|SAME AS||SAME AS A09905-B|
|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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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. LBD11582-09-6S. 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.