S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  236--A
                                                          Cal. No. 14
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              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:
 
   Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
 health law is REPEALED.
   § 2. The public health law is amended by adding a new section 280-c to
 read as follows:
   §  280-C.  GENERIC  DRUG PRODUCTS. 1. THE COMMISSIONER SHALL ESTABLISH
 AND PUBLISH A LIST OF DRUG PRODUCTS, REFERRED  TO  IN  THIS  SECTION  AS
 "GENERIC  DRUG"  PRODUCTS, EACH OF WHICH SHALL MEET THE FOLLOWING CONDI-
 TIONS:
   (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
 ER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND  EFFEC-
 TIVE  FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION OR
 AN ABBREVIATED NEW-DRUG APPLICATION APPROVED  PURSUANT  TO  THE  FEDERAL
 FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
   (B)  THE  COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION HAS
 EVALUATED SUCH DRUG  PRODUCT  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY
 EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
 PRODUCTS  WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED, HOWEV-
 ER, THAT THE LIST PREPARED BY THE COMMISSIONER  SHALL  NOT  INCLUDE  ANY
 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
 
 ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
 PROBLEM.
   2.  THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE TO
 THE DEPARTMENT THE  BIOPHARMACEUTIC  STUDIES  AND  SUMMARIES,  INCLUDING
 BIOEQUIVALENCE  DATA  AND  INCIDENCE  OF  ADVERSE EVENTS, AND ASSOCIATED
 ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METHODS PROVIDED
 TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF  THE  APPLICATION
 FOR  SUCH  GENERIC DRUG PRODUCT. THE DEPARTMENT SHALL MAKE SUCH INFORMA-
 TION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
   § 3. Paragraphs (a) and (e) of subdivision 6 of section  6810  of  the
 education  law,  paragraph  (a) as amended by chapter 590 of the laws of
 2011 and paragraph (e) as amended by chapter 357 of the  laws  of  2017,
 are amended to read as follows:
   (a) Every prescription written in this state by a person authorized to
 issue  such  prescription  shall be on prescription forms containing one
 line for the prescriber's signature. The  prescriber's  signature  shall
 validate  the  prescription. Every electronic prescription shall provide
 for the prescriber's electronic  signature,  which  shall  validate  the
 electronic  prescription.  Imprinted conspicuously on every prescription
 written in this state in eight point upper case type  immediately  below
 the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
 GENERICALLY  UNLESS  PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless
 the prescriber writes d a w in such box in the  prescriber's  own  hand-
 writing  or,  in  the case of electronic prescriptions, inserts an elec-
 tronic direction to dispense  the  drug  as  written,  the  prescriber's
 signature  or  electronic  signature shall designate approval of substi-
 tution by a pharmacist of a GENERIC drug product pursuant to  [paragraph
 (o)  of subdivision one of] section [two hundred six] TWO HUNDRED EIGHT-
 Y-C of the public health law.  No other letters or  marks  in  such  box
 shall  prohibit  substitution. No prescription forms used or intended to
 be used by a person authorized to issue a prescription shall have  'd  a
 w'  preprinted  in such box. Such box shall be placed directly under the
 signature line and shall be three-quarters inch in length  and  one-half
 inch  in height, or in comparable form for an electronic prescription as
 may be specified by regulation of the  commissioner.  Immediately  below
 such  box  shall  be  imprinted in six point type the words "Dispense As
 Written".  Notwithstanding any other provision of law,  no  state  offi-
 cial,  agency,  board or other entity shall promulgate any regulation or
 guideline modifying those elements of the prescription  form's  contents
 specified in this subdivision. To the extent otherwise permitted by law,
 a  prescriber  may modify only those elements of the prescription form's
 contents not specified in this subdivision.  Notwithstanding  any  other
 provision  of  this section or any other law, when a generic drug is not
 available and the brand name drug originally prescribed is available and
 the pharmacist agrees to dispense the brand name  product  for  a  price
 that  will  not  exceed  the  price that would have been charged for the
 generic substitute had it been available, substitution of a generic drug
 product will not be required. If the generic drug product is not  avail-
 able  and  a  medical  emergency  situation,  which for purposes of this
 section is defined as any condition requiring alleviation of severe pain
 or which threatens to cause disability or  take  life  if  not  promptly
 treated, exists, then the pharmacist may dispense the brand name product
 at  his  regular price. In such instances the pharmacist must record the
 date, hour and nature of the  medical  emergency  on  the  back  of  the
 prescription and keep a copy of all such prescriptions.

 A. 236--A                           3
 
   (e) No prescriber shall be subjected to civil liability arising solely
 from  authorizing, in accordance with this subdivision, the substitution
 by a pharmacist of a GENERIC drug product pursuant to [paragraph (o)  of
 subdivision  one  of]  section  two hundred [six] EIGHTY-C of the public
 health law.
   §  4.  Paragraph (d) of subdivision 6 of section 6810 of the education
 law, as added by chapter 913 of the laws of 1986, is amended to read  as
 follows:
   (d) No prescriber shall be subjected to civil liability arising solely
 from  authorizing, in accordance with this subdivision, the substitution
 by a pharmacist of a GENERIC drug product pursuant to [paragraph (o)  of
 subdivision  one  of]  section  two hundred [six] EIGHTY-C of the public
 health law.
   § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
 law, as added by chapter 776 of the laws of 1977, is amended to read  as
 follows:
   (b)  The  substituted drug product is contained in the list of GENERIC
 drug products established pursuant to [paragraph (o) of subdivision  one
 of]  section [two hundred six] TWO HUNDRED EIGHTY-C of the public health
 law; and
   § 6. This act shall take effect on the ninetieth day  after  it  shall
 have  become  a  law;  provided  that the amendments to paragraph (e) of
 subdivision 6 of section 6810 of the  education  law,  made  by  section
 three  of  this  act, shall not affect the expiration of such paragraph,
 when upon such date the provisions of section four  of  this  act  shall
 take  effect.  Effective  immediately,  the  addition,  amendment and/or
 repeal of any rule or regulation necessary  for  the  implementation  of
 this act on its effective date is authorized to be made and completed on
 or before such effective date.