DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS

DIRECTOR'S OFFICE

PHARMACY - GENERAL RULES

Filed with the secretary of state on February 29, 2024

These rules become effective immediately after filing with the secretary of state

unless adopted under section 33, 44, or 45a(9) of the administrative procedures act of

1969, 1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these

sections become effective 7 days after filing with the secretary of state.

(By authority conferred on the 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 338.486, R 338.501, R 338.505, R 338.511, R 338.513, R 338.515, R 338.517,

R 338.519, R 338.521, R 338.523, R 338.525, R 338.531, R 338.531a, R 338.532,

R 338.533, R 338.534, R 338.535, R 338.536, R 338.537, R 338.538, R 338.551,

R 338.555, R 338.557, R 338.559, R 338.563, R 338.569, R 338.571, R 338.575,

R 338.577, R 338.583, R 338.583a, R 338.584, R 338.585, R 338.586, R 338.587,

R 338.588, R 338.589, and R 338.590 of the Michigan Administrative Code are

amended, and R 338.534a, R 338.588a, R 338.588b, and R 338.591 are added, as

follows:

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.

October 25, 2023

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(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:

(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.

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(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.

(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.

PART 1. GENERAL PROVISIONS

R 338.501 Definitions.

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

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

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

has candidate status by the ACPE.

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

code, MCL 333.17721.

(d) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.

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

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

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

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

treatment of patients within the course of the prescriber's professional practice.

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

routine, regularly observed prescription, or medical or dental order patterns.

(iv) For the purpose of or incidental to research, teaching, or chemical analysis and not

for the purpose of sale or dispensing.

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

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

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

product.

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

directions contained in approved labeling provided by the manufacturer of a

commercially available product.

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

(iv) Flavoring agents added to conventionally manufactured and commercially

available liquid medications. Flavoring agents must be nonallergenic and inert, not

exceeding 5% of a drug product’s total volume.

(g) “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.

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(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:

(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.

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.

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(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.

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.

(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.

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

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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.

(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.

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.

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(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.

R 338.517 Preceptor license and responsibilities.

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

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

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

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

the past year.

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

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

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

at the same time. The approved preceptor is responsible for the overall internship

program at the pharmacy.

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

338.501(1)(u) and develop a training program where the intern can improve the intern's

skill in these areas.

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

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

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

submit to the department a training affidavit that includes the number of internship hours

completed by the intern in the practice of pharmacy.

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.

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(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.

R 338.521 Pharmacist licensure by examination.

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

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

requisite fee.

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

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

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

(a) Obtain 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.

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.

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

meets all of the following:

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

Examining Board of Canada Pharmacists Qualifying Examination.

(B) The applicant completed educational requirements for a pharmacist license from a

school of pharmacy accredited by the ACPE or accredited by the Canadian Council for

Accreditation of Pharmacy Programs.

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

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

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

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

of the code and the board’s rules to competently practice pharmacy in this state.

(c) An applicant 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.

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.

X

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.

(i) Retake and pass the NAPLEX within

2 years before applying for relicensure,

as provided in R 338.519.

X

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(j) 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:

X

(i) Disclose each license, registration, or

certification on the application form.

(ii) Satisfy the requirements of section

16174(2) of the code, MCL 333.16174,

including verification from the issuing

entity showing that disciplinary

proceedings are not pending against the

applicant and sanctions are not in force

at the time of application.

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

renewable limited license to complete the practical experience.

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

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

experience on a form provided by the department.

(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

13

hours. The application must be held and

the license may not be issued until the

continuing education requirements are

met.

(e) Submit proof of completing a 1-time

training in identifying victims of human

trafficking as required in R 338.511, 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.

PART 3. PHARMACY LICENSES

R 338.531 Pharmacy license; remote pharmacy license; applications; requirements.

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

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

together with the requisite fee.

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

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

copies of assumed name certificates, if applicable.

14

(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.

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:

15

(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.

R 338.532 Sterile compounding accrediting organizations; board

approval; inspection entities.

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

333.17748a, accrediting organizations or inspection entities for pharmacies that

compound pharmaceuticals according to standards adopted by reference in R 338.533.

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

subrule (1) of this rule.

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

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

(a) Requirements for accreditation or compliance.

(b) Requirements for inspectors.

(c) Training provided to inspectors.

(d) Copy of the most current inspection form.

(e) The length of accreditation.

