DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS

DIRECTOR'S OFFICE

PHARMACY - GENERAL RULES

(By authority conferred on the director of the department of licensing and

regulatory affairs by sections 16141, 16145, 16148, 16174, 16175, 16178, 16182,

16186, 16201, 16204, 16205, 16215, 16287, 17707, 17722, 17724, 17724a,

17731, 17737, 17739, 17742a, 17742b, 17744f, 17744g, 17746, 17748, 17748a,

17748b, 17748e, 17751, 17753, 17754a, 17757, 17760, 17767, and 17775 of the

public health code, 1978 PA 368, MCL 333.16141, 333.16145, 333.16148,

333.16174, 333.16175, 333.16178, 333.16182, 333.16186, 333.16201,

333.16204, 333.16205, 333.16215, 333.16287, 333.17707, 333.17722,

333.17724, 333.17724a, 333.17731, 333.17737, 333.17739, 333.17742a,

333.17742b, 333.17744f, 333.17744g, 333.17746, 333.17748, 333.17748a,

333.17748b, 333.17748e, 333.17751, 333.17753, 333.17754a, 333.17757,

333.17760, 333.17767, and 333.17775 and Executive Order Nos. 1991-9, 1996-

2, 2003-1, and 2011-4, MCL 338.3501, 445.2001, 445.2011, and 445.2030)

R 338.471 Rescinded.

History: 1979 AC; 2020 AACS.

R 338.471a Rescinded.

History: 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.471b Rescinded.

History: 2017 AACS; 2020 AACS.

R 338.472 Rescinded.

History: 1979 AC; 1980 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.473 Rescinded.

History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.473a Rescinded.

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History: 1979 AC; 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.473b Rescinded.

History: 1979 AC; 1980 AACS; 1986 AACS; 2013 AACS; 2020 AACS.

R 338.473c Rescinded.

History: 1980 AACS; 1986 AACS; 2020 AACS.

R 338.473d Rescinded.

History: 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.474 Rescinded.

History: 1979 AC; 1980 AACS; 1988 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.474a Rescinded.

History: 1983 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.475 Rescinded.

History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.476 Rescinded.

History: 1979 AC; 1980 AACS; 1998-2000 AACS.

R 338.477 Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 AACS.

R 338.477a Rescinded.

History: 1979 AC; 2020 AACS.

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R 338.477b Rescinded.

History: 1980 AACS; 1986 AACS; 1998-2000 AACS; 2013 AACS; 2020 AACS.

R 338.477c Rescinded.

History: 2013 AACS; 2020 AACS.

R 338.477d Rescinded.

History: 2013 AACS; 2020 AACS.

R 338.478 Rescinded.

History: 1979 AC; 2020 AACS.

R 338.479 Rescinded.

History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.

R 338.479a Rescinded.

History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.

R 338.479b Rescinded.

History: 1998-2000 AACS; 2000 AACS; 2007 AACS; 2013 AACS; 2020 AACS.

R 338.479c Rescinded.

History: 1998-2000 AACS; 2020 AACS.

R 338.480 Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 AACS.

R 338.480a Rescinded.

History: 1992 AACS; 1998-2000 AACS; 2020 AACS.

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R 338.481 Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2013 AACS; 2020 AACS.

R 338.482 Rescinded.

History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.

R 338.483 Rescinded.

History: 1979 AC; 1992 AACS.

R 338.484 Rescinded.

History: 1979 AC.

ADMINISTRATIVE HEARINGS

R 338.485 - R 338.485y Rescinded.

History: 1979 AC; 1980 AACS.

PHARMACY SERVICES IN MEDICAL INSTITUTIONS

R 338.486 “Medical institution” and “pharmacy services” defined;

pharmacy services in medical institutions.

Rule 16. (1) As used in this rule:

(a) "Medical institution" means a hospital, skilled nursing facility, county

medical care facility, nursing home, freestanding surgical outpatient facility,

hospice, or other health facility that is licensed or approved by the state, which

directly or indirectly provides or includes pharmacy services.

(b) "Pharmacy services" means the direct and indirect patient care services

for patients in a medical institution, associated with the practice of pharmacy.

(2) Pharmacy services in a medical institution must be directed and provided

by a licensed pharmacist.

(3) Pharmacy personnel who assist the pharmacist by performing delegated

functions in the care of patients of a medical institution are supervised by a

pharmacist who is on the premises of the medical institution.

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(4) The pharmacist who directs the pharmacy services shall develop,

implement, supervise, and coordinate the services provided, including, at a

minimum, all of the following:

(a) Dispensing medications in a form that minimizes additional preparation

before administration to the patient, including the admixture of parenterals.

(b) Obtaining the prescriber's original medication order, a direct carbonized

copy, an electromechanical facsimile, or other electronic order transmission.

Security measures must be in place to ensure that system access by unauthorized

individuals is not allowed.

(c) Interpreting and reviewing the prescriber's medication orders and

communicating problems with these orders to the prescriber before the

administration of first doses. If the interpretation and review will cause a delay that

would adversely affect a patient’s medical condition, a limited number of

medications may be stocked at the patient care areas for the administration of first

doses. Medications must be provided in a manner that ensures security and

immediate availability, including sealed or secured medication kits, carts, or

treatment trays. A pharmacist shall routinely inspect the medications and, after

use, shall verify the contents and replace the medications as necessary.

(d) Furnishing medications for administration to registered patients under R

338.588 and 338.588b.

(e) Monitoring medication therapy to promote positive patient outcomes while

evaluating clinically significant chemical and therapeutic incompatibilities.

(f) Establishing the specifications for the procurement of all pharmaceuticals

and related biologicals and chemicals approved for use in the medical institution.

(g) Inspecting all areas in the medical institution where medications are

stored to verify compliance with the standards for the safe use and storage of the

medications, not less than once every 6 months.

(h) Maintaining proper security for all medications stored or maintained within

the medical institution.

(i) Providing educational programs that include, but are not limited to,

medications used by the medical institution and their safe use.

(j) Providing a process by which medications can be obtained during the

absence of a pharmacist in a medical institution where a pharmacist is not

available 24 hours a day. The process must comply with all of the following:

(i) Minimize the potential for medication error.

(ii) During the absence of a pharmacist, the services of a pharmacist must

be available on an on-call basis.

(iii) Only a limited number of medications that are packaged in units of use

must be available.

(iv) The medications must be approved and reviewed periodically as

determined necessary, but not less than once a year, by an appropriate

interdisciplinary practitioner committee of the medical institution.

(v) The medication must be maintained in a securely locked, substantially

constructed cabinet or its equivalent in an area of limited access in a centralized

area outside the pharmacy.

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(vi) Each medication must be labeled to include the name of the medication;

the strength; the expiration date, if dated; and the lot number.

(vii) A written order and a proof of removal and use document are obtained

for each medication unit removed and reviewed by the pharmacist within 48 hours

of removing medication from the cabinet or its equivalent.

(viii) The pharmacist who directs pharmacy services in the medical institution

shall designate the practitioners who are allowed to remove the medication.

(ix) A pharmacist shall audit the storage locations as often as needed to

guarantee control, but not less than once every 30 days.

(5) On the recommendation of an interdisciplinary practitioners’ committee,

the pharmacist who directs pharmacy services in the medical institution shall adopt

written policies and procedures to promote safe medication practices, to conduct

medication utilization review, to approve medications for the medical institution's

formulary or medication list, and to promote positive patient outcomes.

A

pharmacist shall meet with the committee not less than quarterly to conduct

assigned responsibilities.

(6) A pharmacy shall ensure that every medication dispensed is identified with

its name and strength labeled on the container in which it is dispensed or on each

single unit package. A pharmacy that is engaged in drug distribution to medical

institutions which use unit-of-use packaging shall place identification on the label

of its package to allow the package to be readily traced. The name of the patient,

or a unique identifier, must be labeled on the medication container. The container

may be the individual patient’s assigned medication drawer. The directions for use

must be on the label of the container if the directions are not communicated in

another effective manner. If the medication is to be self-administered, then

directions for use must be on the container. The provisions of this subrule are

minimum labeling standards only and do not supersede other applicable laws or

rules.

(7) A pharmacist shall supervise the destruction of unused portions of

prescription medication, other than controlled substances under part 71 of the

code, MCL 333.7101 to 333.7125, dispensed to patients. However, medications in

single-unit packages and intravenous solutions that are designed to be tamper-

evident, and show no evidence that tampering has occurred, may be returned to

stock. Medications that leave the medical institution or its legal affiliates must not

be returned to stock for dispensing.

(8) The licensed pharmacist that directs pharmacy services in the medical

institution shall make the policies and procedures required by this rule available to

an agent of the board, on request.

History: 1979 AC; 1980 AACS; 1998-2000 AACS; 2013 AACS; 2020 AACS; 2024 AACS.

R 338.487 Rescinded.

History: 1979 AC.

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R 338.488 Rescinded.

History: 1979 AC; 1982 AACS; 1988 AACS; 1990 AACS; 2013 AACS.

R 338.489 Rescinded.

History: 1979 AC; 1980 AACS; 2007 AACS; 2020 AACS.

R 338.490 Rescinded.

History: 1979 AC; 1990 AACS; 1998-2000 AACS; 2020 AACS.

R 338.491 Rescinded.

History: 1979 AC.

R 338.492 Rescinded.

History: 1979 AC.

R 338.493a Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 AACS.

R 338.493b Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 AACS.

R 338.493c Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.

R 338.493d Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.

R 338.493e Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.

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R 338.493f Rescinded.

History: 1979 AC; 1980 AACS; 2020 AACS.

R 338.493g Rescinded.

History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.

R 338.493h Rescinded.

History: 1979 AC; 1980 AACS.

R 338.494 Rescinded.

History: 1979 AC; 1982 AACS; 1988 AACS.

R 338.495 Rescinded.

History: 1979 AC; 1988 AACS; 1998-2000 AACS.

R 338.496 Rescinded.

History: 1979 AC; 1998-2000 AACS.

R 338.497 Rescinded.

History: 1981 AACS; 2013 AACS; 2014 AACS.

R 338.500 Rescinded.

History: 1995 AACS; 2020 AACS.

PART 1. GENERAL PROVISIONS

R 338.501 Definitions.

Rule 1. (1) As used in these rules:

(a) “ACPE” means the Accreditation Council for Pharmacy Education.

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(b) “Approved education program” means a school of pharmacy that is

accredited by or has candidate status by the ACPE.

(c) “Board” means the Michigan board of pharmacy, created in section 17721

of the code, MCL 333.17721.

(d) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to

333.25211.

(e) “Compounding” means the preparation, mixing, assembling, packaging,

and labeling of a drug or device by a pharmacist under any of the following

circumstances:

(i) On receipt of a prescription for a specific patient.

(ii) On receipt of a medical or dental order from a prescriber or agent for use

in the treatment of patients within the course of the prescriber's professional

practice.

(iii) In anticipation of the receipt of a prescription or medical or dental order

based on routine, regularly observed prescription, or medical or dental order

patterns.

(iv) For the purpose of or incidental to research, teaching, or chemical

analysis and not for the purpose of sale or dispensing.

(f) "Compounding" does not include any of the following:

(i) Except as provided in section 17748c of the code, MCL 333.17748c, the

compounding of a drug product that is essentially a copy of a commercially

available product.

(ii) The reconstitution, mixing, or other similar act that is performed under the

directions contained in approved labeling provided by the manufacturer of a

commercially available product.

(iii) The compounding of allergenic extracts or biologic products.

(iv) Flavoring agents added to conventionally manufactured and

commercially available liquid medications. Flavoring agents must be nonallergenic

and inert, not exceeding 5% of a drug product’s total volume.

(g) “Contraceptive” means a hormonal contraceptive patch, a self-administered

hormonal contraceptive, an emergency contraceptive, or a vaginal ring hormonal

contraceptive eligible for dispensing under section 17744g of the code, MCL

333.17744g.

(h) “CPMP” means a customized patient medication package that is prepared

by a pharmacist for a specific patient and contains 2 or more prescribed solid oral

dosage forms.

(i) “DEA” means the Federal Drug Enforcement Administration.

(j) “Department” means the department of licensing and regulatory affairs.

(k) “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 is a unique

identifier protected by appropriate security measures that is only available for use

by the intended individual and ensures non-repudiation so that the signature may

not be rejected based on its validity.

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(l) “Error prevention technology” means machinery and equipment used in a

pharmacy setting to reduce dispensing medication errors including, but not limited

to, barcode verification and radio frequency identification.

(m) “FDA” means the United States Food and Drug Administration.

(n) “FDCA” means the federal food, drug, and cosmetic act, 21 USC 301 to

399d.

(o) “FEIN” means a federal employer identification number.

(p) “FPGEC” means the Foreign Pharmacy Graduate Examination

Committee.

(q) “GED” means a general education development certificate.

(r) “Manual signature” means a signature that is handwritten or computer-

generated if a prescription is electronically transmitted, as that term is defined in

section 17703 of the code, MCL 333.17703.

(s) “NABP” means the National Association of Boards of Pharmacy.

