SB 405 — 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.

PRINTER'S NO.    396

                     THE GENERAL ASSEMBLY OF PENNSYLVANIA



                        SENATE BILL
                        No. 405
                                               Session of
                                                 2025

     INTRODUCED BY BARTOLOTTA, MASTRIANO, STEFANO, DUSH AND KEEFER,
        MARCH 17, 2025

     REFERRED TO HEALTH AND HUMAN SERVICES, MARCH 17, 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.
12      The General Assembly of the Commonwealth of Pennsylvania
13   hereby enacts as follows:
14      Section 1.    The definition of "drug" in section 2(b) of the
15   act of April 14, 1972 (P.L.233, No.64), known as The Controlled
16   Substance, Drug, Device and Cosmetic Act, is amended and the
17   subsection is amended by adding a definition to read:
18      Section 2.    Definitions.--* * *
19      (b)   As used in this act:
20      * * *
21      "Drug" means: (i) substances recognized in the official
22   United States Pharmacopeia, or official National Formulary, or
 1   any supplement to either of them; and (ii) substances intended
 2   for use in the diagnosis, cure, mitigation, treatment or
 3   prevention of disease in man or other animals; and (iii)
 4   substances (other than food) intended to affect the structure or
 5   any function of the human body or other animal body; and (iv)
 6   food that contains a vaccine or vaccine material; and (v)
 7   substances intended for use as a component of any article
 8   specified in clause (i), (ii) or (iii), but not including
 9   devices or their components, parts or accessories.
10      * * *
11      "Vaccine or vaccine material" means a substance intended for
12   use in humans to stimulate the production of antibodies and
13   provide immunity against disease, prepared from the causative
14   agent of a disease, its products or a synthetic substitute,
15   treated to act as an antigen without inducing the disease, that
16   is authorized or approved by the United States Food and Drug
17   Administration.
18      Section 2.     This act shall take effect immediately.




20250SB0405PN0396                    - 2 -