Department of Licensing and Regulatory Affairs
Bureau of Professional Licensing
Administrative Rules for Pharmacy - Controlled Substances
Rule Set 2022-6 LR
NOTICE OF PUBLIC HEARING
Monday, October 16, 2023
09:00 AM
UL-3
611 W. Ottawa Street, Lansing, Michigan or
The Department of Licensing and Regulatory Affairs will hold a public hearing to receive public
comments on proposed changes to the Pharmacy - Controlled Substances rule set.
The proposed rules will be modified as follows:
For schedules, the proposed 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 and Gabapentin as exceptions to the federal schedule; remove Pentazocine from Schedule 5
to Schedule 4; provide an exception to the federal scheduling for isomers, Salvia Divorum, Salvinorum A,
Synthetic Cannabinoids, and Synthetic Cathinones.
For controlled substances licensure, the proposed 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 and provide an exception to licensure for an
emergency kit that contains controlled substances.
For records, the proposed rules permit an electronic duplicate of the original paper prescription, which
will become the original prescription, 2 years from the last dispensing date; require a pharmacy that
holds an additional license for an automated dispensing system, that dispenses controlled substances,
to store inventories and schedule order forms at the licensed location of the automated device; 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 proposed 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 stored electronically; allow a prescriber to
seek waiver of electronic prescription transmission requirements if the prescriber can attest that he or
she intends, within 12 months, to not regularly practice their licensed profession for financial gain or as a
means of livelihood; and 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.
For controlled substance distributions, the proposed changes require a licensee to provide written
notification to the department 15 days before controlled substances are transferred.
By authority conferred on the director of the department of licensing and regulatory affairs and the board
of pharmacy by sections 7106, 7109, 7203, 7216, 7301, 7303, 7303a, 7321, 7333, 7333a, and 17754 of
the public health code, 1978 PA 368, MCL 333.7106, 333.7109, 333.7203, 333.7216, 333.7301,
333.7303, 333.7303a, 333.7321, 333.7333, 333.7333a, and 333.17754, and Executive Reorganization
Order Nos. 1991-9, 1996-2, 2003-1, and 2011-4, MCL 338.3501, 445.2001, 445.2011, and 445.2030.