NY State Senate Bill 2017-S4788A

Archive: Last Bill Status Via A7509 - 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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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Oct 23, 2017	signed chap.357
Oct 11, 2017	delivered to governor
Jun 21, 2017	returned to assembly passed senate 3rd reading cal.2161 substituted for s4788a
Jun 21, 2017	substituted by a7509a ordered to third reading cal.2161 committee discharged and committed to rules
Jun 16, 2017	print number 4788a
Jun 16, 2017	amend (t) and recommit to higher education
Mar 01, 2017	referred to higher education

Votes

- Jun 21, 2017 - Floor Vote
  A7509
  
  62
  
  Aye
  
  0
  
  Nay
  
  1
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Floor Vote: Jun 21, 2017
      
      aye (62)
      
      Addabbo Jr.
      
      Akshar
      
      Alcantara
      
      Amedore
      
      Avella
      
      Bailey
      
      Benjamin
      
      Bonacic
      
      Boyle
      
      Breslin
      
      Brooks
      
      Carlucci
      
      Comrie
      
      Croci
      
      DeFrancisco
      
      Diaz
      
      Dilan
      
      Felder
      
      Flanagan
      
      Funke
      
      Gallivan
      
      Gianaris
      
      Golden
      
      Griffo
      
      Hamilton
      
      Hannon
      
      Helming
      
      Hoylman-Sigal
      
      Jacobs
      
      Kaminsky
      
      Kennedy
      
      Klein
      
      Krueger
      
      LaValle
      
      Lanza
      
      Larkin
      
      Latimer
      
      Little
      
      Marcellino
      
      Marchione
      
      Montgomery
      
      Murphy
      
      O'Mara
      
      Ortt
      
      Parker
      
      Peralta
      
      Persaud
      
      Phillips
      
      Ranzenhofer
      
      Ritchie
      
      Rivera
      
      Robach
      
      Savino
      
      Serino
      
      Serrano
      
      Seward
      
      Squadron
      
      Stavisky
      
      Stewart-Cousins
      
      Tedisco
      
      Valesky
      
      Young
      
      absent (1)
      
      Sanders Jr.
  Jun 21, 2017 - Rules Committee Vote
  S4788A
  
  23
  
  Aye
  
  1
  
  Nay
  
  1
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Rules Committee Vote: Jun 21, 2017
      
      aye (23)
      
      Bonacic
      
      Breslin
      
      Carlucci
      
      DeFrancisco
      
      Dilan
      
      Flanagan
      
      Griffo
      
      Hannon
      
      Krueger
      
      LaValle
      
      Lanza
      
      Larkin
      
      Little
      
      Marcellino
      
      Montgomery
      
      Parker
      
      Ranzenhofer
      
      Robach
      
      Savino
      
      Seward
      
      Squadron
      
      Stewart-Cousins
      
      Valesky
      
      nay (1)
      
      Gianaris
      
      aye wr (1)
      
      Kennedy

Bill Amendments

Original

A (Active)

co-Sponsors

View additional co-sponsors

2017-S4788 - Details

See Assembly Version of this Bill:: A7509
Law Section:: Education Law
Laws Affected:: Amd §§6802, 6810 & 6816-a, Ed L; amd §206, Pub Health L

2017-S4788 - Summary

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

2017-S4788 - Sponsor Memo

                                 BILL NUMBER:  S4788

 TITLE OF BILL :  An act to amend the education law and the public
health law, in relation to the substitution of interchangeable
biological products for prescribed products

 PURPOSE :

This bill would establish requirements for pharmacies to substitute
and dispense biological products.

 SUMMARY OF PROVISIONS :

Section 1 amends section 6802 of the education law to add the
definition of biological product as defined in subsection (i) of
section 351 of the Public Health Service Act 42 U.S.C. Section 262(i);
and adds the definition of interchangeable biologic product as defined
pursuant to 42 U.S.C. Section 262(k)(4) or as determined by the FDA to
be therapeutically equivalent.

Sections 2 and 3 amend sections 6810 and 6816-a of the education law
to extend notification to the patient by the prescriber regarding the
product prescribed to include an interchangeable biological product,
as is existing practice with a brand name or its generic equivalent
drug product and suspends the requirement that a pharmacist substitute
a biologic product when an interchangeable biological substitute is

not available; makes technical changes necessary to reflect the
substitution of an interchangeable biological product; sets forth the
conditions under which the substitution of a biologic product is
required; provides for the appropriate method of communication by the
pharmacist to the prescriber notifying the prescriber of the
substitution of the biologic product dispensed; requires the
Department of Health to maintain a link on its web site to the current
list of all biological products determined by the Federal Food and
Drug Administration to be an interchangeable biological product for a
specific biological product.

