NY State Senate Bill 2019-S3164

Senate Bill S3164

2019-2020 Legislative Session

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

download bill text pdf

Archive: Last 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 08, 2020	referred to consumer protection
Feb 04, 2019	referred to consumer protection

2019-S3164 (ACTIVE) - Details

See Assembly Version of this Bill:: A171
Current Committee:: Senate Consumer Protection
Law Section:: General Business Law
Laws Affected:: Add §392-k, Gen Bus L
Versions Introduced in Other Legislative Sessions:: 2009-2010: A604
2011-2012: A320
2013-2014: A1372
2015-2016: A1215
2017-2018: A101
2021-2022: S276, A1156
2023-2024: S2310

2019-S3164 (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.

2019-S3164 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S3164

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 392-a is added to Article 26 (Miscellaneous) of the General
Business Law to include false labels and misrepresentations of pharma-
ceutical drugs as a fraud and is subject to civil penalties.

 
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
of some 8,000 individual companies.  This measure would aid New York
State in its ability to regulate the market, thus eliminating the avail-
ability of these dangerous counterfeit pharmaceuticals.

 
LEGISLATIVE HISTORY:

2017-2018: A.101 - Referred to Consumer Affairs and Protection
2015-2016: A.1215 - Referred to Consumer Affairs and Protection
2013-2014: A.1372 - Referred to Consumer Affairs and Protection
2011-2012: A.320 - Referred to Consumer Affairs and Protection
2009-2010: A.604 - Referred to Consumer Affairs and Protection
2007-2008: A.290 - Referred to Consumer Affairs and Protection
2005-2006: A.2040 - Referred to Consumer Affairs and Protection
2003-2004: A.9352 - Referred to Consumer Affairs and Protection

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2019-S3164 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3164
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                             February 4, 2019
                                ___________
 
 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 HIS OR HER
 KNOWLEDGE  IS  FALSELY  DESCRIBED OR INDICATED UPON ANY SUCH PACKAGE, OR
 VESSEL CONTAINING THE SAME, OR LABEL THEREUPON, IN ANY  OF  THE  PARTIC-
 ULARS 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.

                                                            LBD01890-01-9

 S. 3164                             2
 
 ORIGIN; OR WHO SELLS OR CAUSES TO BE SOLD AN ARTICLE OF MERCHANDISE FROM
 OR UPON WHICH TO HIS OR ITS KNOWLEDGE, OR TO THE KNOWLEDGE OF HIS 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 MISDEMEANOR, 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 CONTAIN-
 ER  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 HIM,  UNLESS  THE  ATTORNEY

 S. 3164                             3
 
 GENERAL  SHALL  FIND,  IN ANY CASE IN WHICH HE 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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