LICENSING AND REGULATORY AFFAIRS  
DIRECTOR'S OFFICE  
PHARMACY - GENERAL RULES  
(By authority conferred on the director of the department of licensing and regulatory  
affairs by sections 16145, 16148, 16174, 16175, 16178, 16182, 16186, 17722, 17731,  
17737, 17746, 17748, 17748a, 17748b, 17751, 17753, 17757, 17760, and 17767 of the  
public health code, 1978 PA 368, MCL 333.16145, 333.16148, 333.16174, 333.16175,  
333.16178, 333.16182, 333.16186, 333.17722, 333.17731, 333.17737, 333.17746,  
333.17748, 333.17748a, 333.17748b, 333.17751, 333.17753, 333.17757, 333.17760, and  
333.17767, and Executive Order Nos. 1991-9, 1996-2, 2003-1, and 2011-4, MCL  
338.3501, 445.2001, 445.2011, and 445.2030)  
R 338.471 Rescinded.  
History: 1979 AC; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.471a Rescinded.  
History: 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.471b Rescinded.  
History: 2017 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.472 Rescinded.  
History: 1979 AC; 1980 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.473 Rescinded.  
History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
R 338.473a Rescinded.  
History: 1979 AC; 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
Page 1  
R 338.473b Rescinded.  
History: 1979 AC; 1980 AACS; 1986 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.473c Rescinded.  
History: 1980 AACS; 1986 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.473d Rescinded.  
History: 1986 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.474 Rescinded.  
History: 1979 AC; 1980 AACS; 1988 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
R 338.474a Rescinded.  
History: 1983 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.475 Rescinded.  
History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
R 338.476 Rescinded.  
History: 1979 AC; 1980 AACS; 1998-2000 AACS.  
R 338.477 Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.477a Rescinded.  
History: 1979 AC; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.477b Rescinded.  
Page 2  
History: 1980 AACS; 1986 AACS; 1998-2000 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
R 338.477c Rescinded.  
History: 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.477d Rescinded.  
History: 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.478 Rescinded.  
History: 1979 AC; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.479 Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.479a Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.479b Rescinded.  
History: 1998-2000 AACS; 2000 AACS; 2007 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22,  
2020.  
R 338.479c Rescinded.  
History: 1998-2000 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.480 Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.480a Rescinded.  
History: 1992 AACS; 1998-2000 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
Page 3  
R 338.481 Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2013 AACS; 2020 MR 24, Eff.  
Dec 22, 2020.  
R 338.482 Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.483 Rescinded.  
History: 1979 AC; 1992 AACS.  
R 338.484 Rescinded.  
History: 1979 AC.  
ADMINISTRATIVE HEARINGS  
R 338.485 - R 338.485y Rescinded.  
History: 1979 AC; 1980 AACS.  
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  
associated with the practice of pharmacy.  
(2) Pharmacy services in a medical institution must be directed and provided by a  
licensed pharmacist.  
(3) Pharmacy personnel who assist the pharmacist by performing delegated  
functions in the care of patients of a medical institution shall be 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:  
Page 4  
(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 administration of first  
doses. If the interpretation and review will cause a medically unacceptable delay, then 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, such as 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) Delegating the stocking of an automated device. 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.  
(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 kept within the  
medical institution.  
(i) Providing educational programs regarding medications and their safe use.  
(j) Providing a method 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 method shall minimize the potential for medication error. During the absence of a  
pharmacist, the services of a pharmacist must be available on an on-call basis. Only a  
limited number of medications that are packaged in units of use must be available. The  
medications must be approved and reviewed periodically as deemed necessary, but not  
less than once a year, by an appropriate interdisciplinary practitioner committee of the  
medical institution. The medication must be kept in a securely locked, substantially  
constructed cabinet or its equivalent in an area of limited access in a centralized area  
outside the pharmacy. Each medication must be labeled to include the name of the  
medication, the strength, the expiration date, if dated, and the lot number. A written  
order and a proof of removal and use document must be obtained for each medication  
unit removed. The order and document shall be reviewed by the pharmacist within 48  
hours of removing medication from the cabinet or its equivalent. The pharmacist who  
directs pharmacy services in the medical institution shall designate the practitioners who  
are permitted to remove the medication. A pharmacist shall audit the storage locations as  
often as needed to guarantee control, but not less than once every 30 days.  
