Provides that residential health care facilities may return and redistribute unused medication provided that such medication is in the manufacturer's original, tamper evident packaging; directs the commissioner of health to establish a reasonable fee of reimbursement of costs related to the receipt, restocking and redistribution of such medication payable to the pharmacy to which such medication is returned.
STATE OF NEW YORK
________________________________________________________________________
4150--A
2011-2012 Regular Sessions
IN ASSEMBLY
February 1, 2011
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Introduced by M. of A. ENGLEBRIGHT, LUPARDO, WEISENBERG -- read once and
referred to the Committee on Health -- recommitted to the Committee on
Health in accordance with Assembly Rule 3, sec. 2 -- committee
discharged, bill amended, ordered reprinted as amended and recommitted
to said committee
AN ACT to amend the public health law, in relation to return and redis-
tribution of unused medication
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 2803-e of the public health law, as added by chap-
2 ter 902 of the laws of 1977 and renumbered by chapter 340 of the laws of
3 1980, is amended to read as follows:
4 § 2803-e. Residential health care facilities; return and redistrib-
5 ution of unused medication. 1. Notwithstanding any inconsistent
6 provision of law, rule or regulation to the contrary, the commissioner
7 is hereby authorized and directed to permit either a resident or
8 consultant pharmacist or his or her designee in a residential health
9 care facility to return to the pharmacy from which it was purchased any
10 unused medication provided that such medication is sealed in the
11 manufacturer's original unopened[,] tamper evident packaging and either
12 individually packaged [units] or packaged in unit-dose packaging and
13 within the recommended period of shelf life, and, if oral or parenteral
14 medications, sealed in single-dose containers approved by the federal
15 Food and Drug Administration, and, if a topical or inhalant drug, is
16 sealed in units-of-use containers approved by the federal Food and Drug
17 Administration and provided that such medication is not a controlled
18 substance as defined in section thirty-three hundred six of [the public
19 health law] this chapter.
20 2. The pharmacy to which such medication as described in subdivision
21 one of this section is returned shall be permitted to receive, restock
22 and redistribute that medication. The commissioner, in consultation
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD04234-02-1
A. 4150--A 2
1 with the advisory committee established by subdivision six of this
2 section, shall establish a reasonable fee of reimbursement of costs
3 related to the receipt, restocking and redistribution of such medication
4 payable to the pharmacy to which such medication is returned.
5 3. The pharmacy to which such medication as described in subdivision
6 one of this section is returned shall be required to reimburse or credit
7 the purchaser of that medication for the unused medication that is
8 restocked and redistributed. No pharmacy shall be required to accept any
9 medication returned under subdivision one of this section.
10 4. Neither an individual patient or the state, if a patient is a
11 recipient of a state funded program, shall be charged for unused medica-
12 tion which according to the provisions of this law is returned for
13 reimbursement or credit.
14 5. The commissioner shall establish procedures to assure that any
15 return of medications authorized by this section, and any receipt,
16 restocking or redistribution of medication so returned shall comply with
17 the federal Health Insurance Portability and Accountability Act (HIPAA)
18 of 1996, as amended.
19 6. The department shall convene an advisory committee to assist the
20 commissioner in developing a reasonable fee of reimbursement pursuant to
21 the provisions of subdivision two of this section. The advisory commit-
22 tee shall be comprised of licensed pharmacists currently engaged in the
23 provision of long term care pharmacy services. Members of the committee
24 shall be appointed by the governor: two members of the committee shall
25 be appointed on the recommendation of the temporary president of the
26 senate and the speaker of the assembly; and two members shall be
27 appointed on the recommendation of the minority leader of the assembly
28 and the minority leader of the senate.
29 7. A prescription drug manufacturer shall not, in the absence of bad
30 faith, be subject to criminal or civil liability for injury, death, or
31 loss to person or property for matters related to the return, donation,
32 acceptance, redistribution or dispensing of a prescription drug manufac-
33 tured by the prescription drug manufacturer that is donated by any
34 person under the program, including but not limited to liability for
35 failure to transfer or communicate product or consumer information or
36 the expiration date of the donated prescription drug.
37 § 2. This act shall take effect on the one hundred twentieth day after
38 it shall have become a law; provided, however, that the commissioner of
39 health shall promulgate rules and regulations prior to such effective
40 date.