Enacts the "foreign drug transparency act"; requires the disclosure to a health plan, pharmacy and patient whether a prescription drug was manufactured or compounded in a foreign country; whether the prescription was approved by the federal food and drug administration foreign drug inspection program; requires the date of the last inspection of such prescription drug by the federal food and drug administration foreign drug inspection program
S T A T E O F N E W Y O R K
________________________________________________________________________
10479
I N A S S E M B L Y
May 29, 2024
___________
Introduced by COMMITTEE ON RULES -- (at request of M. of A. Blumencranz)
-- read once and referred to the Committee on Health
AN ACT to amend the public health law and the education law, in relation
to the labeling of prescriptions that are manufactured or compounded
in a foreign country and subject to approval by the federal Food and
Drug Administration foreign drug inspection program
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Short title. This act shall be known and may be cited as
the "foreign drug transparency act".
§ 2. Subdivision 3 of section 280-a of the public health law, as
amended by chapter 128 of the laws of 2022, is amended to read as
follows
3. Prescriptions. A pharmacy benefit manager may not substitute or
cause the substituting of one prescription drug for another in dispens-
ing a prescription, or alter or cause the altering of the terms of a
prescription, except with the approval of the prescriber or as explicit-
ly required or permitted by law, including regulations of the department
of financial services or the department of health. The superintendent
and commissioner, in coordination with each other, are authorized to
promulgate regulations to determine when substitution of prescription
drugs may be required or permitted. A PHARMACY BENEFIT MANAGER SHALL
DISCLOSE TO A HEALTH PLAN, PHARMACY AND PATIENT WHETHER A PRESCRIPTION
DRUG WAS MANUFACTURED OR COMPOUNDED IN A FOREIGN COUNTRY; WHETHER THE
PRESCRIPTION WAS APPROVED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION
FOREIGN DRUG INSPECTION PROGRAM; AND THE DATE OF THE LAST INSPECTION OF
SUCH PRESCRIPTION DRUG BY THE FEDERAL FOOD AND DRUG ADMINISTRATION
FOREIGN DRUG INSPECTION PROGRAM.
§ 3. Subdivision 1 of section 6810 of the education law, as amended by
section 2 of part V of chapter 57 of the laws of 2012, is amended to
read as follows
1. No drug for which a prescription is required by the provisions of
the Federal Food, Drug and Cosmetic Act or by the commissioner of health
shall be distributed or dispensed to any person except upon a
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
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