DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
BOARD OF PHARMACY  
PHARMACY – CONTROLLED SUBSTANCES  
Filed with the secretary of state on January 6, 2022  
These rules take effect immediately upon filing with the secretary of state unless  
adopted under section 33, 44, or 45a(9) of the administrative procedures act of 1969,  
1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections  
become effective 7 days after filing with the secretary of state.  
(By authority conferred on 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)  
R 338.3101, R 338.3102, R 338.3104, R 338.3108, R 338.3111, R 338.3132, R 338.3135,  
R 338.3137, R 338.3141, R 338.3143, R 338.3145, R 338.3151, R 338.3153,  
R 338.3153a, R 338.3154, R 338.3161, R 338.3161a, R 338.3162, R 338.3162a,  
R 338.3162b, R 338.3162c, R 338.3162d, R 338.3163, R 338.3164, R 338.3165,  
R 338.3166, R 338.3167, R 338.3168, R 338.3170, R 338.3181, R 338.3183, R 338.3185  
and R 338.3186 of the Michigan Administrative Code are amended, R 338.3109,  
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, R 338.3129, R 338.3136, R 338.3152, R 338.3162e, and R 338.3182 are  
rescinded, as follows:  
PART 1. GENERAL PROVISIONS  
R 338.3101 Definitions; A to H.  
Rule 1. As used in these rules:  
(a) “Automated device” means a mechanical system that performs an operation or  
activity, other than compounding or administration, relating to the storage, packaging,  
dispensing, or delivery of a drug and that collects, controls, and maintains transaction  
information.  
(b) “Board” means the board of pharmacy.  
(c) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.  
(d) "Department" means the department of licensing and regulatory affairs (LARA).  
October 11, 2021  
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(e) "Electronic signature" means an electronic sound, symbol, or process attached to or  
logically associated with a record and executed or adopted by an individual with the  
intent to sign the record. An electronic signature also is a unique identifier protected by  
appropriate security measures such that it is only available for use by the intended  
individual and ensures nonrepudiation so that the signature may not be rejected based on  
its validity.  
R 338.3102 Definitions; I to P.  
Rule 2. As used in these rules:  
(a) "Inventory" means all stocks in finished form of a controlled substance that are  
manufactured or otherwise acquired by a licensee, whether in bulk or commercial  
containers or contained in pharmaceutical preparations in the possession of the licensee.  
(b) "Licensee" means a person who is licensed pursuant to section 7303 of the code,  
MCL 333.7303.  
(c) "Michigan automated prescription system (MAPS) claim form" means a form, to be  
determined by the department, that is in the format and includes the information as  
specified by the American Society for Automation in Pharmacy (ASAP) 4.1 Standard for  
Prescription Drug Monitoring Programs and contains the information specified in R  
338.3162b.  
(d) "National drug code number (NDC)" means a number that identifies the labeler,  
vendor, product, and package size and is assigned to each drug product listed under  
section 510 Registration of Producers of Drugs and Devices, of the Federal Food, Drug,  
and Cosmetic Act (FDCA) of 2017, 21 USC 360.  
(e) "Officer" means a federal, state, county, or local law enforcement officer who  
enforces the laws of this state.  
(f) "Patient identifier" means all of the following information about a patient:  
(i) Full name.  
(ii) Address, including zip code.  
(iii) Date of birth.  
(iv) Any 1 of the following identification numbers:  
(A) A state-issued driver's license number obtained from a state-issued driver’s  
license.  
(B) A state-issued identification number obtained from a state-issued photo  
identification card.  
(C) A federal passport number obtained from a federal passport.  
(D) The number zero. Zeroes must be entered as the identification number, if the  
positive identification presented for the patient or client does not include a license  
number, identification number, or passport number as listed in subparagraphs (A) to (C)  
of this paragraph, the patient is under the age of 16, or the animal’s owner cannot be  
identified.  
(g) "Positive identification" means identification that includes a photograph of an  
individual in addition to his or her date of birth. Positive identification includes an  
identification card issued by a governmental agency, if the identification card meets the  
requirements of this rule.  
(h) "Medical institution" means the term as defined in R 338.486.  
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(i) "Pharmacy services" means the direct and indirect patient care services associated  
with the practice of pharmacy, as defined in section 17707 of the code, MCL 333.17707.  
R 338.3104 Definitions; R, S.  
Rule 4. As used in these rules:  
(a) "Readily retrievable" means a record which is kept so that it can be separated from  
all other records within 48 hours and in which a listed controlled substance is marked  
with an asterisk, redlined, or in some other manner visually identifiable apart from the  
other substances listed in the record.  
(b) "Substance" means a controlled substance unless the context indicates otherwise.  
R 338.3108 Terms defined in code.  
Rule 8. Unless otherwise defined in these rules, the terms defined in the code have the  
same meaning when used in these rules.  
R 338.3109 Rescinded.  
PART 2. SCHEDULES  
R 338.3111 Schedules; federal controlled substance schedules adopt by reference;  
exceptions.  
Rule 11. (1) The board approves and adopts by reference the complete list of drugs and  
other substances that are considered controlled substances under the Controlled  
Substance Act (CSA) of 1970, 21 USC 801, that have been divided into 5 schedules as  
published in 21 CFR 1308.11 to 1308.15, except for those drugs or other substances  
specifically excepted by this state’s laws enacted after the effective date of these rules or  
as listed in subrule (3) of this rule.  
(2) The standards adopted by reference in subrule (1) of this rule are available at no cost  
at https://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm, or at 10 cents per page  
from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of  
Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670,  
Lansing, Michigan 48909.  
(3) The following drugs and other substances are scheduled as follows:  
(a) Marijuana including pharmaceutical-grade cannabis, as those terms are defined in  
parts 71 and 81 of the code, MCL 333.7101 to 333.7125 and MCL 333.8101 to 333.8119,  
is a schedule 2 controlled substance if it is manufactured, obtained, stored, dispensed,  
possessed, grown, or disposed of in compliance with the code and as allowed by federal  
authority but only for the purpose of treating a debilitating medical condition as that term  
is defined in section 3(b) of the Michigan medical marihuana act, 2008 IL 1, MCL  
333.26423, and as allowed under the code.  
(b) Tianeptine sodium by whatever official, common, usual, chemical, or brand name  
designated is a schedule 2 controlled substance.  
(c) Gabapentin by whatever official, common, usual, chemical, or brand name  
designated is a schedule 5 controlled substance.  
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(d) Loperamide is not a scheduled controlled substance in this state.  
(e) Pentazocine is a schedule 4 controlled substance.  
(f) Brorphine is a schedule 1 controlled substance.  
(g) Except in subdivision (h) of this subrule, ephedrine, a salt of ephedrine, an optical  
isomer of ephedrine, a salt of an optical isomer of ephedrine, or a compound, mixture, or  
preparation containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a  
salt of an optical isomer of ephedrine is included in schedule 5.  
(h) A product containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine,  
or a salt of an optical isomer of ephedrine is not included in schedule 5 if the drug  
product meets all of the following criteria:  
(i) May lawfully be sold over the counter without a prescription under federal law.  
(ii) Is labeled and marketed in a manner consistent with the pertinent over-the-  
counter tentative final or final monograph.  
(iii) Is manufactured and distributed for legitimate medical use in a manner that  
reduces or eliminates the likelihood for abuse.  
(iv) Is not marketed, advertised, or labeled for an indication of stimulation, mental  
alertness, energy, weight loss, appetite control, or muscle enhancement.  
(v) The drug product is 1 of the following:  
(A) A solid dosage form, including, but not limited to, a soft gelatin caplet that  
combines as active ingredients not less than 400 milligrams of guaifenesin and not more  
than 25 milligrams of ephedrine per dose and is packaged in blister packs with not more  
than 2 tablets or caplets per blister.  
(B) An anorectal preparation containing not more than 5% ephedrine.  
