HLS 24RS-1905 REENGROSSED 2024 Regular Session HOUSE BILL NO. 813 BY REPRESENTATIVES EDMONSTON, AMEDEE, BAYHAM, CREWS, DICKERSON, EGAN, HORTON, OWEN, SCHAMERHORN, WILDER, AND MCCORMICK DRUGS/PRESCRIPTION: Provides relative to prescribing, administering, and dispensing of drugs for off-label use 1 AN ACT 2To enact R.S. 37:1704, relative to prescribing, administering, and dispensing of drugs by 3 certain licensed healthcare professionals; to provide for prescription, administration, 4 and dispensing of certain drugs for off-label use by healthcare professionals with 5 prescriptive authority; and to provide for related matters. 6Be it enacted by the Legislature of Louisiana: 7 Section 1. R.S. 37:1704 is hereby enacted to read as follows: 8 ยง1704. Prescription, administration, and dispensing of FDA-approved drugs for 9 off-label use 10 A. As used in this Section, the following terms mean: 11 (1) "FDA" means the United States Food and Drug Administration. 12 (2) "Off-label use" means the use of a prescription drug for an indication for 13 which it has not been approved by the FDA or the use of such drug in an age group, 14 dosage, or route of administration that has not been approved by the FDA. 15 B. No licensing board or commission created by the provisions of this Title 16 shall prohibit or restrict the prescribing, administering, or dispensing for an off-label 17 use of a human drug that has been approved for a specific use by the FDA during a 18 declared public health emergency. Page 1 of 2 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 24RS-1905 REENGROSSED HB NO. 813 DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 813 Reengrossed 2024 Regular Session Edmonston Abstract: Provides that no healthcare professional licensing board of the state shall prohibit or restrict the prescribing, administering, or dispensing of drugs for off-label use. Present law provides for licensure and regulation by the state of various types of healthcare professionals. Proposed law retains present law and provides that no healthcare professional licensing board or commission shall prohibit or restrict the prescribing, administering, or dispensing for an off-label use of a human drug that has been approved for a specific use by the U.S. Food and Drug Administration (FDA) during a declared public health emergency. Proposed law defines "off-label use", for purposes of proposed law, as the use of a prescription drug for an indication for which it has not been approved by the FDA or the use of such drug in an age group, dosage, or route of administration that has not been approved by the FDA. (Adds R.S. 37:1704) Summary of Amendments Adopted by House The Committee Amendments Proposed by House Committee on Health and Welfare to the original bill: 1. Remove the La. Dept. of Health from the list of entities prohibited from making rules limiting off-label use of drugs approved by the FDA. The House Floor Amendments to the engrossed bill: 1. Add that a board or commission may not prohibit prescribing, administering, or dispensing a drug for a human that was approved by the FDA during a declared public health emergency. Page 2 of 2 CODING: Words in struck through type are deletions from existing law; words underscored are additions.