(t) “NABP-VPP” means the NABP Verified Pharmacy Program.

(u) “NAPLEX” means the North American pharmacist licensure examination.

(v) “PIC” means pharmacist in charge.

(w) “Practical experience” means professional and clinical instruction in, but

not limited to, all of the following areas:

(i) Pharmacy administration and management.

(ii) Drug distribution, use, and control.

(iii) Legal requirements.

(iv) Providing health information services and advising patients.

(v) Pharmacist’s ethical and professional responsibilities.

(vi) Drug and product information.

(vii) Evaluating drug therapies and preventing or correcting drug-related

issues.

(x) “USP” means the United States Pharmacopeia.

(y) “Virtual manufacturer” means a person who engages in the manufacture

of prescription drugs or devices and meets all of the following:

(i) Owns either of the following:

(A) The new prescription drug application or abbreviated new prescription

drug application number.

(B) The unique device identification number, as available, for a prescription

device.

(ii) Contracts with a contract manufacturing organization for the physical

manufacture of the drugs or devices.

(iii) Is not involved in the physical manufacture of the drugs or devices.

(iv) At no time takes physical possession of or stores the drugs or devices.

(v) Sells or offers for sale to other persons, for resale, compounding, or

dispensing of, drugs or devices, salable on prescription only.

(z) “Written” includes both paper and electronic forms.

(2) Unless otherwise defined in these rules, the terms defined in the code have

the same meaning as used in these rules.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

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R 338.503 Prescription drugs and devices; return or exchange for resale

prohibited.

Rule 3. (1) Prescription drugs or devices that have been dispensed and have

left the control of the pharmacist must not be returned or exchanged for resale.

(2) This rule does not apply to any of the following:

(a) A pharmacy operated by the department of corrections or under contract

with the department of corrections or a county jail, as provided in section 17766d

of the code, MCL 333.17766d.

(b) A pharmacy or charitable clinic that participates in the program for the

utilization of unused prescription drugs, as provided in section 17775 of the code,

MCL 333.17775.

(c) A pharmacy or health facility that participates in the cancer drug

repository program, as provided in section 17780 of the code, MCL 333.17780.

(d) Drugs returned when the wrong medication was dispensed to the patient

or in the instance of a drug recall. Subject to R 338.486(7), in no instance may

returned drugs be reused or returned to active stock.

History: 2020 AACS.

R 338.505 Inspection of applicants and licensees.

Rule 5. (1) The board, board inspector, board agent, or an entity approved

under R 338.532, may enter at reasonable times, any building, place, or facility

that is owned or controlled by any applicant for, or holder of, a license to inspect

to enable the board to determine if the applicant possesses the qualifications and

competence for the license sought or to determine whether a license holder is and

has been complying with the code and rules. The inspection must concern only

matters relevant to the applicant’s or license holder’s practice of pharmacy,

manufacturing, and wholesale distribution of drugs and devices saleable by

prescription only.

(2) Inspections in subrule (1) of this rule must not extend to any of the following

information, however, the following information is subject to a disciplinary

investigation:

(a) Financial data.

(b) Purchasing data, other than shipment data, and the current and historical

selling price of a drug.

(c) Personnel data, other than data as to the qualifications of personnel

performing functions subject to the acts and rules enforced by the board.

(d) Research data, other than research data that confirms the appropriate

use of controlled substances for research purposes, or research data for

accountability for reconciliation of prescription drug inventories.

(3) An applicant or license holder shall allow and cooperate with the

inspection.

History: 2020 AACS; 2022 AACS; 2024 AACS.

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R 338.507 Telehealth.

Rule 7. (1) A health professional or delegate of the health professional shall

obtain consent from the patient for treatment before providing a telehealth

service under section 16284 of the code, MCL 333.16284.

(2) A health professional or delegate of the health professional shall keep

proof of consent for telehealth treatment in the patient’s up-to-date medical

record and satisfy section 16213 of the code, MCL 333.16213.

(3) A pharmacist providing a telehealth service may prescribe a drug if the

pharmacist is a prescriber acting within the scope of the pharmacist’s practice

and complies with section 16285 of the code, MCL 333.16285, and if the

pharmacist does both of the following:

(a) Refers the patient to a provider that is geographically accessible to the

patient, if medically necessary.

(b) Makes the pharmacist available to provide follow-up care services to the

patient, or to refer the patient to another provider, for follow-up care.

(4) A health professional providing any telehealth service shall do both of the

following:

(a) Act within the scope of the health professional’s practice.

(b) Exercise the same standard of care applicable to a traditional, in-person

healthcare service.

History: 2026 MR 6, Eff. March 12, 2026.

PART 2. PHARMACIST LICENSES

R 338.511 Training standards for identifying victims of human trafficking;

requirements.

Rule 11. (1) Under section 16148 of the code, MCL 333.16148, the individual

seeking licensure or who is licensed shall have completed training in identifying

victims of human trafficking that meets the following standards:

(a) Training content must cover all of the following:

(i) Understanding the types and venues of human trafficking in the United

States.

(ii) Identifying victims of human trafficking in healthcare settings.

(iii) Identifying the warning signs of human trafficking in healthcare settings

for adults and minors.

(iv) Identifying resources for reporting the suspected victims of human

trafficking.

(b) 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.

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(iii) Training obtained in an educational program that has been approved by

the board for initial licensure, or by a college or university.

(iv) Reading an article related to the identification of victims of human

trafficking that meets the requirements of subdivision (a) of this subrule and is

published in a peer-reviewed journal, healthcare journal, or professional or

scientific journal.

(c) Acceptable modalities of training may include any of the following:

(i) Teleconference or webinar.

(ii) Online presentation.

(iii) Live presentation.

(iv) Printed or electronic media.

(2) The department may select and audit an individual and request

documentation of proof of completion of training. If audited by the department, the

individual shall provide an acceptable proof of completion of training, including

either of the following:

(a) Proof of completion certificate issued by the training provider that includes

the date, provider name, name of training, and individual’s name.

(b) A self-certification statement by the individual. The certification statement

must include the individual’s name and 1 of the following:

(i) For training completed under subrule (1)(b)(i) to (iii) of this rule, the date,

training provider name, and name of training.

(ii) For training completed under subrule (1)(b)(iv) of this rule, the title of

article, author, publication name of the peer-reviewed journal, healthcare journal,

or professional or scientific journal, and the date, volume, and issue of publication

as applicable.

History: 2020 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.513

practices.

Educational limited license; application and renewal;

Rule 13. (1) An applicant for an educational limited license shall submit to the

department a completed application on a form provided by the department with the

requisite fee. In addition to satisfying the requirements of sections 16174 and

17737 of the code, MCL 333.16174 and 333.17737, the applicant shall establish 1

of the following:

(a) That the applicant is actively enrolled in, or is within 180 days of

completing, an approved educational program.

(b) That the applicant has received a FPGEC certification from the NABP

Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville Drive,

Mount Prospect, Illinois, 60056, https://nabp.pharmacy/programs/fpgec/.

(2) The educational limited license must be renewed annually as follows:

(a) At the time of renewal, the applicant shall submit verification to the

department that the applicant is actively enrolled in, or is within 180 days of

completing, an approved educational program. The educational limited license is

valid for 1 year.

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(b) If an applicant is a graduate of a non-accredited college or school of

pharmacy at the time of renewal, the applicant shall submit verification to the

department from the applicant’s preceptor that the applicant is currently in an

internship program under the preceptor’s supervision. The educational limited

license is valid for 1 year and may be renewed 1 time.

(3) An educational limited licensee may engage in the practice of pharmacy

only under the personal charge of a pharmacist.

(4) An educational limited licensee shall verify that the licensee's pharmacy

preceptor holds a valid preceptor license before engaging in the practice of

pharmacy if the internship hours will be submitted to the department for credit.

(5) An educational limited licensee shall notify the board within 30 days if the

licensee is no longer actively enrolled in an approved educational program.

(6) An applicant for an educational limited license shall meet the requirements

of R 338.511 and R 338.7004.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.515 Internship requirements.

Rule 15. (1) An applicant for a pharmacist license shall acquire a minimum of

1,600 internship hours, which may be completed through an educational program,

under the personal charge of a preceptor, through a preapproved unconventional

internship, or through an educational program outside of the United States under

subrule (2) of this rule. An internship is subject to all of the following:

(a) Not more than 40 hours per week may be earned.

(b) An unconventional internship requires prior board approval and is limited

to a maximum of 400 hours, with a maximum of 16 hours earned per week, and

not more than 40 hours earned per week when the intern’s pharmacy school is not

in session. As used in this subdivision, "unconventional internship” means an

educational program of professional and practical experience involving the

pharmacy or related pharmaceutical experiences which, through on-the-job

training, provides knowledge useful to the practice of the profession of pharmacy.

(c) The licensed pharmacy preceptor, an approved education program, or

other individual previously approved by the board shall verify internship hours.

(d) An individual participating in a preapproved unconventional internship

shall annually submit to the department an affidavit from the internship supervisor

that includes the type of activities performed and the number of internship hours

completed.

(e) The internship must provide professional and practical experience.

(2) An individual who graduated from a program outside the United States

may petition the board for approval of a maximum of 1,400 internship hours if an

internship is not completed through an approved educational program or under the

personal charge of a preceptor licensed in this state. The internship hours must be

obtained through an educational program experience.

(3) An individual shall obtain an educational limited license under R 338.513

before starting an internship that includes the practice of pharmacy in this state.

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History: 2020 AACS; 2024 AACS.

R 338.517 Preceptor license and responsibilities.

Rule 17. (1) An applicant for licensure as a pharmacist preceptor shall submit

to the department a completed application on a form provided by the department.

(2) The applicant shall satisfy both of the following:

(a) Have an unrestricted pharmacist license from this state that is in good

standing for the past year.

(b) Have been engaged in the practice of pharmacy in this state for at least 1

year.

(3) A preceptor shall do all of the following:

(a) Ensure that the pharmacist on duty is supervising not more than 2

pharmacist interns at the same time. The approved preceptor is responsible for the

overall internship program at the pharmacy.

(b) Determine the degree of the intern’s professional skill on the topics listed

in R 338.501(1)(u) and develop a training program where the intern can improve

the intern's skill in these areas.

(c) Ensure sufficient time to instruct the intern on the topics in R 338.501(1)(u)

and review and discuss the intern’s progress on the topics in R 338.501(1)(u).

(4) Unless the hours are completed in an educational program, the preceptor

shall submit to the department a training affidavit that includes the number of

internship hours completed by the intern in the practice of pharmacy.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.519 Examinations adoption; passing scores; reexamination.

Rule 19. (1) The board adopts the NAPLEX developed and administered by

the NABP.

(2) The passing score for the NAPLEX accepted for licensure is the passing

score established by the NABP.

(3) An applicant that fails to pass the NAPLEX shall wait not less than 45 days

to retest or comply with the current waiting period established by NABP, whichever

is longer. An applicant that has not achieved a passing score on the NAPLEX may

not take the NAPLEX more than 3 times in a 12-month period.

(4) If an applicant for licensure fails to pass the NAPLEX within 3 attempts,

the applicant shall request preapproval from the department, after consultation with

a board member, if necessary, of a live or interactive examination preparation

course, or instruction with an instructor with expertise on the subject matter, for the

examination that the applicant failed. After participating in the course or instruction

the applicant shall provide the department with proof that the applicant completed

the course or instruction.

(5) An applicant may not sit for the NAPLEX specified in subrule (4) of this

rule more than 5 times, unless the applicant successfully repeats an approved

education program, as specified in R 338.521(2)(a)(i) and provides proof of

completion to the department.

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History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.521 Pharmacist licensure by examination.

Rule 21. (1) An applicant for licensure as a pharmacist by examination shall

submit to the department a completed application on a form provided by the

department with the requisite fee.

(2) In addition to meeting the requirements of section 16174 of the code, MCL

333.16174; R 338.7001 to R 338.7005; and any other rules promulgated under the

code, an applicant for licensure shall satisfy all of the following requirements:

(a) Obtain 1 of the following:

(i) A professional degree from a school of pharmacy accredited by the ACPE.

(ii) A FPGEC certification from the NABP. An applicant who has an FPGEC

certification from NABP has met the English proficiency requirement as the

applicant’s credentials and English proficiency have been evaluated and

determined to be equivalent to the credentials required in this state.

(iii) A score transfer from NABP if the applicant has been licensed in another

state for 1 day to 1 year.

(b) Pass the NAPLEX.

(c) Complete an internship as set forth in R 338.515.

(d) Complete a 1-time training identifying victims of human trafficking as

required in R 338.511 and section 16148 of the code, MCL 333.16148.

(e) Complete training in opioids and other controlled substances awareness

as required in R 338.3135.

(f) Provide an attestation to the department that the applicant has sufficient

knowledge of the code and the board’s rules to competently practice pharmacy in

this state.

(3) An applicant who is or has ever been licensed, registered, or certified in a

health profession or specialty by another state, the United States military, the

federal government, or another country, shall do both of the following:

(a) Disclose each license, registration, or certification on the application form.

