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

Statutes affected:
S8544: 178.00 penal law, 178.00(3) penal law, 6802 education law, 6802(13) education law, 6815 education law