NY State Senate Bill 2025-S1862

Senate Bill S1862

2025-2026 Legislative Session

Provides for the proper packaging and labeling of pharmaceutical drugs; creates penalties for intentional fraud

download bill text pdf

Current Bill Status - In Senate Committee Consumer Protection Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 14, 2025	referred to consumer protection

2025-S1862 (ACTIVE) - Details

Current Committee:: Senate Consumer Protection
Law Section:: General Business Law
Laws Affected:: Add §392-k, Gen Bus L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S3164
2021-2022: S276
2023-2024: S2310

2025-S1862 (ACTIVE) - Summary

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.

2025-S1862 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S1862

SPONSOR: MYRIE
 
TITLE OF BILL:

An act to amend the general business law, in relation to preserving the
integrity and safety of pharmaceutical drugs

 
PURPOSE:

This measure provides better consumer protection against the fraudulent
sales, distribution, improper packaging, and labeling of pharmaceutical
drugs as well as creates penalties for individuals or business entities
intentionally deceiving consumers with feigned drug products.

 
SUMMARY OF PROVISIONS:

Section 1 amends the general business law by adding a new section 392-k
which defines a person with intent to defraud as one who puts on a phar-
maceutical drug any false description, or sells or offers for sale a
pharmaceutical he or she knows is falsely described, or distributes,
sells or exposes for sale any goods in bulk under the misrepresentation

of some other manufacturer or producer. It also includes that one who
removes, or conceals the mark of origin from a pharmaceutical drug, or
knowingly causes to be sold, an article of merchandise, where there has
been in whole or part removed or concealed the mark of origin, will be
guilty of a misdemeanor.

Section 2 provides the effective date.

 
JUSTIFICATION:

While the regulation of the pharmaceutical industry is largely a federal
matter, more can and should be done at the state level to assure the
safe, fair, and honest practice of pharmaceutical distribution and clear
penalties need to be established when laws are violated endangering the
lives of consumers.

Recently, there has been an explosion of domestic pharmaceutical coun-
terfeiting cases. In 2002, the Federal Drug Administration opened at
least 20 separate cases of illegal and fraudulent drug products being
distributed on the open market. In Florida, the FDA seized $7 million
worth of fake pharmaceuticals and in Texas, $1.5 million in phony
products were confiscated. In 1998, the federal government passed the
Prescription Drug Market Act, which required the states to license
wholesalers and distributors as well as prohibited hospitals or pharma-
cies from reselling drugs to anyone but patients.  Unfortunately, the
drug distribution industry is not as highly regulated as the law intends
it to be, thus leaving a gray unevenly monitored market that comprises
some 8,000 individual companies. This measure would aid New York State
in its ability to regulate the market, thus eliminating the availability
of these dangerous counterfeit pharmaceuticals.

 
LEGISLATIVE HISTORY:

S2310 of 2023-24: Referred to Consumer Protection.

S276 of 2021-22: Referred to Consumer Protection.

S3164 of 2019-20: Referred to Consumer Protection.

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2025-S1862 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1862
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   Section 1. The general business law is amended by adding a new section
 392-k to read as follows:
   § 392-K. FALSE LABELS AND MISREPRESENTATIONS OF PHARMACEUTICAL  DRUGS.
 1. A PERSON, WHO WITH INTENT TO DEFRAUD:
   A.  PUTS  UPON A PHARMACEUTICAL DRUG, OR UPON A CASK, BOTTLE, STOPPER,
 VESSEL, CASE, COVER, WRAPPER, PACKAGE,  BAND,  TICKET,  LABEL  OR  OTHER
 THING,  CONTAINING  OR  COVERING SUCH PHARMACEUTICAL DRUG, OR WITH WHICH
 SUCH A PHARMACEUTICAL DRUG IS INTENDED TO BE SOLD, OR IS SOLD, ANY FALSE
 DESCRIPTION OR OTHER INDICATION OF OR RESPECTING THE TYPE OF  PHARMACEU-
 TICAL  SUBSTANCE  OR COMPOUND, KIND, NUMBER, QUANTITY, WEIGHT OR MEASURE
 OF SUCH SUBSTANCE, OR ANY PART THEREOF, OR THE PLACE OR COUNTRY WHERE IT
 WAS MANUFACTURED OR PRODUCED  OR  THE  QUALITY  OR  GRADE  OF  ANY  SUCH
 SUBSTANCE,  IF  THE  QUALITY  OR  GRADE THEREOF IS REQUIRED BY LAW TO BE
 MARKED, BRANDED OR OTHERWISE INDICATED ON OR  WITH  SUCH  PHARMACEUTICAL
 DRUG; OR
   B.  SELLS  OR  OFFERS  FOR  SALE  A PHARMACEUTICAL DRUG, WHICH TO SUCH
 PERSON'S KNOWLEDGE IS FALSELY DESCRIBED OR INDICATED UPON ANY SUCH PACK-
 AGE, OR VESSEL CONTAINING THE SAME, OR LABEL THEREUPON, IN  ANY  OF  THE
 PARTICULARS SPECIFIED; OR
   C.  DISTRIBUTES,  SELLS OR EXPOSES FOR SALE ANY GOODS IN BULK TO WHICH
 NO NAME OR TRADEMARK SHALL BE ATTACHED, AND ORALLY OR OTHERWISE  REPRES-
 ENTS THAT SUCH PHARMACEUTICAL DRUGS ARE THE MANUFACTURE OR PRODUCTION OF
 SOME OTHER THAN THE ACTUAL MANUFACTURER OR PRODUCER; OR
   D.  REMOVES  OR  CONCEALS OR WHO SHALL CAUSE TO BE, WHOLLY OR IN PART,
 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
 
