EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0536*
HOUSE BILL 536
J1, J2, F5 5lr1960
By: Delegates Guzzone, Boafo, Chisholm, Hill, Lopez, Martinez, and M. Morgan
Introduced and read first time: January 22, 2025
Assigned to: Ways and Means and Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Education and Health – Emergency Use Epinephrine – Alterations 2
FOR the purpose of altering the defined term “auto–injectable epinephrine” to be 3
“emergency use epinephrine” and to include certain drug delivery devices and 4
products; altering the name of the Emergency Use Auto–Injectable Epinephrine 5
Program to be the Emergency Use Epinephrine Program; and generally relating to 6
emergency use epinephrine. 7
BY repealing and reenacting, with amendments, 8
Article – Education 9
Section 7–426.2, 7–426.3, and 9.5–117(a)(3) and (f) 10
Annotated Code of Maryland 11
(2022 Replacement Volume and 2024 Supplement) 12
BY repealing and reenacting, without amendments, 13
Article – Education 14
Section 9.5–117(a)(1) 15
Annotated Code of Maryland 16
(2022 Replacement Volume and 2024 Supplement) 17
BY repealing and reenacting, with amendments, 18
Article – Health – General 19
Section 13–702, 13–704(e), 13–705, 13–706(a), 13–707(a) and (b), and 13–708(b); and 20
13–7A–01, 13–7A–02, 13–7A–03(a)(5), 13–7A–06, 13–7A–07(a) and (b), 21
13–7A–08(b), and 13–7A–09 to be under the amended subtitle “Subtitle 7A. 22
Emergency Use Epinephrine Program” 23
Annotated Code of Maryland 24
(2023 Replacement Volume and 2024 Supplement) 25
BY repealing and reenacting, without amendments, 26
Article – Health Occupations 27 2 HOUSE BILL 536
Section 14–5F–01(a) and 14–5F–04.1(a)(1) 1
Annotated Code of Maryland 2
(2021 Replacement Volume and 2024 Supplement) 3
BY repealing 4
Article – Health Occupations 5
Section 14–5F–01(c) 6
Annotated Code of Maryland 7
(2021 Replacement Volume and 2024 Supplement) 8
BY repealing and reenacting, with amendments, 9
Article – Health Occupations 10
Section 14–5F–01(d) through (g), 14–5F–04.1(d)(1), and 14–5F–14(a)(5) 11
Annotated Code of Maryland 12
(2021 Replacement Volume and 2024 Supplement) 13
BY adding to 14
Article – Health Occupations 15
Section 14–5F–01(g) 16
Annotated Code of Maryland 17
(2021 Replacement Volume and 2024 Supplement) 18
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19
That the Laws of Maryland read as follows: 20
Article – Education 21
7–426.2. 22
(a) (1) In this section the following words have the meanings indicated. 23
(2) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 24
allergic reaction that occurs when an individual is exposed to an allergen. 25
(3) [“Auto–injectable] “EMERGENCY USE epinephrine” means a portable, 26
disposable drug delivery device OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 27
DRUG ADMINISTRATION that contains a premeasured single dose of epinephrine that is 28
used to treat anaphylaxis in an emergency situation. 29
(b) Each county board shall establish a policy for public schools within its 30
jurisdiction to authorize the school nurse and other school personnel to administer 31
[auto–injectable] EMERGENCY USE epinephrine, if available, to a student who is 32
determined to be or perceived to be in anaphylaxis, regardless of whether the student: 33
(1) Has been identified as having an anaphylactic allergy, as defined in § 34
7–426.1 of this subtitle; or 35
HOUSE BILL 536 3
(2) Has a prescription for epinephrine as prescribed by an authorized 1
licensed health care practitioner under the Health Occupations Article. 2
(c) The policy established under subsection (b) of this section shall include: 3
(1) Training for school personnel on how to recognize the symptoms of 4
anaphylaxis; 5
(2) Procedures for the emergency administration of [auto–injectable] 6
EMERGENCY USE epinephrine; 7
(3) The proper follow–up emergency procedures; 8
(4) A provision authorizing a school nurse to obtain and store at a public 9
school [auto–injectable] EMERGENCY USE epinephrine to be used in an emergency 10
situation; and 11
(5) A requirement that each public school develop and implement a method 12
for notifying the parents or guardians of students of the school’s policy under this section 13