(5) Upon recommendation of an interdisciplinary practitioners’ committee, the  
pharmacist who directs pharmacy services in the medical institution shall adopt written  
Page 5  
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 at least 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 which are designed to be tamper-evident and which show no  
evidence that tampering has occurred may be returned to stock. Medications that leave  
the medical institution or its legal affiliates may not be returned to stock for dispensing.  
(8) The licensed pharmacist who directs pharmacy services in the medical  
institution shall make the policies, procedures, and written reports required by this rule  
available to the board, upon request.  
History: 1979 AC; 1980 AACS; 1998-2000 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.487 Rescinded.  
History: 1979 AC.  
R 338.488 Rescinded.  
History: 1979 AC; 1982 AACS; 1988 AACS; 1990 AACS; 2013 AACS.  
R 338.489 Rescinded.  
History: 1979 AC; 1980 AACS; 2007 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.490 Rescinded.  
History: 1979 AC; 1990 AACS; 1998-2000 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
Page 6  
R 338.491 Rescinded.  
History: 1979 AC.  
R 338.492 Rescinded.  
History: 1979 AC.  
R 338.493a Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493b Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493c Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493d Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493e Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.  
R 338.493f Rescinded.  
History: 1979 AC; 1980 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493g Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
R 338.493h Rescinded.  
Page 7  
History: 1979 AC; 1980 AACS.  
R 338.494 Rescinded.  
History: 1979 AC; 1982 AACS; 1988 AACS.  
R 338.495 Rescinded.  
History: 1979 AC; 1988 AACS; 1998-2000 AACS.  
R 338.496 Rescinded.  
History: 1979 AC; 1998-2000 AACS.  
R 338.497 Rescinded.  
History: 1981 AACS; 2013 AACS; 2014 AACS.  
R 338.500 Rescinded.  
History: 1995 AACS; 2020 MR 24, Eff. Dec 22, 2020.  
PART 1. GENERAL PROVISIONS  
R 338.501 Definitions.  
Rule 1. (1) As used in these rules:  
(a) “Approved education program” means a school of pharmacy that is accredited  
by or has candidate status by the Accreditation Council for Pharmacy Education.  
(b) “Board” means the Michigan board of pharmacy, created in section 17721 of  
the code, MCL 333.17721.  
(c) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to  
333.25211.  
(d) “Compounding” means the preparation, mixing, assembling, packaging, and  
labeling of a drug or device by a pharmacist under any of the following circumstances:  
(i) Upon the receipt of a prescription for a specific patient.  
(ii) Upon the 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.  
Page 8  
(e) "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 pursuant to  
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.  
(f) “Department” means the department of licensing and regulatory affairs.  
(g) “Electronic signature” means an electronic sound, symbol, or process attached  
to or logically associated with a record and executed or adopted by a person with the  
intent to sign the record. An electronic signature is a unique identifier protected by  
appropriate security measures such that it 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.  
(h) “Manual signature” means a signature that is handwritten or computer-  
generated if a prescription is electronically transmitted as defined in section 17703(7) of  
the code, MCL 333.17703(7).  
(i) “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.  
(j) “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.  
(2) The terms defined in the code have the same meaning when used in these rules.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
Page 9  
R 338.503 Prescription drugs and devices; return or exchange for resale  
prohibited.  
Rule 3. (1) Prescription drugs or devices that have been dispensed and have left the  
control of the pharmacist must not be returned or exchanged for resale.  
(2) This rule does not apply to any of the following:  
(a) A pharmacy operated by the department of corrections or under contract with  
the department of corrections or a county jail, as provided in section 17766d of the code,  
MCL 333.17766d.  
(b) A pharmacy or charitable clinic that participates in the program for the  
utilization of unused prescription drugs, as provided in section 17775 of the code, MCL  
333.17775.  