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

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

approval. The organization may submit a petition that complies with subrule (3) of this

rule to seek continuing approval.

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

will not immediately affect the compliance of a pharmacy using the accreditation. Within

12 months after the rescission date or by the next licensure renewal date, whichever is

later, the accreditation is void, and a pharmacy shall obtain accreditation or an inspection

from an organization that satisfies subrule (1) of this rule.

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

16

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.

(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.

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

17

pharmacy licensure renewal inspection.

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

state as a pharmacy that will not ship compounded sterile pharmaceutical 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.

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.

(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.

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.

18

(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).

R 338.536 Housing of a pharmacy.

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

drugs must be housed in a suitable, well-lighted, and well-ventilated room or department

with clean and sanitary surroundings.

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

practice of pharmacy that occupies not less than 150 square feet of space, and that

includes a prescription counter that provides not less than 10 square feet of free working

surface. For each additional pharmacist on duty at any 1 time, the free working space

must be increased by not less than 4 square feet. The prescription counter must be orderly

and clean. The space behind the prescription counter must be sufficient to allow free

movement within the area and must be free of obstacles.

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

of the premises owned, leased, used, or controlled by the licensee shall be permanently

enclosed by partitions from the floor to the ceiling. All partitions must be of substantial

construction and must be securely lockable so that drugs and devices that can be sold

only by a pharmacist are unobtainable during the absence of the pharmacist. Only the

area of the premises owned, leased, used, or controlled by the licensee may be identified

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

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

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

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.

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:

19

(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.

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.

20

(E) Knowledge and understanding of pharmaceutical terminology, abbreviations,

dosages, and format.

(iii) Experience equal to either of the following:

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

of prescription drugs or devices where the responsibilities included, but were not limited

to, recordkeeping.

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

(iv) Employment with the applicant.

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

manufacturer of biologicals.

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

that is dated not more than 2 years before application or current NABP drug distributor

accreditation.

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

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

another country, shall do both of the following:

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

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

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

application.

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

are manufactured.

(4) A manufacturer 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.

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,

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

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

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.

21

(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.

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.

PART 5. WHOLESALE DISTRIBUTOR AND

WHOLESALE DISTRIBUTOR-BROKER LICENSE

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:

22

(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.

(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.

R 338.569 Wholesale distributor and wholesale distributor-broker recordkeeping and

policy requirements.

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

of transactions regarding the receipt, if applicable, and the distribution or other

disposition of prescription drugs or devices. These records must include all of the

following information:

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

address of the seller or transferor and the address from which the prescription drugs or

devices were shipped.

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

and distributed or disposed of.

23

(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.

(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.

24

(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.

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.

R 338.575 Closing a wholesale distributor or wholesale distributor-broker.

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

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

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

days before closing:

(a) The effective date of closing.

(b) How controlled substances will be disposed.

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

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

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

discontinuing a business that handles a controlled substance.

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(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.

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.

PART 6. PRACTICE OF PHARMACY

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

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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.

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.

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.

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(6) This rule does not apply to pharmacy services provided in a medical institution.

R 338.585 Customized patient medication package.

Rule 85. (1) A pharmacist may, with the consent of the patient, the patient’s caregiver,

or a prescriber, provide a CPMP. The CPMP is designed and labeled to indicate the day

and time or period of time that the contents within each CPMP are to be taken. The

individual that dispenses the medication shall instruct the patient or caregiver on the use

of the CPMP.

(2) If medication is dispensed in a CPMP, all of the following conditions must be met:

(a) Each CPMP must bear a readable label that states all of the following information:

(i) A serial number for the CPMP and a separate identifying serial number for each of

the prescription orders for each of the drug products contained in the CPMP.

(ii) The name, strength, physical description, and total quantity of each drug product

contained in the CPMP.

(iii) The name of the prescriber for each drug product.

(iv) The directions for use and cautionary statements, if any, contained in the

prescription order for each drug product in the CPMP.

(v) The date of the preparation of the CPMP.

(vi) An expiration date for the CPMP. The date must not be later than the earliest

manufacturer’s expiration date for any medication included in the CPMP or 60 days after

the date of dispensing.

(vii) The name, address, and telephone number of the dispenser.

(viii) Any other information, statements, or warnings required for any of the drug

products contained in the CPMP.