at the beginning of each school year. 14
(d) Except for any willful or grossly negligent act, a school nurse or other school 15
personnel who respond in good faith to the anaphylactic reaction of a child in accordance 16
with this section may not be held personally liable for any act or omission in the course of 17
responding to the reaction. 18
(e) (1) Each public school shall submit, on the form that the Department 19
requires, a report to the Department on each incident at the school or at a related school 20
event that required the use of [auto–injectable] EMERGENCY USE epinephrine. 21
(2) The Department shall develop and disseminate a standard form to 22
report each incident requiring the use of [auto–injectable] EMERGENCY USE epinephrine 23
at a public school. 24
7–426.3. 25
(a) (1) In this section the following words have the meanings indicated. 26
(2) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 27
allergic reaction that occurs when an individual is exposed to an allergen. 28
(3) [“Auto–injectable] “EMERGENCY USE epinephrine” means a portable, 29
disposable drug delivery device OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 30
DRUG ADMINISTRATION that contains a premeasured single dose of epinephrine that is 31
used to treat anaphylaxis in an emergency situation. 32
4 HOUSE BILL 536
(4) “School personnel” means individuals who are employed by a nonpublic 1
school, including part–time employees, teachers and substitute teachers employed by the 2
school for at least 7 days each school year, a school nurse, registered nurse case manager, 3
delegating nurse, and administrative staff. 4
(b) Each nonpublic school in the State may establish a policy authorizing school 5
personnel to administer [auto–injectable] EMERGENCY USE epinephrine, if available, to a 6
student who is determined to be or perceived to be in anaphylaxis, regardless of whether 7
the student: 8
(1) Has been identified as having an anaphylactic allergy, as defined in § 9
7–426.1 of this subtitle; or 10
(2) Has a prescription for epinephrine as prescribed by an authorized 11
licensed health care practitioner under the Health Occupations Article. 12
(c) The policy established under subsection (b) of this section shall include: 13
(1) Training for school personnel on how to recognize the signs and 14
symptoms of anaphylaxis by a licensed health care practitioner who is authorized to 15
administer [auto–injectable] EMERGENCY USE epinephrine and who has been trained in 16
an established protocol on how to recognize the signs and symptoms of anaphylaxis; 17
(2) Procedures for the emergency administration of [auto–injectable] 18
EMERGENCY USE epinephrine; 19
(3) The proper follow–up emergency procedures; 20
(4) A provision authorizing a school nurse or other licensed health care 21
practitioner to obtain, and[,] school personnel to store, at a nonpublic school 22
[auto–injectable] EMERGENCY USE epinephrine to be used in an emergency situation; 23
(5) A requirement that the nonpublic school develop and implement a 24
method for notifying the parents or guardians of students of the school’s policy under this 25
section at the beginning of each school year; and 26
(6) An ongoing process for oversight and monitoring by a licensed health 27
care practitioner of the implementation of the policy established under subsection (b) of this 28
section. 29
(d) Except for any willful or grossly negligent act, school personnel who respond 30
in good faith to the anaphylactic reaction of a child in accordance with this section may not 31
be held personally liable for any act or omission in the course of responding to the reaction. 32
9.5–117. 33
HOUSE BILL 536 5
(a) (1) In this section the following words have the meanings indicated. 1
(3) [“Auto–injectable] “EMERGENCY USE epinephrine” has the meaning 2
stated in § 7–426.2 of this article. 3
(f) Except for any willfully or grossly negligent act, a child care provider or an 4
employee of a child care provider who responds in good faith to the anaphylactic reaction 5
of a child in accordance with the guidelines implemented under this section or by use of 6
