STATE OF NEW YORK
________________________________________________________________________
5903--A
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.
LBD11582-09-6
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.