HLS 22RS-404 ENGROSSED 2022 Regular Session HOUSE BILL NO. 117 BY REPRESENTATIVE ECHOLS 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 have the meaning ascribed 11 in this Subsection: 12 (1) "FDA" means the United States Food and Drug Administration. 13 (2) "Off-label use" means the use of a prescription drug for an indication for 14 which it has not been approved by the FDA or the use of such drug in an age group, 15 dosage, or route of administration that has not been approved by the FDA. 16 B. Neither the Louisiana Department of Health nor any licensing board or 17 commission created by the provisions of this Title shall prohibit or restrict the 18 prescribing, administering, or dispensing for an off-label use of a drug that has been 19 approved for a specific use by the FDA. Page 1 of 2 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 22RS-404 ENGROSSED HB NO. 117 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 117 Engrossed 2022 Regular Session Echols Abstract: Provides that neither the state health agency nor any 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 stipulates that neither the La. Dept. of Health nor any healthcare professional licensing board or commission shall prohibit or restrict the prescribing, administering, or dispensing for an off-label use a drug that has been approved for a specific use by the U.S. Food and Drug Administration (FDA). 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. Delete proposed law prohibiting certain actions against healthcare professionals by licensing boards and commissions in connection with the prescription, administration, and dispensing of drugs for off-label use. 2. Delete proposed law prohibiting certain actions against healthcare professionals by hospitals in connection with the prescription, administration, and dispensing of drugs for off-label use. 3. Provide that neither the La. Dept. of Health nor any healthcare professional licensing board or commission shall prohibit or restrict the prescribing, administering, or dispensing for an off-label use a drug that has been approved for a specific use by the FDA. 4. Make technical changes. Page 2 of 2 CODING: Words in struck through type are deletions from existing law; words underscored are additions.