[auto–injectable] EMERGENCY USE epinephrine is immune from civil liability for any act 7
or omission in the course of responding to the reaction. 8
Article – Health – General 9
13–702. 10
(a) In this subtitle the following words have the meanings indicated. 11
(b) “Agent” means an individual who: 12
(1) Is at least 18 years of age; 13
(2) Has successfully completed, at the expense of an applicant, an 14
educational training program approved by the Department; and 15
(3) Is appointed by a certificate holder to administer [auto–injectable] 16
EMERGENCY USE epinephrine in accordance with the provisions of this subtitle. 17
(c) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 18
allergic reaction that occurs when an individual is exposed to an allergen. 19
[(d) “Auto–injectable epinephrine” means a portable, disposable drug delivery 20
device that contains a premeasured single dose of epinephrine that is used to treat 21
anaphylaxis in an emergency situation.] 22
[(e)] (D) “Certificate” means a certificate or an endorsement on the operating 23
certificate of a youth camp issued by the Department to an individual who operates a youth 24
camp under Title 14, Subtitle 4 of this article to obtain, store, and administer 25
[auto–injectable] EMERGENCY USE epinephrine. 26
[(f)] (E) “Certificate holder” means an individual who is authorized by the 27
Department to obtain, store, and administer [auto–injectable] EMERGENCY USE 28
epinephrine to be used in an emergency situation. 29
(F) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 30
DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 31 6 HOUSE BILL 536
DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 1
EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 2
(g) “Program” means the Emergency and Allergy Treatment Program. 3
(h) “Registered nurse practitioner” has the meaning stated in § 8–101 of the 4
Health Occupations Article. 5
(i) “Youth camp” has the meaning stated in § 14–401 of this article. 6
13–704. 7
(e) An applicant shall have a written policy that includes: 8
(1) Authorization for the certificate holder or agent to administer 9
[auto–injectable] EMERGENCY USE epinephrine, if available, to an individual who has 10
been determined to be or is believed to be experiencing anaphylaxis, whether or not the 11
individual: 12
(i) Has previously been known to have experienced anaphylaxis; or 13
(ii) Has a prescription for epinephrine prescribed by an authorized 14
health care practitioner licensed under the Health Occupations Article; 15
(2) A requirement that youth camp personnel complete training on how to 16
recognize the symptoms of anaphylaxis; 17
(3) Procedures for the emergency administration of [auto–injectable] 18
EMERGENCY USE epinephrine; 19
(4) Procedures for proper emergency follow–up; 20
(5) Authorization for a certificate holder to obtain and store 21
[auto–injectable] EMERGENCY USE epinephrine to be used in an emergency; and 22
(6) A requirement that each certificate holder implement a method for 23
notifying the parent or guardian of a camper of the youth camp’s policy under this section 24
before the camper’s attendance. 25
13–705. 26
(a) (1) A registered nurse practitioner or a physician licensed to practice 27
medicine in the State may prescribe [auto–injectable] EMERGENCY USE epinephrine in 28
the name of a certificate holder. 29
HOUSE BILL 536 7
(2) A registered nurse practitioner, a pharmacist licensed to practice 1
pharmacy in the State, or a physician may dispense [auto–injectable] EMERGENCY USE 2
epinephrine under a prescription issued to a certificate holder. 3
(b) A certificate holder may: 4
(1) On presentment of a certificate, receive from any registered nurse 5
practitioner or any physician licensed to practice medicine in the State a prescription for 6
[auto–injectable] EMERGENCY USE epinephrine and the necessary paraphernalia for the 7
administration of [auto–injectable] EMERGENCY USE epinephrine; and 8
(2) Possess and store prescribed [auto–injectable] EMERGENCY USE 9
epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 10
EMERGENCY USE epinephrine. 11
(c) In an emergency situation when registered nurse practitioner, physician, or 12
