HB 1044 — 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
 1   Amending Title 35 (Health and Safety) of the Pennsylvania
 2      Consolidated Statutes, in epinephrine auto-injector entities,
 3      further providing for scope of chapter, for definitions and
 4      for epinephrine auto-injectors for authorized entities; and
 5      making an editorial change.
 6      The General Assembly of the Commonwealth of Pennsylvania
 7   hereby enacts as follows:
 8      Section 1.    Chapter 55 heading and section 5501 of Title 35
 9   of the Pennsylvania Consolidated Statutes are amended to read:
10                                 CHAPTER 55
11         EPINEPHRINE [AUTO-INJECTOR] DELIVERY SYSTEM ENTITIES
12   § 5501.   Scope of chapter.
13      This chapter relates to epinephrine [auto-injector] delivery
14   system entities.
15      Section 2.    The definitions of "administer" and "epinephrine
16   auto-injector" in section 5502 of Title 35 are amended and the
17   section is amended by adding a definition to read:
18   § 5502.   Definitions.
 1      The following words and phrases when used in this chapter
 2   shall have the meanings given to them in this section unless the
 3   context clearly indicates otherwise:
 4      "Administer."      The direct application of an epinephrine
 5   [auto-injector] delivery system to the body of an individual.
 6      * * *
 7      ["Epinephrine auto-injector."          A single-use device used for
 8   the automatic injection of a premeasured dose of epinephrine
 9   into the human body.]
10      "Epinephrine delivery system."         A device approved by the
11   Federal Food and Drug Administration that contains a pre-
12   measured dose of epinephrine and is used to administer
13   epinephrine into the human body to prevent or treat a life-
14   threatening allergic reaction.
15      * * *
16      Section 3.      Section 5503 of Title 35 is amended to read:
17   § 5503.    Epinephrine [auto-injectors] delivery systems for
18                   authorized entities.
19      (a)    Prescribing and dispensing.--Notwithstanding any
20   provision of law to the contrary, a health care practitioner
21   with prescriptive authority may prescribe epinephrine [auto-
22   injectors] delivery systems in the name of an authorized entity
23   for use in accordance with this section. Pharmacists and health
24   care practitioners may dispense epinephrine [auto-injectors]
25   delivery systems pursuant to a prescription issued in the name
26   of an authorized entity.
27      (b)    Supply.--
28             (1)   An authorized entity may acquire and stock a supply
29      of epinephrine [auto-injectors] delivery systems pursuant to
30      a prescription issued in accordance with this section. The

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 1      epinephrine [auto-injectors] delivery systems shall be
 2      stored:
 3                  (i)    in a location readily accessible in an
 4            emergency; and
 5                  (ii)    in accordance with:
 6                         (A)   the epinephrine [auto-injector's] delivery
 7                  system's instructions for use; and
 8                         (B)   any additional requirements that may be
 9                  established by the department.
10            (2)   An authorized entity shall designate employees or
11      agents who have completed the training required under
12      subsection (d) to be responsible for the storage,
13      maintenance, control and general oversight of epinephrine
14      [auto-injectors] delivery systems acquired by the authorized
15      entity.
16      (c)   Use.--An employee or agent of an authorized entity or
17   other individual associated with the entity who has completed
18   the training required under subsection (d) may use epinephrine
19   [auto-injectors] delivery systems prescribed under subsection
20   (a) to do any of the following:
21            (1)   Provide an epinephrine [auto-injector] delivery
22      system for immediate administration to any individual, or the
23      parent, guardian or caregiver of the individual, who the
24      employee, agent or other individual associated with the
25      entity believes, in good faith, is experiencing anaphylaxis,
26      regardless of whether the individual has a prescription for
27      an epinephrine [auto-injector] delivery system or has
28      previously been diagnosed with an allergy.
29            (2)   Administer an epinephrine [auto-injector] delivery
30      system to any individual who the employee, agent or other

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 1    individual believes, in good faith, is experiencing
 2    anaphylaxis, regardless of whether the individual has a
 3    prescription for an epinephrine [auto-injector] delivery
 4    system or has previously been diagnosed with an allergy.
 5    (d)   Training.--
 6          (1)   An employee or agent of the authorized entity or
 7    other individual associated with the entity shall complete an
 8    anaphylaxis training program as required by the department.
 9    The training shall be conducted by a nationally recognized
10    organization experienced in training laypersons in emergency
11    health treatment, a health care practitioner employed or
12    contracted by the authorized entity or an entity or
13    individual approved by the department. The department may
14    approve specific entities or individuals or may approve
15    classes of entities or individuals to conduct the training.
16    Training may be conducted online or in person and, at a
17    minimum, shall cover:
18                (i)    how to recognize signs and symptoms of severe
19          allergic reactions, including anaphylaxis;
20                (ii)    standards and procedures for the storage and
21          administration of an epinephrine [auto-injector] delivery
22          system; and
23                (iii)    emergency follow-up procedures.
24          (2)   The entity or individual that conducts the training
25    shall issue a certificate, on a form developed or approved by
26    the department, to each individual who successfully completes
27    the anaphylaxis training program.
28    (e)   Good Samaritan protections.--
29          (1)   The following shall not be liable for any injuries
30    or related damages that result from any act or omission taken

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 1    under this section:
 2              (i)    An authorized entity that possesses and makes
 3        available epinephrine [auto-injectors] delivery systems
 4        and its employees, agents and other individuals
 5        associated with the entity;
 6              (ii)    a health care practitioner that prescribes or
 7        dispenses epinephrine [auto-injectors] delivery systems
 8        to an authorized entity;
 9              (iii)    a pharmacist or health care practitioner that
10        dispenses epinephrine [auto-injectors] delivery systems
11        to an authorized entity; and
12              (iv)    an individual or entity that conducts the
13        training described under subsection (d).
14        (2)   The immunity provided under paragraph (1) shall not
15    apply to acts or omissions constituting intentional
16    misconduct or gross negligence.
17        (3)   The administration of an epinephrine [auto-injector]
18    delivery system in accordance with this section shall not be
19    considered the practice of medicine or any other profession
20    that otherwise requires licensure.
21        (4)   This subsection shall not eliminate, limit or reduce
22    any other immunity or defense that may be available under
23    law, including that provided under 42 Pa.C.S. § 8332
24    (relating to emergency response provider and bystander good
25    Samaritan civil immunity).
26        (5)   An entity located in this Commonwealth shall not be
27    liable for any injuries or related damages that result from
28    the provision or administration of an epinephrine [auto-
29    injector] delivery system outside of this Commonwealth if the
30    entity:

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1              (i)    would not have been liable for the injuries or
2         related damages had the provision or administration
3         occurred within this Commonwealth; or
4              (ii)    is not liable for the injuries or related
5         damages under the law of the state in which the provision
6         or administration occurred.
7     Section 4.     This act shall take effect in 60 days.




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