Section 4 makes conforming amendments to section 206 of the public
health law. Section 5 provides for an immediate effective date.

 JUSTIFICATION :

Biologic products represent the cutting edge of medical science and
research. They successfully treat patients with difficult to treat
diseases including cancer, heart disease, arthritis, multiple
sclerosis, HIV/AIDS, among others. Biologics are often used to treat
patients with complex chronic disease and/or critically ill patients
that have not been responsive to traditional medical treatments alone.

There are currently more than 200 FDA approved biologic therapies,
including some of the most innovative new treatments for patients
suffering from debilitating diseases and conditions. While New York
State law governs the substitution by pharmacists of generic drugs for
their branded counterparts, the existing law has not been updated to
allow for the substitution of biologic products with FDA approved
interchangeable biologics. This bill will update the law to reflect
the growing market of biologic products and increased availability of
biosimilar products that are designated as interchangeable by the FDA.
Without this change to current law, automatic substitution of biologic
products will be prohibited.

 PRIOR LEGISLATIVE HISTORY :

Similar to S6311 of 2016

 FISCAL IMPLICATIONS :
None

 EFFECTIVE DATE :
Immediately.

2017-S4788 - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4788
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                               March 1, 2017
                                ___________
 
 Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
   printed to be committed 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.

                                                            LBD02608-02-7

 S. 4788                             2
 
 WILL NOT EXCEED THE PRICE THAT WOULD HAVE BEEN CHARGED  FOR  THE  INTER-
 CHANGEABLE  BIOLOGICAL SUBSTITUTE HAD IT BEEN AVAILABLE, SUBSTITUTION OF
 AN INTERCHANGEABLE BIOLOGICAL PRODUCT  WILL  NOT  BE  REQUIRED.  IF  THE
 INTERCHANGEABLE  BIOLOGICAL PRODUCT IS NOT AVAILABLE AND A MEDICAL EMER-
 GENCY 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 PRESCRIBED BIOLOGICAL 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.
   (C) The prescriber shall inform the patient  whether  he  or  she  has
 prescribed a brand name or its generic equivalent drug product OR INTER-
 CHANGEABLE BIOLOGICAL PRODUCT.
   [(c)]  (D)  The  provisions  of  this subdivision shall not apply to a
 hospital as defined in article twenty-eight of the public health law.
   [(d)] (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 drug product pursuant to paragraph (o)
 of subdivision one of section two hundred six of the public health law.
   § 3. Section 6816-a of the education law is amended  by  adding  three
 new subdivisions 3, 4 and 5 to read as follows:
   3.  A  PHARMACIST SHALL SUBSTITUTE A LESS EXPENSIVE BIOLOGICAL PRODUCT
 FOR A PRESCRIBED BIOLOGICAL PRODUCT PROVIDED THAT ALL OF  THE  FOLLOWING
 CONDITIONS ARE MET:
   (A)  THE  BIOLOGICAL  PRODUCT HAS BEEN DETERMINED BY THE UNITED STATES
 FOOD AND DRUG ADMINISTRATION TO BE INTERCHANGEABLE WITH  THE  PRESCRIBED
 PRODUCT;
   (B) THE PRESCRIBER DOES NOT DESIGNATE THAT A SUBSTITUTION IS PROHIBIT-
 ED AS DESCRIBED IN SUBDIVISION SIX OF SECTION SIXTY-EIGHT HUNDRED TEN OF
 THIS ARTICLE; AND
   (C)  THE  PHARMACIST  INDICATES  ON THE LABEL AFFIXED TO THE IMMEDIATE
 CONTAINER IN WHICH THE BIOLOGICAL PRODUCT IS  SOLD  OR  DISTRIBUTED  THE
 NAME  AND  STRENGTH OF THE PRODUCT AND ITS MANUFACTURER UNLESS THE PRES-
 CRIBER SPECIFICALLY STATES OTHERWISE.
   4. (A) WITHIN FIVE BUSINESS DAYS FOLLOWING THE DISPENSING OF A BIOLOG-
 ICAL PRODUCT, THE DISPENSING PHARMACIST  OR  THE  PHARMACIST'S  DESIGNEE
 SHALL COMMUNICATE TO THE PRESCRIBER THE SPECIFIC PRODUCT PROVIDED TO THE
 PATIENT,  INCLUDING  THE  NAME  OF THE PRODUCT AND THE MANUFACTURER. THE
 COMMUNICATION SHALL BE CONVEYED TO THE PRESCRIBER (I) BY MAKING AN ENTRY
 THAT IS ELECTRONICALLY ACCESSIBLE TO THE PRESCRIBER THROUGH AN  INTEROP-
 ERABLE  ELECTRONIC  MEDICAL  RECORDS  SYSTEM,  AN ELECTRONIC PRESCRIBING
 TECHNOLOGY OR A PHARMACY RECORD; OR (II) BY USING FACSIMILE,  ELECTRONIC
 TRANSMISSION OR OTHER ELECTRONIC MEANS. IF AN ELECTRONIC MEANS DESCRIBED
 IN  THIS  PARAGRAPH  IS  NOT  AVAILABLE TO THE PHARMACIST AT THE TIME OF
 COMMUNICATION, THE DISPENSING PHARMACIST OR  THE  PHARMACIST'S  DESIGNEE
 MAY COMMUNICATE THE INFORMATION BY TELEPHONE.
   (B) COMMUNICATION UNDER PARAGRAPH (A) OF THIS SUBDIVISION SHALL NOT BE
 REQUIRED WHERE:
   (I)  THERE IS NO FDA-APPROVED INTERCHANGEABLE BIOLOGIC FOR THE PRODUCT
 PRESCRIBED; OR
   (II) A REFILL PRESCRIPTION IS NOT CHANGED FROM THE  PRODUCT  DISPENSED
 ON THE PRIOR FILLING OF THE PRESCRIPTION.
   5. THE DEPARTMENT SHALL MAINTAIN A LINK ON ITS WEB SITE TO THE CURRENT
 LIST  OF ALL BIOLOGICAL PRODUCTS DETERMINED BY THE FEDERAL FOOD AND DRUG

