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A09729 Summary:

BILL NOA09729
 
SAME ASSAME AS S09186
 
SPONSORMcDonald
 
COSPNSRFahy
 
MLTSPNSR
 
Amd 6802 & 6808-b, add 6809, Ed L
 
Establishes conditions under which resident or non-resident pharmacists and pharmacies may participate in shared pharmacy services.
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A09729 Actions:

BILL NOA09729
 
04/03/2024referred to higher education
04/09/2024reported
04/12/2024advanced to third reading cal.417
05/14/2024passed assembly
05/14/2024delivered to senate
05/14/2024REFERRED TO HIGHER EDUCATION
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A09729 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A9729
 
SPONSOR: McDonald
  TITLE OF BILL: An act to amend the education law, in relation to shared pharmacy services   PURPOSE: To allow for the implementation of shared pharmacy services in New York State.   SUMMARY OF PROVISIONS: Section 1 adds a new subdivision 30 to Section 6802 of the Education law to define shared pharmacy services. Section 2 adds a new Section 6809 to the Education Law to provide the general requirements, operations, notification to patients, drug storage and security, and policies and procedures for pharmacists and pharmacies engaging in shared pharmacy services. Section 3 amends Subdivisions 1, 2, and 3 of Section 6808-b of the Education Law making conforming changes for nonresident establishments to allow participation in shared pharmacy services. Section 4 is the effective date.   JUSTIFICATION: The practice of pharmacy, including the requirements for the registra- tion and operation of pharmacy establishments, are set forth in Article 137 of the New York State Education Law, Part 29 of the Regents Rules, and Part 63 of the Commissioner's regulations. Over the past several years, the scope of practice for pharmacists has expanded to include increased direct patient care responsibilities, such as administering immunizations and medications. Simultaneously, the methods by which pharmacies operate to provide these patient services have also evolved incorporating new technologies and streamlining busi- ness models. To ensure that pharmacies can provide the appropriate patient care services, statutory revisions to permit shared pharmacy services are necessary. The implementation of shared pharmacy services would allow registered pharmacies and pharmacists in New York State to keep pace with the evolution of pharmacy practice.   LEGISLATIVE HISTORY: This is a new bill.   BUDGET IMPLICATIONS: None noted.   EFFECTIVE DATE: This bill takes effect eighteen months after it shall have become a law. Effective immediately, the addition, amendment and /or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
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A09729 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          9729
 
                   IN ASSEMBLY
 
                                      April 3, 2024
                                       ___________
 
        Introduced  by  M. of A. McDONALD, FAHY -- read once and referred to the
          Committee on Higher Education
 
        AN ACT to amend the  education  law,  in  relation  to  shared  pharmacy
          services
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. Section 6802 of the education law is amended  by  adding  a
     2  new subdivision 30 to read as follows:
     3    (30)  "Shared  pharmacy  services" means a system that allows a regis-
     4  tered pharmacist or a registered pharmacy, pursuant to  a  request  from
     5  another  registered  pharmacist  or  pharmacy,  to  process  or  fill  a
     6  prescription or  order,  pursuant  to  regulations  promulgated  by  the
     7  commissioner.
     8    § 2. The education law is amended by adding a new section 6809 to read
     9  as follows:
    10    §  6809. Shared pharmacy services. 1. General requirements. No pharma-
    11  cist or pharmacy shall provide shared pharmacy services unless they  are
    12  registered  in accordance with sections sixty-eight hundred five, sixty-
    13  eight hundred eight, or sixty-eight hundred eight-b of this article, and
    14  are in compliance with the provisions of this section.
    15    2. Qualification. A pharmacy may provide or engage in shared  pharmacy
    16  services only if the pharmacies involved:
    17    a. (i) have the same owner; or
    18    (ii)  have  a written contract or agreement that outlines the services
    19  provided and the shared responsibilities of each pharmacy  in  complying
    20  with  all applicable federal and state statutory and regulatory require-
    21  ments; and
    22    b. share a common electronic file or technology that allows access  to
    23  information necessary or required to perform shared pharmacy services in
    24  compliance with all applicable federal and state statutory and regulato-
    25  ry requirements.
    26    3.  Operations.  A  pharmacy  or pharmacist engaged in shared pharmacy
    27  services shall:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD15019-01-4

