S T A T E O F N E W Y O R K
________________________________________________________________________
1923
2021-2022 Regular Sessions
I N A S S E M B L Y
January 13, 2021
___________
Introduced by M. of A. PAULIN, GOTTFRIED, DINOWITZ, GALEF, J. RIVERA,
WEPRIN, ABINANTI -- read once and referred 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health law is REPEALED.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
A. 1923 2
2. THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE TO
THE DEPARTMENT THE STUDIES AND SUMMARIES, INCLUDING BIOEQUIVALENCE DATA,
THERAPEUTIC EQUIVALENCE DATA, AND INCIDENCE OF ADVERSE EVENTS, AND ASSO-
CIATED ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METHODS
PROVIDED TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF THE
APPLICATION FOR SUCH GENERIC DRUG PRODUCT. THE DEPARTMENT SHALL MAKE
SUCH INFORMATION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
§ 3. Paragraphs (a) and (e) of subdivision 6 of section 6810 of the
education law, paragraph (a) as amended by chapter 590 of the laws of
2011 and paragraph (e) as amended by chapter 357 of the laws of 2017,
are amended to read as follows:
(a) Every prescription written in this state by a person authorized to
issue such prescription shall be on prescription forms containing one
line for the prescriber's signature. The prescriber's signature shall
validate the prescription. Every electronic prescription shall provide
for the prescriber's electronic signature, which shall validate the
electronic prescription. Imprinted conspicuously on every prescription
written in this state in eight point upper case type immediately below
the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless
the prescriber writes d a w in such box in the prescriber's own hand-
writing or, in the case of electronic prescriptions, inserts an elec-
tronic direction to dispense the drug as written, the prescriber's
signature or electronic signature shall designate approval of substi-
tution by a pharmacist of a GENERIC drug product pursuant to [paragraph
(o) of subdivision one of] section [two hundred six] TWO HUNDRED EIGHT-
Y-D of the public health law. No other letters or marks in such box
shall prohibit substitution. No prescription forms used or intended to
be used by a person authorized to issue a prescription shall have 'd a
w' preprinted in such box. Such box shall be placed directly under the
signature line and shall be three-quarters inch in length and one-half
inch in height, or in comparable form for an electronic prescription as
may be specified by regulation of the commissioner. Immediately below
such box shall be imprinted in six point type the words "Dispense As
Written". Notwithstanding any other provision of law, no state offi-
cial, agency, board or other entity shall promulgate any regulation or
guideline modifying those elements of the prescription form's contents
specified in this subdivision. To the extent otherwise permitted by law,
a prescriber may modify only those elements of the prescription form's
contents not specified in this subdivision. Notwithstanding any other
provision of this section or any other law, when a generic drug is not
available and the brand name drug originally prescribed is available and
the pharmacist agrees to dispense the brand name product for a price
that will not exceed the price that would have been charged for the
generic substitute had it been available, substitution of a generic drug
product will not be required. If the generic drug product is not avail-
able and a medical emergency 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 brand name 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.
(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 GENERIC drug product pursuant to [paragraph (o) of
A. 1923 3
subdivision one of] section two hundred [six] EIGHTY-D of the public
health law.
§ 4. Paragraph (d) of subdivision 6 of section 6810 of the education
law, as added by chapter 913 of the laws of 1986, is amended to read as
follows:
(d) No prescriber shall be subjected to civil liability arising solely
from authorizing, in accordance with this subdivision, the substitution
by a pharmacist of a GENERIC drug product pursuant to [paragraph (o) of
subdivision one of] section two hundred [six] EIGHTY-D of the public
health law.
§ 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
law, as added by chapter 776 of the laws of 1977, is amended to read as
follows:
(b) The substituted drug product is contained in the list of GENERIC
drug products established pursuant to [paragraph (o) of subdivision one
of] section [two hundred six] TWO HUNDRED EIGHTY-D of the public health
law; and
§ 6. This act shall take effect on the ninetieth day after it shall
have become a law; provided that the amendments to paragraph (e) of
subdivision 6 of section 6810 of the education law, made by section
three of this act, shall not affect the expiration of such paragraph,
when upon such date the provisions of section four of this act shall
take effect. Effective immediately, the addition, amendment and/or
repeal of any rule or regulation necessary for the implementation of
this act on its effective date are authorized to be made and completed
on or before such effective date.