(C) A food product or a dietary supplement containing ephedrine, if the food  
product or dietary supplement meets all of the following criteria:  
(I) Contains, per dosage unit or serving, not more than the lesser of 25 milligrams  
of ephedrine alkaloids or the maximum amount of ephedrine alkaloids in applicable  
regulations adopted by the Federal Food and Drug Administration (FDA) and contains no  
other controlled substance.  
(II) Does not contain hydrochloride or sulfate salts of ephedrine alkaloids.  
(III) Is packaged with a prominent label securely affixed to each package that  
includes all of the following:  
(1) The amount in milligrams of ephedrine in a serving or dosage unit.  
(2) The amount of the food product or dietary supplement that constitutes a  
serving or dosage unit.  
(3) That the maximum recommended dosage of ephedrine for a healthy adult  
human is the lesser of 100 milligrams in a 24-hour period or the maximum recommended  
dosage or period of use in applicable regulations adopted by the FDA.  
(4) That improper use of the product may be hazardous to an individual’s  
health.  
R 338.3112 Rescinded.  
R 338.3113 Rescinded.  
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R 338.3113a Rescinded.  
R 338.3114 Rescinded.  
R 338.3114a Rescinded.  
R 338.3116 Rescinded.  
R 338.3117 Rescinded.  
R 338.3118 Rescinded.  
R 338.3119 Rescinded.  
R 338.3119a Rescinded.  
R 338.3119b Rescinded.  
R 338.3120 Rescinded.  
R 338.3121 Rescinded.  
R 338.3121a Rescinded.  
R 338.3122 Rescinded.  
R 338.3123 Rescinded.  
R 338.3125 Rescinded.  
R 338.3126 Rescinded.  
R 338.3127 Rescinded.  
R 338.3129 Rescinded.  
PART 3. LICENSES  
R 338.3132 Controlled substance license.  
Rule 32. (1) A person who manufactures, distributes, prescribes, or dispenses a  
controlled substance in this state or who proposes to engage in the manufacture,  
distribution, prescribing, or dispensing of a controlled substance in this state shall apply  
for a controlled substance license by submitting to the department a completed  
application on a form provided by the department along with the requisite fee.  
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(2) In addition to meeting the requirements of section 7303 of the code, MCL 333.7303,  
an applicant’s license shall be verified by the licensing agency of any state of the United  
States in which the applicant holds or has ever held a controlled substance license. This  
includes, but is not limited to, showing proof of any disciplinary action taken or pending  
against the applicant.  
(3) Except as otherwise provided in subrules (8) and (9) of this rule, a separate  
controlled substance license is required in each of the following circumstances:  
(a) For each principal place of business or professional practice where the applicant  
stores, manufactures, distributes, prescribes, or dispenses controlled substances.  
(b) Manufacturing and distributing a controlled substance in schedules 2-5. An  
individual, partnership, cooperative, association, private corporation, other legal entity, or  
governmental entity that is licensed in this state to manufacture a controlled substance  
listed in schedules 2 to 5 may also conduct chemical analysis and research with a  
substance that is listed in the schedules under the same controlled substance license.  
(c) Dispensing a controlled substance listed in schedules 2 to 5. A prescriber or  
practitioner who is licensed in this state to prescribe or dispense controlled substances  
listed in schedules 2 to 5 may also prescribe, dispense, administer, and conduct research  
with those substances under the same controlled substance license.  
(d) Conducting research and instructional activity with a controlled substance listed in  
schedule 1. An individual, partnership, cooperative, association, private corporation,  
other legal entity, or governmental entity that is licensed in this state to conduct research  
with controlled substances listed in schedule 1 may do both of the following:  
(i) Manufacture the specific substances as set forth in the research protocol that is  
filed and approved by the FDA and the DEA pursuant to the provisions of 21 CFR  
1301.18 and submitted to the department with the application for licensure.  
(ii) Distribute the specific substances to others who are licensed by this state to  
conduct research or chemical analysis with the schedule 1 substances.  
(e) Conducting research with a controlled substance listed in schedules 2 to 5. An  
individual, partnership, cooperative, association, private corporation, other legal entity, or  
governmental entity who is licensed in this state to conduct research with the controlled  
substances listed in schedules 2 to 5 may also participate in all of the following activities:  
(i) Conduct chemical analysis with the specific substances listed in those schedules.  
(ii) Manufacture the specific substances if, and to the extent that, the manufacture of  
the specific controlled substances is set forth in a statement filed with the application for  
licensure.  
(iii) Distribute the specific substances to others who are licensed in this state to  
conduct research, chemical analysis, or instructional activity with the substances.  
(iv) Conduct instructional activities with the specific substances.  
(f) Conducting instructional activities with a specific controlled substance listed in  
schedules 2 to 5.  
(g) Conducting chemical analysis with a controlled substance listed in any schedule An  
individual, partnership, cooperative, association, private corporation, other legal entity, or  
governmental entity that is licensed in this state to conduct chemical analysis with all  
controlled substances may manufacture the substances for analytical or instructional  
purposes, distribute the substances to others who are licensed to conduct chemical  
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analysis, instructional activity or research with the substances, and conduct instructional  
activities with the substances.  
(h) A pharmacy stocking patient medication in an automated device located at an  
affiliated hospital location pursuant to section 17760 of the code, MCL 333.17760, or a  
hospital, county medical care facility, nursing home, hospice, or other skilled nursing  
facility as defined in section 20109 of the code, MCL 333.20109. The pharmacy  
responsible for the device shall obtain an additional controlled substance license for each  
location. If substances are stored at a health facility without an onsite pharmacy or an  
automated device stocked by a pharmacy, a designated prescriber shall obtain a  
controlled substance license.  
(4) An applicant shall obtain a separate controlled substance license for each practitioner  
license issued under article 15 of the code, MCL 333.16101 to 333.18838. The controlled  
substance license must be renewed when the article 15 license is renewed and the  
controlled substance license is renewed for an equal number of years as the article 15  
license.  
(5) An applicant who intends to conduct research involving controlled substances shall  
submit all of the following with his or her application required under subrule (1) of this  
rule:  
(a) The applicant’s credentials to conduct the proposed research.  
(b) The protocol and description of the nature of the proposed research that is filed  
and approved by the FDA and the Federal Drug Enforcement Administration (DEA)  
pursuant to the provisions of 21 CFR 1301.18.  
(c) A list of the controlled substances and doses to be used.  
(6) An applicant who intends to conduct instructional activity involving controlled  
substances shall submit all of the following information with his or her application  
required under subrule (1) of this rule:  
(a) The applicant’s credentials to conduct the proposed instructional activity.  
(b) A course outline for the proposed instructional activity.  
(c) A list of the controlled substances and doses to be used.  
(7) An applicant who intends to conduct chemical analysis involving controlled  
substances shall submit all of the following information with his or her application  
required under subrule (1) of this rule:  
(a) The applicant’s credentials to conduct the proposed chemical analysis.  
(b) The protocol and description of the nature of the chemical analysis that is filed  
and approved by the FDA and the DEA pursuant to the provisions of 21 CFR 1301.18.  
(c) A list of the controlled substances and doses to be used.  
(8) A prescriber or practitioner who is licensed in this state to prescribe, administer, or  
dispense controlled substances at a principal place of business or professional practice  
consisting of multiple locations is not required to obtain a separate controlled substance  
license for each additional physical location of the business or professional practice if the  
prescriber or practitioner only prescribes controlled substances at each additional physical  
location of the business or professional practice.  
(9) A pharmacist shall maintain 1 controlled substance license in this state to dispense  
from any licensed pharmacy in this state.  
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R 338.3135 Opioids and other controlled substances awareness training standards for  
prescribers and dispensers of controlled substances; requirements.  