(b) Satisfy the requirements of section 16174(2) of the code, MCL 333.16174,

including verification from the issuing entity showing that disciplinary proceedings

are not pending against the applicant and sanctions are not in force at the time of

application.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.523 Pharmacist license by endorsement; requirements.

Rule 23. (1) An applicant who has never held a pharmacist license in this

state and is licensed in another state or Canada, may apply for licensure as a

pharmacist by endorsement by submitting to the department a completed

application on a form provided by the department with the requisite fee. An

applicant who meets the requirements of this rule, R 338.7001 to R 338.7005, and

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any other rules promulgated under the code is presumed to meet the requirements

of section 16186 of the code, MCL 333.16186.

(2) An applicant shall satisfy all of the following requirements:

(a) Establish 1 of the following:

(i) The applicant holds a license in good standing as a pharmacist in another

state and submits the NABP licensure transfer report to the department.

(ii) The applicant holds a pharmacy license in Canada that is in good

standing and meets all of the following:

(A) The applicant has passed the NAPLEX or both part I and part II of the

Pharmacy Examining Board of Canada Pharmacists Qualifying Examination.

(B) The applicant completed educational requirements for a pharmacist

license from a school of pharmacy accredited by the ACPE or accredited by the

Canadian Council for Accreditation of Pharmacy Programs.

(C) If the applicant held a pharmacist license for less than 1 year in Canada,

the applicant had acquired a minimum of 1,600 hours of pharmacy practice either

through an approved internship or hours engaged in the practice as a pharmacist.

(b) Provide an attestation to the department that the applicant has sufficient

knowledge of the code and the board’s rules to competently practice pharmacy in

this state.

(c) An applicant who is or has ever been licensed, registered, or certified in a

health profession or specialty by another state, the United States military, the

federal government, or another country, shall do both of the following:

(i) Disclose each license, registration, or certification on the application form.

(ii) Satisfy the requirements of section 16174(2) of the code, MCL

333.16174, including verification from the issuing entity showing that disciplinary

proceedings are not pending against the applicant and sanctions are not in force

at the time of application.

(d) The applicant meets section 16174 of the code, MCL 333.16174, and

submits the applicant’s fingerprints to the department of state police to have a

criminal background check conducted by the state police and the Federal Bureau

of Investigation.

(e) The applicant completes a 1-time training identifying victims of human

trafficking as required in R 338.511 and section 16148 of the code, MCL

333.16148.

(f) The applicant completes training in opioids and other controlled

substances awareness as required in R 338.3135.

(2) An applicant who has an FPGEC certification from NABP has met the

English proficiency requirement. The applicant’s credentials and English

proficiency have been evaluated and determined to be equivalent to the

credentials required in this state.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.525 Relicensure of a pharmacist license; requirements.

Rule 25. (1) An applicant for relicensure whose pharmacist license has

lapsed in this state, under sections 16201(3) or (4) and 17733 of the code, MCL

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333.16201 and 333.17733, as applicable, may be relicensed by complying with

the following requirements as noted by (x):

For a pharmacist whose license has License lapsed License lapsed License lapsed

lapsed in this state and is not 0-3 years.

currently licensed in good standing in

another state or a province of

Canada:

more than 3 8

years, but less years.

than 8 years.

or

more

(a) Submit to the department a

completed application on a form

provided by the department with the

requisite fee.

X

(b) Establish that the applicant is of

good moral character as that term is

defined in, and determined under,

1974 PA 381, MCL 338.41 to MCL

338.47.

X

(c) Submit fingerprints as required

under section 16174(3) of the code,

MCL 333.16174.

X

(d) Submit proof of completing 30

hours of continuing education that

satisfy R 338.3041 to R 338.3045 in

the 2 years immediately before the

application for relicensure. However,

if the continuing education hours

submitted with the application are

deficient, the applicant has 2 years

after the date of the application to

complete the deficient hours. The

application must be held and the

license may not be issued until the

continuing education requirements

are met.

X

(e) Provide an attestation to the

department that the applicant has

sufficient knowledge of the code and

the board’s rules to competently

practice pharmacy in this state.

(f) Submit proof of completing a 1-

time training in identifying victims of

human trafficking as required in R

338.511, training in opioids and other

controlled substances awareness as

required in R 338.3135, and implicit

X

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bias training as required in R

338.7004.

(g) Complete 200 hours of practical

experience under the personal

charge of a pharmacist currently

licensed in this state who is located in

or outside of this state, within 6

months after being granted a limited

license.

X

(h) Complete 400 hours of practical

experience under the personal

charge of a pharmacist currently

licensed in this state who is located in

or outside of this state, within 6

months after being granted a limited

license.

X

(i) Retake and pass the NAPLEX

within 2 years before applying for

X

relicensure, as provided in

338.519.

R

(j) An applicant who is or has ever

been licensed, registered, or certified

in a health profession or specialty by

another state, the United States

military, the federal government, or

another country, shall do both of the

following:

X

(i) Disclose each license, registration,

or certification on the application

form.

(ii) Satisfy the requirements of section

16174(2) of the code, MCL

333.16174, including verification from

the issuing entity showing that

disciplinary proceedings are not

pending against the applicant and

sanctions are not in force at the time

of application.

(2) As used in subrule (1)(g) and (h) of this rule, an applicant may be granted

a non-renewable limited license to complete the practical experience.

(3) To demonstrate compliance with subrule (1)(g) or (h), the supervising

pharmacist shall provide verification to the department of the applicant’s

completion of the experience on a form provided by the department.

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(4) For

a

pharmacist whose

pharmacist license has lapsed in this

state, but who holds a current and

valid pharmacist license in good

standing in another state or a

Canadian province:

License

lapsed

License lapsed 0-

3 years.

License lapsed 8

or more years.

more than 3 years,

but less than 8

years.

(a) Submit to the department a

completed application on a form

provided by the department with the

requisite fee.

(b) Establish that the applicant is of

good moral character as that term is

defined in, and determined under,

1974 PA 381, MCL 338.41 to MCL

338.47.

X

(c) Submit fingerprints as required

under section 16174(3) of the code,

MCL 333.16174.

X

(d) Submit proof of completing 30

hours of continuing education that

satisfy

R 338.3041 to R 338.3045 in the 2

years

immediately

before

the

application for relicensure. However, if

the continuing education hours

submitted with the application are

deficient, the applicant has 2 years

after the date of the application to

complete the deficient hours. The

application must be held and the

license may not be issued until the

continuing education requirements are

met.

(e) Submit proof of completing a 1-

time training in identifying victims of

human trafficking as required in R

338.511, training in opioids and other

controlled substances awareness as

required in R 338.3135, and implicit

bias training as required in R

338.7004.

X

(f) Provide an attestation to the

department that the applicant has

sufficient knowledge of the code and

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the board’s rules to competently

practice pharmacy in this state.

(g) An applicant who is or has ever

been licensed, registered, or certified

in a health profession or specialty by

another state, the United States

military, the federal government, or

another country, shall do both of the

following:

(i) Disclose each license, registration,

or certification on the application form.

(ii) Satisfy the requirements of section

X

16174(2)

of

the

code,

MCL

333.16174, including verification from

the issuing entity showing that

disciplinary proceedings are not

pending against the applicant and

sanctions are not in force at the time

of application.

(5) If relicensure is granted and it is determined that a sanction has been

imposed by another state, the United States military, the federal government, or

another country, the disciplinary subcommittee may impose appropriate sanctions

under section 16174(5) of the code, MCL 333.16174.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

PART 3. PHARMACY LICENSES

R 338.531 Pharmacy license; remote pharmacy license; applications;

requirements.

Rule 31. (1) An applicant for a pharmacy license or a remote pharmacy license

shall submit to the department a completed application on a form provided by the

department together with the requisite fee.

(2) An applicant shall submit all of the following information:

(a) Certified copies of articles of incorporation or partnership certificates and

certified copies of assumed name certificates, if applicable.

(b) Submission of fingerprints for the purpose of a criminal history background

check required under section 17748(6) of the code, MCL 333.17748.

(c) A FEIN certificate.

(d) The name and license number of the pharmacist in this state designated

as the PIC under section 17748(2) of the code, MCL 333.17748, who must have a

valid and unrestricted license. If a PIC is unable to fulfill the PIC’s duties for 120

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consecutive days, the pharmacy shall appoint a new PIC and notify the department

as required in section 17748(4) of the code, MCL 333.17748.

(e) The identity and address of each partner, officer, or owner, as applicable.

(f) A completed self-inspection form.

(g) If the applicant is an out-of-state pharmacy that will not provide sterile

compounding services, an inspection report that satisfies the requirements of R

338.534.

(h) If the applicant is an in-state pharmacy that intends to compound sterile

pharmaceutical products, the applicant shall submit to an inspection under R

338.534a.

(i) If the applicant is a governmental entity, an individual shall be designated

as the licensee. The licensee and the pharmacist on duty are responsible for

complying with all federal and state laws regulating the practice of pharmacy and

the dispensing of prescription drugs.

(j) If the applicant is applying for a remote pharmacy license, the applicant

shall submit the following:

(i) Ownership documents to demonstrate to the satisfaction of the

department that the parent pharmacy and the proposed remote pharmacy share

common ownership.

(ii) Copies of the policies and procedure manual required in section 17742b

of the code, MCL 333.17742b.

(iii) A map showing all of the existing pharmacies within 10 miles of the

proposed remote pharmacy if the remote pharmacy will not be located at a hospital

or mental health facility.

(k) If the applicant is or has ever been licensed, registered, or certified as a

pharmacy by another state, the United States military, the federal government, or

another country, the applicant shall do both of the following:

(i) Disclose each license, registration, or certification on the application form.

(ii) Submit verification from the issuing entity showing that disciplinary

proceedings are not pending against the applicant and sanctions are not in force

at the time of application.

(3) The department shall issue only 1 pharmacy license per address. If an

applicant has more than 1 location at which drugs are prepared or dispensed, each

address location must obtain a separate license.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.531a Remote pharmacy waiver from mileage requirement.

Rule 31a. (1) An applicant seeking a remote pharmacy license may apply to

the board for a waiver from the prohibition of locating a remote pharmacy within 10

miles of another pharmacy in section 17742a(2)(c) of the code, MCL 333.17742a,

by submitting a completed application to the department.

(2) The applicant shall submit the following with the application:

(a) A map showing the location of any existing pharmacies within 10 miles of

the proposed remote pharmacy if the remote pharmacy will not be located at a

hospital or mental health facility.

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(b) A list and explanation of the services or availability of services that will be

offered at the remote pharmacy or otherwise not readily available to patients that

are different from the services offered at a pharmacy located within 10 miles of the

proposed remote pharmacy.

(c) A statement of facts to support 1 or more of the following:

(i) The proposed remote pharmacy is located in an area where there is

limited access to pharmacy services.

(ii) The proposed remote pharmacy will offer a service that is unique from

other pharmacies in the 10-mile radius from the remote pharmacy and the service

will satisfy an unmet need of the surrounding community.

(iii) There exists a limitation on travel that justifies waiving the requirement.

(iv) There are other compelling circumstances that justify waiving the

requirement.

(3) If the waiver is denied, the application is considered closed unless within

30 days after receipt of the denial, the applicant notifies the department that it is

requesting a hearing on the matter.

History: 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.532

Sterile compounding accrediting organizations; board

approval; inspection entities.

Rule 32. (1) The board shall approve, under section 17748a of the code, MCL

333.17748a, accrediting organizations or inspection entities for pharmacies that

compound pharmaceuticals according to standards adopted by reference in R

338.533.

(2) The department shall post on its website, the list of organizations approved

under subrule (1) of this rule.

(3) An organization may petition the board for approval under subrule (1) of

this rule. The petition must include, but is not limited to, all of the following:

(a) Requirements for accreditation or compliance.

(b) Requirements for inspectors.

(c) Training provided to inspectors.

(d) Copy of the most current inspection form.

(e) The length of accreditation.

(f) Agreement and plan to share results of inspections with the department.

(4) If the board approves the petition, the approval is valid for 3 years after the

date of approval. The organization may submit a petition that complies with subrule

(3) of this rule to seek continuing approval.

(5) The board may rescind approval of an organization upon just cause. The

rescission will not immediately affect the compliance of a pharmacy using the

accreditation. Within 12 months after the rescission date or by the next licensure

renewal date, whichever is later, the accreditation is void, and a pharmacy shall

obtain accreditation or an inspection from an organization that satisfies subrule (1)

of this rule.

History: 2020 AACS; 2024 AACS.

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R 338.532a Outsourcing facilities; board approval; inspection entities.

Rule 32a. (1) The board shall approve, under section 17748a of the code,

MCL 333.17748a, inspection entities for outsourcing facilities that compound

pharmaceuticals under current and as amended good manufacturing practice for

finished pharmaceuticals set forth in 21 CFR part 211.

(2) The department shall post the list of organizations approved under subrule

(1) of this rule on its website.