(c) A pharmacy or health facility that participates in the cancer drug repository  
program, as provided in section 17780 of the code, MCL 333.17780.  
(d) Drugs returned when the wrong medication was dispensed to the patient or in  
the instance of a drug recall. Subject to R 338.486(7), in no instance may returned drugs  
be reused or returned to active stock.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.505 Inspection of applicants and licensees.  
Rule 5. (1) The board, board inspector, board agent, or approved entity pursuant to 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 make an inspection 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 distributing of  
drugs and devices saleable by prescription only.  
(2) The inspection must not extend to any of the following information:  
(a) Financial data.  
(b) Sales data other than shipment data.  
(c) Pricing data.  
(d) Personnel data other than data as to the qualifications of personnel performing  
functions subject to the acts and rules enforced by the board.  
(e) Research data.  
(3) An applicant or license holder shall permit and cooperate with the inspection.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
PART 2. PHARMACIST LICENSES  
R 338.511 Training standards for identifying victims of human trafficking;  
requirements.  
Page 10  
Rule 11. (1) Pursuant to section 16148 of the code, MCL 333.16148, an individual  
seeking licensure or who is licensed shall complete 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 health care settings.  
(iii) Identifying the warning signs of human trafficking in health care settings for  
adults and minors.  
(iv) 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  
reviewed journal, health care 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 a sample of individuals and request  
documentation of proof of completion of training. If audited by the department, an  
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 an individual. The certification statement must  
include the individual’s name and either of the following:  
(i) For training completed pursuant to subrule (1)(b)(i) to (iii) of this rule, the  
date, training provider name, and name of training.  
(ii) For training completed pursuant to subrule (1)(b)(iv) of this rule, the title of  
article, author, publication name of peer review journal, health care journal or  
professional or scientific journal, and date, volume, and issue of publication as  
applicable.  
(3) Pursuant to section 16148 of the code, MCL 333.16148, the requirements  
specified in subrule (1) of this rule apply for license renewals beginning January 1, 2020  
and for initial licenses issued after November 13, 2022.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.513 Educational limited license; application and renewal; practices.  
Rule 13. (1) An applicant for an educational limited license shall submit to the  
department a completed application on a form provided by the department with the  
Page 11  
requisite fee. In addition to satisfying the requirements of sections 16174 and 17737 of  
the code, MCL 333.16174 and MCL 333.17737, the applicant shall establish either of the  
following:  
(a) That he or she is actively enrolled in, or is within 180 days of having graduated  
from, an approved educational program.  
(b) That he or she has successfully passed the foreign pharmacy graduate  
equivalency examination administered by the national association of boards of pharmacy  
(NABP) Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville Dr.,  
(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 he or she is actively enrolled in, or is within 180 days of having graduated from, 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 his or her pharmacy preceptor  
holds a valid preceptor license prior to 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 he or she  
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.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.515 Internship requirements.  
Rule 15. (1) An internship must be a minimum of 1,600 hours, 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.  
“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  
person previously approved by the board shall verify the hours.  
(2) The internship must provide professional and practical experience.  
Page 12  
(3) If an internship is not completed through an approved educational program or  
under the personal charge of a preceptor licensed in this state, the individual shall petition  
the board for approval of hours.  
(4) An individual shall obtain an educational limited license pursuant to R 338.513  
before starting an internship that includes the practice of pharmacy in this state.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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)(i) and develop a training program whereby the intern can improve his or her  
skill in these areas.  
(c) Ensure sufficient time to instruct the intern on the topics in R 338.501(1)(i) and  
review and discuss the intern’s progress on the topics in R 338.501(1)(i).  
(d) Annually submit training affidavits and, upon completion of the training,  
provide comments regarding the ability of the intern to practice pharmacy without  
supervision on a form provided by the department.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.519 Examinations adoption; passing scores; reexamination.  
Rule 19. (1) The board adopts the North American pharmacist licensure examination  
(NAPLEX) developed and administered by the NABP.  
(2) The board adopts the Michigan multistate pharmacy jurisprudence examination  
(MPJE) that is developed and administered by NABP.  
