Bill Text: NY S02310 | 2023-2024 | General Assembly | Introduced


Bill Title: 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.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2024-01-03 - REFERRED TO CONSUMER PROTECTION [S02310 Detail]

Download: New_York-2023-S02310-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                          2310

                               2023-2024 Regular Sessions

                    IN SENATE

                                    January 19, 2023
                                       ___________

        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 his or her
    17  knowledge  is  falsely  described or indicated upon any such package, or
    18  vessel containing the same, or label thereupon, in any  of  the  partic-
    19  ulars 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.
                                                                   LBD01301-01-3

        S. 2310                             2

     1  origin; or who sells or causes to be sold an article of merchandise from
     2  or upon which to his or its knowledge, or to the knowledge of his or its
     3  agents,  servants  or  employees  there  has  been  in whole or in part,
     4  removed  or  concealed  the mark of origin, or who sells or causes to be
     5  sold a pharmaceutical drug from the inspection of which  such  knowledge
     6  could  have  been  obtained,  shall be guilty of a misdemeanor, provided
     7  that it shall not be deemed a violation of this section if at  the  time
     8  of sale said article of merchandise and the immediate and outer contain-
     9  er  or  containers  thereof shall be marked, stamped, tagged, branded or
    10  labeled in legible and conspicuous  English  words  with  said  mark  of
    11  origin  or  the  concealment  thereof shall have completely ceased, in a
    12  case where the punishment for such offense is not specially provided for
    13  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 him,  unless  the  attorney

        S. 2310                             3

     1  general  shall  find,  in any case in which he seeks preliminary relief,
     2  that to give such notice and opportunity is not in the public interest.
     3    5.  In  any  such action it shall be a complete defense that the actor
     4  practice is, or if in interstate  commerce  would  be,  subject  to  and
     5  complies  with  the  rules and regulations of, and the statutes adminis-
     6  tered by, the federal food  and  drug  administration  or  any  official
     7  department,  division, commission or agency of the United States as such
     8  rules, regulations or statutes are interpreted by the federal  food  and
     9  drug  administration  or such department, division, commission or agency
    10  or the federal courts.
    11    § 2. This act shall take effect immediately.
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