(b) A CPMP must be accompanied by any mandated patient information required under

federal law. Alternatively, required medication information may be incorporated by the

pharmacist into a single educational insert that includes information regarding all of the

medications in the CPMP.

(c) At a minimum, each CPMP must comply with the USP and National Formulary, for

moisture permeation requirements for a class b single-unit or unit-dose container. Each

container must be either non-reclosable or so designed as to show evidence of being

opened. Each CPMP must comply with all of the provisions of the poison prevention

packaging act of 1970, 15 USC 1471 to 1477.

(d) If preparing a CPMP, the dispenser shall consider any applicable compendial

requirements or guidelines, the physical and chemical compatibility of the dosage forms

placed within each container, and any therapeutic incompatibilities that may attend the

simultaneous administration of the medications. Medications must not be dispensed in

CPMP packaging in any of the following situations:

(i) The USP monograph or official labeling requires dispensing in the original

container.

(ii) The drugs or dosage forms are incompatible with packaging components or each

other.

(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.

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(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.

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.

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.

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(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.

(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

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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.

(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.

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(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.

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.

(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:

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(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.

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.

(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

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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.

R 338.588b Automated devices in medical institutions.

Rule 88b. (1) An automated device used by staff to store medications intended for

patient administration in any hospital, county medical care facility, nursing home,

hospice, or another skilled nursing facility, as that term is defined in section 20109 of the

code, MCL 333.20109, must comply with all of the following:

(a) The automated device must be stocked, maintained, and controlled by a pharmacy

that is licensed in this state.

(b) If the stocking of the automated device is performed by non-pharmacist personnel,

then technologies must be in place and utilized to ensure that the correct drugs are

stocked in their appropriate assignment utilizing bar-coding or another board-approved

error-prevention technology that complies with R 338.3154.

(c) A pharmacy operating an automated device is responsible for all medications that

are stocked and stored in that device, as well as removed from that device.

(d) If any medication or device is dispensed from an automated device, then

documentation as to the type of equipment, serial numbers, content, policies, procedures,

and location within the facility must be maintained by the pharmacy for review by an

agent of the board. The documentation must include all of the following information:

(i) Name and address of the pharmacy responsible for the operation of the automated

device.

(ii) Name and address of the facility where the automated device is located.

(iii) Manufacturer name and model number.

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(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.

R 338.589 Professional responsibility; patient counseling; “caregiver” defined.

Rule 89. (1) A pharmacist has a professional responsibility for the strength, quality,

purity, and the labeling of all drugs and devices dispensed under a prescription. In

discharging this responsibility, a pharmacist shall utilize only those drugs and devices

that are obtained from manufacturers and wholesale distributors licensed under section

17748 of the code, MCL 333.17748, or from other lawful channels of distribution.

(2) A pharmacist shall not fill a prescription order if, in the pharmacist’s professional

judgment, any of the following provisions apply:

(a) The prescription appears to be improperly written.

(b) The prescription is susceptible to more than 1 interpretation.

(c)The pharmacist has reason to believe that the prescription could cause harm to the

patient.

(d) The pharmacist has reason to believe that the prescription may be used for other

than legitimate medical purposes.

(3) A prescription drug must be dispensed only when the pharmacy is open and under

the personal charge of a pharmacist.

(4) To encourage intended, positive patient outcomes, a pharmacist shall communicate

to the patient, or the patient’s caregiver, necessary and appropriate information regarding

safe and effective medication use when a prescription is dispensed. As used in this

subrule, “caregiver” means the parent, guardian, or other individual who has assumed

responsibility for providing a patient’s care. All of the following provisions apply to

communicating medication safety and effectiveness information:

(a) The information must be communicated orally and in person, except when the

patient or patient’s caregiver is not at the pharmacy or when a specific communication

barrier prohibits oral communication. In either situation, providing printed or

electronic/digital material designed to help the patient use the medication safely and

effectively satisfies the requirements of this subrule.

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(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.

(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.

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.

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(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.

(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.

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(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.

R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an individual

if the pharmacist complies with all of the following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensed from a pharmacy with real

time access to the qualified prescription for insulin.

(c) Only 1 emergency supply, as that term is defined in MCL 333.17744f, per patient,

may be dispensed for each of 3 qualified prescriptions per year.

(2) If the smallest single package of insulin available exceeds a 30-day supply,

dispensing the package of insulin that is available complies with this rule and section

17744f of the code, MCL 333.17744f.