Got this notice from Michigan:
May 31, 2024
Dear Licensee,
The Bureau of Professional Licensing (BPL) within the Michigan Department of Licensing and Regulatory Affairs (LARA) would like to inform you that the Pharmacy – Controlled Substances Rules have been revised and the changes are effective immediately.
One particular amendment of note is the descheduling of Gabapentin, meaning it is no longer classified as a controlled substance in the state of Michigan. A prescriber without a controlled substance license can now prescribe Gabapentin, and Gabapentin no longer needs to be included in reporting to the Michigan Automated Prescription System (MAPS). Despite this, we encourage prescribers and dispensers to continue to monitor the use and potential misuse of this drug.
Below is a summary of the significant changes to the rules:
- For definitions, the rule changes clarify definitions and adds a tribal government identification number to the definition of patient identifier.
- For schedules, the rule changes adopt the federal schedule subject to drugs scheduled by the state after January 6, 2022, and the rules promulgated by the Michigan Board of Pharmacy; remove Brorphine, Gabapentin, and Pentazocine as exceptions to the federal schedule; provide an exception to the federal scheduling for isomers, Salvia Divorum, Salvinorum A, Synthetic Cannabinoids, and Synthetic Cathinones.
- For controlled substance licensure, the rule changes require a designated prescriber to have a controlled substance license for a health facility if substances are stored there without an on-site pharmacy or an automated device stocked by a pharmacy, provide an exception to licensure for an emergency kit that contains controlled substances, clarify the investigator information required for research and chemical analysis laboratory applicants, and require training in opioids and controlled substances awareness for initial licensure and license renewal for individual licensees, and removes training requirements that are duplicative with federal requirements for a DEA registration for licensees required to obtain a DEA registration.
- For records, the rule changes permit an electronic duplicate of the original paper prescription, which will become the original prescription, 2 years from the last dispensing date and clarify that if a controlled substance is dispensed from an automated device, documentation maintained on-site in the pharmacy must include the automated device’s manufacture’s name, model number, and the name and address of the facility where the automated device is located.
- For controlled substance prescriptions, the rule changes clarify that a paper prescription is not required to have preprinted numbers representing the quantity next to a box or line; require that the professional designation for the prescribing practitioner be written on the prescription or stored electronically in the pharmacy’s automated data processing system; allow a prescriber to seek waiver of electronic prescription transmission requirements if the prescriber can attest that they intend, within 12 months, to not regularly practice their licensed profession for financial gain or as a means of livelihood; clarify that the prescriber must deliver to the dispensing pharmacist a written prescription postmarked within 7 days after the date the prescription was dispensed, or electronically transmit the prescription under R 338.3162a; and rescind R 338.3163 concerning prescribing, dispensing, and administering a controlled substance to an individual with substance use disorder.
- For controlled substance distributions, the rule changes require a licensee to provide written notification to the department 15 days before controlled substances are transferred.
- For individuals applying for their initial controlled substance license, as well as those renewing their controlled substance license, rule changes made to R 338.3135 now require continued training in opioids and controlled substance awareness before applying for the initial license and each subsequent renewal of a controlled substance license.
Please click HERE to view the revised Pharmacy – Controlled Substances Rules.
Our office is diligently working on updating relative information on our website to reflect the revisions of the revised rules. For more information, please visit our website at www.michigan.gov/bpl.
Please send questions about the revised rules to BPLHELP@michigan.gov.
Thank you,
Bureau of Professional Licensing
Licensing Division
517-241-0199