received  by  the  recipient  entity in
tamper-evident packaging as defined by United States pharmacopoeia (USP)
general chapter 659, or in unit-dose or multiple-dose packaging, may  be
redispensed. No prescription drugs may be redispensed that:
(a) show evidence of being adulterated or misbranded;
(b) show evidence of packaging having been tampered with;
(c) will expire before the use by the patient based on the prescribing
practitioner's directions for use;
(d)  or  have  been excluded from the program under regulations of the
commissioner.
5. A prescription drug shall not be redispensed if it is restricted to
a patient registered with the drug's manufacturer under federal Food and
Drug Administration requirements including, but not  limited  to,  those
relating to risk evaluation and mitigation strategies (REMS), unless the
redispensing  is  effectively restricted to ensure that the prescription
drug  is  only  dispensed  in  accordance  with  those  requirements  as
applicable.
6. A recipient entity may also be a donor entity.
7. Prescription drugs having passed inspection under subdivision three
of this section may be repackaged or prepackaged by the recipient entity
prior to further redispensing.
8. Recipient entities shall give priority for redispensing to patients
who are indigent, uninsured, or under-insured.
9.  A  redispensed prescription drug shall not be resold by any person
or entity. However,  this  subdivision  does  not  bar  the  payment  of
reasonable processing fees.
10.  No  person  or  entity  shall  be  subject  to  criminal or civil
liability, or professional discipline for any action taken in reasonable
good  faith  compliance  with  this  section,  except  under   otherwise
applicable grounds for liability.
11.  The  department  shall  work  with prospective and approved donor
entities, recipient entities and third-party intermediaries  to  educate
them  about  redispensing and promote participation in redispensing. The

department shall maintain a list of recipient entities, and  third-party
intermediaries and publish it on the department's website.