S07170 Summary:

BILL NOS07170
 
SAME ASSAME AS A06051
 
SPONSORCOONEY
 
COSPNSR
 
MLTSPNSR
 
Add 6833, Ed L
 
Establishes under the direction of the state board of pharmacy a drug repository program to accept and dispense donated prescription drugs; authorizes such board and the commissioner of health to promulgate rules and regulations; makes definitions; exempts such persons or entities who dispense such donated drugs from criminal or tort liability or professional disciplinary action.
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S07170 Actions:

BILL NOS07170
 
05/18/2023REFERRED TO HIGHER EDUCATION
01/03/2024REFERRED TO HIGHER EDUCATION
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S07170 Committee Votes:

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S07170 Floor Votes:

There are no votes for this bill in this legislative session.
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S07170 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          7170
 
                               2023-2024 Regular Sessions
 
                    IN SENATE
 
                                      May 18, 2023
                                       ___________
 
        Introduced  by  Sen.  COONEY -- read twice and ordered printed, and when
          printed to be committed to the Committee on Higher Education
 
        AN ACT to amend the education law, in relation to establishing under the
          direction of the state board of pharmacy a drug repository program  to
          accept and dispense donated prescription drugs

          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. The education law is amended by adding a new  section  6833
     2  to read as follows:
     3    §  6833.  Repository program; accept and dispense donated prescription
     4  drugs. 1. As used in this section: a. "Hospital" has the same meaning as
     5  in subdivision one of section twenty-eight hundred  one  of  the  public
     6  health law.
     7    b.  "Nonprofit  clinic" means a corporation as defined in subparagraph
     8  five of paragraph (a) of section one hundred two of  the  not-for-profit
     9  corporation  law,  or  any charitable organization not organized and not
    10  operated for profit, that provides health care services to indigent  and
    11  uninsured  persons. "Nonprofit clinic" shall not include a hospital or a
    12  facility as defined in subdivision one of section  twenty-eight  hundred
    13  one of the public health law.
    14    c. "Prescription drug" means any drug to which the following applies:
    15    (1)  Under  the Food, Drug, and Cosmetic Act, 52 Stat. 1040 (1938), 21
    16  U.S.C.A. 301, as amended, the drug is required to bear a label  contain-
    17  ing  the  legend,  "Caution:  Federal  law  prohibits dispensing without
    18  prescription" or "Caution: Federal law restricts this drug to use by  or
    19  on  the  order  of  a  licensed veterinarian" or any similar restrictive
    20  statement, or the drug may be dispensed only upon a prescription.
    21    (2) Under this  article,  the  drug  may  be  dispensed  only  upon  a
    22  prescription.
    23    (3)  Drugs that can only be dispensed to a patient registered with the
    24  drug's manufacturer in accordance with federal Food  and  Drug  Adminis-
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD09083-01-3

        S. 7170                             2
 
     1  tration  requirements  may  not  be  accepted  or  distributed under the
     2  provisions of this section.
     3    2.  The  state  board  of  pharmacy  shall establish a drug repository
     4  program to accept  and  dispense  prescription  drugs  donated  for  the
     5  purpose  of  being  dispensed  to  individuals who are residents of this
     6  state and meet eligibility standards  established  in  rules  and  regu-
     7  lations  adopted  by  the  board under subdivision five of this section.
     8  Only prescription drugs in their original sealed and tamper-evident unit
     9  dose packaging shall be accepted and dispensed. The packaging  shall  be
    10  unopened,  except  that  drugs  packaged  in  single unit doses shall be
    11  accepted and dispensed when the  outside  packaging  is  opened  if  the
    12  single unit dose packaging is undisturbed. Prescription drugs donated by
    13  individuals bearing an expiration date that is less than six months from
    14  the  date  the  drug  is  donated  shall not be accepted or dispensed. A
    15  prescription drug shall not be accepted or dispensed if there is  reason
    16  to  believe  that  it is adulterated as described in section sixty-eight
    17  hundred fifteen of this article. Subject to the limitation specified  in
    18  this  subdivision,  unused  prescription drugs dispensed for purposes of
    19  the medicaid program may be accepted and dispensed under the drug repos-
    20  itory program.
    21    3. a. Any person, including a drug manufacturer  or  any  health  care
    22  facility  may  donate prescription drugs to the drug repository program.
    23  The drugs shall be donated at a pharmacy, hospital or  nonprofit  clinic
    24  that  elects  to  participate  in  the drug repository program and meets
    25  criteria for participation in the program established in rules and regu-
    26  lations adopted by the state board of pharmacy under subdivision five of
    27  this section. Participation in the program by pharmacies, hospitals  and
    28  nonprofit clinics is voluntary. Nothing in this section requires a phar-
    29  macy, hospital or nonprofit clinic to participate in the program.
    30    b. A pharmacy, hospital or nonprofit clinic eligible to participate in
    31  the program shall dispense prescription drugs donated under this section
    32  to  individuals who are residents of this state and meet the eligibility
    33  standards established in rules and  regulations  adopted  by  the  board
    34  under  subdivision  five of this section or to other government entities
    35  and nonprofit private entities to be dispensed to individuals  who  meet
    36  the  eligibility standards.  A prescription drug shall be dispensed only
    37  pursuant to a prescription issued  by  a  licensed  health  professional
    38  authorized to prescribe drugs, as defined in section sixty-eight hundred
    39  two  of  this  article.  A  pharmacy,  hospital or nonprofit clinic that
    40  accepts donated drugs shall comply with all applicable federal laws  and
    41  laws  of  this  state dealing with storage and distribution of dangerous
    42  drugs and shall inspect all prescription drugs prior to dispensing  them
    43  to determine that such drugs are not adulterated. The pharmacy, hospital
    44  or   nonprofit   clinic   shall  charge  individuals  receiving  donated
    45  prescription drugs a handling fee established in accordance  with  rules
    46  and  regulations  adopted  by  the  board under subdivision five of this
    47  section. Prescription drugs donated  to  the  repository  shall  not  be
    48  resold.
    49    4. a. As used in this section, "health care professional" means any of
    50  the  following who provide medical, dental or other health-related diag-
    51  nosis, care or treatment:
    52    (1) Individuals authorized under this title to practice  medicine  and
    53  surgery or podiatric medicine and surgery;
    54    (2)  Registered  professional  nurses  and  licensed  practical nurses
    55  licensed under article one hundred thirty-nine of this title;

