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S08544 Summary:

BILL NOS08544
 
SAME ASNo Same As
 
SPONSORHINCHEY
 
COSPNSR
 
MLTSPNSR
 
Amd §178.00, Pen L; amd §§6802 & 6815, Ed L
 
Provides that the prescribing, dispensing, or receipt of mifepristone or any drug used for medication abortion shall not be considered a criminal conversion act under certain circumstances; provides that mifepristone or any drug used for medication abortion shall not be deemed to be adulterated or misbranded under certain circumstances.
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S08544 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          8544
 
                               2025-2026 Regular Sessions
 
                    IN SENATE
 
                                    October 24, 2025
                                       ___________
 
        Introduced  by  Sen. HINCHEY -- read twice and ordered printed, and when
          printed to be committed to the Committee on Rules
 
        AN ACT to amend the penal law, in relation to excluding certain  medica-
          tion from being deemed unlawful to prescribe or dispense; and to amend
          the  education  law,  in relation to excluding certain medication from
          being deemed misbranded
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1. Subdivision 3 of section 178.00 of the penal law, as added
     2  by chapter 81 of the laws of 1995, is amended to read as follows:
     3    3. (a) "Criminal diversion act" means an act or acts in which a person
     4  knowingly:
     5    [(a)] (i) transfers or delivers, in exchange for anything of pecuniary
     6  value, a prescription medication or device with knowledge or  reasonable
     7  grounds to know that the recipient has no medical need for it; or
     8    [(b)]  (ii)  receives,  in exchange for anything of pecuniary value, a
     9  prescription medication or device with knowledge or  reasonable  grounds
    10  to  know  that the seller or transferor is not authorized by law to sell
    11  or transfer such prescription medication or device; or
    12    [(c)] (iii) transfers or  delivers  a  prescription  in  exchange  for
    13  anything of pecuniary value; or
    14    [(d)] (iv) receives a prescription in exchange for anything of pecuni-
    15  ary value.
    16    (b)  The  prescribing, dispensing, or receipt of brand name or generic
    17  mifepristone or any drug used  for  medication  abortion  shall  not  be
    18  considered  a  criminal  diversion  act  for purposes of this definition
    19  solely because it is no longer approved by the  federal  food  and  drug
    20  administration  or  because  it  no  longer bears the label currently in
    21  effect, provided that:
    22    (i) its labeling was true and accurate at the time of manufacture; and

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD13908-02-5

        S. 8544                             2
 
     1    (ii) the drug  is  recommended  for  the  purpose  for  which  it  was
     2  prescribed  under  World Health Organization guidelines that are current
     3  at the time of prescribing or dispensing.
     4    §  2. Subdivision 13 of section 6802 of the education law, as added by
     5  chapter 987 of the laws of 1971, is amended to read as follows:
     6    13. "Misbranding". a. If a drug, device or cosmetic is alleged  to  be
     7  misbranded because the labeling is misleading, or if an advertisement is
     8  alleged to be false because it is misleading then in determining whether
     9  the  labeling  or  advertisement is misleading there shall be taken into
    10  account (among other things) not only representations made or  suggested
    11  by  statement,  word,  design, device, sound or any combination thereof,
    12  but also the extent to which the labeling fails to reveal facts material
    13  in the light of such representations or material with respect to  conse-
    14  quences  which  may result from the use of the drug, device, or cosmetic
    15  to which the labeling or advertising relates under the conditions of use
    16  prescribed in the labeling or advertising thereof or under  such  condi-
    17  tions of use as are customary or usual.
    18    b.  No drug, device or cosmetic which is subject to, and complies with
    19  regulations promulgated under the provisions of the federal food,  drug,
    20  and  cosmetic  act,  relating  to  adulteration and misbranding shall be
    21  deemed to be adulterated or misbranded in violation of the provisions of
    22  this article because of its failure to comply  with  the  board's  regu-
    23  lations,  or  the  rules  of the state board of pharmacy, insofar as the
    24  regulations are in conflict with regulations  relating  to  adulteration
    25  and misbranding under the federal food, drug and cosmetic act.
    26    c.  Notwithstanding  paragraph  b  of  this subdivision, brand name or
    27  generic mifepristone or any drug used for medication abortion shall  not
    28  be deemed to be adulterated or misbranded in violation of the provisions
    29  of  this  article  solely  because it is no longer approved or no longer
    30  bears the label currently in effect, provided that (1) its labeling  was
    31  true and accurate at the time of manufacture; and (2) the drug is recom-
    32  mended  for  the  purpose for which it was prescribed under World Health
    33  Organization guidelines that are current at the time of  prescribing  or
    34  dispensing.
    35    §  3.  Section  6815  of  the education law is amended by adding a new
    36  subdivision 3 to read as follows:
    37    3. Drugs used for medication abortion. Brand name or generic  mifepri-
    38  stone  or  any  drug used for medication abortion shall not be deemed an
    39  adulterated or misbranded drug in violation of the  provisions  of  this
    40  article  solely  because it is no longer approved or no longer bears the
    41  label currently in effect, provided that:
    42    a. its labeling was true and accurate at the time of manufacture; and
    43    b. the drug is recommended for the purpose for which it was prescribed
    44  under World Health Organization guidelines that are current at the  time
    45  of prescribing or dispensing.
    46    § 4. Severability. If any item, clause, sentence, subparagraph, subdi-
    47  vision, section or other part of this act, or the application thereof to
    48  any  person  or  circumstances shall be held to be invalid, such holding
    49  shall not affect, impair or invalidate the remainder of this act, or the
    50  application of such section or part of a section held  invalid,  to  any
    51  other person or circumstances, but shall be confined in its operation to
    52  the  item, clause, sentence, subparagraph, subdivision, section or other
    53  part of this act directly involved in such holding, or to the person and
    54  circumstances therein involved.
    55    § 5. This act shall take effect immediately.
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