(3) The passing score for the NAPLEX or the MPJE accepted for licensure will be  
the passing score established by the NABP.  
(4) If an applicant for licensure fails to pass either of these examinations, within 3  
attempts, he or she shall provide the board, after the third attempt and prior to retesting,  
certification from an approved education program certifying that he or she satisfactorily  
completed courses that provide a thorough review of the area or areas that he or she failed  
in the most recent examination.  
(5) An applicant who fails to pass the NAPLEX shall wait at least 45 days to retest  
or comply with the current waiting period established by NABP, whichever is later. An  
Page 13  
applicant who has not achieved a passing score on the NAPLEX shall not take the  
NAPLEX more than 3 times in a 12-month period.  
(6) An applicant who fails to pass the MPJE shall wait at least 30 days to retest or  
comply with the current waiting period established by NABP, whichever is later.  
(7) An applicant shall not sit for the NAPLEX specified in subrule (5) of this rule  
more than 5 times, unless he or she successfully repeats an approved education program,  
as specified in R 338.521(2)(a)(i), and provides proof of completion to the board.  
(8) An applicant shall not sit for the MPJE specified in subrule (6) of this rule more  
than 5 times, unless he or she successfully repeats an approved pharmacy law course in  
an educational program, as specified in R 338.521(2)(a)(i), and provides proof of  
completion to the board.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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, an applicant for licensure shall satisfy all of the following requirements:  
(a) Earned either of the following:  
(i) A professional degree from a school of pharmacy accredited by the American  
council of pharmaceutical education.  
(ii) A foreign pharmacy graduate examination committee certificate administered  
by the NABP.  
(b) Successfully passed the MPJE and the NAPLEX.  
(c) Completed an internship as set forth in R 338.515.  
(3) An applicant’s license shall be verified by the licensing agency of any state of  
the United States in which the applicant holds or has ever held a license to practice  
pharmacy. This includes, but is not limited to, showing proof of any disciplinary action  
taken or pending against the applicant.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.523 Pharmacist license by endorsement; requirements.  
Rule 23. (1) An applicant for licensure as a pharmacist by endorsement shall submit  
to the department a completed application on a form provided by the department with the  
requisite fee. An applicant who meets the requirements of this rule 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 that the he or she is currently licensed in another state or he or she  
successfully passed the foreign pharmacy graduate examination administered by NABP  
and was initially licensed by examination in another state.  
(b) Pass the MPJE as required under R 338.519.  
Page 14  
(c) Have his or her license verified by the licensing agency of any state of the  
United States in which the applicant holds or has ever held a license to practice  
pharmacy. This includes, but is not limited to, showing proof of any disciplinary action  
taken or pending against the applicant.  
(d) Submit the MPJE examination score report and NABP licensure transfer report  
to the department.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.525 Relicensure of a pharmacist license; requirements.  
Rule 25. (1) An applicant for relicensure whose pharmacist license has lapsed, under  
the provisions of sections 16201(3) or (4), and 17733 of the code, MCL 333.16201(3)  
and (4), and MCL 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  
License  
License  
license lapse and who is not currently lapsed 0-3 years  
licensed in another state:  
lapsed more than lapsed 8 or more  
3 years, but less years  
than 8 years  
(a) Application and fee: submit to  
the department a completed application  
on a form provided by the department,  
with the requisite fee.  
(b) Good moral character: establish  
that he or she is of good moral character  
as defined under sections 1 to 7 of 1974  
PA 381, MCL 338.41 to MCL 338.47.  
(c) Submit fingerprints: submit  
fingerprints as required under section  
X
X
X
X
X
X
X
X
X
X
16174(3)  
of  
the  
code,  
MCL  
333.16174(3).  
(d) Continuing education: submit  
proof of having completed 30 hours of  
continuing education that satisfy R  
338.3041 to R 338.3045 in the 2 years  
immediately preceding the date of  
application for relicensure. However, if  
X
the  
continuing  
education  
hours  
submitted with the application are  
deficient, the applicant has 2 years from  
the date of the application to complete  
the deficient hours. The application will  
be held and the license will not be issued  
until  
the  
continuing  
education  
requirements have been met.  
