New York State Assembly

 
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A00236 Summary:

A00236 Actions:

A00236 Committee Votes:

Committee:HEALTH   Chair:Gottfried      
DATE:01/17/2017AYE/NAY:26/0  Action: Favorable refer to committee Codes        
Gottfried
Aye
Raia
Aye
Schimminger
Aye
McDonough
Aye
Galef
Aye
Ra
Aye
Dinowitz
Aye
Walter
Aye
Cahill
Aye
Garbarino
Aye
Paulin
Aye
Byrne
Aye
Cymbrowitz
Aye
Norris
Aye
Gunther
Aye
Rosenthal
Aye
Hevesi
Aye
Lavine
Aye
Titone
Aye
Mayer
Aye
Jaffee
Aye
Steck
Aye
Abinanti
Aye
Braunstein
Aye
Kim
Aye
Solages
Aye

Committee:CODES   Chair:Lentol      
DATE:01/24/2017AYE/NAY:21/1  Action: Favorable refer to committee Ways and Means        
Lentol
Aye
Graf
Nay
Schimminger
Aye
Giglio
Aye
Weinstein
Aye
McKevitt
Aye
Pretlow
Aye
Montesano
Aye
Cook
Aye
Ra
Aye
Cymbrowitz
Aye
Morinello
Aye
Titus
Aye
O'Donnell
Aye
Lavine
Aye
Perry
Aye
Zebrowski
Aye
Abinanti
Aye
Weprin
Aye
Mosley
Aye
Hevesi
Aye
Fahy
Aye

Committee:WAYS AND MEANS   Chair:Farrell      
DATE:05/22/2017AYE/NAY:34/0  Action: Favorable         
Farrell
Aye
Oaks
Aye
Lentol
Aye
Crouch
Aye
Schimminger
Aye
Barclay
Aye
Gantt
Aye
Fitzpatrick
Aye
Weinstein
Aye
Hawley
Aye
Glick
Aye
Malliotakis
Aye
Nolan
Aye
Walter
Aye
Pretlow
Aye
Montesano
Aye
Perry
Aye
Curran
Aye
Colton
Aye
Ra
Aye
Cook
Aye
Cahill
Aye
Aubry
Aye
Hooper
Aye
Thiele
Aye
Cusick
Aye
Ortiz
Excused
Benedetto
Aye
Moya
Aye
Weprin
Aye
Rodriguez
Aye
Ramos
Aye
Braunstein
Aye
McDonald
Aye
Rozic
Aye

A00236 Floor Votes:

A00236 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         236--A
                                                                 Cal. No. 14
 
                               2017-2018 Regular Sessions
 
                   IN ASSEMBLY
 
                                     January 5, 2017
                                       ___________
 
        Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, HOOPER,
          JAFFEE, M. G. MILLER,  RIVERA,  WEPRIN,  ABINANTI  --  read  once  and
          referred  to  the Committee on Health -- ordered to a third reading --
          passed by Assembly and delivered to  the  Senate,  recalled  from  the
          Senate,  vote reconsidered, bill amended, ordered reprinted, retaining
          its place on the order of third reading
 
        AN ACT to amend the public health law and the education law, in relation
          to generic drug products; and to repeal paragraph (o) of subdivision 1
          of section 206 of the public health law relating thereto
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
     2  health law is REPEALED.
     3    § 2. The public health law is amended by adding a new section 280-c to
     4  read as follows:
     5    §  280-c.  Generic  drug products. 1. The commissioner shall establish
     6  and publish a list of drug products, referred  to  in  this  section  as
     7  "generic  drug"  products, each of which shall meet the following condi-
     8  tions:
     9    (a) The drug product has been certified or approved by the commission-
    10  er of the Federal Food and Drug Administration as being safe and  effec-
    11  tive  for its labeled indications for use, and a new-drug application or
    12  an abbreviated new-drug application approved  pursuant  to  the  Federal
    13  Food, Drug, and Cosmetic Act is held for such drug product; and
    14    (b)  The  commissioner of the Federal Food and Drug Administration has
    15  evaluated such drug  product  as  pharmaceutically  and  therapeutically
    16  equivalent and has listed such drug product on the list of approved drug
    17  products  with the therapeutic equivalence evaluations, provided, howev-
    18  er, that the list prepared by the commissioner  shall  not  include  any
    19  drug  product which the commissioner of the Federal Food and Drug Admin-
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01072-04-8
        A. 236--A                           2
 
