S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  612--A
 
                        2019-2020 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 9, 2019
                                ___________
 
 Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, JAFFEE,
   M. G. MILLER, RIVERA, WEPRIN, ABINANTI -- read once  and  referred  to
   the Committee on Health -- committee discharged, bill amended, ordered
   reprinted as amended and recommitted to said committee

 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 health law is REPEALED.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-d to
 read as follows:
   § 280-D. 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: (I) 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-
 ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
 PROBLEM OR (II) AS AN INTERCHANGEABLE BIOLOGICAL PRODUCT AND HAS  LISTED
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
              

                       [ ] is old law to be omitted.
                                                            LBD00594-02-9

 A. 612--A                           2
 
 SUCH PRODUCT ON THE LIST OF APPROVED DRUG PRODUCTS WITH INTERCHANGEABIL-
 ITY.
   2.  THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE TO
 THE DEPARTMENT THE STUDIES AND SUMMARIES, INCLUDING BIOEQUIVALENCE DATA,
 THERAPEUTIC EQUIVALENCE DATA, AND INCIDENCE OF ADVERSE EVENTS, AND ASSO-
 CIATED 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 INFORMATION 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-D  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. 612--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-D  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-D 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-D 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 are authorized to be made and completed
 on or before such effective date.