S T A T E O F N E W Y O R K
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10967
I N A S S E M B L Y
April 14, 2026
___________
Introduced by 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 enhancing transparency in the prescription drug supply chain,
including disclosure of country of origin and manufacturer information
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. This act shall be entitled the "foreign drug transparency
act".
§ 2. Legislative intent. The legislature hereby finds and declares
that:
1. The United States prescription drug supply chain is increasingly
globalized, with a significant portion of finished drug products and
active pharmaceutical ingredients (APIs) manufactured outside of the
United States.
2. Patients, pharmacists, and health care providers often lack access
to clear and accessible information regarding the origin and manufactur-
ing of prescription drugs.
3. Transparency regarding the origin, manufacture, and distribution of
prescription drugs is essential to ensuring patient confidence, informed
decision-making, and supply chain accountability.
4. The legislature recognizes and supports ongoing bipartisan federal
efforts, including the CLEAR LABELS Act, to require disclosure of drug
manufacturing and supply chain information.
5. It is the intent of this act to complement federal law by ensuring
that such information is readily accessible to consumers at the point of
dispensing within New York State.
§ 3. Subdivision 1 of section 280-a of the public health law is
amended by adding three new paragraphs (j), (k), and (l) to read as
follows:
(J) "ACTIVE PHARMACEUTICAL INGREDIENT" OR "API" MEANS ANY SUBSTANCE OR
COMPONENT INTENDED TO FURNISH PHARMACOLOGICAL ACTIVITY IN THE DIAGNOSIS,
CURE, MITIGATION, TREATMENT, OR PREVENTION OF DISEASE.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD15453-01-6
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(K) "ORIGINAL MANUFACTURER" MEANS THE ENTITY THAT PERFORMS THE FINAL
SUBSTANTIAL MANUFACTURING STEP PRIOR TO THE INTRODUCTION OF AN API OR
FINISHED DRUG PRODUCT INTO INTERSTATE COMMERCE.
(L) "SUPPLY CHAIN INFORMATION" MEANS:
(I) THE COUNTRY OF ORIGIN OF THE FINISHED DRUG PRODUCT;
(II) THE COUNTRY OR COUNTRIES OF ORIGIN OF ANY ACTIVE PHARMACEUTICAL
INGREDIENTS;
(III) THE NAME AND PLACE OF BUSINESS OF THE ORIGINAL MANUFACTURER OF
THE API;
(IV) THE NAME AND PLACE OF BUSINESS OF THE MANUFACTURER OF THE
FINISHED DRUG PRODUCT; AND
(V) THE NAME AND PLACE OF BUSINESS OF ANY PACKER OR DISTRIBUTOR, IF
APPLICABLE.
§ 4. Section 6810 of the education law is amended by adding a new
subdivision 1-b to read as follows:
1-B.(A) IN ADDITION TO THE LABELING REQUIREMENTS PURSUANT TO SUBDIVI-
SION ONE OF THIS SECTION, A PHARMACY SHALL ENSURE THAT, AT THE TIME A
PRESCRIPTION DRUG IS DISPENSED TO A PATIENT, SUPPLY CHAIN INFORMATION,
AS DEFINED IN PARAGRAPH (L) OF SUBDIVISION ONE OF SECTION TWO HUNDRED
EIGHTY-A OF THE PUBLIC HEALTH LAW, IS MADE READILY ACCESSIBLE TO THE
PATIENT.
(B) SUCH INFORMATION SHALL BE PROVIDED THROUGH ONE OR MORE OF THE
FOLLOWING METHODS:
(I) A CLEARLY VISIBLE NOTATION ON THE PRESCRIPTION LABEL OR ACCOMPANY-
ING DOCUMENTATION INDICATING THE COUNTRY OF ORIGIN OF THE FINISHED DRUG
PRODUCT;
(II) A MACHINE-READABLE CODE, INCLUDING BUT NOT LIMITED TO A QR CODE,
OR A DIGITAL LINK THAT DIRECTS THE PATIENT TO A PUBLICLY ACCESSIBLE
SOURCE CONTAINING SUPPLY CHAIN INFORMATION; OR
(III) A PRINTED OR ELECTRONIC DOCUMENT PROVIDED TO THE PATIENT AT THE
POINT OF SALE.
(C) SUCH DISCLOSURES SHALL BE PRESENTED IN A CLEAR, CONSPICUOUS, AND
CONSUMER-FRIENDLY MANNER, CONSISTENT WITH APPLICABLE FEDERAL LAW AND
REGULATIONS.
§ 5. Subdivision 2 of section 280-a of the public health law is
amended by adding a new paragraph (f-1) to read as follows:
(F-1) (I) A PHARMACY BENEFIT MANAGER SHALL MAINTAIN, AND MAKE AVAIL-
ABLE TO PHARMACIES, HEALTH PLANS, AND PATIENTS UPON REQUEST, SUPPLY
CHAIN INFORMATION FOR PRESCRIPTION DRUGS COVERED UNDER ITS NETWORK.
(II) SUCH INFORMATION SHALL BE TRANSMITTED IN A STANDARDIZED ELECTRON-
IC FORMAT SUFFICIENT TO ENABLE COMPLIANCE WITH THE REQUIREMENTS OF THIS
TITLE.
§ 6. The public health law is amended by adding a new section 278-b to
read as follows:
§ 278-B. ELECTRONIC PORTAL. THE COMMISSIONER SHALL:
(A) DEVELOP OR DESIGNATE A PUBLICLY ACCESSIBLE ELECTRONIC PORTAL OR
DATABASE THROUGH WHICH PATIENTS MAY ACCESS SUPPLY CHAIN INFORMATION FOR
PRESCRIPTION DRUGS DISPENSED WITHIN THE STATE;
(B) PROMULGATE RULES AND REGULATIONS NECESSARY TO IMPLEMENT THE
PROVISIONS OF THIS ACT, INCLUDING STANDARDS FOR DATA FORMATTING, ACCES-
SIBILITY, AND CONSUMER READABILITY; AND
(C) ENSURE THAT IMPLEMENTATION OF THIS ACT IS CONSISTENT WITH, AND
DOES NOT CONFLICT WITH, FEDERAL LAW GOVERNING DRUG LABELING AND REGU-
LATION.
§ 7. Construction. Nothing in this act shall be construed to require
labeling or disclosures that are preempted by federal law, including the
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Federal Food, Drug, and Cosmetic Act. The provisions of this act shall
be implemented to complement and align with federal requirements relat-
ing to drug labeling and supply chain transparency.
§ 8. This act shall take effect on the one hundred eightieth day after
it shall have become a law. Effective immediately, the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date are authorized to be made and
completed on or before such effective date.