 S. 4788                             3
 
 ADMINISTRATION TO BE AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A SPECIF-
 IC BIOLOGICAL PRODUCT.
   §  4.  Subparagraph 2 of paragraph (o) of subdivision 1 of section 206
 of the public health law, as amended by chapter 913 of the laws of 1986,
 is amended to read as follows:
   (2) 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 drugs products with the thera-
 peutic  equivalence  evaluations,  provided,  however,  that  the   list
 prepared  by  the  commissioner shall not include any drug product which
 the commissioner of the Federal Food and Drug Administration has identi-
 fied 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 INTERCHANGEABILITY.
   § 5. This act shall take effect immediately.

co-Sponsors

2017-S4788A (ACTIVE) - Details

See Assembly Version of this Bill:: A7509
Law Section:: Education Law
Laws Affected:: Amd §§6802, 6810 & 6816-a, Ed L; amd §206, Pub Health L

2017-S4788A (ACTIVE) - Summary

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

2017-S4788A (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S4788A

 TITLE OF BILL :  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

 PURPOSE :

This bill would establish requirements for pharmacies to substitute
and dispense biological products.

 SUMMARY OF PROVISIONS :

Section 1 amends section 6802 of the education law to add the
definition of biological product as defined in subsection (i) of
section 351 of the Public Health Service Act 42 U.S.C. Section 262(i);
and adds the definition of interchangeable biologic product as defined
pursuant to 42 U.S.C. Section 262(k)(4) or as determined by the FDA to
be therapeutically equivalent.

Sections 2 and 3 amend sections 6810 and 6816-a of the education law
to extend notification to the patient by the prescriber regarding the
product prescribed to include an interchangeable biological product,
as is existing practice with a brand name or its generic equivalent
drug product and suspends the requirement that a pharmacist substitute

a biologic product when an interchangeable biological substitute is
not available; makes technical changes necessary to reflect the
substitution of an interchangeable biological product; sets forth the
conditions under which the substitution of a biologic product is
required; provides for the appropriate method of communication by the
pharmacist to the prescriber notifying the prescriber of the
substitution of the biologic product dispensed; requires the
Department of Health to maintain a link on its web site to the current
list of all biological products determined by the Federal Food and
Drug Administration to be an interchangeable biological product for a
specific biological product.

