STATE OF NEW YORK
________________________________________________________________________
7379
2019-2020 Regular Sessions
IN ASSEMBLY
April 29, 2019
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Introduced by M. of A. BRAUNSTEIN -- read once and referred to the
Committee on Higher Education
AN ACT to amend the education law, in relation to labeling of
prescription drugs containing gluten, lactose or food dye
The People of the State of New York, represented in Senate and Assem-
bly, do enact as follows:
1 Section 1. Subdivision 2 of section 6811-a of the education law, as
2 amended by section 9 of part D of chapter 60 of the laws of 2014, is
3 amended to read as follows:
4 2. Except as otherwise authorized in the Federal Food, Drug and
5 Cosmetic Act, no drug for which any prescription is required by the
6 provisions of the Federal Food, Drug and Cosmetic Act or by the commis-
7 sioner of health contained within a bottle, vial, carton or other
8 container, or in any way affixed or appended to or enclosed within a
9 package of any kind, and designed or intended for delivery in such
10 container or package to an ultimate consumer, shall be manufactured or
11 distributed within this state unless such container or package has
12 clearly and permanently marked or imprinted upon it in conformance with
13 the applicable plan required by subdivision three of this section:
14 (a) an individual symbol, N. D. C. number, company name, number,
15 letters, words or marking identifying the manufacturer or distributor of
16 the drug;
17 (b) an N. D. C. number, symbol, number, letters, words or marking
18 identifying such drug or combination of drugs;
19 (c) where a prescription drug product contains any active or inactive
20 ingredient made from any gluten-containing grain, including wheat,
21 barley, rye, or any crossbred hybrid of such grains, or where a
22 prescription drug product contains any active or inactive ingredient
23 containing lactose, or where a prescription drug product contains food
24 dye, such ingredients shall appear on the label in words clearly identi-
25 fying each; and
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD10881-02-9
A. 7379 2
1 [(c)] (d) whenever the distributor of the prescription drug product
2 does not also manufacture the product the names and places of business
3 of both shall appear on the label in words clearly distinguishing each.
4 § 2. This act shall take effect immediately.