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, 16204,

16205, 16215, 16287, 17707, 17721, 17722, 17731, 17737, 17739, 17742a, 17742b,

17744f, 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, 333.16204,

333.16205, 333.16215, 333.16287, 333.17707, 333.17721, 333.17722, 333.17731,

333.17737, 333.17739, 333.17742a, 333.17742b, 333.17744f, 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R 338.471 Rescinded.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R 338.471a Rescinded.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R 338.471b Rescinded.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R 338.472 Rescinded.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R 338.473 Rescinded.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R 338.473a Rescinded.

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

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R 338.473b Rescinded.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R 338.473c Rescinded.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R 338.473d Rescinded.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R 338.474 Rescinded.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R 338.474a Rescinded.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R 338.475 Rescinded.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R 338.476 Rescinded.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R 338.477 Rescinded.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R 338.477a Rescinded.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.

R 338.477b Rescinded.

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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R 338.477c Rescinded.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R 338.477d Rescinded.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R 338.478 Rescinded.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.

R 338.481 Rescinded.

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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.

(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:

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(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.

(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.

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(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 MR 5, Eff. Feb.

29, 2024.

R 338.487 Rescinded.

History: 1979 AC.

R 338.488 Rescinded.

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

R 338.489 Rescinded.

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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.

R 338.493f Rescinded.

History: 1979 AC; 1980 AACS; 2020 AACS.

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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 Accreditation Council for Pharmacy Education.

(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.

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

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

forms.

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

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

(j) “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.

(k) “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.

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

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

(n) “FPGEC” means the Foreign Pharmacy Graduate Examination Committee.

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

(p) “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.

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

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

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

(t) “PIC” means pharmacist in charge.

(u) “Practical experience” means professional and clinical instruction in, but not

limited to, all of the following areas:

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(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.

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

(w) “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.

(x) “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 MR 5, Eff. Feb. 29, 2024.

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.

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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 MR 5, Eff. Feb. 29, 2024.

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.

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

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

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(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-

review 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-review journal, healthcare journal, or professional or

scientific journal, and the date, volume, and issue of publication as applicable.

History: 2020 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

R 338.513 Educational limited license; application and renewal; practices.

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.

(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 his

or her 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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

History: 2020 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

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:

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(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 MR 5, Eff. Feb. 29, 2024.

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.

History: 2020 AACS; 2022 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

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.

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(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 one 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 that 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 a 1-time 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 that 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 MR 5, Eff. Feb. 29, 2024.

R 338.523 Pharmacist license by endorsement; requirements.

Rule 23. (1) An applicant that 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 that meets the requirements of this

rule, R 338.7001 to R 338.7005, and 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.

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(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 that 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

his or her 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 a 1-time training in opioids and other controlled

substances awareness as required in R 338.3135.

(2) An applicant that 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 MR 5, Eff. Feb. 29, 2024.

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 333.16201 and

333.17733, as applicable, may be relicensed by complying with the following

requirements as noted by (x):

For a pharmacist who has let his or her

license lapse in this state and is not

currently licensed in another state or a

province of Canada:

(a) Submit to the department a

completed application on a form

provided by the department with the

requisite fee.

License lapsed 0- License lapsed

License lapsed 8

or more years.

3 years.

more than 3

years, but less

than 8 years.

X

(b) Establish that the applicant is of

good moral character as that term is

X

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defined in, and determined under, 1974

PA 381, MCL 338.41 to MCL 338.47.

(c) Submit fingerprints as required under

section 16174(3) of the code, MCL

333.16174.

(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

X

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) Provide an attestation to the

X

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, a 1-

time training in opioids and other

controlled substances awareness as

required in R 338.3135, and implicit 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 relicensure,

as provided in R 338.519.

X

(j) An applicant that is or has ever been

X

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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.

(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.