Rule 35. (1) An individual who is applying for a controlled substance license or who is  
licensed to prescribe or dispense controlled substances pursuant to section 7303 of the  
code, MCL 333.7303, shall complete a 1-time training in opioids and controlled  
substances awareness that meets the following standards:  
(a) Training content must cover all of the following topics:  
(i) Use of opioids and other controlled substances.  
(ii) Integration of treatments.  
(iii) Alternative treatments for pain management.  
(iv) Counseling on the effects and risks associated with using opioids and other  
controlled substances.  
(v) The stigma of addiction.  
(vi) Utilizing the MAPS.  
(vii) State and federal laws regarding prescribing and dispensing controlled  
substances.  
(viii) Security features for opioids and other controlled substances and prescriptions,  
and proper disposal requirements for opioids and other controlled substances.  
(b) Topics covered under subrule (1)(a) of this rule may be obtained from more than 1  
program.  
(c) Acceptable providers or methods of training include any of the following:  
(i) Training offered by a nationally recognized or state-recognized health-related  
organization.  
(ii) Training offered by, or in conjunction with, a state or federal agency.  
(iii) Training offered by a continuing education program or activity that is accepted  
by a licensing board established under article 15 of the code, MCL 333.16101 to  
333.18838.  
(iv) Training obtained in an educational program that has been approved by a board  
established under article 15 of the code, MCL 333.16101 to 333.18838, for initial  
licensure or registration, or by a college or university.  
(d) Acceptable modalities of training include any of the following:  
(i) Teleconference or webinar.  
(ii) Online presentation.  
(iii) Live presentation.  
(iv) Printed or electronic media.  
(2) A prescriber or dispenser shall not delegate, allow by a practice agreement, or order  
the prescribing, or dispensing of a controlled substance as allowed by the code to an  
individual, other than a physician’s assistant, only after the individual has complied with  
subrules (1) and (5) of this rule. A physician’s assistant is subject to subrules (1), (3), and  
(4) of this rule.  
(3) The department may select and audit licensees and request documentation of proof  
of completion of training. A licensee shall maintain proof of completion of training for 3  
renewal periods plus 1 additional year. If audited, an individual shall provide an  
acceptable proof of completion of training, including either of the following:  
(a) A completion certificate issued by the training provider that includes the date,  
provider name, name of training, and individual’s name.  
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(b) A self-attestation by the individual that includes the date, provider name, name of  
training, and individual’s name.  
(4) An individual who has been issued a controlled substance license pursuant to section  
7303 of the code, MCL 333.7303, shall complete the controlled substance training  
required by subrule (1) of this rule as follows:  
(a) A licensee who is renewing his or her controlled substance license shall complete  
the controlled substance training by the end of the first renewal cycle that begins after  
January 4, 2019.  
(b) Other than a license renewal under subdivision (a) of this subrule, beginning  
September 1, 2019, the department shall not issue a controlled substance license until an  
applicant provides proof of having completed the controlled substance training.  
(5) Beginning December 31, 2021, an individual, other than a physician’s assistant, who  
is a delegatee, or allowed by a practice agreement or an order to prescribe or dispense a  
controlled substance by a prescriber or dispenser as allowed by the code, shall complete  
the controlled substance training required by subrule (1) of this rule.  
(6) An individual who is licensed under section 7303 of the code, MCL 333.7303, to  
prescribe or dispense controlled substances only for research on animals is exempt from  
this rule.  
R 338.3136 Rescinded.  
R 338.3137 Eliminate drug treatment program prescriber license requirement.  
Rule 37. The drug treatment program prescriber license is eliminated.  
PART 4. SECURITY  
R 338.3141 Thefts and diversions.  
Rule 41. (1) An applicant or licensee shall provide effective controls against theft and  
diversion of controlled substances.  
(2) A licensee shall confirm that a person is licensed to possess a controlled substance  
before distributing the substance to the person.  
(3) Within 15 days of completion of an investigation regarding a suspected theft or  
significant loss of a controlled substance, a licensee shall notify the department of the  
suspected theft or significant loss of a controlled substance and submit a copy of the DEA  
theft and loss report form 106, or equivalent document, to the department, whether or not  
the controlled substance is recovered or the responsible person is identified and action is  
taken against him or her, and whether or not it is also reported to the DEA.  
(4) A licensee shall use all of the following criteria to determine if the loss in subrule (3)  
of this rule is significant:  
(a) The quantity of the controlled substance lost in relation to the type of business.  
(b) The specific controlled substance lost.  
(c) Whether the loss of the controlled substance can be associated with access to the  
controlled substance by specific individuals, or whether the loss can be attributed to  
unique activities that may take place involving the controlled substance.  
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(d) A pattern of loss over a specific time period, whether the loss appears to be  
random, and the results of efforts taken to resolve the loss.  
(e) Whether the specific controlled substance is a likely candidate for diversion.  
(f) Local trends and other indicators of the diversion potential of the missing controlled  
substance.  
R 338.3143 Storage of controlled substances.  
Rule 43. (1) A licensee shall store controlled substances that are listed in schedule 1 in a  
securely locked, substantially constructed cabinet that is anchored to a wall or the floor.  
(2) A licensee shall store controlled substances that are listed in schedules 2, 3, 4, and 5  
in a securely locked, substantially constructed cabinet, room, or cart. However, in a  
pharmacy, the controlled substances may be dispersed throughout the stock of  
noncontrolled substances in a manner to obstruct the theft or diversion of controlled  
substances.  
R 338.3145 Employees; disqualification.  
Rule 45. (1) An individual, partnership, cooperative, association, private corporation,  
other legal entity, or governmental entity who is licensed by the department pursuant to  
section 7303 of the code, MCL 333.7303 or section 17748 of the code, MCL 333.17748,  
shall not employ or utilize, with or without compensation, or allow the following  
individuals access to controlled substances:  
(a) An individual who the licensee knows, or should reasonably know, to be a  
substance abuser as defined in section 16106a of the code, MCL 333.16106a. This  
subdivision does not apply to a licensee enrolled in the health professional recovery  
program under a current monitoring agreement.  
(b) An individual whose controlled substance license is suspended, revoked, or denied.  
(c) An individual whose license issued by this state or another state is under suspension  
or revoked for a violation that involves controlled substances.  
(d) An individual who has been convicted of a crime that involves controlled  
substances and who is currently under sentence for that conviction.  
(2) A licensee shall not delegate, pursuant to section 16215 of the code, MCL  
333.16215, to a licensed or unlicensed individual unless the delegation complies with this  
rule.  
PART 5. RECORDS  
R 338.3151 Inventories.  
Rule 51. (1) An individual, partnership, cooperative, association, private corporation,  
other legal entity, or governmental entity licensed to manufacture, distribute, prescribe, or  
dispense controlled substances shall annually perform and maintain a complete and  
accurate inventory of all stocks of controlled substances in the possession and control of  
the licensee.  
(2) The inventory must contain a complete and accurate record of all controlled  
substances in the possession or control of the licensee on the date the inventory is taken  
as follows:  
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(a) If the substance is listed in schedule 1 or 2, then the licensee shall make an exact  
count or measure of the contents.  
(b) If the substance is listed in schedule 3, 4, or 5, then the licensee shall make an  
estimated count or measure of the contents, but if the container holds more than 1,000  
dosage units, then the licensee shall make an accurate account of the contents.  
(3) A licensee shall make a separate inventory for each licensed location on the date that  
he or she first engages in the activity covered by his or her license, including a change of  
a pharmacist in charge. The beginning inventory record for a licensed location shall be  
kept at the licensed location and a copy shall be forwarded to the department upon  
request.  
(4) A licensee shall indicate on the inventory record whether the inventory was taken at  
the opening or closing of the day that the inventory is taken.  
(5) A licensee shall maintain the inventory in a written, typewritten, or printed form at  
the licensed location. The inventory taken by use of an oral recording device must be  
promptly transcribed.  
