SB 628 — 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
 1   Amending the act of April 14, 1972 (P.L.233, No.64), entitled
 2      "An act relating to the manufacture, sale and possession of
 3      controlled substances, other drugs, devices and cosmetics;
 4      conferring powers on the courts and the secretary and
 5      Department of Health, and a newly created Pennsylvania Drug,
 6      Device and Cosmetic Board; establishing schedules of
 7      controlled substances; providing penalties; requiring
 8      registration of persons engaged in the drug trade and for the
 9      revocation or suspension of certain licenses and
10      registrations; and repealing an act," further providing for
11      definitions and for misbranding.
12      The General Assembly of the Commonwealth of Pennsylvania
13   hereby enacts as follows:
14      Section 1.     Section 2(b) of the act of April 14, 1972
15   (P.L.233, No.64), known as The Controlled Substance, Drug,
16   Device and Cosmetic Act, is amended by adding definitions to
17   read:
18      Section 2.     Definitions.--* * *
19      (b)   As used in this act:
20      * * *
21      "Food allergen" means any of the following:
22      (1)   Milk.
 1      (2)    Eggs.
 2      (3)    Fish.
 3      (4)    Shellfish.
 4      (5)    Tree nuts.
 5      (6)    Peanuts.
 6      (7)    Wheat.
 7      (8)    Soybeans.
 8      (9)    Sesame.
 9      "Gluten-containing grain" means any of the following grains
10   or a crossbred hybrid of any of the following grains:
11      (1)    wheat, including any species belonging to the genus
12   Triticum;
13      (2)    rye, including any species belonging to the genus
14   Secale;
15      (3)    barley, including any species belonging to the genus
16   Hordeum; or
17      (4)    oat, including any species belonging to the genus Avena
18   sativa.
19      * * *
20      Section 2.      Section 8 of the act is amended by adding a
21   clause to read:
22      Section 8.      Misbranding.--A controlled substance, other drug
23   or device or cosmetic shall be deemed to be misbranded:
24      * * *
25      (13)     If it is an oral controlled substance or other oral
26   drug containing an ingredient derived directly or indirectly
27   from a gluten-containing grain or food allergen, unless its
28   label bears a statement that the drug contains the ingredient
29   and identifies the ingredient and type of gluten-containing
30   grain from which the ingredient is derived.

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1     Section 3.    This act shall take effect in two years.




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