Provides for the proper packaging and labeling of pharmaceutical drugs; creates penalties for intentional fraudulent replacement, packaging, and labeling of such drugs; provides for better consumer protection.
STATE OF NEW YORK
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1862
2025-2026 Regular Sessions
IN SENATE
January 14, 2025
___________
Introduced by Sen. MYRIE -- read twice and ordered printed, and when
printed to be committed to the Committee on Consumer Protection
AN ACT to amend the general business law, in relation to preserving the
integrity and safety of pharmaceutical drugs
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The general business law is amended by adding a new section
2 392-k to read as follows:
3 § 392-k. False labels and misrepresentations of pharmaceutical drugs.
4 1. A person, who with intent to defraud:
5 a. Puts upon a pharmaceutical drug, or upon a cask, bottle, stopper,
6 vessel, case, cover, wrapper, package, band, ticket, label or other
7 thing, containing or covering such pharmaceutical drug, or with which
8 such a pharmaceutical drug is intended to be sold, or is sold, any false
9 description or other indication of or respecting the type of pharmaceu-
10 tical substance or compound, kind, number, quantity, weight or measure
11 of such substance, or any part thereof, or the place or country where it
12 was manufactured or produced or the quality or grade of any such
13 substance, if the quality or grade thereof is required by law to be
14 marked, branded or otherwise indicated on or with such pharmaceutical
15 drug; or
16 b. Sells or offers for sale a pharmaceutical drug, which to such
17 person's knowledge is falsely described or indicated upon any such pack-
18 age, or vessel containing the same, or label thereupon, in any of the
19 particulars specified; or
20 c. Distributes, sells or exposes for sale any goods in bulk to which
21 no name or trademark shall be attached, and orally or otherwise repres-
22 ents that such pharmaceutical drugs are the manufacture or production of
23 some other than the actual manufacturer or producer; or
24 d. Removes or conceals or who shall cause to be, wholly or in part,
25 removed or concealed from or upon a pharmaceutical drug the mark of
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD05414-01-5
S. 1862 2
1 origin; or who sells or causes to be sold an article of merchandise from
2 or upon which to such person's or its knowledge, or to the knowledge of
3 such person's or its agents, servants or employees there has been in
4 whole or in part, removed or concealed the mark of origin, or who sells
5 or causes to be sold a pharmaceutical drug from the inspection of which
6 such knowledge could have been obtained, shall be guilty of a misdemea-
7 nor, provided that it shall not be deemed a violation of this section if
8 at the time of sale said article of merchandise and the immediate and
9 outer container or containers thereof shall be marked, stamped, tagged,
10 branded or labeled in legible and conspicuous English words with said
11 mark of origin or the concealment thereof shall have completely ceased,
12 in a case where the punishment for such offense is not specially
13 provided for otherwise by statute, is guilty of a misdemeanor.
14 2. For the purposes of this section, the following words shall have
15 the following definitions:
16 a. "Person" shall be deemed to include a firm, partnership, associ-
17 ation or corporation.
18 b. "Sell" shall be deemed to include offer to sell, expose for sale,
19 and possess with intent to dispose of or to sell.
20 c. "Pharmaceutical drug" shall be deemed to include a cask, bottle,
21 stopper, vessel, case, cover, wrapper, package, band, ticket, label or
22 other thing containing or covering a pharmaceutical, or with which a
23 pharmaceutical drug is intended to be sold, or is sold.
24 d. "Remove" shall be deemed to include deface, alter and obliterate.
25 e. "Conceal" shall be deemed to include the original placing of a mark
26 of origin upon an article of merchandise in any manner whatsoever, or
27 the arranging or combining of two or more articles of merchandise into a
28 single unit whereby the mark of origin is removed from open view, or is
29 rendered illegible or inconspicuous.
30 f. The terms "remove" and "conceal" are not to be deemed mutually
31 exclusive.
32 3. Whenever there shall be a violation of this section, an application
33 may be made by the attorney general in the name of the people of the
34 state of New York to a court or justice having jurisdiction by a special
35 proceeding to issue an injunction to enjoin and restrain the continuance
36 of such violations; and if it shall appear to the satisfaction of the
37 court or justice that the defendant has, in fact, violated this article,
38 an injunction may be issued by such court or justice enjoining and
39 restraining any further violation, without requiring proof that any
40 person has, in fact, been injured or damaged thereby. In any such
41 proceeding, the court may make allowances to the attorney general as
42 provided in paragraph six of subdivision (a) of section eighty-three
43 hundred three of the civil practice law and rules, and direct restitu-
44 tion. Whenever the court shall determine that a violation of this
45 section has occurred the court may impose a civil penalty of not more
46 than five hundred dollars for each violation. For the purposes of this
47 section each group of identical items shall constitute a single
48 violation. In connection with any such proposed application, the attor-
49 ney general is authorized to take proof and make a determination of the
50 relevant facts and to issue subpoenas in accordance with the civil prac-
51 tice law and rules.
52 4. Before any violation of this section is sought to be enjoined, the
53 attorney general shall be required to give the person against whom such
54 proceeding is contemplated notice by certified mail and an opportunity
55 to show in writing within five business days after receipt of notice why
56 proceedings should not be instituted against such person, unless the
S. 1862 3
1 attorney general shall find, in any case in which the attorney general
2 seeks preliminary relief, that to give such notice and opportunity is
3 not in the public interest.
4 5. In any such action it shall be a complete defense that the actor
5 practice is, or if in interstate commerce would be, subject to and
6 complies with the rules and regulations of, and the statutes adminis-
7 tered by, the federal food and drug administration or any official
8 department, division, commission or agency of the United States as such
9 rules, regulations or statutes are interpreted by the federal food and
10 drug administration or such department, division, commission or agency
11 or the federal courts.
12 § 2. This act shall take effect immediately.
