An Act amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, in epinephrine auto-injector entities, further providing for scope of chapter, for definitions and for epinephrine auto-injectors for authorized entities; and making an editorial change.

PRINTER'S NO. 1133
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 1044
Session of
2025
INTRODUCED BY VENKAT, CERRATO, GIRAL, KOSIEROWSKI, MARCELL,
MIHALEK, SHAFFER, WARNER, MADDEN, HILL-EVANS, KHAN, CAUSER,
HANBIDGE, OTTEN, RIVERA, NEILSON, McANDREW, HOHENSTEIN,
SANCHEZ, D. WILLIAMS, CEPEDA-FREYTIZ AND STEELE,
MARCH 25, 2025
REFERRED TO COMMITTEE ON HEALTH, MARCH 25, 2025
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in epinephrine auto-injector entities,
further providing for scope of chapter, 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. Chapter 55 heading and section 5501 of Title 35
of the Pennsylvania Consolidated Statutes are amended to read:
CHAPTER 55
EPINEPHRINE [AUTO-INJECTOR] DELIVERY SYSTEM ENTITIES
§ 5501. Scope of chapter.
This chapter relates to epinephrine [auto-injector] delivery
system entities.
Section 2. The definitions of "administer" and "epinephrine
auto-injector" in section 5502 of Title 35 are amended and the
section is amended by adding a definition to read:
§ 5502. Definitions.
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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.
* * *
["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
Federal Food and Drug Administration that contains a pre-
measured 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.
(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
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.
(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
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epinephrine [auto-injectors] delivery systems shall be
stored:
(i) in a location readily accessible in an
emergency; and
(ii) in accordance with:
(A) the epinephrine [auto-injector's] delivery
system'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
subsection (d) to be responsible for the storage,
maintenance, control and general oversight of epinephrine
[auto-injectors] delivery systems acquired by the authorized
entity.
(c) Use.--An employee or agent of an authorized entity or
other individual associated with the entity 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
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 believes, in good faith, is experiencing anaphylaxis,
regardless of whether the individual has a prescription for
an epinephrine [auto-injector] delivery system or has
previously been diagnosed with an allergy.
(2) Administer an epinephrine [auto-injector] delivery
system to any individual who the employee, agent or other
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individual believes, in good faith, is experiencing
anaphylaxis, regardless of whether the individual has a
prescription for an epinephrine [auto-injector] delivery
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 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 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 may be conducted online or in person and, at a
minimum, shall cover:
(i) how to recognize signs and symptoms of severe
allergic reactions, including anaphylaxis;
(ii) standards and procedures for the storage and
administration of an epinephrine [auto-injector] delivery
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.
(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
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under this section:
(i) An authorized entity that possesses and makes
available epinephrine [auto-injectors] delivery systems
and its employees, agents and other individuals
associated with the entity;
(ii) a health care practitioner that prescribes or
dispenses epinephrine [auto-injectors] delivery systems
to an authorized entity;
(iii) a pharmacist or health care practitioner that
dispenses epinephrine [auto-injectors] delivery systems
to an authorized entity; 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 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
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 system outside of this Commonwealth if the
entity:
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(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 60 days.
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