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S05903 Summary:

Add Art 2-A Title 2 280-b, Pub Health L
Directs the commissioner of health to make regulations for the donation and redispensing of unused prescription drugs.
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S05903 Text:

                STATE OF NEW YORK
            Cal. No. 783
                               2015-2016 Regular Sessions
                    IN SENATE
                                      June 10, 2015
        Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
          printed to be committed to the Committee on Rules  --  recommitted  to
          the  Committee  on  Health in accordance with Senate Rule 6, sec. 8 --
          reported favorably from said committee, ordered to  first  and  second
          report,  ordered to a third reading, passed by Senate and delivered to
          the Assembly, recalled, vote reconsidered, restored to third  reading,
          amended  and  ordered  reprinted,  retaining its place in the order of
          third reading
        AN  ACT  to  amend  the  public  health  law,  in  relation  to   unused
          prescription drug donation and redispensing
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
     1    Section 1. Title 2 of article 2-A of the public health law is  amended
     2  by adding a new section 280-b to read as follows:
     3    §  280-b.  Unused prescription drug donation and redispensing program.
     4  1. As used in this section:
     5    (a) "Donor entity" means a manufacturer, wholesaler, or distributor of
     6  prescription drugs; a pharmacy; or a hospital authorized  under  article
     7  twenty-eight of this chapter.
     8    (b)  "Recipient entity" means a manufacturer, wholesaler, or distribu-
     9  tor of prescription drugs; a pharmacy; or a  hospital  authorized  under
    10  article twenty-eight of this chapter.
    11    (c)"Third party intermediary" means a not-for-profit organization that
    12  facilitates  the  donation  or transfer of prescription drugs under this
    13  section but does not take possession or ownership  of  the  prescription
    14  drugs.
    15    (d)  "Redispense"  means  to  dispense  a  prescription  drug that was
    16  donated and received under this section.
    17    2. The commissioner shall make regulations governing the donation  and
    18  redispensing of unused prescription drugs under this section.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        S. 5903--A                          2
     1    3.  A donor entity may donate unused prescription drugs to a recipient
     2  entity, directly or through a  third-party  intermediary,  in  a  secure
     3  manner,   ensuring   the   privacy  of  any  individuals  for  whom  the
     4  prescription drugs were initially dispensed or intended to be dispensed.
     5  Prescription  drugs redispensed under this section shall be inspected by
     6  a pharmacist or other licensed health care provider as provided by regu-
     7  lations.  The participation of any donor or recipient entity  in  redis-
     8  pensing shall be voluntary.
     9    4.  Only  prescription  drugs  received  by  the  recipient  entity in
    10  tamper-evident packaging as defined by United States pharmacopoeia (USP)
    11  general chapter 659, or in unit-dose or multiple-dose packaging, may  be
    12  redispensed. No prescription drugs may be redispensed that:
    13    (a) show evidence of being adulterated or misbranded;
    14    (b) show evidence of packaging having been tampered with;
    15    (c) will expire before the use by the patient based on the prescribing
    16  practitioner's directions for use;
    17    (d)  or  have  been excluded from the program under regulations of the
    18  commissioner.
    19    5. A prescription drug shall not be redispensed if it is restricted to
    20  a patient registered with the drug's manufacturer under federal Food and
    21  Drug Administration requirements including, but not  limited  to,  those
    22  relating to risk evaluation and mitigation strategies (REMS), unless the
    23  redispensing  is  effectively restricted to ensure that the prescription
    24  drug is only dispensed in accordance with those requirements as applica-
    25  ble.
    26    6. A recipient entity may also be a donor entity.
    27    7. Prescription drugs having passed inspection under subdivision three
    28  of this section may be repackaged or prepackaged by the recipient entity
    29  prior to further redispensing.
    30    8. Recipient entities shall give priority for redispensing to patients
    31  who are indigent, uninsured, or under-insured.
    32    9. A redispensed prescription drug shall not be resold by  any  person
    33  or entity. However, this subdivision does not bar the payment of reason-
    34  able processing fees.
    35    10.  No person or entity shall be subject to criminal or civil liabil-
    36  ity, or professional discipline for any action taken in reasonable  good
    37  faith  compliance  with  this section, except under otherwise applicable
    38  grounds for liability.
    39    11. The department shall work  with  prospective  and  approved  donor
    40  entities,  recipient  entities and third-party intermediaries to educate
    41  them about redispensing and promote participation in  redispensing.  The
    42  department  shall maintain a list of recipient entities, and third-party
    43  intermediaries and publish it on the department's website.
    44    § 2. This act shall take effect immediately.
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