(6) A licensee shall sign and date the inventory record.  
(7) A licensee's printed name, address, and DEA number shall be recorded on the  
inventory.  
(8) Schedule 2 drugs must be separated on the inventory from all other drugs.  
(9) A licensee that is open for 24 hours shall indicate the time that the inventory was  
taken.  
(10) On the effective date of the addition of a controlled substance to a schedule, which  
substance was not previously listed in any schedule, a licensee who possesses the  
substance shall take an inventory of all stocks of the substance on hand and incorporate it  
in the current inventory. Thereafter, the substance shall be included in each inventory  
taken.  
R 338.3152 Rescinded.  
R 338.3153 Invoices, acquisition, dispensing, administration, and distribution records.  
Rule 53. For 2 years, a licensee shall maintain in the pharmacy responsible for the  
automated device, for review by the department, an agency, or the board, all records for  
controlled substances, including invoices, acquisition records, and sales receipts, as  
follows:  
(a) A licensee may keep acquisition records, except for executed or voided DEA 222  
order forms, in an electronic form at a central location with notice to the department.  
(b) A licensee shall maintain invoices and other acquisition records of all controlled  
substances listed in schedules 1 and 2 in a separate file from invoices and other  
acquisition records of controlled substances listed in schedules 3, 4, and 5. The  
information must be readily retrievable from the ordinary acquisition records maintained  
by the dispenser.  
(c) A licensee shall retain sales receipts for 90 days in electronic or paper form.  
(d) A licensee shall initial or electronically initial the invoice and indicate the date that  
the controlled substances are received.  
(e) A licensee shall keep a record, which may be electronic, of all controlled substances  
dispensed by him or her.  
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(f) A licensee that prescribes controlled substances shall keep a record separate from  
the patient chart which contains all of the following information for controlled substances  
dispensed or administered by the prescriber:  
(i) Name of the patient.  
(ii) Name and strength of the controlled substance.  
(iii) Quantity of the controlled substance.  
(iv) Date the controlled substance was dispensed or administered.  
(v) Name of the individual who dispensed or administered the controlled substance.  
(g) Except in medical institutions, a licensee shall sequentially number and maintain in  
chronological order the patients’ original prescriptions as follows:  
(i) A licensee shall maintain a separate file for dispensed substances listed in schedule  
2.  
(ii) A licensee shall maintain a separate file for dispensed substances listed in  
schedules 3, 4, and 5.  
(h) The licensee shall keep the original prescription record on site for 5 years from the  
last date of dispensing. However, after 2 years from the last date of dispensing, if an  
electronic duplicate is made of the original paper prescription, which becomes the  
original prescription, the original prescription may be destroyed.  
(i) A licensee shall maintain records of controlled substances distributed to another  
licensee, which shall include all of the following information and be maintained in the  
appropriate file described in subdivision (b) of this rule or in a separate record that is  
available for inspection:  
(i) Name, address, and DEA number of receiver.  
(ii) Name, address, and DEA number of supplier.  
(iii) Name and quantity of the controlled substances distributed.  
(iv) Date the controlled substances were distributed.  
(j) A DEA 222 order form must be used for schedule 2 drugs.  
(k) Except for controlled substance prescriptions pursuant to subdivision (h) of this  
rule, a licensee shall maintain controlled substances records for 2 years.  
R 338.3153a Medication orders for patients in medical institutions.  
Rule 53a. (1) A licensee shall include all of the following information in a prescription  
for controlled substance medications to be dispensed for administration to an inpatient in  
a medical institution:  
(a) The patient's name.  
(b) The prescriber's name, address, and DEA number. In place of including the address  
and DEA number on each medication order, the pharmacy may maintain a separate list of  
prescribers. The list must contain the prescriber's name, address, and DEA number.  
(c) The prescriber's signature.  
(d) The name, dose, and frequency of administration of the medication.  
(e) The date of the medication order.  
(2) If alternative therapy has been evaluated and the immediate administration of a  
controlled substance, including a schedule 2 medication, is necessary for the proper  
treatment of a patient, then a pharmacist may dispense the controlled substance for  
administration to the inpatient if all of the following conditions are satisfied:  
13  
(a) The oral order of the prescriber is committed to a written or electronic order in the  
patient chart by a nurse licensed under part 172 of the code, MCL 333.17201 to  
333.17242, a physician's assistant licensed under part 170 of the code, MCL 333.17001 to  
333.17097, or part 175 of the code, MCL 333.17501 to 333.17556, or a pharmacist  
licensed under part 177 of the code, MCL 333.17701 to 333.17780, who has  
communicated directly with the prescriber.  
(b) The order states the name of the prescriber and the name of the nurse, physician's  
assistant, or pharmacist who received the verbal order.  
(c) The order is forwarded to the pharmacy.  
(d) The prescriber signs the original order at the next visit or within 7 days.  
(3) A licensee shall preserve an original order for a period of 5 years from the patient  
discharge date and the original order must be readily retrievable. After 2 years, a licensee  
may make an electronic duplicate of the original order which becomes the original order.  
If a licensee maintains patient records electronically, then a printed copy must be  
immediately available for a current inpatient and within 48 hours upon request of an  
authorized agent of the board for any patient of the previous 5 years.  
R 338.3154 Medication records in medical institutions.  
Rule 54. (1) A patient's chart shall constitute a record of medications ordered for, and  
actually administered to, a patient of medical institutions.  
(2) Medication records are required for all controlled substances listed in schedules 2, 3,  
4, and 5. At a minimum, these records must include all of the following information:  
(a) The number of doses of controlled substances purchased.  
(b) The number of doses dispensed to individual patients or distributed to nursing  
stations or both.  
(c) The number of doses administered.  
(d) The number of doses dispensed, but not administered, to the patient.  
(3) If the controlled substance is not dispensed to an individual patient, all of the  
following provisions must be complied with:  
(a) Medication records for those controlled substances in schedules 2, 3, 4, and 5 must  
be maintained.  
(b) Distribution of a controlled substance to a nursing unit may not be more than 25  
doses per container.  
(c) A distribution record for each multiple of 25 doses must be used to account for  
delivery to a nursing unit. The record must include all of the following information:  
(i) The name and dose of the controlled substance.  
(ii) The quantity of the substance.  
(iii) The date of delivery.  
(iv) The location of the nursing unit.  
(v) The name of the distributing pharmacy and address if a different location from the  
medical institution.  
(vi) Name of distributing pharmacist.  
(vii) The name of the individual on the nursing unit who receives the substance.  
(d) A proof of use record must be maintained to account for all doses of an  
administered substance. The record must include all of the following:  
(i) The name of the substance.  
14  
(ii) The dose administered.  
(iii) The date and time a dose was administered.  
(iv) The name of the patient.  
(v) The signature of the individual who administered the dose.  
(e) Subrule 3 of this rule does not apply to automated devices.  
(4) A controlled substance that is maintained at a nursing unit must be stored in a  
securely locked cabinet or medication cart that is accessible only to an individual who is  
responsible for the administration or distribution of the medication.  
(5) If a controlled substance is dispensed from an automated device, then documentation  
of all of the following must be maintained on-site in the pharmacy responsible for the  
automated device for 2 years for review by the department, an agency, or the board:  
(a) The name and address of the pharmacy or facility responsible for the operation of  
the automated device.  
(b) The manufacturer, serial number, and model number of the automated device.  
(c) The location of the automated device.  
(d) The contents of the automated device.  
(e) The quality assurance policy and procedure to determine continued appropriate use  
and performance of the automated device that includes all of the following quality  
assurance documentation for the use and performance of the automated device:  
(i) Use of monitors that alert the user when the wrong medication is filled or removed  
for administration to a patient.  
(ii) Use of security monitors that include an alert for unauthorized access, patients not  
in the system, system security breaches, and controlled substance audits.  
(iii) Corrective measures to address issues and errors identified in the internal quality  
assurance program.  
