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 for secure storage of xylazine; and adding provisions relating to medetomidine.

PRINTER'S NO. 1082
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 866
Session of
2025
INTRODUCED BY BROOKS, MASTRIANO, TARTAGLIONE AND BOSCOLA,
JULY 24, 2025
REFERRED TO AGRICULTURE AND RURAL AFFAIRS, JULY 24, 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 for secure storage of
xylazine; and adding provisions relating to medetomidine.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 4(3) of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act, is amended by adding subclauses 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.
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(3) Schedule III--In determining that a substance comes
within this schedule, the secretary shall find: a potential for
abuse less than the substances listed in Schedules I and II;
well documented and currently accepted medical use in the United
States; and abuse may lead to moderate or low physical
dependence or high psychological dependence. The following
classes of controlled substances are included in this schedule:
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(xii) Medetomidine, including any compound, mixture or
preparation which contains any quantity of the substances
referred to in this clause.
(xiii) Medetomidine as described in subclause (xii) is not a
controlled substance when used in any of the following manners:
1. Dispensing or prescribing for, or administering to, a
nonhuman species of a drug containing medetomidine that:
(A) has been approved by the United States Secretary of
Health and Human Services under 21 U.S.C. § 360b (relating to
new animal drugs); or
(B) is authorized under 21 U.S.C. § 360b(a)(4).
2. The manufacturing, distribution or use of medetomidine as
an active pharmaceutical ingredient for manufacturing an animal
drug approved under 21 U.S.C. § 360b or an animal drug that has
been issued an investigation use exemption under 21 U.S.C. §
360b(j).
3. The manufacturing, distribution or use of a medetomidine
bulk chemical for pharmaceutical compounding by a licensed
pharmacist or veterinarians.
4. Any other use approved or authorized under 21 U.S.C. Ch.
9 (relating to Federal Food, Drug, and Cosmetic Act).
5. Another use approved or permissible under Federal or
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State law.
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Section 2. Section 13.9 of the act, added May 15, 2024
(P.L.364, No.17), is amended to read:
Section 13.9. Secure Storage of Medetomidine and Xylazine.--
A practitioner who is a veterinarian shall comply with the
provisions of section 4(a)(5) of the act of September 27, 1961
(P.L.1700, No.699), known as the "Pharmacy Act," for the storage
and protection of medetomidine and xylazine.
Section 3. This act shall take effect immediately.
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