Assembly Bill A145A

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 145--A

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 7, 2015
                               ___________

Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, HOOPER,
  JAFFEE, MARKEY, MILLER, RIVERA, WEPRIN -- read once  and  referred  to
  the  Committee  on Health -- recommitted to the Committee on Health in
  accordance with Assembly Rule 3, sec. 2 -- committee discharged,  bill
  amended,  ordered reprinted as amended and recommitted to said commit-
  tee

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health law is REPEALED.
  S 2. The public health law is amended by adding a new section 280-b to
read as follows:
  S  280-B.  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.
              

                                                           LBD00283-03-6

A. 145--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.
  S 3. Paragraphs (a) and (d) of subdivision 6 of section  6810  of  the
education  law,  paragraph  (a) as amended by chapter 590 of the laws of
2011 and paragraph (d) as added by chapter 913 of the laws of 1986,  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-B 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. 145--A                           3

  (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] TWO HUNDRED EIGHTY-B of
the public health law.
  S 4. 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-B of the public  health
law; and
  S  5.  This  act shall take effect on the ninetieth day after it shall
have become a law. 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.