An Act amending the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, further providing for schedules of controlled substances and providing for tianeptine-related adverse health events.

PRINTER'S NO. 1067
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 946
Session of
2025
INTRODUCED BY MASTRIANO AND LAUGHLIN, JULY 23, 2025
REFERRED TO HEALTH AND HUMAN SERVICES, JULY 23, 2025
AN ACT
Amending the act of April 14, 1972 (P.L.233, No.64), entitled
"An act relating to the manufacture, sale and possession of
controlled substances, other drugs, devices and cosmetics;
conferring powers on the courts and the secretary and
Department of Health, and a newly created Pennsylvania Drug,
Device and Cosmetic Board; establishing schedules of
controlled substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
revocation or suspension of certain licenses and
registrations; and repealing an act," further providing for
schedules of controlled substances and providing for
tianeptine-related adverse health events.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 4(2)(i) of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act, is amended to read:
Section 4. Schedules of Controlled Substances.--The
following schedules include the controlled substances listed or
to be listed by whatever official name, common or usual name,
chemical name, or trade name designated.
* * *
(2) Schedule II--In determining that a substance comes
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within this schedule, the secretary shall find: a high potential
for abuse, currently accepted medical use in the United States,
or currently accepted medical use with severe restrictions, and
abuse may lead to severe psychic or physical dependence. The
following controlled substances are included in this schedule:
(i) Any of the following substances, of any quantity, except
those narcotics specifically excepted or listed in other
schedules, whether produced directly or indirectly by extraction
from substances of vegetable origin, or independently by means
of chemical synthesis, or by combination of extraction and
chemical synthesis:
1. Opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate, including hydrocodone, morphine
and oxycodone.
2. Any salt, compound, derivative, or preparation thereof
which is chemically equivalent or identical with any of the
substances referred to in subclause 1, except that these
substances shall not include the isoquinoline alkaloids of
opium.
3. Opium poppy and poppy straw.
4. Coca leaves and any salt, compound, derivative, or
preparation of coca leaves, and any salt, compound, derivative,
or preparation thereof which is chemically equivalent or
identical with any of these substances, but shall not include
decocainized coca leaves or extracts of coca leaves, which
extracts do not contain cocaine or ecgonine.
5. Tianeptine.
* * *
Section 2. The act is amended by adding a section to read:
Section 13.10. Tianeptine-related Adverse Health Events.--
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(a) The department shall monitor adverse health events
associated with tianeptine and may collect data from health care
providers, hospitals, poison control centers, coroners, medical
examiners and law enforcement agencies.
(b) The department shall issue public advisories regarding
the dangers of tianeptine exposure when adverse health events or
usage trends present a significant threat to public safety. The
department may coordinate with local health departments,
emergency responders and relevant Federal agencies to inform and
protect the public.
(c) The department may promulgate rules and regulations
necessary to carry out the provisions of this section, including
mandatory reporting requirements, data collection standards and
interagency coordination protocols.
(d) As used in this section, the term "adverse health event"
shall mean the following:
(1) Any acute or chronic physical, mental or behavioral
condition that arises from the ingestion, use, misuse, abuse or
withdrawal of tianeptine or any substance containing tianeptine,
whether occurring independently or in combination with other
substances, including:
(i) Neurological symptoms, including confusion, sedation,
loss of consciousness, seizures or coma.
(ii) Respiratory effects, including depressed breathing or
respiratory failure.
(iii) Cardiovascular symptoms, including elevated or
decreased heart rate, abnormal blood pressure or cardiac arrest.
(iv) Psychological effects, including addiction, dependence,
paranoia, hallucinations, anxiety or suicidal ideation.
(v) Gastrointestinal symptoms, including nausea, vomiting or
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abdominal distress.
(vi) Withdrawal-related symptoms, including agitation,
muscle pain, insomnia, tremors or cravings.
(vii) Any fatal or life-threatening reaction, including
those resulting from overdose or interaction with other
substances.
(2) Any emergency medical intervention, hospitalization or
death linked to confirmed or suspected tianeptine exposure, as
determined by medical or toxicological evidence.
Section 3. This act shall take effect in 60 days.
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