RFR-Page 2
MCL 333.7106, MCL 333.7109, MCL 333.7203, MCL 333.7216, MCL 333.7301, MCL 333.7303,
MCL 333.7303a, MCL 333.7321, MCL 333.7333, MCL 333.17754, MCL 333.7333a, and
Executive Reorganization Order No. 1991-9, MCL 338.3501; Executive Reorganization Order No.
1996-2, MCL 445.2001; Executive Reorganization Order 2003-1, MCL 445.2011, and Executive
Reorganization Order 2011-4, MCL 445.2030.
B. Are the rules mandated by any applicable constitutional or statutory provision? If so, please
explain.
Yes. MCL 333.7333a requires the Department to establish an electronic system for monitoring
controlled substances. MCL 333.7203 requires the Board to promulgate a rule to schedule a
substance if it finds the substance has a potential for abuse. MCL 333.7303 requires the Board to
designate by rule the controlled substances in schedules 3 to 5 to be reported.
9. Please describe the extent to which the rules conflict with or duplicate similar rules,
compliance requirements, or other standards adopted at the state, regional, or federal level.
Under the Controlled Substances Act, 21 USC 801 et seq., and federal regulations, the federal
government regulates the production, possession, and distribution of controlled substances. The
Act and federal regulations place drugs, chemicals, and plants into one of five schedules based on
certain factors, including but not limited to, the medical use of the substance and the potential
abuse of the substance. In addition, the Act and federal regulations require individuals who
manufacture, distribute, or dispense a controlled substance to be registered with the Drug
Enforcement Administration in the U.S. Department of Justice. The Act and federal regulations do
not require registrants to take training on opioids and controlled substances. Registrants, however,
are required to keep a record of each controlled substance that was manufactured, received, sold,
delivered, or disposed of, and maintain detailed inventories. There are also federal regulations on
issuing prescriptions, refilling prescriptions, and labeling and packaging prescriptions. Each state
establishes its own requirements with respect to the manufacture, distribution, and dispensing of
controlled substances. In Michigan, Article 7, Controlled Substances, of the Public Health Code
provides for the scheduling of controlled substances as well as establishing requirements for the
manufacture, distribution, and dispensing of controlled substances. While there is no federal rule
or standard, or national licensing agency or accreditation association that requires a controlled
substance licensee to take a training regarding opioids and controlled
substances, the federal act requires individuals who are registered under that act to keep certain
records.
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,
instructional bulletin, form with instructions, or operational memoranda?
No. The subject matter of these rules is not currently contained in any guideline, handbook,
manual, instructional bulletin, form with instructions, or operational memoranda.
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed
for the current year?
Yes.
12. Will the proposed rules be promulgated under Section 44 of the Administrative Procedures
Act, 1969 PA 306, MCL 24.244, or under the full rulemaking process?
Full Process
13. Please describe the extent to which the rules exceed similar regulations, compliance
requirements, or other standards adopted at the state, regional, or federal level.
MCL 24.239