emergency medical services are not immediately available, a certificate holder or agent may 13
administer [auto–injectable] EMERGENCY USE epinephrine to an individual who is 14
experiencing or believed in good faith by the certificate holder or agent to be experiencing 15
anaphylaxis. 16
13–706. 17
(a) A certificate holder shall submit to the Department, on a form required by the 18
Department, a report of each incident that occurs while the youth camp is in session that 19
required the administration of [auto–injectable] EMERGENCY USE epinephrine. 20
13–707. 21
(a) A cause of action may not arise against a certificate holder or agent authorized 22
under this subtitle for any act or omission when the certificate holder or agent is acting in 23
good faith while administering [auto–injectable] EMERGENCY USE epinephrine to an 24
individual experiencing or believed by the certificate holder or agent to be experiencing 25
anaphylaxis, except where the conduct of the certificate holder or agent amounts to gross 26
negligence, willful or wanton misconduct, or intentionally tortious conduct. 27
(b) (1) A cause of action may not arise against any physician for any act or 28
omission when the physician in good faith prescribes or dispenses [auto–injectable] 29
EMERGENCY USE epinephrine and the necessary paraphernalia for the administration of 30
[auto–injectable] EMERGENCY USE epinephrine to a person certified by the Department 31
under this subtitle. 32
(2) A cause of action may not arise against any pharmacist for any act or 33
omission when the pharmacist in good faith dispenses [auto–injectable] EMERGENCY U SE 34
epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 35
EMERGENCY USE epinephrine to a person certified by the Department under this subtitle. 36 8 HOUSE BILL 536
(3) A cause of action may not arise against any nurse practitioner for any 1
act or omission when the nurse practitioner in good faith prescribes or dispenses 2
[auto–injectable] EMERGENCY USE epinephrine and the necessary paraphernalia for the 3
administration of [auto–injectable] EMERGENCY USE epinephrine to a person certified by 4
the Department under this subtitle. 5
13–708. 6
(b) An individual may not be held civilly liable in any action arising from or in 7
connection with the administration of [auto–injectable] EMERGENCY USE epinephrine by 8
the individual solely because the individual did not possess a certificate issued under this 9
subtitle. 10
Subtitle 7A. Emergency Use [Auto–Injectable] Epinephrine Program. 11
13–7A–01. 12
(a) In this subtitle the following words have the meanings indicated. 13
(b) “Agent” means an individual who: 14
(1) Is at least 18 years of age; 15
(2) Has successfully completed, at the expense of the participating facility, 16
an educational training program approved by the Department under § 13–7A–03 of this 17
subtitle; and 18
(3) Is designated by a certificate holder to administer [auto–injectable] 19
EMERGENCY USE epinephrine in accordance with the provisions of this subtitle. 20
(c) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 21
allergic reaction that occurs when an individual is exposed to an allergen. 22
[(d) “Auto–injectable epinephrine” means a portable, disposable drug delivery 23
device that contains a premeasured single dose of epinephrine that is used to treat 24
anaphylaxis in an emergency situation.] 25
[(e)] (D) “Certificate” means a certificate issued by the Department to an 26
individual to obtain, store, and administer [auto–injectable] EMERGENCY USE 27
epinephrine. 28
[(f)] (E) “Certificate holder” means an individual who is authorized by the 29
Department to obtain, store, and administer [auto–injectable] EMERGENCY USE 30
epinephrine to be used in an emergency situation. 31
HOUSE BILL 536 9
[(g)] (F) “Eligible institution” means an institution of higher education that has 1
a food service facility or a recreation and wellness facility on the premises and that is 2
authorized under this subtitle to obtain and store [auto–injectable] EMERGENCY USE 3
epinephrine. 4
(G) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 5
DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 6
DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 7
EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 8
(h) “Food service facility” has the meaning indicated in § 21–301 of this article. 9
(i) “Participating facility” means a recreation or wellness facility at an eligible 10
institution or a food service facility, including a food service facility at an eligible 11
institution, in the State that voluntarily participates in the Program. 12
(j) “Program” means the Emergency Use [Auto–Injectable] Epinephrine 13
Program established under § 13–7A–02 of this subtitle. 14
13–7A–02. 15
(a) There is an Emergency Use [Auto–Injectable] Epinephrine Program. 16
(b) The purpose of the Program is to authorize individuals employed by a 17
participating facility to obtain and store [auto–injectable] EMERGENCY USE epinephrine 18
and administer [auto–injectable] EMERGENCY USE epinephrine to individuals who are 19
experiencing or are believed to be experiencing anaphylaxis when a physician or emergency 20
medical services are not immediately available. 21
(c) (1) Subject to paragraph (4) of this subsection, each participating facility 22
may obtain: 23
(i) A prescription for a supply of [auto–injectable] EMERGENCY 24
USE epinephrine from a licensed physician as provided in § 13–7A–06 of this subtitle; and 25
(ii) A supply of [auto–injectable] EMERGENCY USE epinephrine 26
from a licensed pharmacist or a licensed physician as provided in § 13–7A–06 of this 27
subtitle. 28
(2) Each participating facility shall store a supply of [auto–injectable] 29
EMERGENCY USE epinephrine obtained under paragraph (1)(ii) of this subsection: 30
(i) In accordance with the manufacturer’s instructions; and 31
(ii) In a location that is readily accessible to employees or affiliated 32
individuals in an emergency situation. 33 10 HOUSE BILL 536
(3) Each participating facility shall designate the employees who are 1
certificate holders or designated affiliated individuals who are certificate holders who will 2
be responsible for the storage, maintenance, and control of the supply of [auto–injectable] 3
EMERGENCY USE epinephrine. 4
(4) A participating facility may not obtain or store [auto–injectable] 5
EMERGENCY USE epinephrine unless the participating facility has at least two employees 6
or designated affiliated individuals who are certificate holders. 7
(5) Each participating facility shall maintain a copy of the certificate issued 8
to an employee or a designated affiliated individual under § 13–7A–05 of this subtitle. 9
13–7A–03. 10
(a) The Department shall: 11
(5) Develop a method by which certificate holders may submit a report to 12
the Department about each incident that occurred on the premises of a participating facility 13
that involved the administration of [auto–injectable] EMERGENCY USE epinephrine by a 14
certificate holder or an agent; and 15
13–7A–06. 16
(a) (1) A physician licensed to practice medicine in the State may prescribe 17
[auto–injectable] EMERGENCY USE epinephrine in the name of a certificate holder. 18
(2) A pharmacist licensed to practice pharmacy in the State or a physician 19
may dispense [auto–injectable] EMERGENCY USE epinephrine under a prescription issued 20
to a certificate holder. 21
(b) A certificate holder may: 22
(1) On presentment of a certificate, receive from any physician licensed to 23
practice medicine in the State a prescription for [auto–injectable] EMERGENCY USE 24
epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 25
EMERGENCY USE epinephrine; and 26
(2) Possess and store prescribed [auto–injectable] EMERGENCY USE 27
epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 28
EMERGENCY USE epinephrine. 29
(c) In an emergency situation when a physician or emergency medical services 30
are not immediately available, a certificate holder or an agent may administer 31
[auto–injectable] EMERGENCY USE epinephrine to an individual who is experiencing or is 32
believed in good faith by the certificate holder or agent to be experiencing anaphylaxis. 33 HOUSE BILL 536 11
13–7A–07. 1
(a) (1) Except as provided in paragraph (2) of this subsection, a cause of action 2
may not arise against a certificate holder for any act or omission if the certificate holder or 3