     1  istration has identified as having an actual or potential bioequivalence
     2  problem.
     3    2.  The manufacturer of a generic drug product shall make available to
     4  the department the  biopharmaceutic  studies  and  summaries,  including
     5  bioequivalence  data  and  incidence  of  adverse events, and associated
     6  analytical methods, including dissolution data and test methods provided
     7  to the Federal Food and Drug Administration as part of  the  application
     8  for  such  generic drug product. The department shall make such informa-
     9  tion freely and publicly available on its website.
    10    § 3. Paragraphs (a) and (e) of subdivision 6 of section  6810  of  the
    11  education  law,  paragraph  (a) as amended by chapter 590 of the laws of
    12  2011 and paragraph (e) as amended by chapter 357 of the  laws  of  2017,
    13  are amended to read as follows:
    14    (a) Every prescription written in this state by a person authorized to
    15  issue  such  prescription  shall be on prescription forms containing one
    16  line for the prescriber's signature. The  prescriber's  signature  shall
    17  validate  the  prescription. Every electronic prescription shall provide
    18  for the prescriber's electronic  signature,  which  shall  validate  the
    19  electronic  prescription.  Imprinted conspicuously on every prescription
    20  written in this state in eight point upper case type  immediately  below
    21  the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
    22  GENERICALLY  UNLESS  PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless
    23  the prescriber writes d a w in such box in the  prescriber's  own  hand-
    24  writing  or,  in  the case of electronic prescriptions, inserts an elec-
    25  tronic direction to dispense  the  drug  as  written,  the  prescriber's
    26  signature  or  electronic  signature shall designate approval of substi-
    27  tution by a pharmacist of a generic drug product pursuant to  [paragraph
    28  (o)  of subdivision one of] section [two hundred six] two hundred eight-
    29  y-c of the public health law.  No other letters or  marks  in  such  box
    30  shall  prohibit  substitution. No prescription forms used or intended to
    31  be used by a person authorized to issue a prescription shall have  'd  a
    32  w'  preprinted  in such box. Such box shall be placed directly under the
    33  signature line and shall be three-quarters inch in length  and  one-half
    34  inch  in height, or in comparable form for an electronic prescription as
    35  may be specified by regulation of the  commissioner.  Immediately  below
    36  such  box  shall  be  imprinted in six point type the words "Dispense As
    37  Written".  Notwithstanding any other provision of law,  no  state  offi-
    38  cial,  agency,  board or other entity shall promulgate any regulation or
    39  guideline modifying those elements of the prescription  form's  contents
    40  specified in this subdivision. To the extent otherwise permitted by law,
    41  a  prescriber  may modify only those elements of the prescription form's
    42  contents not specified in this subdivision.  Notwithstanding  any  other
    43  provision  of  this section or any other law, when a generic drug is not
    44  available and the brand name drug originally prescribed is available and
    45  the pharmacist agrees to dispense the brand name  product  for  a  price
    46  that  will  not  exceed  the  price that would have been charged for the
    47  generic substitute had it been available, substitution of a generic drug
    48  product will not be required. If the generic drug product is not  avail-
    49  able  and  a  medical  emergency  situation,  which for purposes of this
    50  section is defined as any condition requiring alleviation of severe pain
    51  or which threatens to cause disability or  take  life  if  not  promptly
    52  treated, exists, then the pharmacist may dispense the brand name product
    53  at  his  regular price. In such instances the pharmacist must record the
    54  date, hour and nature of the  medical  emergency  on  the  back  of  the
    55  prescription and keep a copy of all such prescriptions.
        A. 236--A                           3
 
     1    (e) No prescriber shall be subjected to civil liability arising solely
     2  from  authorizing, in accordance with this subdivision, the substitution
     3  by a pharmacist of a generic drug product pursuant to [paragraph (o)  of
     4  subdivision  one  of]  section  two hundred [six] eighty-c of the public
     5  health law.
     6    §  4.  Paragraph (d) of subdivision 6 of section 6810 of the education
     7  law, as added by chapter 913 of the laws of 1986, is amended to read  as
     8  follows:
     9    (d) No prescriber shall be subjected to civil liability arising solely
    10  from  authorizing, in accordance with this subdivision, the substitution
    11  by a pharmacist of a generic drug product pursuant to [paragraph (o)  of
    12  subdivision  one  of]  section  two hundred [six] eighty-c of the public
    13  health law.
    14    § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
    15  law, as added by chapter 776 of the laws of 1977, is amended to read  as
    16  follows:
    17    (b)  The  substituted drug product is contained in the list of generic
    18  drug products established pursuant to [paragraph (o) of subdivision  one
    19  of]  section [two hundred six] two hundred eighty-c of the public health
    20  law; and
    21    § 6. This act shall take effect on the ninetieth day  after  it  shall
    22  have  become  a  law;  provided  that the amendments to paragraph (e) of
    23  subdivision 6 of section 6810 of the  education  law,  made  by  section
    24  three  of  this  act, shall not affect the expiration of such paragraph,
    25  when upon such date the provisions of section four  of  this  act  shall
    26  take  effect.  Effective  immediately,  the  addition,  amendment and/or
    27  repeal of any rule or regulation necessary  for  the  implementation  of
    28  this act on its effective date is authorized to be made and completed on
    29  or before such effective date.