(4) For a pharmacist who has let his or

License lapsed

her pharmacist license lapse in this state, License lapsed 0-3

License lapsed 8 or

more years.

more than 3 years,

but less than 8

years.

but who holds a current and valid

pharmacist license in good standing in

another state or a Canadian province:

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

X

application to complete the deficient

hours. The application must be held and

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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, a 1-

time training in opioids and other

controlled substances awareness as

required in R 338.3135, and implicit bias

training as required in R 338.7004.

(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.

X

(g) An applicant that 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

X

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 MR 5, Eff. Feb. 29, 2024.

PART 3. PHARMACY LICENSES

R 338.531

Pharmacy license; remote pharmacy license; applications;

requirements.

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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 his or her duties for 120 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 MR 5, Eff. Feb. 29, 2024.

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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, on a form provided by 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.

(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 the statement of 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 or the availability of 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 MR 5, Eff. Feb. 29, 2024.

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.

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(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 MR 5, Eff. Feb. 29, 2024.

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) and 797 (revised 2023), with the exception of flavoring.

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

cost of $250.00 at http://www.usp.org/compounding , or can be viewed 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 shall comply with the standards

adopted in subrule (1) of this rule.

(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 practices for finished pharmaceuticals set

forth in 21 CFR 211.1 to 211.208.

(6) An outsourcing facility 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 practices for finished

pharmaceuticals set forth in 21 CFR 211.1 to 211.208.

(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.

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(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 MR 5, Eff. Feb. 29, 2024.

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

licensure renewal inspection.

pharmacy

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 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 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.

History: 2020 AACS; 2022 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

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 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.

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(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 will end 6 months after initial

licensure if a subsequent inspection to assess USP compliance or accreditation is not

successful.

History: 2024 MR 5, Eff. Feb. 29, 2024.

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 MR 5, Eff. Feb. 29, 2024.

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

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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 MR 5, Eff. Feb. 29, 2024.

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 MR 5, Eff. Feb. 29, 2024.

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 MR 5, Eff. Feb. 29, 2024.

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 fulfil his or her 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.

(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.

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(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 who 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 MR 5, Eff. Feb. 29, 2024.

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 and as amended

good manufacturing practice for finished pharmaceuticals regulations set forth in 21 CFR

211.1 to 211.208 (2022).

(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 at no

cost

at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=21

1 , or at 10 cents per page from the Board of Pharmacy, Bureau of Professional Licensing,

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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 MR 5, Eff. Feb. 29, 2024.

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 MR 5, Eff. Feb. 29, 2024.

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 MR 5, Eff. Feb. 29, 2024.

PART 5. WHOLESALE DISTRIBUTOR AND

WHOLESALE DISTRIBUTOR-BROKER LICENSE

R 338.561 Pharmacy as wholesale distributor; licensure.

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).

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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 fulfil his or her 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.

(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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

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.

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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, 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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

(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 MR 5, Eff. Feb. 29, 2024.

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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.

(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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

(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 MR 5, Eff. Feb. 29, 2024.

PART 6. PRACTICE OF PHARMACY

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.

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(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."

(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 prescribed 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 MR 5, Eff. Feb. 29, 2024.

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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 MR 5, Eff. Feb. 29, 2024.

R 338.584 Non-controlled prescriptions.

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.

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History: 2020 AACS; 2022 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

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:

(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.

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(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.

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

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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.

(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 MR 5, Eff. Feb. 29, 2024.

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.

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History: 2020 AACS; 2022 AACS; 2024 MR 5, Eff. Feb. 29, 2024.

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 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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

(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.

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(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 MR 5, Eff. Feb. 29, 2024.

R 338.588a Automated devices in non-inpatient settings.

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.

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(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.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

History: 2024 MR 5, Eff. Feb. 29, 2024.

R 338.588b Automated devices in medical institutions.

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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.

(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 MR 5, Eff. Feb. 29, 2024.

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

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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 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.

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(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 MR 5, Eff. Feb. 29, 2024.

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.

(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.

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(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:

(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 MR 5, Eff. Feb. 29, 2024.

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.

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(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 MR 5, Eff. Feb. 29, 2024.

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