LARA: New Controlled Substance Administrative Rules Announced

LANSING–The Bureau of Professional Licensing (BPL) within the Department of Licensing and Regulatory Affairs (LARA) would like to inform you that the new Controlled Substance Rules were effective as of January 6, 2022. A list of the notable changes is below. This is not intended to provide a comprehensive listing of all changes or current requirements. Licensees should review the rules and statute for a complete understanding of all applicable requirements.

• Except for a few exceptions, adopt the complete list of drugs and substances that are controlled substances under the federal Controlled Substances Act.
• Clarify who must obtain a controlled substance license and reorganize the licensing rule.
• Require physician’s assistants to meet the opioid training requirements that apply to controlled substances licensees.
• Expand the individuals who must take the opioid/controlled substances training.
• Exempt an individual who prescribes or dispenses controlled substances only for research on animals from taking the opioid/controlled substances training.
• Eliminate the drug treatment program prescriber license.
• Clarify when inventories and records are required.
• Require that technologies are in place and used, such as bar-coding, when stocking of an automated device is delegated.
• Require information to be submitted to the Prescription Drug Monitoring Program (MAPS) database.
• Require electronic transmission of prescriptions when the same is required by the Federal Centers for Medicare and Medicaid Services, pursuant to the Public Health Code.
• Provide a state waiver from the electronic transmission of prescriptions at any time a waiver is granted by CMS.
• Provide a process and basis to obtain a waiver from the mandate to electronically transmit prescriptions.
• Provide specific exceptional circumstances to the waiver rule.
• Align the requirements to treat an individual with a substance use disorder for maintenance and detoxification with federal regulations. Use “individual with substance use disorder” instead of “drug dependent person.” Clarify the definition of a “program.”
• Update prescription requirements.
• Update emergency and partial dispensing of controlled substances.
• Update refilling of prescriptions.
• Clarify that a cash discount card is a cash transaction for entry into the MAPS program.

Please click HERE to view the revised Controlled Substance Rules.

The BPL office is diligently working on updating relative information on its website to reflect the revisions of the revised rules. For more information, please visit the website at www.michigan.gov/bpl.

Please send questions about the revised rules to [email protected].