 ORIGIN; OR WHO SELLS OR CAUSES TO BE SOLD AN ARTICLE OF MERCHANDISE FROM
 OR  UPON WHICH TO SUCH PERSON'S OR ITS KNOWLEDGE, OR TO THE KNOWLEDGE OF
 SUCH PERSON'S OR ITS AGENTS, SERVANTS OR EMPLOYEES  THERE  HAS  BEEN  IN
 WHOLE  OR IN PART, REMOVED OR CONCEALED THE MARK OF ORIGIN, OR WHO SELLS
 OR CAUSES TO BE SOLD A PHARMACEUTICAL DRUG FROM THE INSPECTION OF  WHICH
 SUCH  KNOWLEDGE COULD HAVE BEEN OBTAINED, SHALL BE GUILTY OF A MISDEMEA-
 NOR, PROVIDED THAT IT SHALL NOT BE DEEMED A VIOLATION OF THIS SECTION IF
 AT THE TIME OF SALE SAID ARTICLE OF MERCHANDISE AND  THE  IMMEDIATE  AND
 OUTER  CONTAINER OR CONTAINERS THEREOF SHALL BE MARKED, STAMPED, TAGGED,
 BRANDED OR LABELED IN LEGIBLE AND CONSPICUOUS ENGLISH  WORDS  WITH  SAID
 MARK  OF ORIGIN OR THE CONCEALMENT THEREOF SHALL HAVE COMPLETELY CEASED,
 IN A CASE WHERE  THE  PUNISHMENT  FOR  SUCH  OFFENSE  IS  NOT  SPECIALLY
 PROVIDED FOR OTHERWISE BY STATUTE, IS GUILTY OF A MISDEMEANOR.
   2.  FOR  THE  PURPOSES OF THIS SECTION, THE FOLLOWING WORDS SHALL HAVE
 THE FOLLOWING DEFINITIONS:
   A. "PERSON" SHALL BE DEEMED TO INCLUDE A  FIRM,  PARTNERSHIP,  ASSOCI-
 ATION OR CORPORATION.
   B.  "SELL"  SHALL BE DEEMED TO INCLUDE OFFER TO SELL, EXPOSE FOR SALE,
 AND POSSESS WITH INTENT TO DISPOSE OF OR TO SELL.
   C. "PHARMACEUTICAL DRUG" SHALL BE DEEMED TO INCLUDE  A  CASK,  BOTTLE,
 STOPPER,  VESSEL,  CASE, COVER, WRAPPER, PACKAGE, BAND, TICKET, LABEL OR
 OTHER THING CONTAINING OR COVERING A PHARMACEUTICAL,  OR  WITH  WHICH  A
 PHARMACEUTICAL DRUG IS INTENDED TO BE SOLD, OR IS SOLD.
   D. "REMOVE" SHALL BE DEEMED TO INCLUDE DEFACE, ALTER AND OBLITERATE.
   E. "CONCEAL" SHALL BE DEEMED TO INCLUDE THE ORIGINAL PLACING OF A MARK
 OF  ORIGIN  UPON  AN ARTICLE OF MERCHANDISE IN ANY MANNER WHATSOEVER, OR
 THE ARRANGING OR COMBINING OF TWO OR MORE ARTICLES OF MERCHANDISE INTO A
 SINGLE UNIT WHEREBY THE MARK OF ORIGIN IS REMOVED FROM OPEN VIEW, OR  IS
 RENDERED ILLEGIBLE OR INCONSPICUOUS.
    F.  THE  TERMS  "REMOVE"  AND "CONCEAL" ARE NOT TO BE DEEMED MUTUALLY
 EXCLUSIVE.
   3. WHENEVER THERE SHALL BE A VIOLATION OF THIS SECTION, AN APPLICATION
 MAY BE MADE BY THE ATTORNEY GENERAL IN THE NAME OF  THE  PEOPLE  OF  THE
 STATE OF NEW YORK TO A COURT OR JUSTICE HAVING JURISDICTION BY A SPECIAL
 PROCEEDING TO ISSUE AN INJUNCTION TO ENJOIN AND RESTRAIN THE CONTINUANCE
 OF  SUCH  VIOLATIONS;  AND IF IT SHALL APPEAR TO THE SATISFACTION OF THE
 COURT OR JUSTICE THAT THE DEFENDANT HAS, IN FACT, VIOLATED THIS ARTICLE,
 AN INJUNCTION MAY BE ISSUED BY  SUCH  COURT  OR  JUSTICE  ENJOINING  AND
 RESTRAINING  ANY  FURTHER  VIOLATION,  WITHOUT  REQUIRING PROOF THAT ANY
 PERSON HAS, IN FACT, BEEN  INJURED  OR  DAMAGED  THEREBY.  IN  ANY  SUCH
 PROCEEDING,  THE  COURT  MAY  MAKE ALLOWANCES TO THE ATTORNEY GENERAL AS
 PROVIDED IN PARAGRAPH SIX OF SUBDIVISION  (A)  OF  SECTION  EIGHTY-THREE
 HUNDRED  THREE  OF THE CIVIL PRACTICE LAW AND RULES, AND DIRECT RESTITU-
 TION. WHENEVER THE COURT  SHALL  DETERMINE  THAT  A  VIOLATION  OF  THIS
 SECTION  HAS  OCCURRED  THE COURT MAY IMPOSE A CIVIL PENALTY OF NOT MORE
 THAN FIVE HUNDRED DOLLARS FOR EACH VIOLATION. FOR THE PURPOSES  OF  THIS
 SECTION  EACH  GROUP  OF  IDENTICAL  ITEMS  SHALL  CONSTITUTE  A  SINGLE
 VIOLATION. IN CONNECTION WITH ANY SUCH PROPOSED APPLICATION, THE  ATTOR-
 NEY  GENERAL IS AUTHORIZED TO TAKE PROOF AND MAKE A DETERMINATION OF THE
 RELEVANT FACTS AND TO ISSUE SUBPOENAS IN ACCORDANCE WITH THE CIVIL PRAC-
 TICE LAW AND RULES.
   4. BEFORE ANY VIOLATION OF THIS SECTION IS SOUGHT TO BE ENJOINED,  THE
 ATTORNEY  GENERAL SHALL BE REQUIRED TO GIVE THE PERSON AGAINST WHOM SUCH
 PROCEEDING IS CONTEMPLATED NOTICE BY CERTIFIED MAIL AND  AN  OPPORTUNITY
 TO SHOW IN WRITING WITHIN FIVE BUSINESS DAYS AFTER RECEIPT OF NOTICE WHY
 PROCEEDINGS  SHOULD  NOT  BE  INSTITUTED AGAINST SUCH PERSON, UNLESS THE
 S. 1862                             3
 
