NY Pub Health L § 280-B (2021)
2021 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.