Requires physicians and other prescribers to obtain electronic or written consent for certain medications with "black box warnings."

A1154

ASSEMBLY, No. 1154

STATE OF NEW JERSEY

222nd LEGISLATURE

�

PRE-FILED FOR INTRODUCTION IN THE 2026 SESSION

Sponsored by:

Assemblyman JOE DANIELSEN

District 17 (Middlesex and Somerset)

Assemblywoman ANNETTE QUIJANO

District 20 (Union)

SYNOPSIS

���� Requires physicians and other prescribers to obtain
electronic or written consent for certain medications with "black box
warnings."

CURRENT VERSION OF TEXT

���� Introduced Pending Technical Review by Legislative
Counsel.

��

An Act
concerning the prescribing of certain medications and
supplementing Title 45 of the Revised Statutes.

����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:

���� 1.��� Prior to prescribing an
individual any psychotropic medication, including but not limited to medication
for the treatment of Attention Deficit Disorder or Attention Deficit and
Hyperactivity Disorder, required by the federal Food and Drug Administration to
have a �black box warning� on its labeling, a physician or other authorized
prescriber shall inform the individual or the individual�s legal guardian about
the possible side effects of the medication and shall obtain informed
electronic or written consent from the individual or the individual�s legal
guardian acknowledging receipt of the notification and authorizing issuance of
the prescription.� In the event electronic or written consent cannot be
obtained but oral consent is provided, the physician or other authorized
prescriber shall make a notation in the patient�s file setting forth the date
and circumstances of the informed consent.

���� A physician or other
authorized prescriber who prescribes a medication in violation of this act
shall be subject to disciplinary action by the State Board of Medical
Examiners.

���� 2.��� Prior to prescribing an
individual any psychotropic medication, including but not limited to medication
for the treatment of Attention Deficit Disorder or Attention Deficit and
Hyperactivity Disorder, required by the federal Food and Drug Administration to
have a �black box warning� on its labeling, a physician assistant shall inform
the individual or the individual�s legal guardian about the possible side
effects of the medication, and shall obtain informed electronic or written
consent from the individual or the individual�s legal guardian acknowledging
receipt of the notification and authorizing issuance of the prescription.� In
the event electronic or written consent cannot be obtained but oral consent is
provided, the physician assistant shall make a notation in the patient�s file
setting forth the date and circumstances of the informed consent.

���� A physician assistant who
prescribes a medication in violation of this act shall be subject to
disciplinary action by the State Board of Medical Examiners.

���� 3.��� Prior to prescribing an
individual any psychotropic medication, including but not limited to medication
for the treatment of Attention Deficit Disorder or Attention Deficit and
Hyperactivity Disorder, required by the federal Food and Drug Administration to
have a �black box warning� on its labeling, an advanced practice nurse shall inform
the individual or the individual�s legal guardian about the possible side
effects of the medication and shall obtain informed electronic or written
consent from the individual or the individual�s legal guardian acknowledging
receipt of the notification and authorizing issuance of the prescription.� In
the event electronic or written consent cannot be obtained but oral consent is
provided, the advanced practice nurse shall make a notation in the patient�s
file setting forth the date and circumstances of the informed consent.

���� An advanced practice nurse who
prescribes a medication in violation of this act shall be subject to
disciplinary action by the New Jersey Board of Nursing.

���� 4.��� The Division of Consumer
Affairs in the Department of Law and Public Safety, in consultation with the
Department of Health, shall adopt, pursuant to the "Administrative
Procedure Act," P.L.1968 c.410 (C.52:14B-1 et seq.), rules and regulations
necessary to implement the provisions of this act.

���� 5.��� This act shall take
effect 180 days after enactment.

STATEMENT

���� This bill requires physicians,
physician assistants, advanced practice nurses, and other authorized
prescribers to obtain informed electronic or written consent prior to
prescribing them psychotropic medications that are accompanied by a �black box
warning,� which consent is to include an electronic or a written
acknowledgement that the patient or the patient�s guardian received
notification about the black box warning.� The bill specifies that in cases
where electronic or written consent cannot be obtained but oral consent is
provided, the prescriber must make a notation in the patient�s file indicating
the date and circumstances of the informed consent.

���� The United States Food and
Drug Administration (FDA) requires pharmaceutical companies to place a �black
box warning� on a drug label if medical studies indicate that the drug carries
a significant risk of serious or life-threatening adverse effects.� A �black
box warning� is the strongest warning that the FDA requires.

���� A physician, physician
assistant, advanced practice nurse, or other authorized prescriber who violates
the requirements established under the bill is subject to disciplinary action
by the applicable State professional licensing board.