        S. 7170                             3
 
     1    (3) Physician assistants authorized  to  practice  under  article  one
     2  hundred thirty-one-B of this title;
     3    (4)  Dentists and dental hygienists licensed under article one hundred
     4  thirty-three of this title;
     5    (5) Optometrists licensed under article  one  hundred  forty-three  of
     6  this title;
     7    (6) Pharmacists licensed under this article.
     8    b.  The  state  board  of  pharmacy;  the  commissioner of health; any
     9  person, including a drug manufacturer or government entity that  donates
    10  prescription  drugs  to  the repository program; any pharmacy, hospital,
    11  nonprofit clinic or health care professional that accepts  or  dispenses
    12  prescription  drugs  under  the  program;  and any pharmacy, hospital or
    13  nonprofit clinic that employs a health care professional who, reasonably
    14  and in good faith, accepts or dispenses  prescription  drugs  under  the
    15  program shall not be subject to any of the following for matters related
    16  to  donating,  accepting  or  dispensing  prescription  drugs  under the
    17  program: criminal prosecution; liability in tort or other  civil  action
    18  for  injury, death or loss to person or property; or professional disci-
    19  plinary action.
    20    A drug manufacturer, who acts reasonably and in good faith, shall  not
    21  be  subject  to criminal prosecution or liability in tort or other civil
    22  action for injury, death or loss  to  person  or  property  for  matters
    23  related to the donation, acceptance or dispensing of a prescription drug
    24  manufactured  by  the  drug  manufacturer  that is donated by any person
    25  under the program, including but not limited to liability for failure to
    26  transfer or communicate product or consumer information or  the  expira-
    27  tion date of the donated prescription drug.
    28    5. In consultation with the commissioner of health, the state board of
    29  pharmacy shall adopt rules and regulations governing the drug repository
    30  program that establish all of the following:
    31    a.  Eligibility criteria for pharmacies, hospitals and nonprofit clin-
    32  ics to  receive  and  dispense  donated  prescription  drugs  under  the
    33  program;
    34    b. Standards and procedures for accepting, safely storing and dispens-
    35  ing donated prescription drugs;
    36    c.  Standards and procedures for inspecting donated prescription drugs
    37  to determine that  the  original  unit  dose  packaging  is  sealed  and
    38  tamper-evident  and  that the drugs are unadulterated, safe and suitable
    39  for dispensing;
    40    d. Eligibility standards based on economic  need  for  individuals  to
    41  receive prescription drugs;
    42    e. A means, such as an identification card, by which an individual who
    43  is  eligible  to  receive  donated  prescription drugs shall demonstrate
    44  eligibility to the pharmacy, hospital or nonprofit clinic dispensing the
    45  drugs;
    46    f. A form that an individual receiving a prescription  drug  from  the
    47  repository  shall  sign  before  receiving  the drug to confirm that the
    48  individual understands the immunity provisions of the program;
    49    g. A formula to determine the amount of a handling  fee  that  pharma-
    50  cies,  hospitals and nonprofit clinics shall charge to prescription drug
    51  recipients to cover restocking and dispensing costs;
    52    h. In addition, for prescription drugs donated to  the  repository  by
    53  individuals:
    54    (1)  A  list  of prescription drugs, arranged either by category or by
    55  individual drug, that the repository shall accept from individuals;

        S. 7170                             4
 
     1    (2) A list of prescription drugs, arranged either by  category  or  by
     2  individual  drug, that the repository shall not accept from individuals.
     3  The list shall include but not be limited to, a statement as to why  the
     4  drug is ineligible for donation.
     5    (3)  A  form each donor shall sign stating that the donor is the owner
     6  of the prescription drugs and intends to voluntarily donate  such  drugs
     7  to the repository.
     8    i.  In  addition,  for prescription drugs donated to the repository by
     9  health care facilities:
    10    (1) A list of prescription drugs, arranged either by  category  or  by
    11  individual  drug,  that  the  repository  shall  accept from health care
    12  facilities;
    13    (2) A list of prescription drugs, arranged either by  category  or  by
    14  individual  drug,  that the repository shall not accept from health care
    15  facilities. The list shall include a statement as to why  such  drug  is
    16  ineligible for donation.
    17    j. Any other standards and procedures the board considers appropriate.
    18    § 2. This act shall take effect on the one hundred eightieth day after
    19  it  shall have become a law. Effective immediately, the addition, amend-
    20  ment and/or repeal of any rule or regulation necessary for the implemen-
    21  tation of this act on its effective date is authorized to be made on  or
    22  before such effective date.
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