        A. 9729                             2
 
     1    a. maintain records that identify, individually for each  prescription
     2  or order filled or processed, the name and if applicable, the license or
     3  registration number of each pharmacy and individual who took part in the
     4  processing  or  filling of the prescription or order. Such records shall
     5  be maintained in accordance with subdivision five of section sixty-eight
     6  hundred  ten  of  this article and made available to the department upon
     7  request. Records of prescriptions for  controlled  substances  shall  be
     8  maintained  pursuant  to the requirements of article thirty-three of the
     9  public health law;
    10    b. maintain a system for the tracking of each  prescription  or  order
    11  during  each step of the process including, but not limited to, the name
    12  and if applicable, the license and registration number of each  pharmacy
    13  and  individual  taking  part  in  the  processing  or  filling  of  the
    14  prescription or order;
    15    c. notify the department, in writing, within thirty days of any disci-
    16  plinary action taken by  another  state's  regulatory  agency  involving
    17  shared pharmacy services as defined in this article;
    18    d.  ensure  that  the  labels  for  all prescriptions filled utilizing
    19  shared pharmacy services identify the names and registration numbers  of
    20  the   pharmacies   involved   in  the  dispensing  and  filling  of  the
    21  prescriptions.  All labels shall conform to sections sixty-eight hundred
    22  twenty-nine and sixty-eight hundred thirty of this article and the regu-
    23  lations  promulgated  thereunder.  The  labeling  of  prescriptions  for
    24  controlled  substances  shall  be  subject  to  additional  requirements
    25  provided  in  article  thirty-three  of  the  public  health  law.   The
    26  provisions  of this paragraph shall not apply to hospitals as defined in
    27  article twenty-eight of the public health law when furnishing  drugs  to
    28  patients registered for treatment by the hospital;
    29    e.  maintain a system that adequately protects the confidentiality and
    30  integrity of protected patient information; and
    31    f. maintain processes for the storage, processing  and  dispensing  of
    32  controlled  substances  in  accordance  with article thirty-three of the
    33  public health law.
    34    4. Notification to patients. a.  Pharmacies  participating  in  shared
    35  pharmacy services shall:
    36    (i)  notify  patients  or the patients' authorized representative that
    37  pending their consent, a portion or all of their  prescriptions  may  be
    38  processed  or  filled  off premises. Such notification shall be conveyed
    39  using conspicuously posted signage at or adjacent to the  place  in  the
    40  pharmacy  where prescriptions are presented for compounding and dispens-
    41  ing, in the waiting area for customers, or  the  area  where  prescribed
    42  drugs  are  dispensed. Pharmacies that transact business through the use
    43  of the internet shall conspicuously provide such notification  on  their
    44  website; and
    45    (ii)  obtain  an  initial  onetime  consent to fill current and future
    46  prescriptions through shared  pharmacy  services  from  the  patient  or
    47  patient's  authorized  representative  prior to the dispensing of one or
    48  more prescriptions for the patient. For the purposes  of  this  section,
    49  such  consent  shall  be obtained in writing or electronically and noted
    50  within the patient's medication profile.
    51    b. Nothing in  this  subdivision  shall  prohibit  a  patient  or  the
    52  patients'  authorized  representative  from  opting  out  of  having the
    53  patients' prescription processed or filled via shared pharmacy  services
    54  at any time.

