New York State Assembly

 
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A07509 Summary:

A07509 Actions:

A07509 Committee Votes:

Committee:HIGHER EDUCATION   Chair:Glick      
DATE:06/07/2017AYE/NAY:26/0  Action: Favorable refer to committee Rules        
Glick
Aye
Lupinacci
Aye
Gottfried
Aye
Butler
Aye
Magee
Aye
Fitzpatrick
Aye
Englebright
Aye
Ra
Aye
Cahill
Aye
Garbarino
Aye
Paulin
Aye
Morinello
Aye
Lifton
Aye
Norris
Aye
Cusick
Aye
Lupardo
Aye
Peoples-Stokes
Aye
Lavine
Aye
Brindisi
Aye
Simanowitz
Aye
Stirpe
Aye
Fahy
Aye
Pichardo
Aye
Simon
Aye
Harris
Aye
McDonald
Aye

Committee:RULES   Chair:Heastie      
DATE:06/20/2017AYE/NAY:27/0  Action: Favorable         
Heastie
Aye
Kolb
Aye
Gottfried
Aye
Oaks
Aye
Lentol
Aye
Butler
Excused
Farrell
Aye
Crouch
Aye
Gantt
Aye
Finch
Excused
Nolan
Excused
Barclay
Aye
Weinstein
Aye
Raia
Aye
Hooper
Aye
Hawley
Aye
Ortiz
Aye
Pretlow
Aye
Cook
Aye
Glick
Aye
Morelle
Aye
Aubry
Aye
Englebright
Aye
Dinowitz
Aye
Colton
Aye
Magnarelli
Aye
Perry
Aye
Galef
Aye
Paulin
Aye
Titus
Excused
Peoples-Stokes
Aye

A07509 Floor Votes:

A07509 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         7509--A
 
                               2017-2018 Regular Sessions
 
                   IN ASSEMBLY
 
                                     April 28, 2017
                                       ___________
 
        Introduced  by  M. of A. GOTTFRIED, QUART, RAIA -- Multi-Sponsored by --
          M. of A.  ENGLEBRIGHT, JEAN-PIERRE -- read once and  referred  to  the
          Committee  on Higher Education -- reported and referred to the Commit-
          tee on Rules -- Rules  Committee  discharged,  bill  amended,  ordered
          reprinted as amended and recommitted to the Committee on Rules

        AN ACT to amend the education law and the public health law, in relation
          to   the  substitution  of  interchangeable  biological  products  for
          prescribed  products;  and  providing  for  the  expiration  of   such
          provisions
 
          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  two
     2  new subdivisions 27 and 28 to read as follows:
     3    27.  "Biological  product"  means  a  biological product as defined in
     4  subsection (i) of section 351 of  the  Public  Health  Service  Act,  42
     5  U.S.C. Section 262(i).
     6    28.  "Interchangeable  biological  product" means a biological product
     7  licensed by the United States Food and Drug Administration  pursuant  to
     8  42  U.S.C.    Section  262(k)(4)  as  set forth in the latest edition or
     9  supplement of the United States Food and Drug  Administration  Lists  of
    10  Licensed  Biological  Products  with  Reference  Product Exclusivity and
    11  Biosimilarity or Interchangeability Evaluations, sometimes  referred  to
    12  as  the  "Purple Book," or a biological product determined by the United
    13  States Food and Drug Administration to be therapeutically equivalent  as
    14  set  forth in the latest edition or supplement of the United States Food
    15  and Drug Administration Approved Drug Products with  Therapeutic  Equiv-
    16  alence Evaluations, sometimes referred to as the "Orange Book."
    17    §  2.  Paragraphs (b), (c) and (d) of subdivision 6 of section 6810 of
    18  the education law, paragraph (b) as amended and paragraph (d)  as  added
    19  by  chapter  913  of the laws of 1986, paragraph (c) as added by chapter
    20  776 of the laws of 1977, are amended to read as follows:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11241-02-7
        A. 7509--A                          2
 