(f) The policy and procedure for system operation that includes all of the following:  
(i) Safety.  
(ii) Security systems and procedures that include prevention of unauthorized access  
or use and comply with federal and state regulations.  
(iii) Accuracy.  
(iv) Patient confidentiality.  
(v) Access.  
(vi) Type of controlled substances.  
(vii) Data retention or archival.  
(viii) Definitions.  
(ix) Downtime procedures.  
(x) Emergency procedures.  
(xi) Operator inspections.  
(xii) Installation requirements.  
(xiii) Maintenance.  
(xiv) Medication security.  
(xv) Medication inventory.  
(xvi) Staff education and training.  
(xvii) System set-up and malfunction.  
(xviii) List of medications qualifying for emergency dose removal without  
pharmacist prior review of the prescription or medication order.  
15  
(xix) The use of the automated device that includes a requirement that a pharmacist  
review a prescription or medication order before system profiling or removal of any  
medication from the automated device for immediate patient administration, except in the  
following situations where a pharmacist shall review the orders and authorize any further  
dispensing within 48 hours:  
(A) The automated device is being used as an after-hours cabinet for medication  
dispensing in the absence of a pharmacist under R 338.486(4)(j).  
(B) The system is being used in place of an emergency kit under R 338.486(4)(c).  
(C) The system is being accessed to remove medication required to treat the  
emergent needs of a patient under R 338.486(4)(c). A sufficient quantity to meet the  
emergent needs of the patient may be removed until a pharmacist is available to review  
the medication order.  
(g) The automated device must maintain transaction data that includes all  
activity regarding access to the contents of the automated device.  
(h) The pharmacy responsible for the automated device shall maintain records related  
to access to the automated device. The records must be readily retrievable and must  
include all of the following information:  
(i) The unique identity of the device.  
(ii) Identification of the individual accessing the automated device.  
(iii) The type of transaction.  
(iv) The name, strength, dosage form, and quantity of the drug accessed.  
(v) The name of the patient.  
(vi) The identification of the pharmacist checking for the accuracy of the medications  
to be stocked or restocked in the automated device.  
(vii) Any other information the pharmacist considers necessary.  
(i) For medication removed from the automated device for on-site patient  
administration, the automated device must document all of the following information:  
(i) The name of the patient.  
(ii) The date and time medication was removed from the automated device.  
(iii) The name, initials, or other unique identifier of the individual removing the drug.  
(iv) The name, strength, and dosage form of the drug. The documentation may be on  
paper or electronic medium.  
(j) If the pharmacist delegates the stocking of the automated device, then technologies  
must be in place and utilized to ensure that the correct drugs are stocked in their  
appropriate assignment utilizing bar-coding or another a board-approved error prevention  
technology.  
(k) The automated device must provide a mechanism for securing and accounting for  
controlled substances removed from the automated device return bin. Controlled  
substances may not be returned directly to the automated device for immediate reissue or  
reuse. Controlled substances removed from the automated device may not be reused or  
reissued, except as indicated in R 338.486(7).  
(l) The automated device must provide a mechanism for securing and accounting for  
wasted or discarded medications.  
(6) An individual who is responsible for administering a controlled substance or a  
portion thereof shall record the quantity, disposition and an explanation of the destruction  
of the controlled substance on the proper accountability record. If the institution has a  
16  
policy that reflects current practice standards and delineates the method of destruction, an  
explanation would only be required if policy was not followed.  
PART 6. DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE  
PRESCRIPTIONS  
R 338.3161 Controlled substance prescriptions.  
Rule 61. (1) A prescription that is issued for a controlled substance must be dated and  
signed by the prescriber, when issued, and contain all of the following information:  
(a) The full name and address of the patient for whom the substance is being  
prescribed.  
(b) The prescriber's DEA registration number, preprinted, stamped, typed, or manually  
printed name, address, telephone number or pager number, and professional designation.  
(c) The drug name, strength, and dosage form.  
(d) The quantity prescribed. For a paper prescription received in writing, the  
prescription must contain the quantity in both written and numerical terms. A paper  
prescription must contain preprinted numbers representative of the quantity next to a box  
or line that the prescriber may check.  
(e) The directions for use.  
(f) If the prescription is for an animal, then the species of the animal and the full name  
and address of the owner.  
(2) A written prescription for a controlled substance in schedules 2 to 5 shall be written  
legibly with ink or an indelible pencil or prepared using a printer and signed by the  
prescriber.  
(3) An agent of the prescriber may prepare a prescription for the signature of the  
prescriber, but, pursuant to the code, the prescriber is liable if the prescription does not  
conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a  
prescription not prepared in the form required by these rules is liable pursuant to the  
code.  
(4) If the controlled substance prescription or order in a medical institution is issued  
pursuant to delegation, then the printed name of the delegatee, the licensure designation,  
the delegating prescriber, and the signature of the delegatee shall be on the written  
prescription. In medical facilities, orders must contain the signatures of the delegatee and  
the printed name of the delegating prescriber.  
(5) A prescriber shall not issue a prescription to obtain a stock of a controlled substance  
for the purpose of dispensing or administering the substance to patients.  
R 338.3161a. Exception to bona fide prescriber-patient relationship; alternative  
requirements.  
Rule 61a. (1) A bona fide prescriber-patient relationship is required before a licensed  
prescriber may prescribe a controlled substance listed in schedules 2 to 5.  
(2) Pursuant to Section 16204e of the code, MCL 333.16204e, a licensed prescriber may  
prescribe a controlled substance listed in schedules 2 to 5 without first establishing the  
bona fide prescriber-patient relationship required under Section 7303a of the code, MCL  
333.7303a, in the following situations:  
17  
(a) The prescriber is providing on-call coverage or cross-coverage for another  
prescriber who is not available and has established a bona fide prescriber-patient  
relationship with the patient for whom the on-call or covering prescriber is prescribing a  
controlled substance, the prescriber, or an individual licensed under article 15 of the  
code, MCL 333.16101 to 333.18838, reviews the patient’s relevant medical or clinical  
records, medical history, and any change in medical condition, and provides  
documentation in the patient’s medical record pursuant to medically accepted standards  
of care.  
(b) The prescriber is following or modifying the orders of a prescriber who has  
established a bona fide prescriber-patient relationship with a hospital in-patient or nursing  
care facility resident and provides documentation in the patient’s medical record pursuant  
to medically accepted standards of care.  
(c) The prescriber is prescribing for a patient that has been admitted to a licensed  
nursing care facility, completes the tasks identified in subrule (2)(a) and (2)(b) of this rule  
in compliance with R 325.45377, as applicable, and provides documentation in the  
patient’s medical record pursuant to medically accepted standards of care.  
(d) The prescriber is prescribing for a patient for whom the tasks listed in subrule  
(2)(a) and (2)(b) of this rule have been performed by an individual licensed under article  
15 of the code, MCL 333.16101 to 333.18838, and the prescriber provides documentation  
in the patient’s medical record pursuant to medically accepted standards of care.  
(e) The prescriber is treating a patient in a medical emergency. For purposes of this  
subdivision, “medical emergency” means a situation that, in the prescriber’s good-faith  
professional judgment, creates an immediate threat of serious risk to the life or health of  
the patient for whom the controlled substance prescription is being prescribed.  
R 338.3162 Dispensing by pharmacists; delivery of controlled substances.  
Rule 62. (1) Except for a remote pharmacy, which is regulated by section 17742a of the  
code, MCL 333.17742a, and which allows a qualified pharmacy technician to assist in the  
dispensing process while being overseen by a pharmacist through the use of a  
surveillance system and telepharmacy system, a controlled substance shall be dispensed  
by a pharmacist or a pharmacy intern in the presence, and under the personal charge of a  
pharmacist.  