(3) An organization may petition the board for approval under subrule (1) of

this rule. The petition must include, but is not limited to, all of the following:

(a) Requirements for compliance.

(b) Requirements for inspectors.

(c) Training provided to inspectors.

(d) Copy of the most current inspection form.

(e) Agreement and plan to share results of inspections with the department.

(4) If the board approves the petition, the approval is valid for 3 years after the

date of approval. The organization may submit a petition that complies with subrule

(3) of this rule to seek continuing approval.

(5) The board may rescind approval of an organization on just cause. The

rescission will not immediately affect the compliance of a pharmacy using the

accreditation. Within 12 months after the rescission date or by the next licensure

renewal date, whichever is later, the accreditation is void, and a pharmacy shall

obtain accreditation or an inspection from an organization that satisfies subrule (1)

of this rule.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.533 Compounding standards and requirements; outsourcing

facilities; requirements.

Rule 33. (1) The board approves and adopts by reference the compounding

standards of USP, published by the United States Pharmacopeial Convention,

12601 Twinbrook Parkway, Rockville, Maryland 20852-1790. This includes USP

Chapters 795 (revised 2023), 797 revised 2024), 800 (revised 2020), and 825

(revised 2024), with the exception of flavoring.

(2) The standards adopted by reference in subrule (1) of this rule are available

from the USP Compounding Compendium at https://www.usp.org/products/usp-

compounding-compendium through a 1-year online subscription at a cost of

$250.00 as of the time of adoption of this rule. The standards adopted by reference

in subrule (1) are available for inspection at the Bureau of Professional Licensing,

Michigan Department of Licensing and Regulatory Affairs, Ottawa Building, 611

West Ottawa, P.O. Box 30670, Lansing, Michigan 48909.

(3) A pharmacy that provides compounding services under section 503A of

the FDCA, 21 USC 353a, shall comply with the standards adopted in subrule (1)

of this rule.

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(4) An outsourcing facility located outside of this state that dispenses,

provides, distributes, or otherwise furnishes compounded pharmaceuticals in this

state shall be inspected and registered as an outsourcing facility by the FDA before

applying for a pharmacy license in this state.

(5) An outsourcing facility located within this state that is applying for licensure

as a pharmacy shall complete both of the following:

(a) Obtain an inspection from the department or its designee for the purpose

of meeting R 338.536 and R 338.537 for initial licensure.

(b) Within 6 months after initial licensure under this subrule, a pharmacy shall

obtain, and provide to the department, a subsequent inspection to assess

adherence to the current and as amended good manufacturing practice for finished

pharmaceuticals set forth in 21 CFR part 211.

(6) A pharmacy registered as an outsourcing facility or a pharmacy located in

this state that compounds drugs under section 503B of the FDCA, 21 USC 353b,

shall do all of the following:

(a) Compound drugs by or under the supervision of a licensed pharmacist.

(b) Compound drugs under current good manufacturing practice for finished

pharmaceuticals set forth in 21 CFR part 211.

(c) Ensure that a pharmacist who conducts or oversees compounding at an

outsourcing facility is proficient in the practice of compounding and has acquired

the education, training, and experience to maintain that proficiency by doing any

of the following:

(i) Participating in seminars.

(ii) Studying appropriate literature.

(iii) Consulting with colleagues.

(iv) Being certified by a compounding certification program approved by the

board.

(d) Label compounded drugs and compounded drugs that are patient specific

in compliance with the requirements in R 338.582 and include all of the following:

(i) Required drug and ingredient information.

(ii) Facility identification.

(iii) The following or similar statement: “This is a compounded drug. For office

use only” or “Not for resale.”

(e) Ensure that bulk drug substances used for compounding meet specified

FDA criteria.

(7) An outsourcing facility may compound drugs that appear on an FDA

shortage list, if the bulk drug substances used to compound the drugs comply with

the criteria specified in this rule.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.534 Out-of-state pharmacy licensure inspection; in-state pharmacy

licensure renewal inspection; outsourcing facility licensure renewal

inspection.

Rule 34. (1) A pharmacy located outside of this state that applies for licensure

in this state as a pharmacy that will not ship compounded sterile pharmaceutical

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products into this state shall submit to the department a copy of its most recent

resident state board of pharmacy inspection or an NABP-VPP inspection that was

performed within the last 2 years before the date of application.

(2) Unless accredited by a national accrediting organization, recognized by

the board, an applicant for renewal of an in-state pharmacy license, or an applicant

for an initial or renewal of an out-of-state pharmacy license, that will provide sterile

compounded pharmaceuticals in this state and is not registered as an outsourcing

facility shall have an inspection and submit the inspection report to the department,

completed no more than 18 months before the date of application, that

demonstrates compliance with all applicable standards that are adopted by

reference in R 338.533. The inspection must be conducted by 1 of the following:

(a) The department.

(b) The NABP-VPP.

(c) An accrediting organization according to R 338.532.

(d) A state licensing agency of the state in which the applicant is a resident

and in accordance with the NABP’s multistate pharmacy inspection blueprint

program.

(3) A pharmacy that compounds drugs under section 503B of the FDCA, 21

USC 353b, and is applying for license renewal shall have an inspection and submit

the inspection report to the department, completed no more than 18 months before

the date of the application, that demonstrates compliance with the current and as

amended good manufacturing practice for finished pharmaceuticals set forth in

CFR part 211. The inspection must be conducted by 1 of the following:

(a) The FDA.

(b) An inspection organization according to R 338.532a.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.534a In-state initial pharmacy license inspections.

Rule 34a. (1) An in-state pharmacy that will not compound sterile

pharmaceutical products that is applying for initial licensure shall be inspected by

the department or its designee before licensure.

(2) An applicant for an in-state pharmacy license that intends to compound

sterile pharmaceutical products under section 503A of the FDCA, 21 USC 353a,

shall complete both of the following:

(a) Obtain an inspection from the department or its designee for the purpose

of meeting R 338.536 and R 338.537 for initial licensure.

(b) Within 6 months after initial licensure under this subrule, a pharmacy shall

obtain, and provide to the department, a subsequent inspection to assess USP

compliance or achieve accreditation from 1 of the entities listed in R 338.534(2)(a)

to (c).

(3) Approval to engage in sterile compounding under section 503A of the

FDCA, 21 USC 353a, will end 6 months after initial licensure if a subsequent

inspection to assess USP compliance or accreditation is not successful.

History: 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

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R 338.535 Discontinuing, starting, or resuming sterile compounding

services; requirements to resume sterile compounding services.

Rule 35. (1) A sterile compounding pharmacy or outsourcing facility that

ceases to provide sterile compounding services in this state shall notify the

department within 30 days after ceasing to provide sterile compounding services.

(2) A pharmacy shall apply for approval to start or resume sterile compounding

services by submitting to the department an application on a form provided by the

department together with the requisite fee.

(3) A pharmacy shall not start or resume sterile compounding services in this

state until the pharmacy submits to the department an inspection report, as

required in R 338.534(2), is approved by the department, and is accredited, or an

organization satisfying the requirements of R 338.532(1) verifies that the pharmacy

is USP compliant.

(4) An outsourcing facility shall not start or resume providing sterile

compounding services in this state until the outsourcing facility is approved by the

department, and the department verifies that it is compliant with the requirements

of R 338.533(4) to (7).

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.536 Housing of a pharmacy.

Rule 36. (1) All professional and technical equipment and supplies and

prescription drugs must be housed in a suitable, well-lighted, and well-ventilated

room or department with clean and sanitary surroundings.

(2) All pharmacies shall have a prescription department that is devoted

primarily to the practice of pharmacy that occupies not less than 150 square feet

of space, and that includes a prescription counter that provides not less than 10

square feet of free working surface. For each additional pharmacist on duty at any

1 time, the free working space must be increased by not less than 4 square feet.

The prescription counter must be orderly and clean. The space behind the

prescription counter must be sufficient to allow free movement within the area and

must be free of obstacles.

(3) Except as allowed in R 338.588a(2), pharmacies that occupy less than the

entire area of the premises owned, leased, used, or controlled by the licensee shall

be permanently enclosed by partitions from the floor to the ceiling. All partitions

must be of substantial construction and must be securely lockable so that drugs

and devices that can be sold only by a pharmacist are unobtainable during the

absence of the pharmacist. Only the area of the premises owned, leased, used,

or controlled by the licensee may be identified by the terms “drugstore,”

“apothecary,” or “pharmacy,” or by use of a similar term or combination of terms

as listed in section 17711(2) of the code, MCL 333.17711. A pharmacy department

must be locked when the pharmacist is not on the premises.

History: 2020 AACS; 2022 AACS; 2024 AACS.

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R 338.537 Professional and technical equipment and supplies.

Rule 37. (1) A pharmacy shall be equipped with both of the following:

(a) The necessary facilities, apparatus, utensils, and equipment to allow the

pharmacy to provide prompt and efficient services.

(b) Current print, electronic, or unabridged computerized versions of the

pharmacy laws and rules of this state, and not less than 2 current pharmacy

reference texts that pertain to pharmacology, drug interactions, or drug

composition, or other information necessary for the delivery of safe and effective

practice of pharmacy.

(2) In addition to subrule (1) of this rule, a pharmacy that dispenses drugs

shall maintain, at a minimum, all of the following equipment:

(a) A sink with running water.

(b) A refrigerator for the exclusive use of prescription drugs. Personal or food

items must not be stored in the refrigerator. Refrigeration must be capable of

maintaining temperature within a range compatible with the proper storage of

drugs requiring refrigeration or freezing. Temperatures must be monitored at all

times for out-of-range temperatures during business closure.

(c) A telephone.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.538 Closing pharmacy.

Rule 38. (1) A pharmacy that is ceasing operations shall provide the

department with written notification of all of the following not less than 15 days

before closing:

(a) The effective date of closing.

(b) How controlled substances will be disposed.

(c) How non-controlled substances will be disposed.

(d) The location where records and prescription files will be stored.

(2) A pharmacy shall comply with all applicable federal requirements for

discontinuing operation as a pharmacy that dispenses controlled substances.

(3) Records must be maintained for the same amount of time that is required

if the pharmacy remained open.

History: 2020 AACS; 2022 AACS;2024 AACS.

R 338.539 Relicensure and renewal.

Rule 39. (1) An applicant with an expired license may apply for relicensure of

a pharmacy license by submitting to the department a completed application on a

form provided by the department, satisfying all the requirements for licensure in

part 3 of these rules, R 338.531 to R 338.539, and paying the requisite fee.

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(2) A pharmacy that renews its license during the license renewal period

submit to the department a completed application, on a form provided by the

department, together with the requisite fee.

History: 2020 AACS; 2022 AACS.

PART 4. MANUFACTURER LICENSE

R 338.551 Manufacturer license; application.

Rule 51. (1) An applicant for a manufacturer license shall submit to the

department a completed application on a form provided by the department with the

requisite fee.

(2) An applicant shall provide all of the following information:

(a) A criminal history background check required under section 17748(6) of

the code, MCL 333.17748.

(b) A FEIN certificate.

(c) Certified copies of articles of incorporation or certificates of partnership

and assumed name certificates, if applicable.

(d) The identity and address of each partner, officer, or owner, as applicable.

(e) A completed compliance checklist for manufacturers.

(f) A list or a catalog of all drug products or devices to be manufactured by

the facility.

(g) Unless exempt under section 17748(2) of the code, MCL 333.17748, the

name and license number of the pharmacist designated as the PIC or the name of

the facility manager. If a PIC or facility manager is unable to fulfill the PIC or facility

manager’s duties for 120 consecutive days, the pharmacy shall appoint a new PIC

or facility manager and notify the department as required in section 17748(4) of

the code, MCL 333.17748. For an individual who is designated as a facility

manager, the applicant shall provide proof, in the form of an affidavit, that the

facility manager has achieved the following:

(i) A high school equivalency education, or higher, defined as 1 of the

following:

(A) A high school diploma.

(B) A GED.

(C) A parent-issued diploma for home schooled individuals.

(D) Completion of post-secondary education, including either an

associate’s, bachelor’s, or a master’s degree.

(ii) Completion of a training program that includes, but is not limited to, all of

the following subjects:

(A) Knowledge and understanding of laws in this state and federal laws

relating to the distribution of drugs and devices.

(B) Knowledge and understanding of laws in this state and federal laws

relating to the distribution of controlled substances.

(C) Knowledge and understanding of quality control systems.

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(D) Knowledge and understanding of the USP standards relating to the safe

storage and handling of prescription drugs.

(E) Knowledge and understanding of pharmaceutical terminology,

abbreviations, dosages, and format.

(iii) Experience equal to either of the following:

(A) A minimum of 1 year of work experience related to the distribution or

dispensing of prescription drugs or devices where the responsibilities included, but

were not limited to, recordkeeping.

(B) Previous or current employment as a designated representative of a

manufacturer.

(iv) Employment with the applicant.

(h) A copy of the FDA certification for the site to be licensed, if an applicant

is a manufacturer of biologicals.

