Senate Bill S8544

2025-2026 Legislative Session

Excludes certain medication abortion drugs from being deemed unlawful to prescribe or dispense and from being deemed misbranded under certain circumstances

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Current Bill Status - In Senate Committee Rules 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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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Oct 24, 2025	referred to rules

2025-S8544 (ACTIVE) - Details

Current Committee:: Senate Rules
Law Section:: Penal Law
Laws Affected:: Amd §178.00, Pen L; amd §§6802 & 6815, Ed L

2025-S8544 (ACTIVE) - Summary

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.

2025-S8544 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S8544

SPONSOR: HINCHEY
 
TITLE OF BILL:

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

 
PURPOSE:

Exempts brand name or generic mifepristone or any drug used for medica-
tion abortion from being considered a criminal diversion act if
prescribed, dispensed, or received, and from being considered adulterat-
ed or misbranded solely because it is no longer approved by the federal
food and drug administration.

 
SUMMARY OF PROVISIONS:

Section 1 amends subdivision 3 of § 178.00 of the penal law by renumber-
ing, paragraphs (a), (b), (c), (d) to (i), (ii), (iii), (iv).  It adds a

new paragraph (b) stating the prescribing, dispensing, or receipt of
brand name or generic mifepristone or any drug used for medication
abortion shall not be considered a criminal diversion act solely because
it is no longer approved by the FDA or because it no longer bears the
label currently in effect, provided that, its labelling was true and
accurate at the time of manufacturing and the drug is recommended for
the purpose for which it was prescribed under WHO guidelines.

Section 2 amends subdivision 13 of § 6802 of the education law, by
adding paragraph c stating brand name or generic mifepristone or any
drug used for medication abortion shall not be considered to be adulter-
ated or misbranded solely because it is no longer approved or because it
no longer bears the label currently in effect, provided that, its label-
ling was true and accurate at the time of manufacturing and the drug is
recommended for the purpose for which it was prescribed under WHO guide-
lines.

Section 3 amends § 6815 of the education law by adding a new subdivision
3 stating brand name or generic mifepristone or any drug used for medi-
cation abortion shall not be considered adulterated or misbranded solely
because it is no longer approved or because it no longer bears the label
currently in effect, provided that, its labelling was true and accurate
at the time of manufacturing and the drug is recommended for the purpose
for which it was prescribed under WHO guidelines.

Section 4 provides a severability clause.

Section 5 provides the effective date.

 
JUSTIFICATION:

In September of 2025, the Health and Human Services Secretary announced
the FDA would conduct a review on the safety and efficacy of mifepri-
stone- a crucial component of the 2-drug medication abortion regimen and
used to help manage early pregnancy loss.* While there is no legitimate
scientific basis for this review, the administration is utilizing one
particular paper that claims higher complication rates from mifepristone
than previously known as justification. However, this paper which has
not been peer-reviewed or published in a medical journal, presents
flawed methodology and skewed findings.**

For over two decades, mifepristone has been documented and demonstrated
as safe and effective. The medication is highly effective and serious
complications from the mifepristone are exceedingly rare, with rates of
major adverse events well under 1 percent.*** In fact, data analysis has
shown that mifepristone is even safer than some prescription drugs, like
penicillin and Viagra.****

This bill exempts brand name or generic mifepristone or any drug used
for medication abortion from being considered a criminal diversion act
if prescribed, dispensed, or received, and from being considered adul-
terated or misbranded solely because it is no longer approved by the
federal food and drug administration or because it no longer, bears the
label currently in effect, provided that, its labelling was true and
accurate at the time of manufacturing and the drug is recommended for
the purpose for which it was prescribed under WHO guidelines. Illinois
and California enacted substantially similar legislation, respectively
in August and September of 2025.*****

This bill will ensure New York providers are able to continue prescrib-
ing and dispensing mifepristone without fear of criminal or professional
consequence if the FDA rescinds its approval.  Additionally, the bill
will protect New York patients by ensuring continued access to this
lifesaving drug. Our state must do everything we can to protect access
to safe and effective reproductive health care for all.