 ATTORNEY GENERAL SHALL FIND, IN ANY CASE IN WHICH THE  ATTORNEY  GENERAL
 SEEKS  PRELIMINARY  RELIEF,  THAT TO GIVE SUCH NOTICE AND OPPORTUNITY IS
 NOT IN THE PUBLIC INTEREST.
   5.  IN  ANY  SUCH ACTION IT SHALL BE A COMPLETE DEFENSE THAT THE ACTOR
 PRACTICE IS, OR IF IN INTERSTATE  COMMERCE  WOULD  BE,  SUBJECT  TO  AND
 COMPLIES  WITH  THE  RULES AND REGULATIONS OF, AND THE STATUTES ADMINIS-
 TERED BY, THE FEDERAL FOOD  AND  DRUG  ADMINISTRATION  OR  ANY  OFFICIAL
 DEPARTMENT,  DIVISION, COMMISSION OR AGENCY OF THE UNITED STATES AS SUCH
 RULES, REGULATIONS OR STATUTES ARE INTERPRETED BY THE FEDERAL  FOOD  AND
 DRUG  ADMINISTRATION  OR SUCH DEPARTMENT, DIVISION, COMMISSION OR AGENCY
 OR THE FEDERAL COURTS.
   § 2. This act shall take effect immediately.

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