(2) A pharmacist shall require positive identification of individuals to whom controlled  
substances are dispensed or delivered when the individual is not known to the pharmacist  
or pharmacy employees except when positive identification is not available and a  
pharmacist, who in exercising his or her professional judgment, determines that a delay in  
dispensing the controlled substance may be detrimental to a patient.  
(3) Subrule (2) of this rule does not exempt a pharmacist from the requirement to submit  
a patient identifier to the electronic system for monitoring controlled substances.  
(4) The dispensing pharmacist and pharmacy are both responsible for complying with  
this rule.  
(5) A pharmacist may dispense a controlled substance that is listed in schedules 3 to 5  
and that is a prescription drug pursuant to the provisions of the FDCA of 1991, 21 USC  
353, only pursuant to a prescription on a prescription form, an oral prescription of a  
practitioner, or a prescription that is electronically transmitted pursuant to R 338.3162a  
and that contains all of the required information under R 338.3161, except that the  
18  
signature of the prescriber is not required if the controlled substance is obtained pursuant  
to an oral order.  
(6) In addition to the requirements in section 17744 of the code, MCL 333.17744, if a  
prescriber’s agent under delegation transmits an oral prescription for a controlled  
substance to a pharmacy all of the following shall be recorded on the prescription  
generated at the pharmacy:  
(a) The information required by R 338.3161.  
(b) The transmitting agent's identity.  
(c) The individual who received the prescription at the pharmacy.  
(7) Only a prescription that is issued in the usual course of professional treatment or in  
the course of legitimate and authorized research is a prescription.  
R 338.3162a Electronic transmission of prescription; waiver of electronic transmission.  
Rule 62a. (1) Until the enforcement date established by the federal Centers for Medicare  
and Medicaid Services for the Medicare electronic transmission requirement, a  
prescription may be electronically transmitted, and a pharmacist may dispense the  
electronically transmitted prescription if all of the following conditions are satisfied:  
(a) The prescription is transmitted to the pharmacy of the patient's choice and occurs  
only at the option of the patient.  
(b) The electronically transmitted prescription includes all of the following  
information:  
(i) The name and address of the prescriber.  
(ii) An electronic signature or other board-approved means of ensuring prescription  
validity.  
(iii) The prescriber's telephone number for verbal confirmation of the  
order.  
(iv) The time and date of the electronic transmission.  
(v) The name of the pharmacy intended to receive the electronic transmission.  
(vi) Unless otherwise authorized under section 17754(1)(b) of the code, MCL  
333.17754, the full name of the patient for whom the prescription is issued.  
(vii) All other information that must be contained in a prescription under R 338.3161.  
(c) The pharmacist exercises professional judgment regarding the accuracy, validity,  
and authenticity of the transmitted prescription.  
(d) All requirements in section 17754 of the code, MCL 333.17754, are met.  
(2) An electronically transmitted prescription that meets the requirements of subrule (1)  
of this rule is the original prescription.  
(3) Effective the enforcement date established by the federal Centers for Medicare and  
Medicaid Services for the Medicare electronic transmission requirement, prescribers  
shall, unless an exception under section 17754a of the Code, MCL 333.17754a, applies,  
electronically transmit a prescription for a controlled substance consistent with both of  
the following requirements:  
(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.  
(b) All the requirements in R 338.3161 are met.  
(4) A prescriber applying for a waiver from section 17754a of the code, MCL  
333.17754a, shall submit a completed application to the department, on a form provided  
by the department, and satisfy either of the following requirements:  
19  
(a) The prescriber provides evidence satisfactory to the department that the prescriber  
has received a waiver of the Medicare requirement for the electronic transmission of  
controlled substances prescriptions from the federal Centers for Medicare and Medicaid  
Services.  
(b) The prescriber is unable to meet the requirements of section 17754a(1) or (2) of the  
code, MCL 333.17754a, and the prescriber meets 1 of the following:  
(i) The prescription is dispensed by a dispensing prescriber.  
(ii) The prescriber demonstrates economic hardship or technological limitations that  
are not within the control of the prescriber.  
(iii) The prescriber demonstrates by attesting to exceptional circumstances,  
including, but not limited to, the following:  
(A) Prescribing fewer than 100 controlled substances prescriptions per year or the  
number of controlled substances prescriptions used in the Federal Centers for Medicare and  
Medicaid Services waiver for electronic transmission of prescriptions for controlled  
substances, whichever is more.  
(B) Intention to cease practice within the next twelve months.  
(C) Limited practice due to an illness or other unforeseen event.  
(iv) The prescriber issues prescriptions from a non-profit charitable medical clinic.  
(5) A waiver is valid for 2 years and is applicable to the specific circumstances included  
in the application. A waiver may be renewed by application to the department.  
R 338.3162b Electronic system for monitoring schedules 2, 3, 4, and 5 controlled  
substances.  
Rule 62b. (1) Except as otherwise exempt under section 7333a of the code, MCL  
333.7333a, a pharmacist, dispensing prescriber, and veterinarian licensed under Part 177  
of the code, MCL 333.17701 to 333.17780, who dispenses a prescription drug that is a  
controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the state that  
dispenses in this state or dispenses to an address in this state a controlled substance listed  
in schedules 2 to 5 shall report to the department or the department's contractor by means  
of an electronic data transmittal process the following information for each prescription  
of a scheduled 2 to 5 controlled substance that has been dispensed:  
(a) The patient identifier identification number. For purposes of this subdivision, all of  
the following apply:  
(i) An identification number, as specified in R 338.3102(1)(f)(iv)(A) to (C), is not  
required for patients under the age of 16.  
(ii) If the patient is under 16 years of age, zeroes must be entered as the identification  
number.  
(iii) If the medication being dispensed is for an animal, the patient identification  
number applies to the animal's owner, the client, that meets the requirements of R  
338.3102(1)(f)(iv). If the animal’s owner cannot be identified, zeroes must be entered as  
the identification number.  
(b) The patient’s name; client’s name, including first name, middle name, or middle  
initial, if available; and last name.  
(c) The patient’s or client’s address, including street, city, state, and zip code.  
(d) The patient’s or client’s phone number.  
(e) The patient’s or client’s gender.  
(f) The patient’s or client’s date of birth.  
20  
(g) The species code, as specified by ASAP.  
(h) The metric quantity of the controlled substance dispensed.  
(i) The NDC of the controlled substance dispensed.  
(j) The date of issue of the prescription.  
(k) The date of dispensing.  
(l) The number of refills authorized.  
(m) The refill number of the prescription fill.  
(n) The estimated days of supply of the controlled substance dispensed.  
(o) The prescription number assigned by the dispenser.  
(p) The prescription transmission form code, as specified by ASAP, that indicates how  
the pharmacy received the prescription.  
(q) The prescription payment type. Cash discount cards are considered cash  
transactions.  
(r) The electronic prescription reference number, if applicable.  
(s) The patient’s or client’s location code when receiving pharmacy services, as  
specified by ASAP.  
(t) The DEA registration number of the prescriber and the dispensing pharmacy.  
(2) A pharmacist, dispensing prescriber, or veterinarian may presume that the patient  
identification information provided by a patient, or a patient's representative, or  
veterinarian’s client is correct.  
(3) As used in this rule, R 338.3162c, and R 338.3162d, the term “dispense” or  
“dispensing” means the preparation, compounding, packaging, or labeling of a controlled  
substance along with delivery of the controlled substance pursuant to a prescription or  
other authorization issued by a prescriber, and does not include the acts of prescribing a  
controlled substance or administering a controlled substance directly to a patient.  
(4) As used in this rule, the term “patient” refers to an individual, not an animal.  
R 338.3162c Format for electronic transmission of data to electronic system for  
monitoring; waiver.  
Rule 62c. (1) A pharmacist, dispensing prescriber, or veterinarian who dispenses a  
prescription drug that is a controlled substance listed in schedules 2 to 5 shall transmit the  
data, as specified under R 338.3162b by electronic media or other means as approved by  
the department or the department's contractor.  
