Chapter 04. Emergency Use Epinephrine Program
Regulation .01 Scope.LinkCopy Citation
This chapter applies to employees of food service, recreation, or wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland, and employees of food service facilities, as defined in COMAR 10.15.03, who voluntarily participate in the Program.
Regulation .02 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by a participating facility to serve either as a health supervisor or as a certificate holder.
(2)
“Agent” means an individual who:
(a)
Is 18 years old or older;
(b)
Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department; and
(c)
Is designated in writing by a certificate holder to administer emergency use epinephrine in an emergency situation.
(3)
“Anaphylaxis” means a sudden, severe, and potentially life-threatening allergic reaction that occurs when an individual is exposed to an allergen.
(4)
“Applicant” means an individual applying for a Certificate for Emergency Epinephrine.
(5)
“Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by a participating facility to obtain, store, and administer emergency use epinephrine.
(6)
“Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer emergency use epinephrine to be used in an emergency situation.
(7)
“Department” means the Maryland Department of Health.
(8)
“Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter.
(9)
“Emergency use epinephrine” means a portable, disposable drug delivery device or product approved by the federal Food and Drug Administration that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.
(10)
“Food service facility” has the meaning stated in COMAR 10.15.03.
(11)
“Health supervisor” means an individual who:
(a)
Provides health services for a participating facility; and
(b)
Is licensed by the State as a:
(i)
Physician;
(ii)
Certified nurse practitioner; or
(iii)
Registered nurse.
(12)
“Participating facility” means a recreation or wellness facility at an eligible institution or a food service facility, including a food service facility at an eligible institution, in the State that voluntarily participates in the Program.
(13)
“Successfully completed” means to pass a written examination with a grade of 75 percent or higher.
Regulation .03 Emergency Epinephrine.LinkCopy Citation
A.
An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:
(1)
Is employed by a participating facility;
(2)
Is 18 years old or older; and
(3)
Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department.
B.
The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:
(1)
Designation of agents and affiliated individuals;
(2)
The name of the approved emergency epinephrine educational training program; and
(3)
Procedures to:
(a)
Store emergency use epinephrine;
(b)
Maintain the emergency use epinephrine in a secure manner;
(c)
Report use of emergency use epinephrine according to §L of this regulation;
(d)
Train an emergency epinephrine certificate holder and agent annually; and
(e)
Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.
C.
A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.
D.
An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.
E.
The Department shall:
(1)
Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;
(2)
Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;
(3)
Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;
(4)
Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;
(5)
Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and
(6)
On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency use epinephrine at participating facilities according to §L of this regulation.
F.
A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate holder.
G.
A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense emergency use epinephrine under a prescription issued to a certificate holder.
H.
A certificate holder may:
(1)
On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for emergency use epinephrine; and
(2)
Possess and store prescribed emergency use epinephrine.
I.
A participating facility:
(1)
Shall ensure that there is a written plan for the emergency epinephrine program that:
(a)
Is approved annually, in writing, by a health supervisor;
(b)
Is on file at the participating facility and is available for inspection; and
(c)
Includes at a minimum:
(i)
The name, title, and license number of the health supervisor;
(ii)
Information on the emergency epinephrine educational training program used;
(iii)
Procedures for disseminating information to staff on the emergency epinephrine program;
(iv)
Procedures for the proper storage and handling of medication;
(v)
Procedures for the use of emergency services and 911 services; and
(vi)
Procedures for documenting incidents involving the administration of emergency use epinephrine by a certificate holder in accordance with §L of this regulation;
(2)
Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the participating facility complies with all provisions of this chapter;
(3)
Shall provide the Department with access to records and documents required under this chapter;
(4)
Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of emergency use epinephrine;
(5)
May not obtain or store emergency use epinephrine unless the participating facility has at least two certificate holders; and
(6)
Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.
J.
Certificate Holders.
(1)
Subject to §I(4) of this regulation, a certificate holder may obtain:
(a)
A prescription for a supply of emergency use epinephrine from a licensed physician as provided in §F of this regulation; and
(b)
A supply of emergency use epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.
(2)
A certificate holder shall store a supply of emergency use epinephrine obtained under §J(1) of this regulation:
(a)
In accordance with the manufacturer’s instructions; and
(b)
In a location that is readily accessible to certificate holders and agents in an emergency situation.
K.
In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.
L.
A participating facility shall ensure that an incident that occurred on the premises of the facility that involved the administration of emergency use epinephrine by a certificate holder or agent is reported:
(1)
Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and
(2)
To the Department within 5 business days of the incident on a form prescribed by the Department.
Chapter annotations
Authority: Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland
History: Effective date: May 20, 2019 (46:10 Md. R. 487)
History: Regulation .01 amended effective July 12, 2021 (48:14 Md. R. 538)
History: Regulation .02B amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)
History: Regulation .03 amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)