Assembly Bill A7509

Signed By Governor
2017-2018 Legislative Session

Relates to interchangeable biological products

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Sponsored By

Archive: Last Bill Status - Signed by Governor


  • Introduced
    • In Committee Assembly
    • In Committee Senate
    • On Floor Calendar Assembly
    • On Floor Calendar Senate
    • Passed Assembly
    • Passed Senate
  • Delivered to Governor
  • Signed By Governor

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Bill Amendments

co-Sponsors

multi-Sponsors

2017-A7509 - Details

Law Section:
Education Law
Laws Affected:
Amd §§6802, 6810 & 6816-a, Ed L; amd §206, Pub Health L

2017-A7509 - Summary

Relates to interchangeable biological products; enacts provisions relating to substitutions of biological products by pharmacists.

2017-A7509 - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   7509
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              April 28, 2017
                                ___________
 
 Introduced  by  M.  of  A.  GOTTFRIED  --  read once and referred to the
   Committee on Higher Education
 
 AN ACT to amend the education law and the public health law, in relation
   to  the  substitution  of  interchangeable  biological  products   for
   prescribed products

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 6802 of the education law is amended by adding  two
 new subdivisions 27 and 28 to read as follows:
   27.  "BIOLOGICAL  PRODUCT"  MEANS  A  BIOLOGICAL PRODUCT AS DEFINED IN
 SUBSECTION (I) OF SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT 42 U.S.C.
 SECTION 262(I).
   28. "INTERCHANGEABLE BIOLOGICAL PRODUCT" MEANS  A  BIOLOGICAL  PRODUCT
 LICENSED  BY  THE UNITED STATES FOOD AND DRUG ADMINISTRATION PURSUANT TO
 42 U.S.C.   SECTION 262(K)(4) AS SET FORTH  IN  THE  LATEST  EDITION  OR
 SUPPLEMENT  OF  THE  UNITED STATES FOOD AND DRUG ADMINISTRATION LISTS OF
 LICENSED BIOLOGICAL PRODUCTS  WITH  REFERENCE  PRODUCT  EXCLUSIVITY  AND
 BIOSIMILARITY  OR  INTERCHANGEABILITY EVALUATIONS, SOMETIMES REFERRED TO
 AS THE "PURPLE BOOK," OR A BIOLOGICAL PRODUCT DETERMINED BY  THE  UNITED
 STATES  FOOD AND DRUG ADMINISTRATION TO BE THERAPEUTICALLY EQUIVALENT AS
 SET FORTH IN THE LATEST EDITION OR SUPPLEMENT OF THE UNITED STATES  FOOD
 AND  DRUG  ADMINISTRATION APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIV-
 ALENCE EVALUATIONS, SOMETIMES REFERRED TO AS THE "ORANGE BOOK."
   § 2. Paragraphs (b), (c) and (d) of subdivision 6 of section  6810  of
 the  education  law, paragraph (b) as amended and paragraph (d) as added
 by chapter 913 of the laws of 1986, paragraph (c) as  added  by  chapter
 776 of the laws of 1977, are amended to read as follows:
   (b)  NOTWITHSTANDING  ANY OTHER PROVISION OF THIS SECTION OR ANY OTHER
 LAW, WHEN AN INTERCHANGEABLE BIOLOGICAL PRODUCT IS NOT AVAILABLE AND THE
 BIOLOGICAL PRODUCT ORIGINALLY PRESCRIBED IS AVAILABLE AND THE PHARMACIST
 AGREES TO DISPENSE THE PRESCRIBED BIOLOGICAL PRODUCT FOR  A  PRICE  THAT
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

co-Sponsors

multi-Sponsors

2017-A7509A (ACTIVE) - Details

Law Section:
Education Law
Laws Affected:
Amd §§6802, 6810 & 6816-a, Ed L; amd §206, Pub Health L

2017-A7509A (ACTIVE) - Summary

Relates to interchangeable biological products; enacts provisions relating to substitutions of biological products by pharmacists.

2017-A7509A (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  7509--A
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              April 28, 2017
                                ___________
 
 Introduced  by  M. of A. GOTTFRIED, QUART, RAIA -- Multi-Sponsored by --
   M. of A.  ENGLEBRIGHT, JEAN-PIERRE -- read once and  referred  to  the
   Committee  on Higher Education -- reported and referred to the Commit-
   tee on Rules -- Rules  Committee  discharged,  bill  amended,  ordered
   reprinted as amended and recommitted to the Committee on Rules

 AN ACT to amend the education law and the public health law, in relation
   to   the  substitution  of  interchangeable  biological  products  for
   prescribed  products;  and  providing  for  the  expiration  of   such
   provisions
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 6802 of the education law is amended by adding  two
 new subdivisions 27 and 28 to read as follows:
   27.  "BIOLOGICAL  PRODUCT"  MEANS  A  BIOLOGICAL PRODUCT AS DEFINED IN
 SUBSECTION (I) OF SECTION 351 OF  THE  PUBLIC  HEALTH  SERVICE  ACT,  42
 U.S.C. SECTION 262(I).
   28.  "INTERCHANGEABLE  BIOLOGICAL  PRODUCT" MEANS A BIOLOGICAL PRODUCT
 LICENSED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION  PURSUANT  TO
 42  U.S.C.    SECTION  262(K)(4)  AS  SET FORTH IN THE LATEST EDITION OR
 SUPPLEMENT OF THE UNITED STATES FOOD AND DRUG  ADMINISTRATION  LISTS  OF
 LICENSED  BIOLOGICAL  PRODUCTS  WITH  REFERENCE  PRODUCT EXCLUSIVITY AND
 BIOSIMILARITY OR INTERCHANGEABILITY EVALUATIONS, SOMETIMES  REFERRED  TO
 AS  THE  "PURPLE BOOK," OR A BIOLOGICAL PRODUCT DETERMINED BY THE UNITED
 STATES FOOD AND DRUG ADMINISTRATION TO BE THERAPEUTICALLY EQUIVALENT  AS
 SET  FORTH IN THE LATEST EDITION OR SUPPLEMENT OF THE UNITED STATES FOOD
 AND DRUG ADMINISTRATION APPROVED DRUG PRODUCTS WITH  THERAPEUTIC  EQUIV-
 ALENCE EVALUATIONS, SOMETIMES REFERRED TO AS THE "ORANGE BOOK."
   §  2.  Paragraphs (b), (c) and (d) of subdivision 6 of section 6810 of
 the education law, paragraph (b) as amended and paragraph (d)  as  added
 by  chapter  913  of the laws of 1986, paragraph (c) as added by chapter
 776 of the laws of 1977, are amended to read as follows:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

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