(i) An inspection from the FDA, or manufacturer’s resident state board of

pharmacy, that is dated not more than 2 years before application or current NABP

drug distributor accreditation.

(j) An applicant that is or has ever been licensed, registered, or certified as a

manufacturer by another state, the United States military, the federal government,

or another country, shall do both of the following:

(i) Disclose each license, registration, or certification on the application form.

(ii) Submit verification from the issuing entity showing that disciplinary

proceedings are not pending against the applicant and sanctions are not in force

at the time of application.

(3) A separate license is required for each location where prescription drugs

or devices are manufactured.

(4) A manufacturer that changes its facility manager shall submit all of the

information required in subrule (2)(g) of this rule to the department within 30 days

after the change.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.553 Persons to whom prescription drugs or devices may be sold.

Rule 53. A manufacturer may only supply, distribute, sell, barter, or otherwise

transfer prescription drugs or devices to persons who are licensed by the board to

distribute, prescribe, or dispense prescription drugs or devices in or outside this

state.

History: 2020 AACS.

R 338.555 Federal regulation on good manufacturing practice for finished

pharmaceuticals; adoption by reference; compliance.

Rule 55. (1) The board approves and adopts by reference the current good

manufacturing practice for finished pharmaceuticals regulations set forth in 21 CFR

part 211.

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(2) A manufacturer shall comply with the standards adopted in subrule (1) of

this rule.

(3) The standards adopted by reference in subrule (1) of this rule are available

no cost at

at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFR

Part=211 , or at 25 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.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.557 Closing of a manufacturer.

Rule 57. (1) A manufacturer that is ceasing operations shall return the

manufacturer license and the controlled substance license, if applicable, to the

department, and provide the department with written notification of all of the

following not less than 15 days before closing:

(a) The effective date of closing.

(b) How controlled substances will be disposed.

(c) How non-controlled substances will be disposed.

(d) The location where records and prescription files will be stored.

(2) A manufacturer shall comply with all applicable federal requirements for

discontinuing a controlled substance business.

(3) Records must be maintained for the same amount of time that is required

if the manufacturer remains open.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.559 Relicensure and renewal.

Rule 59. (1) An applicant with an expired license may apply for relicensure of

a manufacturer license by submitting to the department a completed application

on a form provided by the department, satisfying all the requirements for licensure

in part 4 of these rules, R 338.551 to R 338.559, and paying the requisite fee.

(2) A manufacturer that renews its license during the license renewal period

shall submit to the department a completed application on a form provided by the

department together with the requisite fee.

History: 2020 AACS; 2022 AACS; 2024 AACS.

PART 5. WHOLESALE DISTRIBUTOR AND

WHOLESALE DISTRIBUTOR-BROKER LICENSE

R 338.561 Pharmacy as wholesale distributor; licensure.

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Rule 61. A pharmacy shall obtain a license as a wholesale distributor under

this part if the total number of dosage units of all prescription drugs distributed by

the pharmacy to a person during any consecutive 12-month period is more than

5% of the total number of dosage units of prescription drugs distributed and

dispensed by the pharmacy during the same 12-month period. The calculation of

this 5% threshold must not include a distribution of a prescription drug that is

exempt from the definition of wholesale distribution under 21 USC 353(e)(4).

History: 2020 AACS; 2022 AACS.

R 338.563

Wholesale distributor, wholesale distributor-broker;

application for licensure; requirements.

Rule 63. (1) An applicant for a wholesale distributor or wholesale distributor-

broker license shall submit to the department a completed application on a form

provided by the department with the requisite fee. A wholesale distributor includes

virtual manufacturers.

(2) An applicant shall comply with all of the following:

(a) Provide a criminal history background check required under section

17748(6) of the code, MCL 333.17748.

(b) Disclose on the application form each license, registration, or certification

in a health profession or specialty issued by another state, the United States

military, the federal government, or another country.

(c) Satisfy the requirements of section 16174(2) of the code, MCL 333.16174,

including verification from the issuing entity showing that disciplinary proceedings

are not pending against the applicant and sanctions are not in force at the time of

application.

(d) Provide certified copies of articles of incorporation or certificates of

partnership and assumed names if applicable.

(e) Provide the identity and address of each partner, officer, or owner as

applicable.

(f) Provide a completed compliance checklist.

(g) Provide a FEIN certificate.

(h) Unless exempt under section 17748(2) of the code, MCL 333.17748,

provide the name and the license number of the pharmacist designated as the PIC

or the name of the facility manager. If a PIC or facility manager is unable to fulfill

the PIC or facility manager’s duties for 120 consecutive days, the pharmacy shall

appoint a new PIC or facility manager and notify the department as required in

section 17748(4) of the code, MCL 333.17748. For individuals designated as a

facility manager, the applicant shall provide proof, in the form of an affidavit, that

the facility manager has achieved the following:

(i) A high school equivalency education, or higher, defined as 1 of the

following:

(A) A high school diploma.

(B) A GED.

(C) A parent-issued diploma for home schooled individuals.

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(D) Completion of post-secondary education, including an associate’s,

bachelor’s, or master’s degree.

(ii) Completion of a training program that includes, but is not limited to, all of

the following subjects:

(A) Knowledge and understanding of laws in this state and federal laws

relating to the distribution of drugs and devices.

(B) Knowledge and understanding of laws in this state and federal laws

relating to the distribution of controlled substances.

(C) Knowledge and understanding of quality control systems.

(D) Knowledge and understanding of the USP standards relating to the safe

storage and handling of prescription drugs.

(E) Knowledge and understanding of pharmaceutical terminology,

abbreviations, dosages, and format.

(iii) Experience equal to either of the following:

(A) A minimum of 1 year of work experience related to the distribution or

dispensing of prescription drugs or devices where the responsibilities included, but

were not limited to, recordkeeping.

(B) Previous or current employment as a designated representative of a

wholesale distributor certified by the NABP drug distributor accreditation or of a

wholesale distributor-broker.

(iv) Current employment with the applicant.

(i) Provide a list or catalog of all drug products and devices to be distributed,

if a wholesale distributor.

(j) If a wholesale distributor-broker, submit an affidavit, at the time of the

application for initial licensure, that the applicant facilitates deliveries or trades for

not less than 50 qualified pharmacies and that each pharmacy holds a license in

good standing as a pharmacy from the state in which it is located at the time of

application.

(3) A wholesale distributor or wholesale distributor-broker that changes its

facility manager shall submit all of the information required in subrule (2)(h) of this

rule to the department within 30 days after the change.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.565 Persons to whom prescription drugs and devices may be sold.

Rule 65 A wholesale distributor of prescription drugs or devices may supply,

distribute, sell, barter, or otherwise transfer prescription drugs or devices only to

persons who are licensed by the board to distribute, prescribe, or dispense

prescriptions drugs or devices in or outside this state.

History: 2020 AACS.

R 338.567 Wholesale distributor practices; control of prescription drugs

or devices; inspections.

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Rule 67. (1) A wholesale distributor that does not physically touch prescription

drugs or devices shall file an affidavit with the department signed by the PIC or

facility manager attesting to this fact.

(2) A wholesale distributor that previously filed an affidavit under subrule (1)

of this rule shall not obtain custody and control of drugs or devices until both of the

following have occurred:

(a) The licensee provides written notification to the department of physical

custody.

(b) The department conducts an inspection of the premises.

History: 2020 AACS.

R 338.569 Wholesale distributor and wholesale distributor-broker

recordkeeping and policy requirements.

Rule 69. (1) A wholesale distributor shall establish and maintain inventories

and records of transactions regarding the receipt, if applicable, and the distribution

or other disposition of prescription drugs or devices. These records must include

all of the following information:

(a) The source of the prescription drugs or devices, including the name and

principal address of the seller or transferor and the address from which the

prescription drugs or devices were shipped.

(b) The identity and quantity of the prescription drugs or devices received, if

applicable, and distributed or disposed of.

(c) The dates of receipt, if applicable, and distribution of the prescription drugs

or devices.

(2) A wholesale distributor shall establish and maintain a list of officers,

directors, managers, and other individuals who are in charge of wholesale drug

distribution, storage, and handling, including a description of their duties and a

summary of their qualifications.

(3) A wholesale distributor shall have written policies and procedures that

include all of the following:

(a) A procedure where the oldest stock of a prescription drug is distributed

first. The procedure may allow deviation from this requirement if the deviation is

temporary and appropriate.

(b) A procedure for handling recalls and withdrawals of the prescription drugs

or devices. The procedure must deal with recalls and withdrawals due to any of

the following:

(i) Any action initiated at the request of the FDA; other federal, state, or local

law enforcement agency; or other governmental agency.

(ii) Any voluntary action by the manufacturer to remove defective or

potentially defective prescription drugs or devices from the market.

(iii) Any action undertaken to promote public health and safety by replacing

existing merchandise with an improved product or new package design.

(c) A procedure to ensure that a wholesale distributor prepares for, protects

against, and handles any crises that affects security or operation of any facility,

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including employee strike, flood, fire, or other natural disaster, or other local, state,

or national emergency.

(d) A procedure to ensure that any outdated prescription drugs or devices are

segregated from other prescription drugs or devices and either returned to the

manufacturer or destroyed. This procedure must include a provision for the written

documentation of the disposition of outdated prescription drugs or devices that

must be maintained for 2 years after the disposition of the outdated prescription

drugs or devices.

(e) Procedures for identifying, recording, and reporting losses or thefts of

prescription drugs or devices and for correcting errors and inaccuracies in

inventory.

(4) A wholesale distributor-broker shall establish and maintain a list of officers,

directors, managers, and other individuals who are in charge of wholesale drug

delivery and trade, including a description of their duties and a summary of their

qualifications.

(5) A wholesale distributor-broker shall maintain for not less than 7 years the

transaction history, transaction statements, and transaction information required

by section 17748e of the code, MCL 333.17748e.

(6) The records described in subrules (1) to (5), and (8) of this rule and section

of 17748e of the code, MCL 333.17748e, must be made available for inspection

and photocopying by the department, board, authorized federal, state, or local law

enforcement agency officials. The records that are maintained on-site or that are

immediately retrievable by computer or other electronic means must be readily

available for an authorized inspection during the retention period described in

subrules (5) and (7) of this rule. Records that are maintained at a central location

apart from the site must be made available for inspection within 2 working days

after a request.

(7) A wholesale distributor shall retain the records described in this rule for a

minimum of 2 years after the disposition of the prescription drugs or devices.

(8) A purchasing pharmacy using a wholesale distributor-broker to facilitate a

transaction from a pharmacy that is not licensed in this state shall request the

transaction history, transaction statement, or transaction information for the drugs

supplied.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.571 Facility requirements.

Rule 71. (1) A wholesale distributor that has physical custody or control of the

prescription drugs or devices shall satisfy all of the following facility requirements:

(a) Be of suitable size and construction to facilitate cleaning, maintenance,

and proper operations.

(b) Have storage areas that are designed to provide adequate lighting,

ventilation, temperature, sanitation, humidity, space, equipment, and security

conditions.

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(c) Have a quarantine area for the storage of prescription drugs or devices

that are outdated, damaged, deteriorated, misbranded, adulterated, or that are in

immediate or sealed secondary containers that are opened.

(d) Be maintained in a clean and orderly condition.

(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(f) Be secure from unauthorized entry by complying with all of the following:

(i) Access from outside the premises must be kept to a minimum and be well-

controlled. The outside perimeter of the premises must be well-lighted. Entry into

areas where prescription drugs or devices are held must be limited to authorized

personnel.

(ii) Be equipped with an alarm system to detect entry after hours.

(iii) Be equipped with a security system that provides protection against theft

and diversion. If appropriate, the security system must provide protection against

theft or diversion that is facilitated or hidden by tampering with computers or

electronic records.

(2) All prescription drugs or devices must be stored at temperatures and under

appropriate conditions under the label requirements pursuant to the requirements

set forth in the current edition of the USP compendium. If storage requirements

are not established for a prescription drug, the drug may be held at a controlled

room temperature to help ensure that its identity, strength, quality, and purity are

not adversely affected. Appropriate manual, electromechanical, or electronic

temperature and humidity recording equipment devices, or logs must be utilized to

document the proper storage of prescription drugs or devices.

History: 2020 AACS; 2024 AACS.

R 338.573 Examination of materials; returned, damaged and outdated

prescription drugs or devices.

Rule 73. (1) A wholesale distributor shall comply with both of the following

provisions that pertain to the examination of materials:

(a) Each outside shipping container must be visually examined upon receipt

for the identity of the prescription drug or devices and to prevent the acceptance

of contaminated prescription drugs or devices or prescription drugs or devices

otherwise unfit for distribution. The examination must be adequate to reveal

container damage that would suggest possible contamination or other damage to

the contents.

(b) Each outgoing shipment must be visually inspected for identity of the

prescription drug products and to ensure that prescription drugs or devices that

have been damaged in storage or held under conditions that are inconsistent with

USP compendium standards are not delivered.