(2) The data must be transmitted in the format established by the ASAP 4.1 Standard for  
Prescription Drug Monitoring Programs.  
(3) A pharmacist, dispensing prescriber, or veterinarian who dispenses controlled  
substances and who does not have an automated record-keeping system capable of  
producing an electronic report in the format established by subrule (2) of this rule may  
request a waiver from electronic reporting. The request shall be made in writing to the  
department.  
(4) A pharmacist, dispensing prescriber, or veterinarian may be granted a waiver, if he  
or she demonstrates an inability to report as required by R 338.3162b and he or she  
agrees in writing to report the data to the department or the department's contractor by  
submitting a completed MAPS claim form as defined in R 338.3102(1)(c) or transmitting  
data via an internet web portal that is provided by the department or the department’s  
contractor for this purpose.  
21  
R 338.3162d Required reporting of prescription data; error reporting.  
Rule 62d. (1) A pharmacist, pharmacy, dispensing prescriber, or veterinarian shall  
report all scheduled 2 to 5 controlled substances dispensed.  
(2) The licensee shall forward the data required by R 338.3162b by on-line  
transmission, computer diskette, compact disk, or other approved medium, as specified in  
R 338.3162c to the department or the department’s contractor, on a daily basis, by the  
end of the next business day and include the data for all controlled substances dispensed  
since the previous transmission or report.  
(3) A pharmacist, pharmacy, dispensing prescriber, or veterinarian who does not have  
the capacity to forward the information as specified in R 338.3162b, shall mail or deliver  
the information to a location specified by the department or the department’s contractor  
not later than 7 calendar days after the date that the controlled substance has been  
dispensed, and include the data for all controlled substances dispensed since the previous  
transmission or report.  
(4) The department or the department’s contractor shall notify a pharmacist, pharmacy,  
dispensing prescriber, or veterinarian of an error in data reporting. Upon receiving  
notification of an error in data reporting, a pharmacist, pharmacy, dispensing prescriber,  
or veterinarian shall take appropriate measures to correct the error and transmit the  
corrected data to the department or the department’s contractor within 7 calendar days of  
being notified of the error.  
(5) A pharmacist, pharmacy, dispensing prescriber, or veterinarian who fails to report  
the dispensing of a prescription for a controlled substance listed in schedules 2 to 5 as  
required, is subject to the penalty provisions in section 16221, 17741, or 17768 of the  
code, MCL 333.16221, 333.17741, or 333.17768, in article 15 of the code, MCL  
333.16101 to 333.18838.  
R 338.3162e Rescinded.  
R 338.3163 Individual with substance use disorder; prescribing, dispensing, and  
administering controlled substance.  
Rule 63. (1) A practitioner within his or her scope of practice, may either prescribe,  
dispense, or administer a controlled substance to an individual with substance use  
disorder for the purpose of maintenance or detoxification treatment pursuant to any of the  
following situations:  
(a) A practitioner acting pursuant to federal law or regulations to conduct the drug  
treatment of an individual with substance use disorder may prescribe, dispense, and  
administer a controlled substance for the purpose of legitimate treatment of the individual  
with substance use disorder. A prescription may only be issued for a schedule 3 through 5  
substance.  
(b) A practitioner may administer or dispense a controlled substance approved by the  
FDA specifically for use in maintenance or detoxification treatment directly to an  
individual with substance use disorder who is participating in a program.  
(c) A practitioner may administer a controlled substance approved by the FDA  
specifically for use in maintenance or detoxification treatment directly to an individual  
with substance use disorder who is experiencing acute withdrawal symptoms and  
22  
administration of a controlled substance is necessary while the practitioner is arranging  
referral for treatment. The following requirements must be followed:  
(i) Not more than 1 day's supply of medication may be administered or directly  
dispensed to the individual with drug addiction or dependence.  
(ii) The emergency treatment may be carried out for not more than 3 consecutive days  
and may not be renewed or extended.  
(2) Notwithstanding subrule (1) of this rule, a practitioner within the scope of his or her  
practice, may administer or dispense a controlled substance in a hospital or similar setting  
to an individual with substance use disorder consistent with both of the following:  
(a) The controlled substance is administered or dispensed to continue maintenance or  
detoxification treatment as an adjunct to medical or surgical treatment of conditions other  
than addiction.  
(b) The controlled substance is administered or dispensed to relieve intractable pain for  
which no relief or cure is possible, or none has been found after reasonable efforts.  
(3) As use in this rule:  
(a) “Practitioner” means the term defined in section 7109 of the code, MCL 333.7109.  
(b) “Program” means the term defined in section 260 of the mental health code, 1974  
PA 258, MCL 330.1260.  
(c) “Substance use disorder” means that term as defined in section 100d of the mental  
health code, 1974 PA 258, MCL 330.1100d.  
R 338.3164 Emergency dispensing of schedule 2 substances; oral prescriptions.  
Rule 64. A pharmacist may dispense a controlled substance listed in schedule 2 in an  
emergency in which all of the following conditions are met:  
(a) The prescriber advises the pharmacist of all of the following:  
(i) Immediate administration of the controlled substance is necessary for proper  
treatment of the intended ultimate user.  
(ii) Appropriate alternative treatment is not available, including administration of a  
drug that is not a controlled substance under schedule 2.  
(iii) It is not reasonably possible for the prescriber to provide a written prescription to  
be presented to the dispenser before the dispensing.  
(iv) The quantity prescribed and dispensed is limited to the amount adequate to treat  
the patient during the emergency period and pursuant to a written prescription.  
(b) The pharmacist shall immediately put the prescription in writing, which contains the  
information that must be contained in a prescription under R 338.3161, except for the  
prescriber's signature.  
(c) If the prescriber is not known to the pharmacist, then the pharmacist shall make a  
reasonable effort to determine that the oral authorization came from a prescriber by  
returning the prescriber's call, using the telephone number listed in the telephone  
directory, and other good faith efforts to ensure the prescriber's identity.  
R 338.3165 Emergency dispensing of schedule 2 substances; written prescriptions.  
Rule 65. (1) Within 7 days after authorizing an emergency oral prescription of a  
controlled substance listed in schedule 2, the prescriber shall comply with all of the  
following:  
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(a) The prescriber shall deliver to the dispensing pharmacist a written prescription or  
electronically transmit the prescription pursuant to R 338.3162a.  
(b) The prescriber shall include on the prescription both "Authorization for Emergency  
Dispensing" and the date of the oral order.  
(2) A pharmacist that has dispensed a prescription on an emergency oral prescription  
shall comply with all of the following:  
(a) The dispensing pharmacist shall reduce the oral prescription to writing.  
(b) Upon receipt of the prescription, the dispensing pharmacist shall attach the  
prescription to the oral order which was earlier reduced to writing.  
(c) The pharmacy shall notify the department if the prescriber fails to deliver to him or  
her either a written prescription or a prescription transmitted electronically.  
(3) The failure of the pharmacy to notify the department if the prescriber fails to deliver  
a prescription pursuant to subrule (1) of this rule voids the authority conferred by this  
rule.  
R 338.3166 Partial dispensing of controlled substances.  
Rule 66. (1) A pharmacist may partially dispense a controlled substance listed in  
schedule 2 in conformance with the following:  
(a) The pharmacist is unable to supply the full quantity called for in a written or  
emergency oral prescription.  
(b) The pharmacist makes a notation of the quantity supplied on the face of the written  
prescription, written record of the emergency oral prescription, or in the electronic  
prescription record.  
(c) The pharmacist may dispense the remainder of the prescription within 72 hours  
after the first partial dispensing.  
(d) If the remainder of the prescription is not or cannot be dispensed within the 72  
hours, the pharmacist shall notify the prescriber.  
(e) The pharmacist shall not dispense any additional quantity beyond 72 hours without  
a new prescription.  
