HB928: In epinephrine auto-injector entities, further providing for definitions and for epinephrine…

PRIOR PRINTER'S NOS. 992, 1833 PRINTER'S NO. 1979 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL No. 928 Session of 2025 INTRODUCED BY KOSIEROWSKI, MARCELL, VENKAT, SANCHEZ, WAXMAN, GUENST, BURGOS, MADDEN, DEASY, HANBIDGE, HILL-EVANS, OTTEN, KENYATTA, HADDOCK, MAYES, BOYD, CURRY, CERRATO, DONAHUE, BOROWSKI, McNEILL, SCHLOSSBERG, MIHALEK, O'MARA, WEBSTER, CIRESI, WARREN, ISAACSON, FREEMAN, SHUSTERMAN, CEPEDA- FREYTIZ, GIRAL, PIELLI, STEELE, HOWARD, DALEY, MALAGARI, KRAJEWSKI, KHAN, C. WILLIAMS AND MADSEN, MARCH 17, 2025 AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES, JUNE 23, 2025 AN ACT Amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, in epinephrine auto-injector entities, further providing for definitions and for epinephrine auto- injectors for authorized entities; and making an editorial change. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: Section 1. The heading of Chapter 55 of Title 35 of the Pennsylvania Consolidated Statutes is amended to read: CHAPTER 55 EPINEPHRINE [AUTO-INJECTOR ENTITIES] DELIVERY SYSTEM Section 2. The definitions of "administer," "authorized entity" and "epinephrine auto-injector" in section 5502 of Title 35 are amended and the section is amended by adding definitions to read: § 5502. Definitions. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Administer." The direct application of an epinephrine [auto-injector] delivery system to the body of an individual. "Authorized entity." Any entity or organization, other than a school entity or a nonpublic school under section 1414.2 of the act of March 10, 1949 (P.L.30, No.14), known as the Public School Code of 1949, which has an employee or agent who has completed the required training and at which allergens capable of causing anaphylaxis may be present, including, but not limited to: (1) recreation camps; (2) colleges and universities; [(3) day-care facilities;] (4) youth sports leagues; (5) amusement parks; (6) restaurants; (7) places of employment; (8) sports arenas; and (9) law enforcement agencies. "Day-care facility." A child care center and a family child care home as those terms are defined in Article X of the act of June 13, 1967 (P.L.31, No.21), known as the Human Services Code. * * * ["Epinephrine auto-injector." A single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.] "Epinephrine delivery system." A device approved by the United States Food and Drug Administration that contains a 20250HB0928PN1979 - 2 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 premeasured , WEIGHT-BASED dose of epinephrine and is used to administer epinephrine into the human body to prevent or treat a life- threatening allergic reaction. * * * Section 3. Section 5503 of Title 35 is amended to read: § 5503. Epinephrine [auto-injectors] delivery systems for authorized entities and day-care facilities. (a) Prescribing and dispensing.--Notwithstanding any provision of law to the contrary, a health care practitioner with prescriptive authority may prescribe epinephrine [auto- injectors] delivery systems in the name of an authorized entity or day-care facility for use in accordance with this section. Pharmacists and health care practitioners may dispense epinephrine [auto-injectors] delivery systems pursuant to a prescription issued in the name of an authorized entity or day- care facility. (b) Supply.-- [(1)] An authorized entity may acquire and stock a supply of epinephrine [auto-injectors] delivery systems pursuant to a prescription issued in accordance with this section. [The epinephrine auto-injectors shall be stored: (i) in a location readily accessible in an emergency; and (ii) in accordance with: (A) the epinephrine auto-injector's instructions for use; and (B) any additional requirements that may be established by the department. (2) An authorized entity shall designate employees or agents who have completed the training required under 20250HB0928PN1979 - 3 - <--1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 subsection (d) to be responsible for the storage, maintenance, control and general oversight of epinephrine auto-injectors acquired by the authorized entity.] A day-care facility may SHALL , subject to funding being specifically designated to the department , acquire and stock a supply of epinephrine delivery systems pursuant to a prescription issued in accordance with this section. (b.1) Storage.-- (1) An epinephrine delivery systems SYSTEM shall be stored: (i) in a location readily accessible in an emergency; and (ii) in accordance with: (A) the epinephrine delivery system's instructions for use; and (B) any additional requirements that may be established by the department. (2) An authorized entity or day-care facility shall designate employees or agents who have completed the required training under subsection (d) to be responsible for the storage, maintenance, control and general oversight of epinephrine delivery systems acquired by the authorized entity or day-care facility. (c) Use.