(2) All of the following provisions apply to returned, damaged, and outdated

prescription drugs or devices:

(a) Prescription drugs or devices that are outdated, damaged, deteriorated,

misbranded, or adulterated, must be quarantined and physically separated from

other prescription drugs or devices until they are destroyed or returned to the

supplier.

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(b) Any immediate or sealed outer or sealed secondary containers of any

prescription drugs or devices that have been opened or used must be identified as

such and the drugs or devices must be quarantined and physically separated from

other prescription drugs or devices until they are either destroyed or returned to

the supplier.

(c) If the conditions under which a prescription drug has been returned cast

doubt on the drug’s safety, identity, strength, quality, or purity, then the drug must

be destroyed or returned to the supplier, unless examination, testing, or other

investigation proves that the drug meets appropriate standards of safety, identity,

strength, quality, and purity. In determining whether the conditions under which the

drug has been returned cast doubt on the drug’s safety, identity, strength, quality,

or purity, the wholesale distributor shall consider the conditions under which the

drug has been held, stored, or shipped before or during its return and the condition

of the drug and its container, carton, or labeling as a result of storage or shipping.

(3) The recordkeeping requirements of R 338.569 must be followed.

History: 2020 AACS.

R 338.575 Closing a wholesale distributor or wholesale distributor-

broker.

Rule 75. (1) A wholesale distributor that is ceasing operations shall return the

wholesale distributor license and controlled substance license, if applicable, to the

department, and provide the department with written notification of all of the

following not less than 15 days before closing:

(a) The effective date of closing.

(b) How controlled substances will be disposed.

(c) How non-controlled substances will be disposed.

(d) The location where records and prescription files will be stored.

(2) A wholesale distributor shall comply with all applicable federal

requirements for discontinuing a business that handles a controlled substance.

(3) A wholesale distributor-broker that is ceasing operations shall return the

wholesale distributor-broker license and provide the department with written

notification of the location where records will be stored not less than 15 days before

closing.

(4) Records must be maintained for the same amount of time that is required

if the wholesale distributor or wholesale distributor-broker remained open.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.577 Relicensure and renewal of wholesale distributor and

wholesale distributor-broker.

Rule 77. (1) An applicant with an expired license may apply for relicensure of

a license by submitting to the department a completed application on a form

provided by the department, satisfying all the requirements for licensure in part 5

of these rules, R 338.563 to R 338.577, and paying the requisite fee.

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(2) An applicant that renews its license during the license renewal period shall

submit to the department a completed application on a form provided by the

department together with the requisite fee.

(3) A wholesale distributor-broker seeking renewal shall submit an affidavit, at

the time of the application for renewal that the applicant facilitates deliveries or

trades for not less than 50 qualified pharmacies and that each pharmacy holds a

license in good standing as a pharmacy from the state in which it is located at the

time of renewal.

History: 2022 AACS; 2024 AACS.

PART 6. PRACTICE OF PHARMACY

R 338.581 Ordering and administration of qualified immunizing agent;

training program.

Rule 81. Before ordering and administering a qualified immunizing agent

under section 17724 of the code, MCL 333.17724, a pharmacist shall successfully

complete a training course on the administration of vaccines that is provided by an

entity or course accredited by the ACPE.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.581a Ordering and administration of qualified laboratory test;

dispensing drug without prescription based on test result; training program.

Rule 81a. (1) Before ordering and administering a qualified laboratory test

and dispensing, without a prescription, a drug based on the test result, under

section 17724a of the code, MCL 333.17724a, a pharmacist shall complete a

training program requiring the pharmacist to demonstrate sufficient knowledge of

how to administer and interpret each laboratory test that the pharmacist may order

or administer under section 17724a of the code, MCL 333.17724a, and

demonstrate sufficient knowledge of each illness, condition, or disease for which

the pharmacist provides treatment based on the results of the laboratory test.

(2) Any of the following is acceptable to meet the requirements of subrule (1)

of this rule:

(a) Employer-based training.

(b) Training completed as part of a professional degree from a school of

pharmacy accredited by the ACPE.

(c) A certificate program.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.581b Pharmacist prescribing a contraceptive; board-approved

training program required.

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Rule 81b. Before issuing a prescription for a contraceptive under section

17744g of the code, MCL 333.17744g, a pharmacist shall successfully complete a

training course on prescribing and dispensing contraceptives that is provided by

an entity or course accredited by the ACPE.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.581c Prescribing and dispensing a contraceptive; standard

procedure.

Rule 81c. A pharmacist who issues a prescription for a contraceptive under

section 17744g of the code, MCL 333.17744g, shall comply with the following

standard procedure:

(a) Before issuing the prescription, the pharmacist shall comply with both of

the following:

(i) Require the patient to complete the self-screening risk assessment tool

described in R 338.581d and R 338.592. A pharmacist is prohibited from issuing

a contraceptive prescription to an individual who has not completed the self-

screening risk assessment tool.

(ii) Review the patient’s completed self-screening risk assessment tool before

issuing a prescription for contraceptive and use the pharmacist’s clinical judgment

to determine whether prescribing a contraceptive is appropriate to the patient’s

health status.

(b) Upon issuing a prescription for a contraceptive, the pharmacist shall

comply with all of the following:

(i) Refer the patient to the patient’s primary care physician, or if the patient

does not have a primary care physician, to another licensed heath professional

that the pharmacist considers appropriate.

(ii) If the patient has not had a physical examination in the previous 12

months, the pharmacist shall refer the patient to the patient’s primary care provider

for a physical examination.

(iii) Provide the patient with a written record of the prescribed contraceptive

for which the patient is issued a prescription and advise the patient to consult with

a physician or other licensed health professional. An electronic record accessible

to the patient satisfies the requirement for a written record under this paragraph.

(c) A pharmacist issuing a prescription for a contraceptive shall either:

(i) Dispense the contraceptive as soon as practicable.

(ii) Transmit the prescription to a pharmacy of the patient’s choice for

dispensing, if requested.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.581d Self-screening risk assessment tool.

Rule 81d. (1) A pharmacist is prohibited from issuing a prescription for a

contraceptive to an individual who has not completed the self-screening

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assessment tool found in Appendix A in R 338.592, or a substantially similar self-

screening assessment tool under subrule (2) of this rule.

(2) A self-screening risk assessment tool is substantially similar to the tool

found in Appendix A in R 338.592 if it requires, at a minimum, the same information

from the patient as Appendix A in R 338.592. The questions in Appendix A in R

338.592 may be reordered or reformatted. The patient may complete the self-

screening risk assessment tool electronically.

History: 2026 MR 6, Eff. March 12, 2026.

R 338.582 Prescription drug labeling and dispensing.

Rule 82. (1) All labeling of prescription drugs must comply with the

requirements of the code and sections 351 to 399f of the Federal Food, Drug, and

Cosmetic Act, 21 USC 351 to 399f.

(2) All containers in which prescription medication is dispensed must bear a

label that contains, at a minimum, all of the following information:

(a) Pharmacy name and address.

(b) Prescription number.

(c) Patient's name.

(d) Date the prescription was dispensed.

(e) Prescriber's name.

(f) Directions for use.

(g) The name of the medication and the strength, unless the prescriber

indicates "do not label."

(h) The quantity dispensed, if applicable.

(i) The name of the manufacturer or supplier of the drug if the drug has no

brand name, unless the prescriber indicates “do not label.”

(3) If a drug is dispensed that is not the brand prescribed, the pharmacy shall

notify the purchaser and the prescription label must indicate both the name of the

brand prescribed and the name of the brand dispensed. If the dispensed drug does

not have a brand name, the prescription label must indicate the name of the brand

prescribed followed by the generic name of the drug dispensed. This subrule does

not apply if the prescriber indicates "do not label."

(4) If drug product selection takes place, the brand name or the name of the

manufacturer or supplier of the drug dispensed must be noted on the prescription.

(5) This rule does not apply to pharmacy services provided in a medical

institution.

History: 2020 AACS; 2022 AACS.

R 338.583 Prescription drug receipts.

Rule 83. (1) The purchaser of a prescription drug shall receive, when the drug

is delivered to the purchaser, a receipt that contains all of the following information:

(a) The brand name of the drug dispensed, if applicable, unless the prescriber

indicates "do not label."

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(b) The name of the manufacturer or supplier of the drug if the drug has no

brand name, unless the prescriber indicates "do not label."

(c) The strength of the drug, if significant, unless the prescriber indicates "do

not label."

(d) The quantity dispensed, if applicable.

(e) The name and address of the pharmacy.

(f) The serial number of the prescription.

(g) The date the prescription was dispensed.

(h) The name of the prescriber.

(i) The name of the patient for whom the drug was prescribed.

(j) The price for which the drug was sold to the purchaser.

(2) Notwithstanding R 338.582, the information required in this rule must

appear on either the prescription label or on a combination label and receipt.

(3) For prescription services that are covered by a third-party pay contract, the

price included in the receipt is the amount paid by the patient.

(4) A pharmacist shall retain a copy of the receipt for a period of 90 days. The

inclusion of the information required in this rule in the automated data processing

system or on the written prescription form and the retention of the form constitutes

retaining a copy of the receipt. The physical presence of the prescription form in

the pharmacy or the ability to retrieve the information from the automated data

processing system constitutes compliance with the requirement of having the

name and address of the pharmacy on the form.

(5) This rule does not apply to pharmacy services provided in a medical

institution.

History: 2020 AACS; 2022 AACS; 2024 AACS; 2026 MR 6, Eff. March 12, 2026.

R 338.583a Pharmacy acquisition and distribution records.

Rule 83a. (1) A pharmacy shall keep and make available for inspection all

acquisition and distribution records for prescription drugs and devices, including

invoices, packing slips or receipts, for 5 years. All records, which may be

electronic, must be readily retrievable within 48 hours.

(2) Acquisition and distribution records must include the following information:

(a) The source of the prescription drugs or devices, including the name and

principal address of the seller or transferor and the address from which the

prescription drugs or devices were shipped.

(b) The identity and quantity of the prescription drugs or devices received, if

applicable, and distributed or disposed of.

(c) The dates of receipt, if applicable, and distribution of the prescription drugs

or devices.

History: 2022 AACS; 2024 AACS.

R 338.584 Non-controlled prescriptions.

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Rule 84. (1) A prescriber who issues a prescription for a non-controlled

prescription drug shall date the prescription; provide a manual signature on the

prescription; and ensure that the prescription contains all of the following

information:

(a) The full name of the patient for whom the drug is being prescribed.

(b) The prescriber’s preprinted, stamped, typed, or manually printed name

and address.

(c) The drug name and strength, and dosage form if necessary.

(d) The quantity prescribed.

(e) The directions for use.

(f) The number of refills authorized.

(g) The date the prescription was issued.

(h) If the prescription is for an animal, the species of the animal and the full

name of the owner.

(2) A prescriber shall ensure that a prescription is legible, and that the

information specified in subrule (1)(c) to (h) of this rule is clearly separated.

(3) A prescriber shall not prescribe more than 1 of the following on a single

prescription form as applicable:

(a) For a prescription prescribed in handwritten form, up to 4 prescription drug

orders.

(b) For a prescription prescribed on a computer-generated form or a

preprinted list or produced on a personal computer or typewriter, up to 6

prescription drug orders.

(4) A prescription is valid for 1 year after the date the prescription was issued.

(5) A pharmacy shall keep the original prescription record for 5 years. Two

years after the date of the prescription’s issue date, a pharmacy may make an

electronic duplicate of the original non-controlled paper prescription, which

becomes the original prescription. A pharmacy shall present a paper copy of the

electronic duplicate of the prescription to an authorized agent of the board on

request.

(6) This rule does not apply to pharmacy services provided in a medical

institution.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.584a Electronic transmission of prescription; waiver of electronic

transmission.

Rule 84a. (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:

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(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 as 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

338.584.

(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 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 338.584 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 shall satisfy either of the following requirements:

(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 also 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) Intention to cease practice within the next twelve months.

(B) 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.

History: 2022 AACS.

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R 338.585 Customized patient medication package.

Rule 85. (1) A pharmacist may, with the consent of the patient, the patient’s

caregiver, or a prescriber, provide a CPMP. The CPMP is designed and labeled to

indicate the day and time or period of time that the contents within each CPMP are

to be taken. The individual that dispenses the medication shall instruct the patient

or caregiver on the use of the CPMP.

(2) If medication is dispensed in a CPMP, all of the following conditions must

be met:

(a) Each CPMP must bear a readable label that states all of the following

information:

(i) A serial number for the CPMP and a separate identifying serial number

for each of the prescription orders for each of the drug products contained in the

CPMP.

(ii) The name, strength, physical description, and total quantity of each drug

product contained in the CPMP.

(iii) The name of the prescriber for each drug product.

(iv) The directions for use and cautionary statements, if any, contained in the

prescription order for each drug product in the CPMP.

(v) The date of the preparation of the CPMP.

(vi) An expiration date for the CPMP. The date must not be later than the

earliest manufacturer’s expiration date for any medication included in the CPMP

or 60 days after the date of dispensing.

(vii) The name, address, and telephone number of the dispenser.

