The desired outcome of the proposed rules is as follows: licensees and the public will be able to use the federal
schedule of controlled substances in Michigan; providers will know when they must apply for a controlled substance
license; licensees will be educated in opioids and other controlled substances which will make them better providers;
prescribers who provide maintenance or detoxification treatment in the course of their professional practice or who are
registered with the DEA to provide such treatment will no longer need a controlled substance license; a licensee will
only prescribe, dispense, and administer a controlled substance to a drug dependent individual in limited
circumstances; licensees will submit a report of a significant loss only when the criteria of “significant” in the rule is
met; controlled substance inventories will be timely submitted; licensees will keep records for two years and original
prescriptions for 5 years and be able to replace the written prescription with an electronic version after 2 years: unless
there is an exception or waiver all prescribers will electronically transmit prescriptions which will allow for the
electronic exchange of prescription data between physician practices and pharmacies, potentially improve the
efficiency of the prescribing process, and reduce medication errors; licensees will timely report to the electronic system
7. Identify the harm resulting from the behavior that the proposed rules are designed to alter and the likelihood
that the harm will occur in the absence of the rule.
The proposed rules are designed to alter the following harm: the use of a drug by the public without proper protections
because it is not clear to the public and licensees that it is a controlled substance; licensees dealing with controlled
substances without a proper license; health providers lacking education in opioids and other controlled substances;
continuing to require a prescriber to have a license only because they provide maintenance or detoxification treatment;
licensees prescribing, dispensing, and administering a controlled substance to a drug dependent individual; licensees
not reporting a significant loss of a controlled substance; licensees not taking an inventory of controlled substances;
licensees not keeping records; prescribers refusing to electronically transmit prescriptions when it would benefit the
patient and prescribers not having an option to waive the requirement when electronic transmission is not appropriate;
and licensees failing to property report to the electronic system for monitoring.
The harm that will result from the behavior that the proposed rules are designed to alter will continue in the absence of
the proposed rules.
A. What is the rationale for changing the rules instead of leaving them as currently written?
The harm that will result from the behavior that the proposed rules are designed to alter will continue in the absence
of the proposed rules.
8. Describe how the proposed rules protect the health, safety, and welfare of Michigan citizens while promoting a
regulatory environment in Michigan that is the least burdensome alternative for those required to comply.
The proposed rules provide a regulatory system for controlled substances. To protect the health and safety of
Michigan’s citizens, it is important that health professionals that deal with controlled substances adhere to minimal
training and professional standards.
9. Describe any rules in the affected rule set that are obsolete or unnecessary and can be rescinded.
R 338.3109 and R 338.3182 are being rescinded as they are obsolete. R 338.3112, R 338.3113, R 338.3113a, R
338.3114, R 338.3114a, R 338.3116, R 338.3117, R 338.3118, R 338.3119, R 338.3119a, R 338.3119b, R 338.3120,
R 338.3121, R 338.3121a, R 338.3122, R 338.3123, R 338.3125, R 338.3126, R 338.3127 and R 338.3129 regulate
scheduling of substances. They are being rescinded as the proposed rules will adopt the complete list of drugs and
other substances that are controlled substances under the CSA. R 338.3136 and R 338.3152 are being rescinded as
the regulations are found elsewhere in the rules. R 338.3162e is being rescinded pursuant to MCL 333.7333a.
Fiscal Impact on the Agency
Fiscal impact is an increase or decrease in expenditures from the current level of expenditures, i.e. hiring additional staff,
higher contract costs, programming costs, changes in reimbursements rates, etc. over and above what is currently
expended for that function. It does not include more intangible costs for benefits, such as opportunity costs, the value of
time saved or lost, etc., unless those issues result in a measurable impact on expenditures.
10. Please provide the fiscal impact on the agency (an estimate of the cost of rule imposition or potential savings
for the agency promulgating the rule).