S T A T E O F N E W Y O R K
________________________________________________________________________
4584
2019-2020 Regular Sessions
I N A S S E M B L Y
February 4, 2019
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Introduced by M. of A. ENGLEBRIGHT, LUPARDO -- read once and referred to
the Committee on Health
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:
Section 1. Section 2803-e of the public health law, as added by chap-
ter 902 of the laws of 1977 and renumbered by chapter 340 of the laws of
1980, is amended to read as follows:
§ 2803-e. Residential health care facilities; return and redistrib-
ution of unused medication. 1. Notwithstanding any inconsistent
provision of law, rule or regulation to the contrary, the commissioner
is hereby authorized and directed to permit either a resident or
consultant pharmacist OR HIS OR HER DESIGNEE in a residential health
care facility to return to the pharmacy from which it was purchased any
unused medication provided that such medication is sealed in THE
MANUFACTURER'S ORIGINAL unopened[,] TAMPER EVIDENT PACKAGING AND EITHER
individually packaged [units] OR PACKAGED IN UNIT-DOSE PACKAGING and
within the recommended period of shelf life, AND, IF ORAL OR PARENTERAL
MEDICATIONS, SEALED IN SINGLE-DOSE CONTAINERS APPROVED BY THE FEDERAL
FOOD AND DRUG ADMINISTRATION, AND, IF A TOPICAL OR INHALANT DRUG, IS
SEALED IN UNITS-OF-USE CONTAINERS APPROVED BY THE FEDERAL FOOD AND DRUG
ADMINISTRATION and provided that such medication is not a controlled
substance as defined in section thirty-three hundred six of [the public
health law] THIS CHAPTER.
2. The pharmacy to which such medication as described in subdivision
one of this section is returned shall be permitted to receive, restock
and redistribute that medication. THE COMMISSIONER, IN CONSULTATION
WITH THE ADVISORY COMMITTEE ESTABLISHED BY SUBDIVISION SIX OF THIS
SECTION, SHALL ESTABLISH A REASONABLE FEE OF REIMBURSEMENT OF COSTS
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD09062-01-9
A. 4584 2
RELATED TO THE RECEIPT, RESTOCKING AND REDISTRIBUTION OF SUCH MEDICATION
PAYABLE TO THE PHARMACY TO WHICH SUCH MEDICATION IS RETURNED.
3. The pharmacy to which such medication as described in subdivision
one of this section is returned shall be required to reimburse or credit
the purchaser of that medication for the unused medication that is
restocked and redistributed. No pharmacy shall be required to accept any
medication returned under subdivision one of this section.
4. Neither an individual patient or the state, if a patient is a
recipient of a state funded program, shall be charged for unused medica-
tion which according to the provisions of this law is returned for
reimbursement or credit.
5. THE COMMISSIONER SHALL ESTABLISH PROCEDURES TO ASSURE THAT ANY
RETURN OF MEDICATIONS AUTHORIZED BY THIS SECTION, AND ANY RECEIPT,
RESTOCKING OR REDISTRIBUTION OF MEDICATION SO RETURNED SHALL COMPLY WITH
THE FEDERAL HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
OF 1996, AS AMENDED.
6. THE DEPARTMENT SHALL CONVENE AN ADVISORY COMMITTEE TO ASSIST THE
COMMISSIONER IN DEVELOPING A REASONABLE FEE OF REIMBURSEMENT PURSUANT TO
THE PROVISIONS OF SUBDIVISION TWO OF THIS SECTION. THE ADVISORY COMMIT-
TEE SHALL BE COMPRISED OF LICENSED PHARMACISTS CURRENTLY ENGAGED IN THE
PROVISION OF LONG TERM CARE PHARMACY SERVICES. MEMBERS OF THE COMMITTEE
SHALL BE APPOINTED BY THE GOVERNOR: TWO MEMBERS OF THE COMMITTEE SHALL
BE APPOINTED ON THE RECOMMENDATION OF THE TEMPORARY PRESIDENT OF THE
SENATE AND THE SPEAKER OF THE ASSEMBLY; AND TWO MEMBERS SHALL BE
APPOINTED ON THE RECOMMENDATION OF THE MINORITY LEADER OF THE ASSEMBLY
AND THE MINORITY LEADER OF THE SENATE.
7. A PRESCRIPTION DRUG MANUFACTURER SHALL NOT, IN THE ABSENCE OF BAD
FAITH, BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY FOR INJURY, DEATH, OR
LOSS TO PERSON OR PROPERTY FOR MATTERS RELATED TO THE RETURN, DONATION,
ACCEPTANCE, REDISTRIBUTION OR DISPENSING OF A PRESCRIPTION DRUG MANUFAC-
TURED BY THE PRESCRIPTION DRUG MANUFACTURER THAT IS DONATED BY ANY
PERSON UNDER THE PROGRAM, INCLUDING BUT NOT LIMITED TO LIABILITY FOR
FAILURE TO TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFORMATION OR
THE EXPIRATION DATE OF THE DONATED PRESCRIPTION DRUG.
§ 2. This act shall take effect on the one hundred twentieth day after
it shall have become a law. Effective immediately the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date are authorized to be made and
completed on or before such date.