 
LEGISLATIVE HISTORY:

New bill.

 
FISCAL IMPLICATIONS:

None to the State.

 
EFFECTIVE DATE:
This act shall take effect immediately.
*. https://www.thequardian.com/us-news/2025/may/
14/rfk-jr-fda-abortion-pillmifepristone
**. https://www.aclu.org/press-releases/trump-administration- announces-
that-fda-will-consider-imposing-greater-restrictions-on- medication-a-
bortion-nationwide
***. https://www.fda.gov/drugs/postmarket-drug-safety- information-pa-
tients- and-providers/questions-and-answers-mifepristone-medical- termi-
nation-pregnancy-through-ten-weeks-gestation ,and,
https:/www.accessdata.fda.gov/drugsatfdadocsnabel/2016/020687s0201b1.pcif
****. https://www.cnn.com/2023/03/15/health/abortion-pill-safety-dg/
index.html
*****.  https://www.politico.com/news/2025/10/02/fda-approved-new-
genericabortion- pill-before-shutdown-00592352, and,
https://www.politico.com/news/2025/09/26/california- doctors-can-pres-
cribeabortion-anonymously-00582594

2025-S8544 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8544
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   Section  1. Subdivision 3 of section 178.00 of the penal law, as added
 by chapter 81 of the laws of 1995, is amended to read as follows:
   3. (A) "Criminal diversion act" means an act or acts in which a person
 knowingly:
   [(a)] (I) transfers or delivers, in exchange for anything of pecuniary
 value, a prescription medication or device with knowledge or  reasonable
 grounds to know that the recipient has no medical need for it; or
   [(b)]  (II)  receives,  in exchange for anything of pecuniary value, a
 prescription medication or device with knowledge or  reasonable  grounds
 to  know  that the seller or transferor is not authorized by law to sell
 or transfer such prescription medication or device; or
   [(c)] (III) transfers or  delivers  a  prescription  in  exchange  for
 anything of pecuniary value; or
   [(d)] (IV) receives a prescription in exchange for anything of pecuni-
 ary value.
   (B)  THE  PRESCRIBING, DISPENSING, OR RECEIPT OF BRAND NAME OR GENERIC
 MIFEPRISTONE OR ANY DRUG USED  FOR  MEDICATION  ABORTION  SHALL  NOT  BE
 CONSIDERED  A  CRIMINAL  DIVERSION  ACT  FOR PURPOSES OF THIS DEFINITION
 SOLELY BECAUSE IT IS NO LONGER APPROVED BY THE  FEDERAL  FOOD  AND  DRUG
 ADMINISTRATION  OR  BECAUSE  IT  NO  LONGER BEARS THE LABEL CURRENTLY IN
 EFFECT, PROVIDED THAT:
   (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