        A. 9729                             3
 
     1    c. The provisions of this subdivision shall not apply to a hospital as
     2  defined  in  article  twenty-eight  of  the  public  health law which is
     3  furnishing drugs to patients registered for treatment by the hospital.
     4    5. Drug storage and security. a. Drugs shall be stored and transported
     5  in  a  secure manner in compliance with all applicable federal and state
     6  statutory and regulatory requirements.
     7    b. Access to the area where drugs  are  stored  shall  be  limited  to
     8  authorized personnel.
     9    c.  Pharmacies  participating  in  shared pharmacy services shall have
    10  adequate security that complies with all applicable  federal  and  state
    11  statutory  and  regulatory requirements and protects the confidentiality
    12  and integrity of protected patient information.
    13    6. Policies and procedures. a. Each pharmacy participating  in  shared
    14  pharmacy  services shall jointly develop, implement, review, revise, and
    15  comply with joint policies and procedures for shared pharmacy  services.
    16  Such  policies  and procedures shall be made available to the department
    17  upon request and maintained pursuant to regulations promulgated  by  the
    18  commissioner.
    19    b. The policies and procedures shall:
    20    (i) outline the responsibilities of each pharmacy;
    21    (ii)  include  a  list of the names, addresses, telephone numbers, and
    22  all registration numbers of the pharmacies involved in  shared  pharmacy
    23  services; and
    24    (iii) include policies and procedures for:
    25    (A)  notifying the patients or the patients' authorized representative
    26  that the patients' prescriptions may be processed or filled off premises
    27  and providing the names and registration numbers of the other pharmacies
    28  involved in the filling or processing of the prescriptions;
    29    (B) protecting the confidentiality and integrity of protected  patient
    30  information;
    31    (C)  dispensing  a  prescription  when a prescription filled utilizing
    32  shared pharmacy services is not received or the patient comes in  before
    33  such prescription is received;
    34    (D)  maintaining  a required manual or electronic records to track the
    35  prescription or order through each step of the  process  including,  but
    36  not  limited  to, the names and, if applicable, the license or registra-
    37  tion numbers of each individual  who  participated  in  shared  pharmacy
    38  services; and
    39    (E)  complying  with  all  applicable  federal and state statutory and
    40  regulatory requirements; and
    41    (iv) policies and procedures for hospitals as defined  in  the  public
    42  health  law  are  exempt from the requirements of clauses (A) and (C) of
    43  subparagraph (iii) of this paragraph, when furnishing drugs to  patients
    44  registered for treatment by the hospital.
    45    7.  Individual  practice. For the purpose of shared pharmacy services,
    46  persons licensed or otherwise authorized under this article and  article
    47  one  hundred thirty-seven-a of this title, employed by or under contract
    48  with a pharmacy, acting within their respective scopes of practice,  may
    49  access  that  pharmacy's  electronic database from inside or outside the
    50  pharmacy and perform prescription or order processing functions, if both
    51  of the following requirements are met:
    52    a. the pharmacy establishes controls to  protect  the  confidentiality
    53  and integrity of protected patient information; and
    54    b.  no part of the database is duplicated, downloaded, or removed from
    55  the pharmacy's electronic database.

        A. 9729                             4
 
     1    8. Effect. Failure to meet any or all  of  the  requirements  of  this
     2  section may result in a denial of renewal of registration.
     3    §  3. Subdivisions 1, 2, and 3 of section 6808-b of the education law,
     4  as amended by chapter 567 of the laws of 2002, subdivision 1 as  amended
     5  by section 5 of part D of chapter 60 of the laws of 2014, are amended to
     6  read as follows:
     7    1.  Definition.  The  term  "nonresident establishment" shall mean any
     8  pharmacy located outside of the state that participates in shared  phar-
     9  macy services for registered pharmacies and/or patients residing in this
    10  state  or  pharmacy,  manufacturer,  wholesaler, or outsourcing facility
    11  located outside of the state that ships, mails or delivers  prescription
    12  drugs  or devices to other establishments, authorized prescribers and/or
    13  patients residing in this state. Such establishments shall include,  but
    14  not  be limited to, pharmacies that transact business through the use of
    15  the internet.
    16    2. Registration. All nonresident establishments  that  participate  in
    17  shared  pharmacy  services  for  registered  pharmacies  and/or patients
    18  residing in this state or that ship, mail, or deliver prescription drugs
    19  and/or devices to other registered establishments,  authorized  prescri-
    20  bers,  and/or  patients  into  this  state  shall be registered with the
    21  department; except that such registration shall not apply to  intra-com-
    22  pany  transfers between any division, affiliate, subsidiaries, parent or
    23  other  entities  under  complete  common  ownership  and  control.   The
    24  provisions  of this subdivision shall apply solely to nonresident estab-
    25  lishments and shall not affect any other provision of this article.
    26    3. Agent of record. Each nonresident establishment  that  participates
    27  in  shared  pharmacy  services  or ships, mails or delivers drugs and/or
    28  devices into this state shall designate a resident agent in  this  state
    29  for  service  of  process pursuant to rule three hundred eighteen of the
    30  civil practice law and rules.
    31    § 4. This act shall take effect eighteen months after  it  shall  have
    32  become  a  law.  Effective  immediately,  the addition, amendment and/or
    33  repeal of any rule or regulation necessary  for  the  implementation  of
    34  this  act  on its effective date are authorized to be made and completed
    35  on or before such effective date.
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