Page 15  
(e) Pass MPJE: retake and pass the  
MPJE as provided in R 338.519.  
X
X
X
X
(f) Submit proof of having  
completed both a 1-time training in  
identifying victims of human trafficking  
as required in R 338.511 and a 1-time  
training in opioids and other controlled  
substances awareness as required in R  
338.3135.  
X
(g) Practical experience: complete  
200 hours of practical experience under  
the personal charge of a currently  
licensed Michigan pharmacist in or  
outside of Michigan, within 6 months of  
applying for relicensure.  
X
(h) Practical experience: complete  
400 hours of practical experience under  
the personal charge of a currently  
licensed Michigan pharmacist in or  
outside of Michigan, within 6 months of  
applying for relicensure.  
X
(i) Examination: pass the NAPLEX  
within 2 years before applying for  
relicensure, as provided in R 338.519.  
(j) Verification: submit verification  
from the licensing agency of all other  
states of the United States in which the  
applicant has ever held a license to  
practice pharmacy. Verification must  
include the record of any disciplinary  
action taken or pending against the  
applicant.  
X
X
X
X
(2) For purposes of subrule (1)(g) and (h) of this rule, an applicant may be granted a  
nonrenewable 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.  
License  
lapsed more than  
3 years, but lessor more years  
than 8 years  
(4) For a pharmacist who has let his or her  
pharmacist license lapse, but who holds a currentlapsed 0-3  
and valid pharmacist license in another state:  
License  
License lapsed 8  
Years  
(a) Application and fee: submit to the  
department a completed application on a form  
provided by the department, with the requisite  
X
X
X
Page 16  
fee.  
(b) Good moral character: establish that he or  
X
X
X
X
X
she is of good moral character as defined under  
sections 1 to 7 of 1974 PA 381, MCL 338.41 to  
MCL 338.47.  
(c) Submit fingerprints: submit fingerprints  
as required under section 16174(3) of the code,  
MCL 333.16174(3).  
(d) Continuing education: submit proof of  
having completed 30 hours of continuing  
education that satisfy R 338.3041 to R 338.3045  
in the 2 years immediately preceding the date of  
application for relicensure. However, if the  
continuing education hours submitted with the  
application are deficient, the applicant has 2  
years from the date of the application to  
complete the deficient hours. The application  
will be held and the license will not be issued  
until the continuing education requirements have  
been met.  
X
X
X
(e) Submit proof of having completed both a  
1-time training in identifying victims of human  
trafficking as required in R 338.511 and a 1-time  
training in opioids and other controlled  
substances awareness as required in R 338.3135.  
X
X
X
(f) Examination: retake and pass the MPJE as  
provided in R 338.519.  
X
X
X
(g) Verification: submit verification from the  
licensing agency of all other states of the United  
States in which the applicant holds or has ever  
held a license to practice pharmacy. Verification  
must include the record of any disciplinary  
action taken or pending against the applicant.  
X
X
History: 2020 MR 24, Eff. Dec 22, 2020.  
PART 3. PHARMACY LICENSES  
R 338.531 Pharmacy license; applications; requirements.  
Rule 31. (1) An applicant for a 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.  
Page 17  
(b) Submission of fingerprints for the purpose of a criminal history background  
check required under section 17748(6) of the code, MCL 333.17748(6).  
(c) Proof of registration or licensure from every state or province where the  
pharmacy is currently licensed or has ever held a license or registration.  
(d) The name and license number of the pharmacist in this state designated as the  
pharmacist in charge (PIC) pursuant to section 17748(2) of the code, MCL 333.17748(2),  
who must have a valid and unrestricted license.  
(e) The identity and address of each partner, officer, or owner, as applicable.  
(f) A completed self-inspection form.  
(g) If the applicant intends to provide compounding services, proof of application  
with an entity that satisfies the requirements of R 338.532.  
(h) An inspection report that satisfies the requirements of R 338.534.  
