Louisiana § RS 40:5.13 - Rules for administration of medical activities under Emergency Use Authorization

§ RS 40:5.13. 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.