(viii) Any other information, statements, or warnings required for any of the

drug products contained in the CPMP.

(b) A CPMP must be accompanied by any mandated patient information

required under federal law. Alternatively, required medication information may be

incorporated by the pharmacist into a single educational insert that includes

information regarding all of the medications in the CPMP.

(c) At a minimum, each CPMP must comply with the USP and National

Formulary, for moisture permeation requirements for a class b single-unit or unit-

dose container. Each container must be either non-reclosable or so designed as

to show evidence of being opened. Each CPMP must comply with all of the

provisions of the poison prevention packaging act of 1970, 15 USC 1471 to 1477.

(d) If preparing a CPMP, the dispenser shall consider any applicable

compendial requirements or guidelines, the physical and chemical compatibility of

the dosage forms placed within each container, and any therapeutic

incompatibilities that may attend the simultaneous administration of the

medications. Medications must not be dispensed in CPMP packaging in any of the

following situations:

(i) The USP monograph or official labeling requires dispensing in the original

container.

(ii) The drugs or dosage forms are incompatible with packaging components

or each other.

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(iii) The drugs are therapeutically incompatible when administered

simultaneously.

(iv) The drug products require special packaging.

(e) If 2 medications have physical characteristics that make them

indistinguishable from each other, then the medication must not be packaged

together in the same CPMP.

(f) Medications that are dispensed in CPMP packaging may not be returned

to stock or dispensed to another patient when returned to the pharmacy for any

reason. If a prescription for any drug contained in the CPMP is changed, then a

new appropriately labeled CPMP must be prepared for the patient.

(g) In addition to all individual prescription filing requirements, a record of

each CPMP dispensed must be made and filed. At a minimum, each record must

contain all of the following information:

(i) The name and address of the patient.

(ii) The serial number of the prescription order for each drug product

contained in the CPMP.

(iii) Information identifying or describing the design, characteristics, or

specifications of the CPMP sufficient to allow subsequent preparation of an

identical CPMP for the patient.

(iv) The date of preparation of the CPMP and the expiration date assigned.

(v) Any special labeling instructions.

(vi) The name or initials of the pharmacist who prepared the CPMP.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.586 Prescription records; nonapplicability to inpatient medical

institution service.

Rule 86. (1) Each prescription must be chronologically numbered, and the

pharmacist performing final verification before dispensing shall record, manually

or electronically, the prescription number, dispensing date, and the pharmacist's

initials when the prescription is first filled at the pharmacy.

(2) If final product verification is completed by a pharmacy intern under the

supervision of a pharmacist, both the initials of the pharmacy intern and the

delegating pharmacist must be recorded.

(3) If final product verification is completed by a pharmacy technician, under

R 338.3665(b), both the initials of the pharmacy technician and delegating

pharmacist must be recorded.

(4) If the drug that is dispensed is other than the brand prescribed or if the

prescription is written generically, the name of the manufacturer or supplier of the

drug dispensed must be indicated on the prescription.

(5) This rule does not apply to pharmacy services provided in a medical

institution.

History: 2020 AACS; 2022 AACS; 2024 AACS.

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R 338.587 Prescription refill records; manual systems; profile systems;

automated pharmacy data systems; nonapplicability to medical institution

service; record confidentiality; and access.

Rule 87. (1) A pharmacist shall record prescription refills using only 1 of the

systems described in subrule (2), (3), or (4) of this rule and in compliance with the

provisions of subrule (2), (3), or (4) of this rule, as applicable.

(2) A pharmacy may utilize a manual system of recording refills if the system

complies with both of the following criteria:

(a) The amount and date dispensed must be entered on the prescription in

an orderly fashion and the dispensing pharmacist initials the entry. If the

pharmacist only initials and dates the prescription, then the full-face amount of the

prescription must be considered dispensed.

(b) If the drug that is dispensed is other than the brand prescribed or if the

prescription is written generically, then the name of the manufacturer or supplier

of the drug dispensed must be indicated on the prescription.

(3) A pharmacy may utilize a uniform system of recording refills if the system

complies with all of the following criteria:

(a) Records must be created and maintained in written form. All original and

refill prescription information for a particular prescription appears on single

documents in an organized format. The records are subject to inspection by the

board or its agents.

(b) The following information for each prescription must be entered on the

record:

(i) The prescription number.

(ii) The patient's name and address.

(iii) The prescriber's name.

(iv) The prescriber's DEA number, if appropriate.

(v) The number of refills authorized.

(vi) The "dispense as written" instructions, if indicated.

(vii) The name, strength, dosage form, quantity, and name of the

manufacturer of the drug prescribed, and the drug dispensed originally and after

each refill. If the drug dispensed is other than the brand prescribed or if the

prescription is written generically, then the name of the manufacturer or supplier

of the drug dispensed must be indicated.

(viii) The date of issuance of the prescription.

(ix) The date and identifying designation of the dispensing pharmacist for the

original filling and for each refill. If a pharmacy technician performs final product

verification, the identification of the delegating pharmacist and pharmacy

technician must be recorded.

(c) Prescription entries must be made on the record when the prescription is

first filled and at each refill, except that the format of the record may be organized

so that information already entered on the record may appear for a prescription or

refill without reentering the information. The dispensing pharmacist is responsible

for the completeness and accuracy of the entries and shall initial the record each

time a prescription is filled or refilled.

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(d) The information required by subdivision (b) of this subrule must be entered

on the record for all prescriptions filled at a pharmacy, including nonrefillable

prescriptions. This requirement is in addition to the requirements set forth in R

338.586.

(4) A pharmacy may utilize a uniform automated data processing system of

recording refills if the system complies with all of the following criteria:

(a) All information that is pertinent to a prescription must be entered on the

record, including all of the following information:

(i) The prescription number.

(ii) The patient's name and address.

(iii) The prescriber's name.

(iv) The prescriber's DEA number, if appropriate.

(v) The number of refills authorized.

(vi) Whether the drug must be dispensed as written.

(vii) The name, strength, dosage form, quantity, and name of the

manufacturer of the drug prescribed and the drug dispensed originally and after

each refill. If the drug dispensed is other than the brand prescribed or if the

prescription is written generically, then the name of the manufacturer or supplier

of the drug dispensed must be indicated.

(viii) The date of issuance of the prescription.

(ix) The date and identifying designation of the dispensing pharmacist for the

original filling and for each refill. If a pharmacy technician performs final product

verification, the identification of the delegating pharmacist and pharmacy

technician must be recorded.

(b) Prescription entries must be made on the record when the prescription is

first filled and at each refill, except that the format of the record may be organized

so that information already entered on the record may appear for a prescription or

refill without reentering the information. The dispensing pharmacist is responsible

for the completeness and accuracy of the entries. A pharmacy shall keep the

original prescription record on site for 5 years. Two years after the date of the

prescription’s issue date, a pharmacy may make an electronic duplicate of the

original non-controlled paper prescription, which becomes the original prescription.

The records are subject to inspection by the board or its agents. A procedure must

be established to facilitate inspections.

(c) The required information must be entered on the record for all

prescriptions filled at the pharmacy, including nonrefillable prescriptions. This

requirement is in addition to the requirements set forth in R 338.586.

(d) The recording system must provide adequate safeguards against

improper manipulation, the alteration of records, and the loss of records.

(e) The recording system must have the capability of producing a printout of

all original and refilled prescription data, including a prescription-by-prescription

and refill-by-refill audit trail for any specified strength and dosage form of a

controlled substance by either brand or generic name or an audit trail of controlled

substance prescriptions written for a particular patient or by a particular

practitioner. A printout of an audit trail or other required information must be made

available to an authorized agent of the board on request. The prescription data

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must be maintained for 5 years. Data older than 2 years must be provided within

72 hours of the time the request is first made by the agent. Prescription data for

the most current 2 years must be readily retrievable on site and available for

immediate review.

(f) If the automated data processing system is inoperative for any reason,

then the pharmacist shall ensure that all refills are authorized and that the

maximum number of refills is not exceeded. When the automated data processing

system is restored to operation, the pharmacist shall enter the information

regarding prescriptions filled and refilled during the inoperative period into the

automated data processing system within 48 hours.

(g) A pharmacy shall make arrangements with the supplier of data processing

services or materials to ensure that the pharmacy continues to have adequate and

complete prescription and dispensing records if the relationship with the supplier

terminates for any reason. A pharmacy shall ensure continuity in the maintenance

of records.

(h) The automated data processing system must be an integrated system that

complies with all of the requirements of these rules.

(5) This rule does not apply to pharmacy services provided in a medical

institution.

(6) Records that are created under subrule (2), (3), or (4) of this rule are

subject to the same requirements regarding confidentiality and access that apply

to original prescriptions.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.588 Automated devices.

Rule 88. (1) “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.

(2) An automated device may be used only in the following locations:

(a) A pharmacy, or at the same physical address as the pharmacy if the

location of the automated device is owned and operated by the same legal entity

as the pharmacy.

(b) A hospital.

(c) A county medical care facility.

(d) A hospice.

(e) A nursing home.

(f) Other skilled nursing facility, as that term is defined in section 20109 of the

code, MCL 333.20109.

(g) An office of a dispensing prescriber, where the device is operated by the

dispensing prescriber, not a pharmacy.

(h) A location affiliated with a hospital, but not at the same physical address

as the pharmacy, which is owned and operated by the hospital, consistent with

section 17760 of the code, MCL 333.17760.

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(i) A location other than subdivisions (a) to (h) of this subrule, where the

automated device acts as an extension of a pharmacy. In addition to the

requirements in this rule, the automated device must meet the requirements in R

338.588a.

(3) Records and electronic data maintained by automated devices must meet

all of the following requirements:

(a) All events involving access to the contents of the automated devices must

be recorded electronically.

(b) Records must be maintained for 5 years by the pharmacy or dispensing

prescriber and must be retrievable on demand for review by an agent of the board.

The records must include all of the following information:

(i) The unique identifier of the automated device accessed.

(ii) Identification of the individual accessing the automated device.

(iii) The type of transaction.

(iv) The name, strength, dosage form, quantity, and name of the

manufacturer of the drug accessed.

(v) The name of the patient for whom the drug was ordered.

(vi) Identification of the pharmacist responsible for the accuracy of the

medications to be stocked or restocked in the automated device.

(4) Except for devices allowed under R 388.588a(2), policy and procedures

for the use of the automated device must include a requirement for pharmacist

review of the prescription or medication order before removal of any medication.

This subrule does not apply to the following situations:

(a) The system is being used as an after-hours cabinet for medication

dispensing in the absence of a pharmacist as provided in R 338.486(4)(j). A

pharmacist shall review the orders and authorize any further dispensing within 48

hours.

(b) The system is being used in place of an emergency kit as provided in R

338.486(4)(c). A pharmacist shall review the orders and authorize any further

dispensing within 48 hours.

(c) The system is being accessed to remove medication required to treat the

emergent needs of a patient as provided in 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. A pharmacist shall review the orders and

authorize any further dispensing within 48 hours.

(d) The automated device is located in a dispensing prescriber's office to

facilitate dispensing by the dispensing prescriber.

(5) A copy of all policies and procedures related to the use of an automated

device must be maintained at the pharmacy responsible for the device's specific

location or at the dispensing prescriber's office and be available for review by an

agent of the board.

History: 2020 AACS; 2022 AACS; 2024 AACS.

R 338.588a Automated devices in non-inpatient settings.

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Rule 88a. (1) A pharmacy that operates an automated device to deliver

prescription medication directly to an ultimate user that is not included in R

338.588(2)(a) to (h) shall comply with all of the following requirements:

(a) The automated device may only deliver non-controlled drugs.

(b) The automated device is operated as an extension of a pharmacy, under

the control of a pharmacist.

(c) The automated device is secured, lockable, and privacy enabled.

(d) Prescriptions must contain a label that identifies the automated device

where the medication was dispensed.

(e) In order for the automated device to be operable, a pharmacist shall be

available to provide patient consultation through real-time audio and visual

communication. The pharmacist may provide consultation from a remote location.

(f) Before the automated device is put into service, the pharmacy shall notify

the department of the location of the automated device on a form provided by the

department.

(g) Dispensing activities through the automated device must comply with all

recordkeeping, drug utilization review, and patient counseling requirements that

are applicable to a pharmacy.

(2) A pharmacy licensee may locate a non-dispensing storage and pick up

device inside of the pharmacy that is used for a patient or agent of the patient to

pick up prescription medication if the automated device is secured, lockable, and

privacy enabled.

(3) If an automated device is used in a dispensing prescriber's office, and the

automated device is not affiliated with a pharmacy, the device must be used only

to dispense medications to the dispensing prescriber's patients and only under the

control of the dispensing prescriber. All of the following apply to the use of an

automated device in a dispensing prescriber's office:

(a) If a dispensing prescriber 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 a board-approved error

prevention technology that complies with R 338.3154.

(b) A dispensing prescriber operating an automated device is responsible for

all medications that are stocked and stored in that device, as well as removed from

that device.

