HB 928 — 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.

PRIOR PRINTER'S NO.NOS.

992992, 1833 PRINTER'S NO.

18331979 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of No.

928 2025 INTRODUCED BY KOSIEROWSKI, MARCELL, VENKAT, SANCHEZ, WAXMAN, GUENST, BURGOS, MADDEN, DEASY, HANBIDGE, HILL-EVANS, OTTEN, KENYATTA, HADDOCK, MAYES, BOYD, CURRY, CERRATO, DONAHUE,EN,DONAHUE, BOROWSKI, McNEILL, SCHLOSSBERG, MIHALEK, O'MARA, WEBSTER, CIRESI, WARREN, ISAACSON, FREEMAN, SHUSTERMAN, CEPEDA- FREYTIZ, GIRAL, PIELLI, STEELE, HOWARD, DALEY, MALAGARIMALAGARI, AND KRAJEWSKI, MARCHKHAN, 17,C. 2025 AS REPORTED FROM COMMITTEE ON CHILDREN AND YOUTH, HOUSE OF REPRESENTATIVES, AS AMENDED, JUNE 4, 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- CHANGE.rs for authorized entities;

WILLIAMS AND MAKINGMADSEN, MARCH 17, 2025 AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES, JUNE 23, 2025 AN EDITORIALACT <--Amending TheTitle General35 Assembly(Health and Safety) of the CommonwealthPennsylvania ofConsolidated PennsylvaniaStatutes, herebyin enactsepinephrine asauto-injector follows: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:

The definitionsheading of "authorizedChapter entity"55 and <-- "epinephrine auto-injector" in section 5502 of Title 35 of the Pennsylvania Consolidated Statutes areis amended to read:

SECTIONCHAPTER 1.55 EPINEPHRINE [AUTO-INJECTOR ENTITIES] DELIVERY SYSTEM Section 2.

THEThe HEADINGdefinitions OFof CHAPTER"administer," 55"authorized OFentity" TITLEand "epinephrine auto-injector" in section 5502 of Title 35 OFare THEamended <--and PENNSYLVANIAthe CONSOLIDATEDsection STATUTESis ISamended AMENDEDby TOadding READ:definitions 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:

*"Administer." *The *direct <--application "ADMINISTER."of THEan DIRECTepinephrine APPLICATION[auto-injector] OFdelivery ANsystem EPINEPHRINEto <--the [AUTO-INJECTOR]body DELIVERYof SYSTEMan TOindividual. THE BODY OF AN INDIVIDUAL.

"DAY-CARE"Day-care FACILITY."facility." A CHILDchild CAREcare CENTERcenter ANDand Aa FAMILYfamily CHILDchild <--care CAREhome HOMEas ASthose THOSEterms TERMSare AREdefined DEFINEDin INArticle ARTICLE X OFof THEthe ACTact OFof JUNEJune 13, 1967 (P.L.31, NO.21),No.21), KNOWNknown ASas THEthe HUMANHuman SERVICESServices CODE.Code.

* * * "Epinephrine["Epinephrine auto-injector." A single-use device used for <--the 20250HB0928PN1833automatic -injection 2of -a premeasured dose of epinephrine into the automatichuman injectionbody.] of"Epinephrine delivery system." A device approved by the United States Food and Drug Administration that contains a premeasured20250HB0928PN1979 appropriate- weight-2 based- premeasured, WEIGHT-BASED dose of epinephrine and is used to <-- administer epinephrine into the human body.body to prevent or treat a life-threatening allergic reaction.

["EPINEPHRINE* AUTO-INJECTOR."* A* SINGLE-USESection DEVICE3. 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 PREMEASURED DOSE OF EPINEPHRINE AND IS USED TO ADMINISTER EPINEPHRINE INTO THE HUMAN BODY TO PREVENT OR TREAT A LIFE- THREATENING ALLERGIC REACTION.

* * * Section 2 3.

<-- § 5503.

Epinephrine [auto-injectors] DELIVERYdelivery SYSTEMSsystems 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] DELIVERYdelivery SYSTEMSsystems 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] DELIVERYdelivery SYSTEMSsystems 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] DELIVERYdelivery SYSTEMSsystems <-- pursuant to a prescription issued in accordance with this section.

and 20250HB0928PN1833 - 3 - (ii) in accordance with:

(2) An authorized entity shall designate employees or agents who have completed the training required under 20250HB0928PN1979 - 3 - 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 shall,may SHALL, subject to thefunding availabilitybeing ofspecifically funding<-- bydesignated to the department, acquire and stock a supply of epinephrine auto-delivery injectorssystems pursuant to a prescription issued in accordance with this section.

A(b.1) DAY-CAREStorage.-- FACILITY(1) MAY,An SUBJECTepinephrine TOdelivery <--systems FUNDINGSYSTEM BEINGshall SPECIFICALLYbe DESIGNATED<-- TOstored: 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 auto-injector DELIVERY SYSTEMS shall <-- be stored:

(A) the epinephrine auto-injector'sdelivery DELIVERYsystem's <-- SYSTEM'S instructions for use;

(2) An authorized entity or day-care facility shall designate anemployees employee or agentagents who hashave EMPLOYEES OR AGENTS <-- 20250HB0928PN1833 - 4 - WHO HAVE completed the required training under subsection (d) to be responsible for the storage, maintenance, control and general oversight of epinephrine auto-injectorsdelivery DELIVERYsystems <-- 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 ANan EMPLOYEEemployee ORor <--agent AGENTof OFa A day-care facility who has completed the training required under subsection (d) may use epinephrine [auto- <-- injectors] DELIVERYdelivery SYSTEMSsystems prescribed under subsection (a) to <-- do any of the following:

(1) Provide an epinephrine [auto-injector] DELIVERYdelivery <--20250HB0928PN1979 SYSTEMS- 4 - 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] DELIVERYdelivery SYSTEMSsystems SYSTEM or has <-- previously <-- been diagnosed with an allergy.

(2) Administer an epinephrine [auto-injector] DELIVERYdelivery <--systems SYSTEMSSYSTEM 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] DELIVERYdelivery <--systems SYSTEMSSYSTEM 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 orand ANDeach EACHemployee <--or EMPLOYEEagent ORof AGENTthe OF THE day-care facility shall complete an anaphylaxis training program as required by the department.

20250HB0928PN1833 - 5 - 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.

TRAININGTraining SHALLshall BEbe CONDUCTEDconducted INin ENGLISH,English, SPANISHSpanish ANDand <--any ANYother OTHERlanguages LANGUAGESdeemed DEEMEDappropriate APPROPRIATEby BYthe THEdepartment. DEPARTMENT.

Training may be conducted online or in person and, at a 20250HB0928PN1979 - 5 - minimum, shall cover:

(i) how to recognize signs and symptoms of severe allergic reactions INin CHILDRENchildren ANDand ADULTS,adults, including <-- anaphylaxis;

(ii) standards and procedures for the storage and administration of an epinephrine [auto-injector] DELIVERYdelivery <--systems SYSTEMS;SYSTEM;

and <-- (iii) emergency follow-up procedures.

(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 INin ENGLISH,English, SPANISHSpanish ANDand <--any ANYother OTHERlanguages LANGUAGESdeemed DEEMEDappropriate APPROPRIATEby BYthe THEdepartment DEPARTMENT for a day-care facility to distribute to a parent or guardian of a child in the facility's care.

20250HB0928PN1833 - 6 - (i) Signs and symptoms of allergic reactions INin <--children, CHILDREN, including anaphylaxis.