S T A T E O F N E W Y O R K
________________________________________________________________________
8648--A
I N A S S E M B L Y
January 7, 2016
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Introduced by M. of A. GOTTFRIED, TITONE, SKOUFIS, RAIA, LUPINACCI,
BARRETT, McDONOUGH, QUART, STECK -- read once and referred to the
Committee on Higher Education -- committee discharged, bill amended,
ordered reprinted as amended and recommitted to said committee
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."
S 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
WILL NOT EXCEED THE PRICE THAT WOULD HAVE BEEN CHARGED FOR THE INTER-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD13220-03-6
A. 8648--A 2
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.
S 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 BY USING FACSIMILE OR ELECTRONIC TRANS-
MISSION.
(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
ADMINISTRATION TO BE AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A SPECIF-
IC BIOLOGICAL PRODUCT.
S 4. Subparagraphs 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:
A. 8648--A 3
(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.
S 5. This act shall take effect immediately.