Senate Bill S5158

2021-2022 Legislative Session

Requires the commissioner of health to establish and publish a list of generic drug products; repealer

download bill text pdf

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee


  • 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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2021-S5158 (ACTIVE) - Details

See Assembly Version of this Bill:
A1923
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:
2013-2014: S6739, A8057
2015-2016: S5099, A145
2017-2018: S5471, A236
2019-2020: S2391, A612
2023-2024: S4181, A144

2021-S5158 (ACTIVE) - Summary

Requires the commissioner of health to establish and publish a list of generic drug products.

2021-S5158 (ACTIVE) - Sponsor Memo

2021-S5158 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5158
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   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 health law is REPEALED.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
 SUCH PRODUCT ON THE LIST OF APPROVED DRUG PRODUCTS WITH INTERCHANGEABIL-
 ITY.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD01823-01-1
              

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