 
   (II) THE DRUG  IS  RECOMMENDED  FOR  THE  PURPOSE  FOR  WHICH  IT  WAS
 PRESCRIBED  UNDER  WORLD HEALTH ORGANIZATION GUIDELINES THAT ARE CURRENT
 AT THE TIME OF PRESCRIBING OR DISPENSING.
   §  2. Subdivision 13 of section 6802 of the education law, as added by
 chapter 987 of the laws of 1971, is amended to read as follows:
   13. "Misbranding". A. If a drug, device or cosmetic is alleged  to  be
 misbranded because the labeling is misleading, or if an advertisement is
 alleged to be false because it is misleading then in determining whether
 the  labeling  or  advertisement is misleading there shall be taken into
 account (among other things) not only representations made or  suggested
 by  statement,  word,  design, device, sound or any combination thereof,
 but also the extent to which the labeling fails to reveal facts material
 in the light of such representations or material with respect to  conse-
 quences  which  may result from the use of the drug, device, or cosmetic
 to which the labeling or advertising relates under the conditions of use
 prescribed in the labeling or advertising thereof or under  such  condi-
 tions of use as are customary or usual.
   B.  No drug, device or cosmetic which is subject to, and complies with
 regulations promulgated under the provisions of the federal food,  drug,
 and  cosmetic  act,  relating  to  adulteration and misbranding shall be
 deemed to be adulterated or misbranded in violation of the provisions of
 this article because of its failure to comply  with  the  board's  regu-
 lations,  or  the  rules  of the state board of pharmacy, insofar as the
 regulations are in conflict with regulations  relating  to  adulteration
 and misbranding under the federal food, drug and cosmetic act.
   C.  NOTWITHSTANDING  PARAGRAPH  B  OF  THIS SUBDIVISION, BRAND NAME OR
 GENERIC MIFEPRISTONE OR ANY DRUG USED FOR MEDICATION ABORTION SHALL  NOT
 BE DEEMED TO BE ADULTERATED OR MISBRANDED IN VIOLATION OF THE PROVISIONS
 OF  THIS  ARTICLE  SOLELY  BECAUSE IT IS NO LONGER APPROVED OR NO LONGER
 BEARS THE LABEL CURRENTLY IN EFFECT, PROVIDED THAT (1) ITS LABELING  WAS
 TRUE AND ACCURATE AT THE TIME OF MANUFACTURE; AND (2) THE DRUG IS RECOM-
 MENDED  FOR  THE  PURPOSE FOR WHICH IT WAS PRESCRIBED UNDER WORLD HEALTH
 ORGANIZATION GUIDELINES THAT ARE CURRENT AT THE TIME OF  PRESCRIBING  OR
 DISPENSING.
   §  3.  Section  6815  of  the education law is amended by adding a new
 subdivision 3 to read as follows:
   3. DRUGS USED FOR MEDICATION ABORTION. BRAND NAME OR GENERIC  MIFEPRI-
 STONE  OR  ANY  DRUG USED FOR MEDICATION ABORTION SHALL NOT BE DEEMED AN
 ADULTERATED OR MISBRANDED DRUG IN VIOLATION OF THE  PROVISIONS  OF  THIS
 ARTICLE  SOLELY  BECAUSE IT IS NO LONGER APPROVED OR NO LONGER BEARS THE
 LABEL CURRENTLY IN EFFECT, PROVIDED THAT:
   A. ITS LABELING WAS TRUE AND ACCURATE AT THE TIME OF MANUFACTURE; AND
   B. THE DRUG IS RECOMMENDED FOR THE PURPOSE FOR WHICH IT WAS PRESCRIBED
 UNDER WORLD HEALTH ORGANIZATION GUIDELINES THAT ARE CURRENT AT THE  TIME
 OF PRESCRIBING OR DISPENSING.
   § 4. Severability. If any item, clause, sentence, subparagraph, subdi-
 vision, section or other part of this act, or the application thereof to
 any  person  or  circumstances shall be held to be invalid, such holding
 shall not affect, impair or invalidate the remainder of this act, or the
 application of such section or part of a section held  invalid,  to  any
 other person or circumstances, but shall be confined in its operation to
 the  item, clause, sentence, subparagraph, subdivision, section or other
 part of this act directly involved in such holding, or to the person and
 circumstances therein involved.
   § 5. This act shall take effect immediately.

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Senate Bill S8544

Sponsored By

Current Bill Status - In Senate Committee Rules Committee

Actions

2025-S8544 (ACTIVE) - Details

2025-S8544 (ACTIVE) - Summary

2025-S8544 (ACTIVE) - Sponsor Memo

2025-S8544 (ACTIVE) - Bill Text download pdf

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Sponsored By

Michelle Hinchey

Current Bill Status - In Senate Committee Rules Committee

Actions

2025-S8544 (ACTIVE) - Details

2025-S8544 (ACTIVE) - Summary

2025-S8544 (ACTIVE) - Sponsor Memo

2025-S8544 (ACTIVE) - Bill Text download pdf

Comments