Section 4 makes conforming amendments to section 206 of the public
health law.

Section 5 provides for an effective date.

 JUSTIFICATION :

Biologic products represent the cutting edge of medical science and
research. They successfully treat patients with difficult to treat
diseases including cancer, heart disease, arthritis, multiple
sclerosis, HIV/AIDS, among others. Biologics are often used to treat
patients with complex chronic disease and/or critically ill patients
that have not been responsive to traditional medical treatments alone.

There are currently more than 200 FDA approved biologic therapies,
including some of the most innovative new treatments for patients
suffering from debilitating diseases and conditions. While New York
State law governs the substitution by pharmacists of generic drugs for
their branded counterparts, the existing law has not been updated to
allow for the substitution of biologic products with FDA approved
interchangeable biologics. This bill will update the law to reflect
the growing market of biologic products and increased availability of
biosimilar products that are designated as interchangeable by the FDA.
Without this change to current law, automatic substitution of biologic
products will be prohibited.

 PRIOR LEGISLATIVE HISTORY :

Similar to S6311 of 2016

 FISCAL IMPLICATIONS :

None

 EFFECTIVE DATE :
Immediately, provided that it shall expire five years after having
become a law.

2017-S4788A (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  4788--A
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                               March 1, 2017
                                ___________
 
 Introduced by Sens. HANNON, DeFRANCISCO, GRIFFO, HELMING, LATIMER, VALE-
   SKY  -- read twice and ordered printed, and when printed to be commit-
   ted to the Committee on Higher Education -- committee discharged, bill
   amended, ordered reprinted as amended and recommitted to said  commit-
   tee

 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.

                                                            LBD02608-03-7

 S. 4788--A                          2
 
   (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
 WILL  NOT  EXCEED  THE PRICE THAT WOULD HAVE BEEN CHARGED FOR THE INTER-
 CHANGEABLE BIOLOGICAL SUBSTITUTE HAD IT BEEN AVAILABLE, SUBSTITUTION  OF
 AN  INTERCHANGEABLE  BIOLOGICAL  PRODUCT  WILL  NOT  BE REQUIRED. IF THE
 INTERCHANGEABLE BIOLOGICAL PRODUCT IS NOT AVAILABLE AND A MEDICAL  EMER-
 GENCY  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 PRESCRIBED BIOLOGICAL 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.
   (C)  The  prescriber  shall  inform  the patient whether he or she has
 prescribed a brand name or its generic equivalent drug product OR INTER-
 CHANGEABLE BIOLOGICAL PRODUCT.
   [(c)] (D) The provisions of this subdivision  shall  not  apply  to  a
 hospital as defined in article twenty-eight of the public health law.
   [(d)]  (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 drug product pursuant to paragraph (o)
 of subdivision one of section two hundred six of the public health law.
   §  3.  Section  6816-a of the education law is amended by adding three
 new subdivisions 3, 4 and 5 to read as follows:
   3. A PHARMACIST SHALL SUBSTITUTE A LESS EXPENSIVE  BIOLOGICAL  PRODUCT
 FOR  A  PRESCRIBED BIOLOGICAL PRODUCT PROVIDED THAT ALL OF THE FOLLOWING
 CONDITIONS ARE MET:
   (A) THE SUBSTITUTED BIOLOGICAL PRODUCT IS  EITHER  AN  INTERCHANGEABLE
 BIOLOGICAL PRODUCT FOR THE PRESCRIBED PRODUCT OR THE SUBSTITUTED BIOLOG-
 ICAL PRODUCT IS ONE FOR WHICH THE PRESCRIBED PRODUCT IS AN INTERCHANGEA-
 BLE BIOLOGICAL PRODUCT;
   (B) THE PRESCRIBER DOES NOT DESIGNATE THAT A SUBSTITUTION IS PROHIBIT-
 ED AS DESCRIBED IN SUBDIVISION SIX OF SECTION SIXTY-EIGHT HUNDRED TEN OF
 THIS ARTICLE; AND
   (C)  THE  PHARMACIST  INDICATES  ON THE LABEL AFFIXED TO THE IMMEDIATE
 CONTAINER IN WHICH THE BIOLOGICAL PRODUCT IS  SOLD  OR  DISTRIBUTED  THE
 NAME  AND  STRENGTH OF THE PRODUCT AND ITS MANUFACTURER UNLESS THE PRES-
 CRIBER SPECIFICALLY STATES OTHERWISE.
   4. (A) WITHIN FIVE BUSINESS DAYS FOLLOWING THE DISPENSING OF A SUBSTI-
 TUTED BIOLOGICAL PRODUCT, THE DISPENSING PHARMACIST OR THE  PHARMACIST'S
 DESIGNEE  SHALL  COMMUNICATE  TO  THE  PRESCRIBER  THE  SPECIFIC PRODUCT
 PROVIDED TO THE PATIENT, INCLUDING THE  NAME  OF  THE  PRODUCT  AND  THE
 MANUFACTURER.  THE COMMUNICATION SHALL BE CONVEYED TO THE PRESCRIBER (I)
 BY MAKING AN ENTRY THAT IS ELECTRONICALLY ACCESSIBLE TO  THE  PRESCRIBER
 THROUGH AN INTEROPERABLE ELECTRONIC MEDICAL RECORDS SYSTEM, AN ELECTRON-
 IC PRESCRIBING TECHNOLOGY OR A PHARMACY RECORD; OR (II) BY USING FACSIM-
 ILE, ELECTRONIC TRANSMISSION OR OTHER ELECTRONIC MEANS. IF AN ELECTRONIC
 MEANS  DESCRIBED IN THIS PARAGRAPH IS NOT AVAILABLE TO THE PHARMACIST AT
 THE TIME OF COMMUNICATION, THE DISPENSING PHARMACIST OR THE PHARMACIST'S
 DESIGNEE MAY COMMUNICATE THE INFORMATION BY TELEPHONE.
   (B) COMMUNICATION UNDER PARAGRAPH (A) OF THIS SUBDIVISION SHALL NOT BE
 REQUIRED WHERE:
   (I) THERE IS NO FDA-APPROVED INTERCHANGEABLE  BIOLOGICAL  PRODUCT  FOR
 THE PRODUCT PRESCRIBED; OR

