LDH Guidance on Act 246, Regarding Mifepristone and Misoprostol
Date: 09/06/24
To help healthcare providers access the most current information from the Louisiana Department of Health, we share this recent guidance concerning Act 246 of the 2024 Regular Legislative Session, related to Mifepristone and Misoprostol. The full Act 246 memo and attachments have been made available by LDH as a PDF. We have included the text of the memo below for convenient reference.
The Louisiana Department of Health issues the following Memorandum and Guidance regarding Act 246 of the 2024 Louisiana Regular Legislative Session("Act 246"). Act 246 becomes effective October 1, 2024.
This Memorandum and Guidance serves to provide notice of the requirements of Act 246, as well as provide guidance for hospital inpatient settings.
This Act (a copy of which is attached) revised the list of Schedule IV controlled dangerous substance drugs in La. R.S. 40:964 to include Mifepristone and Misoprostol as follows:
§964. Composition of schedules
Schedules I, II. Ill, IV, and V shall, unless and until added pursuant to R.S. 40:962, consist of the following drugs or other substances. by whatever official name, common or usual name, chemical name, or brand name designated:
* * *
SCHEDULE IV
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F. Mifepristone, Misoprostol. Unless listed in another schedule, any material, compound, mixture, or preparation containing any detectable quantity of mifepristone or misoprostol.
Please be advised that Mifepristone and Misoprostol may be prescribed and administered in accordance with R.S. 14:87.9(C)(6). A copy of R.S.14:87.9 is attached. Mifepristone and Misoprostol are legal with a valid prescription in Louisiana subject to compliance with all applicable Louisiana laws.
Hospital Inpatient Settings:
This Memorandum and Guidance seeks to clarify that Mifepristone and Misoprostol may be utilized in Louisiana hospitals to treat postpartum hemorrhage and incomplete miscarriages in accordance with R.S.14:87.9(C)(6), and in compliance Louisiana laws and regulations.
Pursuant to the hospital licensing rules, all scheduled drugs (including Mifepristone and Misoprostol as of October 1, 2024) should becompounded, packaged, dispensed, and securely stored (in locked/securedcabinet, compartment, or other system) in accordance with the hospital'scurrent policies and procedures. In addition, the hospital's pharmacy shallhave a current controlled dangerous substance license to dispense controlled substances to patients in the hospital.
A hospital may include Mifepristone and Misoprostol in a secured automated medication dispensing/delivery system, such as the Pyxis system. Such systems are allowed in hospital emergency departments, labor and delivery units/rooms, operating units/rooms, and other floors/units/rooms of a hospital as deemed appropriate by the hospital.
Further, a hospital may authorize certain scheduled drugs to be included in a locked or secured area of an obstetric hemorrhage cart or "crash cart". Such authorization should be approved by the hospital's Chief Medical Officer and its Director of Pharmacy; additionally, such approval and process should be included in a hospital's pharmacy policy and procedures manual.
Prescription Drug Monitoring Program:
This Memorandum and Guidance directs all questions regarding the Prescription Drug Monitoring Program to the Louisiana Board of Pharmacy who administers and oversees such program. Information for the Louisiana Board of Pharmacy, Prescription Drug Monitoring Program may be found at www.pharmacy.la.gov.
Should any provider or medical professional have additional questions about Act 246, including compliance and implementation concerns, the Louisiana Department of Health recommends that the provider/professional seek legal advice from its own legal counsel.
Download the full Act 246 memo and attachments, made available by LDH as a PDF.