(f) The pharmacy must have the balance of the prescription ready for dispensing before  
the 72-hour limit, but the patient is not required to pick up the balance of the prescription  
within that 72-hour limit.  
(2) A pharmacist may partially dispense a prescription for a controlled substance in  
schedule 2 at the request of the patient or the prescribing practitioner in conformance  
with the following:  
(a) The prescription is written and filled pursuant to the CSA and DEA regulations and  
state law.  
(b) The total quantity dispensed in all partial fillings does not exceed the total quantity  
prescribed.  
(c) The remaining portions of a partially filled prescription in schedule 2, if filled, shall  
be filled not later than 30 days after the date on which the prescription was written.  
(d) For each partial filling, the dispensing pharmacist shall record, on the back of the  
prescription or on another appropriate record that is uniformly maintained and readily  
retrievable, all of the following information:  
(i) Date of the partial filling.  
(ii) Quantity dispensed.  
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(iii) Remaining quantity that may be dispensed.  
(iv) Identification of the dispensing pharmacist.  
(3) A pharmacist may partially dispense, including individual dosage units, a  
prescription for a schedule 2 controlled substance that is written for a patient in a long-  
term care facility or for a patient with a medical diagnosis that documents a terminal  
illness in conformance with all of the following:  
(a) For each partial filling, the dispensing pharmacist shall record, on the back of the  
prescription or on another appropriate record that is uniformly maintained and readily  
retrievable, all of the following information:  
(i) Date of the partial filling.  
(ii) Quantity dispensed.  
(iii) Remaining quantity authorized to be dispensed.  
(iv) Identification of the dispensing pharmacist.  
(b) The total quantity of schedule 2 controlled substances dispensed in all partial  
fillings may not be more than the total quantity prescribed.  
(c) Prescriptions are valid for a period of not more than 60 days from the issue date  
unless terminated at an earlier date by the discontinuance of medication.  
(d) A pharmacist shall record on the prescription whether the patient is terminally ill or  
is a long-term care facility patient.  
(4) A pharmacy may partially fill a prescription for a schedule 3, 4, or 5 controlled  
substance if all of the following provisions are met:  
(a) Each partial filling is recorded in the same manner as a refilling.  
(b) The total quantity dispensed in all partial fillings does not exceed the total quantity  
prescribed.  
(c) No dispensing occurs after 6 months from the date the prescription was issued for  
schedules 3, 4, and 5.  
R 338.3167 Dispensing schedule 5 substances without prescriptions.  
Rule 67. (1) A pharmacist may, without a prescription, dispense a controlled substance  
listed in schedule 5 that is not a prescription medication as determined under the FDCA,  
21 USC 301 to 392, if all of the following provisions are met:  
(a) The dispensing pharmacist determines the controlled substance is intended to be  
used for a medical purpose.  
(b) Not more than 240 cc, 8 ounces, or 48 solid doses of a substance containing opium  
or more than 120 cc, 4 ounces, or 24 solid doses of any other substance listed in schedule  
5 are distributed at retail to the same purchaser in any single 48-hour period.  
(c) The purchaser is not younger than 18 years of age.  
(d) The dispensing pharmacist requires a purchaser, not known to the pharmacist, to  
furnish suitable identification, including proof of age where appropriate.  
(2) If a pharmacist dispenses a controlled substance listed in schedule 5 without a  
prescription, then he or she shall affix to the container in which the substance is  
dispensed a label that shows the date, his or her name, and the name and address of the  
place of practice where the substance is dispensed.  
(3) The pharmacist shall maintain a record of the dispensing without a prescription of  
controlled substances listed in schedule 5 with the following requirements:  
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(a) The record must be kept for 5 years from the date of dispensing. After 2 years, an  
electronic duplicate of the original order may be made which becomes the original  
record.  
(b) The record must be immediately retrievable and may be maintained in the same  
manner as required for schedule 5 prescription medication.  
(c) The record must contain all of the following information:  
(i) The name and address of the patient.  
(ii) The name and address of the purchaser if different from the patient.  
(iii) The name and quantity of substance purchased.  
(iv) The date purchased.  
(v) The name or initials of the pharmacist or pharmacy intern who dispensed the  
substance.  
(vi) The medical purpose for which the medication is being used as determined by the  
pharmacist.  
R 338.3168 Refilling of prescriptions.  
Rule 68. (1) A prescription for a controlled substance listed in schedule 2 may not be  
refilled.  
(2) A prescription for a controlled substance listed in schedules 3 and 4 may not be  
refilled more than 6 months after the prescription's date of issuance and may not be  
refilled more than 5 times. Renewal of the prescription must be consistent with the  
requirements for original prescriptions.  
(3) A prescription for a controlled substance listed in schedule 5 may be refilled only as  
expressly authorized by the prescriber on the prescription up to 1 year; if no authorization  
is indicated, then the prescription may not be refilled.  
R 338.3170 Dispensing and administering controlled substances by prescribers.  
Rule 70. (1) A prescriber in the course of his or her professional practice may dispense,  
or administer, or delegate under direct supervision the administering of a controlled  
substance listed in schedules 2 to 5.  
(2) A veterinarian, in the course of his or her professional practice may dispense,  
administer, or delegate the administering under direct supervision of a controlled  
substance listed in schedules 2 to 5 to an animal.  
PART 7. DISTRIBUTIONS  
R 338.3181 Distributions by dispensers.  
Rule 81. (1) A dispenser who is not licensed as a wholesale distributor may distribute a  
controlled substance to another dispenser for the purpose of general dispensing to his or  
her patients if all of the following conditions are satisfied:  
(a) The receiving dispenser is licensed to dispense the substance.  
(b) The distribution is recorded by the distributing dispenser and a receipt record is  
maintained by the receiving dispenser.  
(c) An order form for substances listed in schedules 1 and 2 is used.  
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(d) The total number of dosage units of all controlled substances distributed by the  
distributing dispenser during the 12-month period in which the dispenser is licensed is  
not more than 5% of the total number of all dosage units distributed and dispensed during  
the 12-month period.  
(2) If the dispenser has reason to believe that the total number of dosage units which  
will be distributed by him or her pursuant to this rule will be more than 5% of the total  
number of dosage units of all controlled substances distributed and dispensed by him or  
her during the 12-month period, the dispenser shall obtain a license to distribute  
controlled substances.  
R 338.3182 Rescinded.  
R 338.3183 Distribution to suppliers.  
Rule 83. (1) A person who is lawfully in possession of a controlled substance that is  
listed in any schedule may distribute the substance to the person from whom he or she  
obtained the substance or to the manufacturer of the substance without obtaining a license  
to distribute. The person who distributes the substance shall maintain a written record  
that contains all of the following information:  
(a) The date of the distribution.  
(b) The name, form, and quantity of the substance.  
(c) The name, address, and license number, if any, of the person who makes the  
distribution.  
(d) The name, address, and license number, if known, of the supplier or manufacturer.  
(2) In the case of a controlled substance listed in schedules 1 or 2, an order form must be  
used and maintained as the written record of the distribution.  
R 338.3185 Discontinuances and transfers.  
Rule 85. A licensee who wants to discontinue or transfer business activities or a  
professional practice altogether or only with respect to controlled substances shall return  
his or her DEA registration and any unexecuted order forms in his or her possession to  
the DEA. The licensee shall return the state controlled substances license to the  
department. The transfer of the controlled substances is subject to approval by the DEA  
pursuant to the provisions of 21 CFR 1301.52 and written notification must be provided  
to the department.  
R 338.3186 Use of order forms and invoices.  
Rule 86. An order form must be used to distribute schedule 2 substances and an invoice  
must be used to distribute schedules 3 to 5 substances. The order form may be executed  
only by a practitioner who is licensed under article 7 of the code, MCL 333.7101 to  
333.7545, to prescribe or dispense controlled substances.  
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