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.
              

                                                            LBD11241-02-7

 A. 7509--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

 A. 7509--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.