 S. 4788--A                          3
 
   (II)  A  REFILL PRESCRIPTION IS NOT CHANGED FROM THE PRODUCT DISPENSED
 ON THE PRIOR FILLING OF THE PRESCRIPTION.
   5. THE DEPARTMENT SHALL MAINTAIN A LINK ON ITS WEB SITE TO THE CURRENT
 LIST  OF ALL BIOLOGICAL PRODUCTS DETERMINED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION TO BE AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A SPECIF-
 IC BIOLOGICAL PRODUCT.
   § 4. Subparagraph 2 of paragraph (o) of subdivision 1 of  section  206
 of the public health law, as amended by chapter 913 of the laws of 1986,
 is amended to read as follows:
   (2)  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 drugs products with the thera-
 peutic   equivalence  evaluations,  provided,  however,  that  the  list
 prepared by the commissioner shall not include any  drug  product  which
 the commissioner of the Federal Food and Drug Administration has identi-
 fied 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 INTERCHANGEABILITY.
   § 5. This act shall take effect  immediately  and  shall  expire  five
 years after having become a law.

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Senate Bill S4788A

Sponsored By

Archive: Last Bill Status Via A7509 - Signed by Governor

Jun 21, 2017 - Floor Vote

Floor Vote: Jun 21, 2017

Jun 21, 2017 - Rules Committee Vote

Rules Committee Vote: Jun 21, 2017

Bill Amendments

co-Sponsors

2017-S4788 - Details

2017-S4788 - Summary

2017-S4788 - Sponsor Memo

2017-S4788 - Bill Text download pdf

co-Sponsors

2017-S4788A (ACTIVE) - Details

2017-S4788A (ACTIVE) - Summary

2017-S4788A (ACTIVE) - Sponsor Memo

2017-S4788A (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S4788A

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Sponsored By

Archive: Last Bill Status Via A7509 - Signed by Governor

Bill Amendments

co-Sponsors

2017-S4788 - Details

2017-S4788 - Summary

2017-S4788 - Sponsor Memo

2017-S4788 - Bill Text download pdf

co-Sponsors

2017-S4788A (ACTIVE) - Details

2017-S4788A (ACTIVE) - Summary

2017-S4788A (ACTIVE) - Sponsor Memo

2017-S4788A (ACTIVE) - Bill Text download pdf

Comments