§5.13. Rules for administration of medical activities under Emergency Use Authorization
A. The purpose of this Section is to ensure the safe, effective, and uniform
administration of medical activities under Emergency Use Authorization by all members of
the healthcare community in this state, during both health emergencies and regular
operations, to protect public health and safety.
B. For the purposes of this Section:
(1) "Emergency Use Authorization" or "EUA" refers to the authority granted under
federal law, specifically Section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
360bbb-3, to allow the use of unapproved medical products or unapproved uses of approved
medical products during a public health emergency.
(2) "Healthcare community" includes but is not limited to hospitals, public and
private clinics, pharmacies, nursing homes, and any other entity that participates in healthcare
activities where EUA may apply, whether during a health emergency or under the regular
order of business for the medical community.
(3) "Health emergency" means a state of emergency declared by the governor or a
public health emergency declared by the state health officer under the Louisiana Health
Emergency Powers Act, R.S. 29:760 et seq.
C.(1) The surgeon general shall promulgate rules in accordance with the
Administrative Procedure Act for the administration of medical activities under Emergency
Use Authorization (EUA) by all members of the healthcare community in this state.
(2) Such rules shall apply to all entities within the healthcare community, including
but not limited to hospitals, public and private clinics, pharmacies, nursing homes, and any
other entity involved in healthcare activities where EUA may apply, whether during a health
emergency or under the regular order of business for the medical community.
D. The rules promulgated by the surgeon general shall include but not be limited to
the following:
(1) Procedures for the safe and effective administration of EUA-authorized medical
products including therapeutics, vaccines, diagnostics, and other interventions.
(2) Guidelines for informed consent, ensuring that patients are fully informed of the
risks, benefits, and alternatives associated with EUA-authorized products.
(3) Protocols for monitoring and reporting adverse events related to EUA-authorized
products, including mandatory reporting to the Louisiana Department of Health and, where
applicable, federal authorities.
(4) Standards for training and education of healthcare providers on the proper use
and administration of EUA-authorized products.
(5) Measures to promote access to EUA-authorized products and protections across
all segments of the population, with specific attention to underserved and rural communities.
(6) Provisions for transparency, including public disclosure of EUA-related activities
by healthcare entities, to maintain public trust during health emergencies.
(7) Procedures for compliance and enforcement, including penalties for
noncompliance by healthcare entities, to ensure uniformity and accountability.
E.(1) The rules promulgated in accordance with this Section shall apply to all
EUA-related medical activities conducted by the healthcare community in this state, whether
during a health emergency or under the regular order of business for the medical community.
(2) The rules shall not supersede federal regulations governing EUA but shall
complement such regulations by providing state-specific guidance to ensure uniformity and
safety in administration.
F. The surgeon general shall coordinate with the following agencies or organizations
during the development of his rules:
(1) The office of the attorney general.
(2) The Louisiana State Law Institute.
(3) The Louisiana State Board of Medical Examiners.
(4) The Louisiana Hospital Association.
(5) The Louisiana Board of Pharmacy.
(6) The Louisiana State Medical Society.
(7) The Louisiana State Board of Nursing.
(8) Any other agencies or organizations deemed appropriate by the surgeon general.
Acts 2025, No. 396, §1, eff. June 20, 2025.