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 definitions and for misbranding.

PRINTER'S NO. 622
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 628
Session of
2025
INTRODUCED BY CAPPELLETTI, HAYWOOD, COMITTA, PENNYCUICK, COSTA,
SAVAL AND TARTAGLIONE, APRIL 11, 2025
REFERRED TO HEALTH AND HUMAN SERVICES, APRIL 11, 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
definitions and for misbranding.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 2(b) 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 definitions to
read:
Section 2. Definitions.--* * *
(b) As used in this act:
* * *
"Food allergen" means any of the following:
(1) Milk.
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(2) Eggs.
(3) Fish.
(4) Shellfish.
(5) Tree nuts.
(6) Peanuts.
(7) Wheat.
(8) Soybeans.
(9) Sesame.
"Gluten-containing grain" means any of the following grains
or a crossbred hybrid of any of the following grains:
(1) wheat, including any species belonging to the genus
Triticum;
(2) rye, including any species belonging to the genus
Secale;
(3) barley, including any species belonging to the genus
Hordeum; or
(4) oat, including any species belonging to the genus Avena
sativa.
* * *
Section 2. Section 8 of the act is amended by adding a
clause to read:
Section 8. Misbranding.--A controlled substance, other drug
or device or cosmetic shall be deemed to be misbranded:
* * *
(13) If it is an oral controlled substance or other oral
drug containing an ingredient derived directly or indirectly
from a gluten-containing grain or food allergen, unless its
label bears a statement that the drug contains the ingredient
and identifies the ingredient and type of gluten-containing
grain from which the ingredient is derived.
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Section 3. This act shall take effect in two years.
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