Michigan Office of Administrative Hearings and Rules  
Administrative Rules Division (ARD)  
611 W. Ottawa Street  
Lansing, MI 48909  
Phone: 517-335-8658 Fax: 517-335-9512  
REQUEST FOR RULEMAKING (RFR)  
1. Department:  
Licensing and Regulatory Affairs  
2. Bureau:  
Bureau of Professional Licensing  
3. Promulgation type:  
Full Process  
4. Title of proposed rule set:  
Pharmacy - Controlled Substances  
5. Rule numbers or rule set range of numbers:  
R 338.3101 – R 338.3199q  
6. Estimated time frame:  
12 months  
Name of person filling out RFR:  
Andria Ditschman  
E-mail of person filling out RFR:  
DitschmanA@michigan.gov  
Phone number of person filling out RFR:  
517-290-3361  
Address of person filling out RFR:  
611 W. Ottawa Street, 3rd. Floor, P.O. Box 30670, Lansing, MI 48909  
7. Describe the general purpose of these rules, including any problems the changes are intended  
to address.  
The purpose of the Pharmacy - Controlled Substances Rules is to regulate the schedules, licenses,  
security, records, dispensing and administering, prescriptions, distributions, and administrative and  
disciplinary procedures for controlled substances. The proposed rules will: clarify R 338.3135 and  
require physician’s assistants to meet the opioid training requirements that apply to controlled  
substances licensees because they hold a controlled substance license; expand the individuals who  
must take the opioid training; require individuals to take the opioid training by July 1, 2022;  
exempt an individual licensed under section 7303 of the code, MCL 333.7303, who prescribes or  
dispenses controlled substances only for research on animals from taking the opioid training;  
clarify that R 338.3162b requires additional information to be submitted to the Prescription Drug  
Monitoring Program (MAPS) database; clarify rules regarding electronic transmission of  
prescriptions pursuant to section 17754a of the Public Health Code; update the controlled  
substances schedules; update rules related to the opioid crisis; clarify licensing provisions;  
evaluate the need for a separate license to treat a drug-dependent person; clarify when inventories  
and records are required; update prescription requirements; clarify dispensing and distribution  
requirements; and clarify refilling of prescriptions.  
8. Please cite the specific promulgation authority for the rules (i.e. department director,  
commission, board, etc.).  
MCL 24.239  
RFR-Page 2  
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 333.7301 authorizes the Board to promulgate rules  
relating to the licensure and control of the manufacture, distribution, prescribing of controlled  
substances included in schedule 2, and dispensing of controlled substances in this state.  
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).  
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.  
MCL 24.239  
RFR-Page 3  
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.  
Although there are similar provisions to some of the proposed rules at the federal level and other  
states, the proposed rules do not exceed similar regulations, compliance requirements, or other  
standards adopted at the state, regional, or federal level.  
Many states have adopted controlled substances or pain control training. Although none of the  
states in the Great Lakes region require individuals delegated, ordered, or allowed by a practice  
agreement to prescribe or dispense controlled substances to take a specific training in opioid and  
controlled substances awareness, New York requires every medical resident who is prescribing  
under a facility registration number from the United States Department of Justice to take a course  
in pain management, palliative care, and addiction.  
All states in the Great Lakes region have a prescription drug monitoring program.  
14. Do the rules incorporate the recommendations received from the public regarding any  
complaints or comments regarding the rules? If yes, please explain.  
The Department will work with associations, related businesses, and lobbyists in preparing the  
proposed rules.  
15. If amending an existing rule set, please provide the date of the last evaluation of the rules  
and the degree, if any, to which technology, economic conditions, or other factors have changed  
the regulatory activity covered by the rules since the last evaluation.  
In 2019, R 338.3135 was promulgated, which required an opioid awareness training by licensees;  
gabapentin was added to schedule 5; and R 338.3161a was promulgated, which established  
exceptions to the bona fide prescriber-patient relationship. Otherwise, the last evaluation of the  
rules was in 2016. There have been no technological factors, economic conditions or other factors  
that would necessitate amendment of the rules.  
16. Are there any changes or developments since implementation that demonstrate there is no  
continued need for the rules, or any portion of the rules?  
No, there are no changes or developments since implementation of the rules that demonstrate there  
is no continued need for the rules, or any portion of the rules.  
17. Is there an applicable decision record (as defined in MCL 24.203(6) and required by MCL  
24.239(2))? If so, please attach the decision record.  
Yes  
MCL 24.239  
;