Amd §280-a, add §278-b, Pub Health L; amd §6810, Ed L
Enacts the "foreign drug transparency act" to provide information on the origin, manufacture and distribution of prescription drugs; requires a pharmacy benefit manager to maintain, and make available to pharmacies, health plans, and patients upon request, supply chain information for prescription drugs covered under its network.
STATE OF NEW YORK
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10967
IN ASSEMBLY
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:
1 Section 1. This act shall be entitled the "foreign drug transparency
2 act".
3 § 2. Legislative intent. The legislature hereby finds and declares
4 that:
5 1. The United States prescription drug supply chain is increasingly
6 globalized, with a significant portion of finished drug products and
7 active pharmaceutical ingredients (APIs) manufactured outside of the
8 United States.
9 2. Patients, pharmacists, and health care providers often lack access
10 to clear and accessible information regarding the origin and manufactur-
11 ing of prescription drugs.
12 3. Transparency regarding the origin, manufacture, and distribution of
13 prescription drugs is essential to ensuring patient confidence, informed
14 decision-making, and supply chain accountability.
15 4. The legislature recognizes and supports ongoing bipartisan federal
16 efforts, including the CLEAR LABELS Act, to require disclosure of drug
17 manufacturing and supply chain information.
18 5. It is the intent of this act to complement federal law by ensuring
19 that such information is readily accessible to consumers at the point of
20 dispensing within New York State.
21 § 3. Subdivision 1 of section 280-a of the public health law is
22 amended by adding three new paragraphs (j), (k), and (l) to read as
23 follows:
24 (j) "Active pharmaceutical ingredient" or "API" means any substance or
25 component intended to furnish pharmacological activity in the diagnosis,
26 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
A. 10967 2
1 (k) "Original manufacturer" means the entity that performs the final
2 substantial manufacturing step prior to the introduction of an API or
3 finished drug product into interstate commerce.
4 (l) "Supply chain information" means:
5 (i) The country of origin of the finished drug product;
6 (ii) The country or countries of origin of any active pharmaceutical
7 ingredients;
8 (iii) The name and place of business of the original manufacturer of
9 the API;
10 (iv) The name and place of business of the manufacturer of the
11 finished drug product; and
12 (v) The name and place of business of any packer or distributor, if
13 applicable.
14 § 4. Section 6810 of the education law is amended by adding a new
15 subdivision 1-b to read as follows:
16 1-b.(a) In addition to the labeling requirements pursuant to subdivi-
17 sion one of this section, a pharmacy shall ensure that, at the time a
18 prescription drug is dispensed to a patient, supply chain information,
19 as defined in paragraph (l) of subdivision one of section two hundred
20 eighty-a of the public health law, is made readily accessible to the
21 patient.
22 (b) Such information shall be provided through one or more of the
23 following methods:
24 (i) A clearly visible notation on the prescription label or accompany-
25 ing documentation indicating the country of origin of the finished drug
26 product;
27 (ii) A machine-readable code, including but not limited to a QR code,
28 or a digital link that directs the patient to a publicly accessible
29 source containing supply chain information; or
30 (iii) A printed or electronic document provided to the patient at the
31 point of sale.
32 (c) Such disclosures shall be presented in a clear, conspicuous, and
33 consumer-friendly manner, consistent with applicable federal law and
34 regulations.
35 § 5. Subdivision 2 of section 280-a of the public health law is
36 amended by adding a new paragraph (f-1) to read as follows:
37 (f-1) (i) A pharmacy benefit manager shall maintain, and make avail-
38 able to pharmacies, health plans, and patients upon request, supply
39 chain information for prescription drugs covered under its network.
40 (ii) Such information shall be transmitted in a standardized electron-
41 ic format sufficient to enable compliance with the requirements of this
42 title.
43 § 6. The public health law is amended by adding a new section 278-b to
44 read as follows:
45 § 278-b. Electronic portal. The commissioner shall:
46 (a) Develop or designate a publicly accessible electronic portal or
47 database through which patients may access supply chain information for
48 prescription drugs dispensed within the state;
49 (b) Promulgate rules and regulations necessary to implement the
50 provisions of this act, including standards for data formatting, acces-
51 sibility, and consumer readability; and
52 (c) Ensure that implementation of this act is consistent with, and
53 does not conflict with, federal law governing drug labeling and regu-
54 lation.
55 § 7. Construction. Nothing in this act shall be construed to require
56 labeling or disclosures that are preempted by federal law, including the
A. 10967 3
1 Federal Food, Drug, and Cosmetic Act. The provisions of this act shall
2 be implemented to complement and align with federal requirements relat-
3 ing to drug labeling and supply chain transparency.
4 § 8. This act shall take effect on the one hundred eightieth day after
5 it shall have become a law. Effective immediately, the addition, amend-
6 ment and/or repeal of any rule or regulation necessary for the implemen-
7 tation of this act on its effective date are authorized to be made and
8 completed on or before such effective date.
