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 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. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: Section 1. The definition of "drug" in 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 and the subsection is amended by adding a definition to read: Section 2. Definitions.--* * * (b) As used in this act: * * * "Drug" means: (i) substances recognized in the official United States Pharmacopeia, or official National Formulary, or 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 any supplement to either of them; and (ii) substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (iii) substances (other than food) intended to affect the structure or any function of the human body or other animal body; and (iv) food that contains a vaccine or vaccine material; and (v) substances intended for use as a component of any article specified in clause (i), (ii) or (iii), but not including devices or their components, parts or accessories. * * * "Vaccine or vaccine material" means a substance intended for use in humans to stimulate the production of antibodies and provide immunity against disease, prepared from the causative agent of a disease, its products or a synthetic substitute, treated to act as an antigen without inducing the disease, that is authorized or approved by the United States Food and Drug Administration. Section 2. This act shall take effect immediately. 20250SB0405PN0396 - 2 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18