--An employee or agent of an authorized entity or other individual associated with the entity or an employee or agent of a day-care facility who has completed the training required under subsection (d) may use epinephrine [auto- injectors] delivery systems prescribed under subsection (a) to do any of the following: (1) Provide an epinephrine [auto-injector] delivery 20250HB0928PN1979 - 4 - <-- <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 systems SYSTEM for immediate administration to any individual, or the parent, guardian or caregiver of the individual, who the employee, agent or other individual associated with the entity OR DAY-CARE FACILITY believes, in good faith, is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine [auto-injector] delivery systems SYSTEM or has previously been diagnosed with an allergy. (2) Administer an epinephrine [auto-injector] delivery systems SYSTEM to any individual who the employee, agent or other individual believes, in good faith, is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine [auto-injector] delivery systems SYSTEM or has previously been diagnosed with an allergy. (d) Training.-- (1) An employee or agent of the authorized entity or other individual associated with the entity and each employee or agent of the day-care facility shall complete an anaphylaxis training program as required by the department. The training shall be conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment, a health care practitioner employed or contracted by the authorized entity or day-care facility, or an entity or individual approved by the department. The department may approve specific entities or individuals or may approve classes of entities or individuals to conduct the training. Training shall be conducted in English, Spanish and any other languages deemed appropriate by the department. Training may be conducted online or in person and, at a 20250HB0928PN1979 - 5 - <-- <-- <-- <-- <--<-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 minimum, shall cover: (i) how to recognize signs and symptoms of severe allergic reactions in children and adults, including anaphylaxis; (ii) standards and procedures for the storage and administration of an epinephrine [auto-injector] delivery systems SYSTEM ; and (iii) emergency follow-up procedures. (2) The entity or individual that conducts the training shall issue a certificate, on a form developed or approved by the department, to each individual who successfully completes the anaphylaxis training program. (d.1) Informational materials for day-care facilities.--The department, in consultation with the Department of Human Services, shall develop, within 90 days of the effective date of this subsection, informational materials in English, Spanish and any other languages deemed appropriate by the department for a day-care facility to distribute to a parent or guardian of a child in the facility's care. The following shall apply: (1) The materials shall include the following: (i) Signs and symptoms of allergic reactions in children , including anaphylaxis. (ii) The requirements under subsections (a), (b), (b.1), (c) and (d). (2) The department shall update the informational materials on a triennial basis. (3) A day-care facility shall provide the informational materials to a parent or guardian of a child : (i) in the day-care facility's care prior to the effective date of this paragraph , within 90 days of the 20250HB0928PN1979 - 6 - <-- <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 effective date of this paragraph; or (ii) admitted to the day-care facility after the effective date of this paragraph, at the time the agreement for admission is signed as provided under 55 Pa. Code § 3270.123 (relating to agreement). (e) Good Samaritan protections.-- (1) The following shall not be liable for any injuries or related damages that result from any act or omission taken under this section: (i) An authorized entity or day-care facility that possesses and makes available epinephrine [auto- injectors] delivery systems and its employees, agents and other individuals associated with the entity OR DAY-CARE FACILITY; (ii) a health care practitioner that prescribes or dispenses epinephrine [auto-injectors] delivery systems to an authorized entity or day-care facility; (iii) a pharmacist or health care practitioner that dispenses epinephrine [auto-injectors] delivery systems to an authorized entity or day-care facility; and (iv) an individual or entity that conducts the training described under subsection (d). (2) The immunity provided under paragraph (1) shall not apply to acts or omissions constituting intentional misconduct or gross negligence. (3) The administration of an epinephrine [auto-injector] delivery systems SYSTEM in accordance with this section shall not be considered the practice of medicine or any other profession that otherwise requires licensure. (4) This subsection shall not eliminate, limit or reduce 20250HB0928PN1979 - 7 - <-- <-- <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 any other immunity or defense that may be available under law, including that provided under 42 Pa.C.S. § 8332 (relating to emergency response provider and bystander good Samaritan civil immunity). (5) An entity located in this Commonwealth shall not be liable for any injuries or related damages that result from the provision or administration of an epinephrine [auto- injector] delivery systems SYSTEM outside of this Commonwealth if the entity: (i) would not have been liable for the injuries or related damages had the provision or administration occurred within this Commonwealth; or (ii) is not liable for the injuries or related damages under the law of the state in which the provision or administration occurred. Section 4. This act shall take effect in 180 days. 20250HB0928PN1979 - 8 - <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16