•  Summary 
  •  
  •  Actions 
  •  
  •  Committee Votes 
  •  
  •  Floor Votes 
  •  
  •  Memo 
  •  
  •  Text 
  •  
  •  LFIN 
  •  
  •  Chamber Video/Transcript 

S05158 Summary:

BILL NOS05158
 
SAME ASSAME AS A01923
 
SPONSORLANZA
 
COSPNSR
 
MLTSPNSR
 
Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L
 
Requires the commissioner of health to establish and publish a list of generic drug products.
Go to top    

S05158 Actions:

BILL NOS05158
 
02/25/2021REFERRED TO HEALTH
Go to top

S05158 Memo:

Memo not available
Go to top

S05158 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          5158
 
                               2021-2022 Regular Sessions
 
                    IN SENATE
 
                                    February 25, 2021
                                       ___________
 
        Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
          printed to be committed to the Committee on Health
 
        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     2  health law is REPEALED.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-d to
     4  read as follows:
     5    §  280-d.  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: (i) 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-
    20  istration has identified as having an actual or potential bioequivalence
    21  problem  or (ii) as an interchangeable biological product and has listed
    22  such product on the list of approved drug products with interchangeabil-
    23  ity.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01823-01-1

        S. 5158                             2
 
     1    2. The manufacturer of a generic drug product shall make available  to
     2  the department the studies and summaries, including bioequivalence data,
     3  therapeutic equivalence data, and incidence of adverse events, and asso-
     4  ciated  analytical  methods, including dissolution data and test methods
     5  provided  to  the  Federal  Food  and Drug Administration as part of the
     6  application for such generic drug product.  The  department  shall  make
     7  such information freely and publicly available on its website.
     8    §  3.  Paragraphs  (a) and (e) of subdivision 6 of section 6810 of the
     9  education law, paragraph (a) as amended by chapter 590 of  the  laws  of
    10  2011  and  paragraph  (e) as amended by chapter 357 of the laws of 2017,
    11  are amended to read as follows:
    12    (a) Every prescription written in this state by a person authorized to
    13  issue such prescription shall be on prescription  forms  containing  one
    14  line  for  the  prescriber's signature. The prescriber's signature shall
    15  validate the prescription. Every electronic prescription  shall  provide
    16  for  the  prescriber's  electronic  signature,  which shall validate the
    17  electronic prescription. Imprinted conspicuously on  every  prescription
    18  written  in  this state in eight point upper case type immediately below
    19  the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
    20  GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless
    21  the  prescriber  writes  d a w in such box in the prescriber's own hand-
    22  writing or, in the case of electronic prescriptions,  inserts  an  elec-
    23  tronic  direction  to  dispense  the  drug  as written, the prescriber's
    24  signature or electronic signature shall designate  approval  of  substi-
    25  tution  by a pharmacist of a generic drug product pursuant to [paragraph
    26  (o) of subdivision one of] section [two hundred six] two hundred  eight-
    27  y-d  of  the  public health law.   No other letters or marks in such box
    28  shall prohibit substitution. No prescription forms used or  intended  to
    29  be  used  by a person authorized to issue a prescription shall have 'd a
    30  w' preprinted in such box. Such box shall be placed directly  under  the
    31  signature  line  and shall be three-quarters inch in length and one-half
    32  inch in height, or in comparable form for an electronic prescription  as
    33  may  be  specified  by regulation of the commissioner. Immediately below
    34  such box shall be imprinted in six point type  the  words  "Dispense  As
    35  Written".    Notwithstanding  any other provision of law, no state offi-
    36  cial, agency, board or other entity shall promulgate any  regulation  or
    37  guideline  modifying  those elements of the prescription form's contents
    38  specified in this subdivision. To the extent otherwise permitted by law,
    39  a prescriber may modify only those elements of the  prescription  form's
    40  contents  not  specified  in this subdivision. Notwithstanding any other
    41  provision of this section or any other law, when a generic drug  is  not
    42  available and the brand name drug originally prescribed is available and
    43  the  pharmacist  agrees  to  dispense the brand name product for a price
    44  that will not exceed the price that would  have  been  charged  for  the
    45  generic substitute had it been available, substitution of a generic drug
    46  product  will not be required. If the generic drug product is not avail-
    47  able and a medical emergency  situation,  which  for  purposes  of  this
    48  section is defined as any condition requiring alleviation of severe pain
    49  or  which  threatens  to  cause  disability or take life if not promptly
    50  treated, exists, then the pharmacist may dispense the brand name product
    51  at his regular price. In such instances the pharmacist must  record  the
    52  date,  hour  and  nature  of  the  medical  emergency on the back of the
    53  prescription and keep a copy of all such prescriptions.
    54    (e) No prescriber shall be subjected to civil liability arising solely
    55  from authorizing, in accordance with this subdivision, the  substitution
    56  by  a pharmacist of a generic drug product pursuant to [paragraph (o) of

        S. 5158                             3

     1  subdivision one of] section two hundred [six]  eighty-d  of  the  public
     2  health law.
     3    §  4.  Paragraph (d) of subdivision 6 of section 6810 of the education
     4  law, as added by chapter 913 of the laws of 1986, is amended to read  as
     5  follows:
     6    (d) No prescriber shall be subjected to civil liability arising solely
     7  from  authorizing, in accordance with this subdivision, the substitution
     8  by a pharmacist of a generic drug product pursuant to [paragraph (o)  of
     9  subdivision  one  of]  section  two hundred [six] eighty-d of the public
    10  health law.
    11    § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
    12  law, as added by chapter 776 of the laws of 1977, is amended to read  as
    13  follows:
    14    (b)  The  substituted drug product is contained in the list of generic
    15  drug products established pursuant to [paragraph (o) of subdivision  one
    16  of]  section [two hundred six] two hundred eighty-d of the public health
    17  law; and
    18    § 6. This act shall take effect on the ninetieth day  after  it  shall
    19  have  become  a  law;  provided  that the amendments to paragraph (e) of
    20  subdivision 6 of section 6810 of the  education  law,  made  by  section
    21  three  of  this  act, shall not affect the expiration of such paragraph,
    22  when upon such date the provisions of section four  of  this  act  shall
    23  take  effect.  Effective  immediately,  the  addition,  amendment and/or
    24  repeal of any rule or regulation necessary  for  the  implementation  of
    25  this  act  on its effective date are authorized to be made and completed
    26  on or before such effective date.
Go to top