     1    (b) Notwithstanding any other provision of this section or  any  other
     2  law, when an interchangeable biological product is not available and the
     3  biological product originally prescribed is available and the pharmacist
     4  agrees  to  dispense  the prescribed biological product for a price that
     5  will  not  exceed  the price that would have been charged for the inter-
     6  changeable biological substitute had it been available, substitution  of
     7  an  interchangeable  biological  product  will  not  be required. If the
     8  interchangeable biological product is not available and a medical  emer-
     9  gency  situation,  which  for purposes of this section is defined as any
    10  condition requiring alleviation of severe pain  or  which  threatens  to
    11  cause  disability or take life if not promptly treated, exists, then the
    12  pharmacist may dispense the prescribed biological product at his regular
    13  price. In such instances the pharmacist must record the date,  hour  and
    14  nature of the medical emergency on the back of the prescription and keep
    15  a copy of all such prescriptions.
    16    (c)  The  prescriber  shall  inform  the patient whether he or she has
    17  prescribed a brand name or its generic equivalent drug product or inter-
    18  changeable biological product.
    19    [(c)] (d) The provisions of this subdivision  shall  not  apply  to  a
    20  hospital as defined in article twenty-eight of the public health law.
    21    [(d)]  (e) No prescriber shall be subjected to civil liability arising
    22  solely from  authorizing,  in  accordance  with  this  subdivision,  the
    23  substitution by a pharmacist of a drug product pursuant to paragraph (o)
    24  of subdivision one of section two hundred six of the public health law.
    25    §  3.  Section  6816-a of the education law is amended by adding three
    26  new subdivisions 3, 4 and 5 to read as follows:
    27    3. A pharmacist shall substitute a less expensive  biological  product
    28  for  a  prescribed biological product provided that all of the following
    29  conditions are met:
    30    (a) the substituted biological product is  either  an  interchangeable
    31  biological product for the prescribed product or the substituted biolog-
    32  ical product is one for which the prescribed product is an interchangea-
    33  ble biological product;
    34    (b) the prescriber does not designate that a substitution is prohibit-
    35  ed as described in subdivision six of section sixty-eight hundred ten of
    36  this article; and
    37    (c)  the  pharmacist  indicates  on the label affixed to the immediate
    38  container in which the biological product is  sold  or  distributed  the
    39  name  and  strength of the product and its manufacturer unless the pres-
    40  criber specifically states otherwise.
    41    4. (a) Within five business days following the dispensing of a substi-
    42  tuted biological product, the dispensing pharmacist or the  pharmacist's
    43  designee  shall  communicate  to  the  prescriber  the  specific product
    44  provided to the patient, including the  name  of  the  product  and  the
    45  manufacturer.  The communication shall be conveyed to the prescriber (i)
    46  by making an entry that is electronically accessible to  the  prescriber
    47  through an interoperable electronic medical records system, an electron-
    48  ic prescribing technology or a pharmacy record; or (ii) by using facsim-
    49  ile, electronic transmission or other electronic means. If an electronic
    50  means  described in this paragraph is not available to the pharmacist at
    51  the time of communication, the dispensing pharmacist or the pharmacist's
    52  designee may communicate the information by telephone.
    53    (b) Communication under paragraph (a) of this subdivision shall not be
    54  required where:
    55    (i) there is no FDA-approved interchangeable  biological  product  for
    56  the product prescribed; or
        A. 7509--A                          3
 
     1    (ii)  a  refill prescription is not changed from the product dispensed
     2  on the prior filling of the prescription.
     3    5. The department shall maintain a link on its web site to the current
     4  list  of all biological products determined by the Federal Food and Drug
     5  Administration to be an interchangeable biological product for a specif-
     6  ic biological product.
     7    § 4. Subparagraph 2 of paragraph (o) of subdivision 1 of  section  206
     8  of the public health law, as amended by chapter 913 of the laws of 1986,
     9  is amended to read as follows:
    10    (2)  The  commissioner of the Federal Food and Drug Administration has
    11  evaluated such drug product as:
    12    (i) pharmaceutically and therapeutically  equivalent  and  has  listed
    13  such drug product on the list of approved drugs products with the thera-
    14  peutic   equivalence  evaluations,  provided,  however,  that  the  list
    15  prepared by the commissioner shall not include any  drug  product  which
    16  the commissioner of the Federal Food and Drug Administration has identi-
    17  fied as having an actual or potential bioequivalence problem; or
    18    (ii)  as  an  interchangeable  biological  product and has listed such
    19  product on the list of approved drug products with interchangeability.
    20    § 5. This act shall take effect  immediately  and  shall  expire  five
    21  years after having become a law.