agent is acting in good faith while administering [auto–injectable] EMERGENCY USE 4
epinephrine to an individual who is experiencing or believed by the certificate holder or 5
agent to be experiencing anaphylaxis except where the conduct of the certificate holder or 6
agent amounts to gross negligence, willful or wanton misconduct, or intentionally tortious 7
conduct. 8
(2) The provisions of paragraph (1) of this subsection do not apply if a 9
certificate holder or participating facility that makes available, or a certificate holder who 10
administers, [auto–injectable] EMERGENCY USE epinephrine to an individual who is 11
experiencing or is believed by the certificate holder or participating facility to be 12
experiencing anaphylaxis: 13
(i) Fails to follow standards and procedures for storage and 14
administration of [auto–injectable] EMERGENCY USE epinephrine; or 15
(ii) Administers [auto–injectable] EMERGENCY USE epinephrine 16
that is beyond the manufacturer’s expiration date. 17
(b) (1) A cause of action may not arise against any physician for any act or 18
omission if the physician in good faith prescribes or dispenses [auto–injectable] 19
EMERGENCY USE epinephrine and the necessary paraphernalia for the administration of 20
[auto–injectable] EMERGENCY USE epinephrine to a certificate holder or participating 21
facility under this subtitle. 22
(2) A cause of action may not arise against any pharmacist for any act or 23
omission if the pharmacist in good faith dispenses [auto–injectable] EMERGENCY USE 24
epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 25
EMERGENCY USE epinephrine to a certificate holder or a participating facility under this 26
subtitle. 27
13–7A–08. 28
(b) An individual may not be held civilly liable in any action arising from or in 29
connection with the administration of [auto–injectable] EMERGENCY USE epinephrine by 30
the individual solely because the individual did not possess a certificate issued under this 31
subtitle. 32
13–7A–09. 33
A certificate holder shall submit to the Department, in the manner required under § 34
13–7A–03 of this subtitle, a report of each incident that occurred on the premises of a 35 12 HOUSE BILL 536
participating facility that involved the administration of [auto–injectable] EMERGENCY 1
USE epinephrine by a certificate holder or an agent. 2
Article – Health Occupations 3
14–5F–01. 4
(a) In this subtitle the following words have the meanings indicated. 5
[(c) “Auto–injectable epinephrine” means a portable, disposable drug delivery 6
device that contains a premeasured single dose of epinephrine that is used to treat 7
anaphylaxis in an emergency situation.] 8
[(d)] (C) “Board” means the State Board of Physicians. 9
[(e)] (D) “Committee” means the Naturopathic Medicine Advisory Committee. 10
[(f)] (E) “Council” means the Naturopathic Doctors Formulary Council. 11
[(g)] (F) (1) “Device” means a device used in the diagnosis, treatment, or 12
prevention of disease. 13
(2) “Device” does not include: 14
(i) Any surgical or dental instrument; 15
(ii) Any physical therapy equipment; 16
(iii) Any X–ray apparatus; or 17
(iv) Any component part or accessory of any of the items listed in 18
items (i) through (iii) of this paragraph. 19
(G) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 20
DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 21
DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 22
EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 23
14–5F–04.1. 24
(a) (1) There is a Naturopathic Doctors Formulary Council within the Board. 25
(d) (1) The formulary adopted by the Board shall include: 26
(i) Nonprescription drugs and devices; 27
HOUSE BILL 536 13
(ii) Prescription oxygen and [auto–injectable] EMERGENCY USE 1
epinephrine; and 2
(iii) Prescription diaphragms and cervical caps for contraception. 3
14–5F–14. 4
(a) A license authorizes a licensee, consistent with naturopathic education and 5
training and competence demonstrated by passing the naturopathic physician licensing 6
examination, to: 7
(5) Administer [auto–injectable] EMERGENCY USE epinephrine; 8
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 9
1, 2025. 10