(c) If any medication or device is dispensed from an automated device in a

dispensing prescriber’s office, then documentation as to the type of equipment,

serial numbers, content, policies, procedures, and location within the facility must

be maintained by the dispensing prescriber for review by an agent of the board.

This documentation must include all of the following information:

(i) Manufacturer name and model.

(ii) Quality assurance policy and procedure to determine continued

appropriate use and performance of the automated device.

(iii) Policy and procedures for system operation that addresses, at a

minimum, all of the following:

(A) Accuracy.

(B) Patient confidentiality.

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(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

History: 2024 AACS.

R 338.588b Automated devices in medical institutions.

Rule 88b. (1) An automated device used by staff to store medications intended

for patient administration in any hospital, county medical care facility, nursing

home, hospice, or another skilled nursing facility, as that term is defined in section

20109 of the code, MCL 333.20109, must comply with all of the following:

(a) The automated device must be stocked, maintained, and controlled by a

pharmacy that is licensed in this state.

(b) If the stocking of the automated device is performed by non-pharmacist

personnel, 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 board-approved error-prevention technology that complies with R

338.3154.

(c) A pharmacy operating an automated device is responsible for all

medications that are stocked and stored in that device, as well as removed from

that device.

(d) If any medication or device is dispensed from an automated device, then

documentation as to the type of equipment, serial numbers, content, policies,

procedures, and location within the facility must be maintained by the pharmacy

for review by an agent of the board. The documentation must include all of the

following information:

(i) Name and address of the pharmacy responsible for the operation of the

automated device.

(ii) Name and address of the facility where the automated device is located.

(iii) Manufacturer name and model number.

(iv) Quality assurance policy and procedure to determine continued

appropriate use and performance of the automated device.

(v) Policy and procedures for system operation that address, at a minimum,

all of the following:

(A) Accuracy.

(B) Patient confidentiality.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

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(I) Ability to provide on demand to an agent of the board a list of medications

qualifying for emergency dose removal without pharmacist prior review of the

prescription or medication order.

(2) An automated device that is operated at a location affiliated with a hospital,

but not at the same physical address as the pharmacy, which is owned and

operated by the hospital, must comply with section 17760 of the code, MCL

333.17760.

History: 2024 AACS.

R 338.589 Professional responsibility; patient counseling; “caregiver”

defined.

Rule 89. (1) A pharmacist has a professional responsibility for the strength,

quality, purity, and the labeling of all drugs and devices dispensed under a

prescription. In discharging this responsibility, a pharmacist shall utilize only those

drugs and devices that are obtained from manufacturers and wholesale distributors

licensed under section 17748 of the code, MCL 333.17748, or from other lawful

channels of distribution.

(2) A pharmacist shall not fill a prescription order if, in the pharmacist’s

professional judgment, any of the following provisions apply:

(a) The prescription appears to be improperly written.

(b) The prescription is susceptible to more than 1 interpretation.

(c)The pharmacist has reason to believe that the prescription could cause

harm to the patient.

(d) The pharmacist has reason to believe that the prescription may be used

for other than legitimate medical purposes.

(3) A prescription drug must be dispensed only when the pharmacy is open

and under the personal charge of a pharmacist.

(4) To encourage intended, positive patient outcomes, a pharmacist shall

communicate to the patient, or the patient’s caregiver, necessary and appropriate

information regarding safe and effective medication use when a prescription is

dispensed. As used in this subrule, “caregiver” means the parent, guardian, or

other individual who has assumed responsibility for providing a patient’s care. All

of the following provisions apply to communicating medication safety and

effectiveness information:

(a) The information must be communicated orally and in person, except when

the patient or patient’s caregiver is not at the pharmacy or when a specific

communication barrier prohibits oral communication. In either situation, providing

printed or electronic/digital material designed to help the patient use the medication

safely and effectively satisfies the requirements of this subrule.

(b) The information must be provided with each prescription for a drug not

previously prescribed for the patient.

(c) If the pharmacist determines it appropriate, the information must be

provided with prescription refills.

(d) The information must be provided if requested by the patient or patient’s

caregiver or agent for any prescription dispensed by the pharmacy. This subrule

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does not require that a pharmacist provide consultation if a patient or a patient’s

caregiver refuses consultation. This subrule does not apply to prescriptions

dispensed for administration to a patient while the patient is in a medical institution.

(5) Pharmacist delegation of acts, tasks, or functions must comply with section

16215 of the code, MCL 333.16215, and be under the personal charge of the

delegating pharmacist, except as provided in section 17742b of the code, MCL

333.17742b, R 338.486, and R 338.3665(c). A pharmacist that delegates acts,

tasks, or functions to a licensed or unlicensed individual shall do all of the

following:

(a) Determine the knowledge and skill required to safely and competently

complete the specific act, task, or function to be delegated.

(b) Before delegating an act, task, or function, determine whether the

delegate has the necessary knowledge and skills to safely and competently

complete the act, task, or function.

(c) Provide written procedures or protocols, or both, to be followed by the

delegatee in the performance of the delegated act, task, or function.

(d) Supervise and evaluate the performance of the delegatee.

(e) Provide remediation of the performance of the delegatee, if indicated.

(6) A delegating pharmacist bears the ultimate responsibility for the

performance of delegated acts, tasks, and functions performed by the delegatee

within the scope of the delegation.

(7) A pharmacist may remotely access a pharmacy database as well as any

other necessary databases that are routinely accessed to perform their functions.

In accessing any database, a pharmacist shall provide adequate security to protect

the confidentiality and integrity of a patient’s protected health information.

History: 2020 AACS; 2024 AACS.

R 338.590 Hospice emergency drug box.

Rule 90. (1) A pharmacy that establishes a medication box exchange program

for hospice emergency care services rendered in patients' homes under section

17746 of the code, MCL 333.17746, shall establish drug boxes that comply with

this rule. Before providing drug boxes for a hospice emergency care system, the

pharmacist in charge shall ensure that the hospice has developed policies and

procedures that require all of the following:

(a) Maintenance by the hospice of a drug box exchange log that accounts for

the hospice's receipt of the boxes from the pharmacy, assignment of the boxes to

registered nurses or physicians' assistants, and return of the boxes to the

pharmacy for restocking.

(b) A procedure to ensure that the drug boxes are inspected not less than

weekly to determine if they have expired or have been opened.

(c) Procedures for the storage and control of a drug box while it is assigned

to, and being used by, the prescriber, a registered nurse, or a physician's assistant.

(d) A procedure for implementing the hospice medical director's responsibility

for ensuring that prescriptions for drugs removed from the drug boxes are obtained

from an appropriate prescriber.

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(2) A pharmacy shall stock drug boxes for a hospice emergency care system

in accordance with the policies and procedures developed by the hospice and

approved by the hospice medical director.

(3) The drugs contained in each drug box must be listed inside the front cover

of the box. Each box must be equipped with only 1 nonreusable, tamper-evident

seal or sealing system that is a color that designates that the box has not been

opened and several nonreusable, tamper-evident seals or sealing systems that

are a different color that designates that the box has been opened.

(4) A drug box must be numbered. A permanent record of all drug boxes must

be maintained at the pharmacy.

(5) A label that contains all of the following information must be attached to

the drug box so that it is visible from the outside of the box:

(a) The name and address of the pharmacy.

(b) The name and address of the hospice.

(c) The name of the pharmacist who last inspected and restocked the drug

box.

(d) The date the drug box was last restocked.

(e) The date the drug box must be returned to the pharmacy for the

replacement of expired drugs.

(f) The number of the drug box.

(6) After the drug box has been stocked and labeled, the pharmacist shall seal

it with the nonreusable, tamper-evident seal or sealing system that is the color that

designates that the box has not been opened.

(7) A drug box must be maintained in a substantially constructed, securely

locked storage compartment when not under the direct control of the pharmacist,

prescriber, registered nurse, or physician’s assistant. The box must be stored

under conditions that maintain the stability, integrity, and effectiveness of the

drugs. Access to the storage compartment and to the drug box must be limited to

individuals who are authorized to stock the drug box or to dispense drugs from the

drug box on the order of an appropriate prescriber.

(8) The drug box must remain sealed at all times, except when in use. All

drugs removed from the box must be recorded on a medication use form. After

completing the form, the physician, registered nurse, or physician's assistant who

removed the drug must place the form in the drug box and seal the box with a

nonreusable, tamper-evident seal or sealing system that is a color that designates

that the box has been opened.

(9) Each drug box under the control of the pharmacy must be examined not

less than weekly to ensure that the seal, which designates that the box has not

been opened is still intact and the expiration date, has not been exceeded. If the

expiration date has been exceeded or the box has been opened, the box must be

returned to the pharmacy. The written prescription for all drugs that have been

administered from the drug box must accompany the drug box when it is returned

to the pharmacy after opening.

(10) The pharmacy shall maintain a permanent record of drug box exchanges

on a drug box exchange log. The record must contain all of the following

information:

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(a) The number of the box.

(b) The name of the hospice to which the box is released.

(c) The date the box is released to the hospice.

(d) The name and signature of the pharmacist who releases the box to the

hospice.

(e) The expiration date assigned.

(f) The date the box is returned to the pharmacy for restocking.

(g) The name and signature of the pharmacist who received the box for

restocking.

(11) On the return of the drug box to the pharmacy, the pharmacist shall

reconcile the drugs dispensed from the drug box with the prescriptions of the

appropriate prescriber or medical director of the hospice. The pharmacist shall

note that the prescriptions were dispensed from the hospice drug box on the back

of the prescriptions. The prescriptions must be filed in the same manner as other

prescriptions are maintained at the pharmacy.

History: 2020 AACS; 2024 AACS.

R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an

individual if the pharmacist complies with all of the following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensed from a pharmacy

with real time access to the qualified prescription for insulin.

(c) Only 1 emergency supply, as that term is defined in MCL 333.17744f, per

patient, may be dispensed for each of 3 qualified prescriptions per year.

(2) If the smallest single package of insulin available exceeds a 30-day

supply, dispensing the package of insulin that is available complies with this rule

and section 17744f of the code, MCL 333.17744f.

History: 2024 AACS.

R 338.592 Appendix A; self-screening risk assessment tool questions.

Rule 92. Appendix A – Self-screening risk assessment tool questions.

1. Do you smoke cigarettes or e-cigarettes?

2. Do you think you might be pregnant now?

2a. Start date of last period: ______.

3. Are you experiencing any of the following:

Nausea/vomiting.

Tender/swollen breasts.

Increased urination.

Fatigue.

None apply.

4. Which of the following are true for you?

I have been using a reliable contraceptive method consistently and correctly.

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I have not had sexual intercourse since my last period or delivery.

I have given birth in the last 6 weeks.

I have lost a pregnancy in the last 7 days.

I have been fully or nearly-fully breastfeeding for 6 months or less AND not had

a menstrual period since delivery.

None of these apply to me.

5. Please select all that apply to you:

Used birth control (pills/patch/ring/shot/injection) in the past.

Currently using birth control (pills/patch/ring/shot/injection).

Drug name:

Have had a bad reaction to hormonal birth control in the past.

Drug name:

Reaction:

None of these apply to me.

6. Please select all that you have been diagnosed with in the past or that apply

to you currently:

Breast cancer.

Ischemic heart disease.

Heart attack or stroke.

Severe/decompensated liver cirrhosis.

Malignant liver tumor.

Hepatocellular adenoma.

Chronic kidney disease.

On dialysis.

Unexplained vaginal bleeding.

Complicated organ transplant.

Blood clot in lung or leg.

High cholesterol.

Hepatitis.

Blood disorder.

Gall bladder disease.

Inflammatory bowel disease (Crohn’s, UC).

Jaundice (yellowing of skin/eyes).

Upcoming major surgery in next 4 weeks.

Lupus.

High blood pressure.

Other heart or valve disease.

Bariatric or stomach reduction surgery.

Sickle cell disease.

None apply.

7. Have you ever been told by a medical professional not to take hormones?

8. Have you ever been told by a medical professional you are at risk of

developing a blood clot?

9. Do you take medication for seizures, tuberculosis (TB), fungal infections, or

HIV?

9a. If yes, list them here: _______

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10. Do you have any conditions or upcoming procedures that will cause you to

be immobile for a prolonged period of time? (e.g., recent/upcoming surgery,

multiple sclerosis, etc.)

11. Do you get migraine headaches or headaches so bad that you feel sick to

your stomach, you lose the ability to see, it makes it hard to be in light, or involves

numbness?

11a. If yes, do these headaches ever start with flashes of light, blind spots, or

tingling in your hand or face that come and go away completely before the

headache starts?

12. Do you have diabetes or other vascular disease other than Gestational

Diabetes?

12a. Due to diabetes I have:

Nerve pain or tingling.

Pain, numbness, or weakness in hands or feet.

Kidney damage.

Vision or eye damage.

None apply.

13. Have you ever been diagnosed with rheumatoid arthritis?

14. Do you have any other medical problems or take regular medications?

14a. If yes, list them here:____

15. Do you have any drug allergies?

15a. If yes, list them here:

History: 2026 MR 6, Eff. March 12, 2026.

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