Bill Text: NY A00101 | 2017-2018 | 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 - Dead) 2018-01-03 - referred to consumer affairs and protection [A00101 Detail]

Download: New_York-2017-A00101-Introduced.html


                STATE OF NEW YORK
        ________________________________________________________________________
                                           101
                               2017-2018 Regular Sessions
                   IN ASSEMBLY
                                       (Prefiled)
                                     January 4, 2017
                                       ___________
        Introduced by M. of A. CAHILL -- read once and referred to the Committee
          on Consumer Affairs and 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
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01393-01-7

        A. 101                              2
     1    d. Removes or conceals or who shall cause to be, wholly  or  in  part,
     2  removed  or  concealed  from  or  upon a pharmaceutical drug the mark of
     3  origin; or who sells or causes to be sold an article of merchandise from
     4  or upon which to his or its knowledge, or to the knowledge of his or its
     5  agents,  servants  or  employees  there  has  been  in whole or in part,
     6  removed or concealed the mark of origin, or who sells or  causes  to  be
     7  sold  a  pharmaceutical drug from the inspection of which such knowledge
     8  could have been obtained, shall be guilty  of  a  misdemeanor,  provided
     9  that  it  shall not be deemed a violation of this section if at the time
    10  of sale said article of merchandise and the immediate and outer contain-
    11  er or containers thereof shall be marked, stamped,  tagged,  branded  or
    12  labeled  in  legible  and  conspicuous  English  words with said mark of
    13  origin or the concealment thereof shall have  completely  ceased,  in  a
    14  case where the punishment for such offense is not specially provided for
    15  otherwise by statute, is guilty of a misdemeanor.
    16    2.  For  the  purposes of this section, the following words shall have
    17  the following definitions:
    18    a. "Person" shall be deemed to include a  firm,  partnership,  associ-
    19  ation or corporation.
    20    b.  "Sell"  shall be deemed to include offer to sell, expose for sale,
    21  and possess with intent to dispose of or to sell.
    22    c. "Pharmaceutical drug" shall be deemed to include  a  cask,  bottle,
    23  stopper,  vessel,  case, cover, wrapper, package, band, ticket, label or
    24  other thing containing or covering a pharmaceutical,  or  with  which  a
    25  pharmaceutical drug is intended to be sold, or is sold.
    26    d. "Remove" shall be deemed to include deface, alter and obliterate.
    27    e. "Conceal" shall be deemed to include the original placing of a mark
    28  of  origin  upon  an article of merchandise in any manner whatsoever, or
    29  the arranging or combining of two or more articles of merchandise into a
    30  single unit whereby the mark of origin is removed from open view, or  is
    31  rendered illegible or inconspicuous.
    32     f.  The  terms  "remove"  and "conceal" are not to be deemed mutually
    33  exclusive.
    34    3. Whenever there shall be a violation of this section, an application
    35  may be made by the attorney general in the name of  the  people  of  the
    36  state of New York to a court or justice having jurisdiction by a special
    37  proceeding to issue an injunction to enjoin and restrain the continuance
    38  of  such  violations;  and if it shall appear to the satisfaction of the
    39  court or justice that the defendant has, in fact, violated this article,
    40  an injunction may be issued by  such  court  or  justice  enjoining  and
    41  restraining  any  further  violation,  without  requiring proof that any
    42  person has, in fact, been  injured  or  damaged  thereby.  In  any  such
    43  proceeding,  the  court  may  make allowances to the attorney general as
    44  provided in paragraph six of subdivision  (a)  of  section  eighty-three
    45  hundred  three  of the civil practice law and rules, and direct restitu-
    46  tion. Whenever the court  shall  determine  that  a  violation  of  this
    47  section  has  occurred  the court may impose a civil penalty of not more
    48  than five hundred dollars for each violation. For the purposes  of  this
    49  section  each  group  of  identical  items  shall  constitute  a  single
    50  violation. In connection with any such proposed application, the  attor-
    51  ney  general is authorized to take proof and make a determination of the
    52  relevant facts and to issue subpoenas in accordance with the civil prac-
    53  tice law and rules.
    54    4. Before any violation of this section is sought to be enjoined,  the
    55  attorney  general shall be required to give the person against whom such
    56  proceeding is contemplated notice by certified mail and  an  opportunity

        A. 101                              3
     1  to show in writing within five business days after receipt of notice why
     2  proceedings  should  not  be instituted against him, unless the attorney
     3  general shall find, in any case in which he  seeks  preliminary  relief,
     4  that to give such notice and opportunity is not in the public interest.
     5    5.  In  any  such action it shall be a complete defense that the actor
     6  practice is, or if in interstate  commerce  would  be,  subject  to  and
     7  complies  with  the  rules and regulations of, and the statutes adminis-
     8  tered by, the federal food  and  drug  administration  or  any  official
     9  department,  division, commission or agency of the United States as such
    10  rules, regulations or statutes are interpreted by the federal  food  and
    11  drug  administration  or such department, division, commission or agency
    12  or the federal courts.
    13    § 2. This act shall take effect immediately.
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