(i) If the applicant is an in-state pharmacy that intends to compound pharmaceutical  
products, the applicant shall submit to an inspection from an approved accrediting  
organization under R 338.532.  
(j) If the applicant is a governmental entity, an individual must be designated as the  
licensee. The licensee and the pharmacist on duty shall be responsible for complying with  
all federal and state laws regulating the practice of pharmacy and the dispensing of  
prescription drugs.  
(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  
shall obtain a separate license.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.532 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 not be 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 from 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 of the rescission date or by the next licensure renewal  
Page 18  
date, whichever is later, the accreditation is void, and a pharmacy shall obtain  
accreditation or an inspection from an organization that satisfies subrule (1) of this rule.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.533 Compounding standards and requirements; outsourcing facilities;  
requirements.  
Rule 33. (1) The board approves and adopts by reference the compounding  
standards of the United States Pharmacopeia (USP), published by the United States  
Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790.  
This includes, but is not limited to, USP Chapters 795 and 797.  
(2) The standards adopted by reference in subrule (1) of this rule are available at  
cost at http://www.usp.org/compounding, or at cost 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, MI 48909.  
(3) A pharmacy that provides compounding services shall comply with all current  
standards adopted in subrule (1) of this rule.  
(4) An outsourcing facility located in this state or that dispenses, provides,  
distributes, or otherwise furnishes compounded pharmaceuticals in this state must be  
inspected and registered as an outsourcing facility by the United States Food and Drug  
Administration (FDA) prior to applying for a pharmacy license in this state.  
(5) A licensed outsourcing facility shall submit to the board a copy of the biannual  
report it provided to the FDA that identifies the drugs compounded in the previous 6-  
month period, including a drug’s active ingredients, strength, and dosage form.  
(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 pursuant to current good manufacturing practices for finished  
pharmaceuticals set forth in 21 CFR 211.1 to 211.208 (1978).  
(c) Ensure that a pharmacist or pharmacists 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 with all of the following and label compounded drugs  
that are patient specific with all of the following and consistent with the requirements in  
R 338.582:  
(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.  
Page 19  
(7) An outsourcing facility may compound drugs that appear on an FDA shortage  
list, if the bulk drug substances used to compound the drugs comply with the criteria  
specified in this rule.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.534 Inspections.  
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 pharmacy inspection  
that was performed within the last 2 years.  
(2) An applicant for a new pharmacy located in this state shall have an inspection  
conducted by the department or its designee prior to licensure.  
(3) An applicant for licensure of a pharmacy that will provide sterile compounded  
pharmaceuticals shall have all of the following:  
(a) An onsite physical inspection conducted by any of the following:  
(i) The department.  
(ii) The national association of boards of pharmacy verified pharmacy program  
(NABP-VPP).  
(iii) An accrediting organization according to R 338.532.  
(iv) 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.  
(b) A physical inspection and corresponding report completed within 18 months of  
application.  
(c) A physical inspection and corresponding report that demonstrates compliance  
with all applicable standards that are adopted by reference in R 338.533.  
(4) An out-of-state pharmacy that intends to ship sterile compounded pharmaceutical  
products into this state shall obtain an inspection from a board approved accrediting  
organization every 18 months.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.535 Discontinuing 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 of ceasing to provide sterile compounding services.  
(2) A pharmacy shall not resume providing sterile compounding services in this state  
until the pharmacy 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.  
(3) A pharmacy shall apply for approval to resume sterile compounding services by  
submitting to the department an application on a form provided by the department  
together with the requisite fee.  
Page 20  
(4) An outsourcing facility shall not resume providing sterile compounding services  
in this state until the outsourcing facility is approved by the department and verifies that  
it is compliant with the requirements of R 338.533(4) to (7).  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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 who is 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  
kept 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) All pharmacies that occupy less than the entire area of the premises owned,  
leased, used, or controlled by the licensee must 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 will  
be 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(2). A pharmacy  
department must be locked when the pharmacist is not on the premises.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.537 Professional and technical equipment and supplies.  
Rule 37. A pharmacy must be equipped with all of the following:  
(a) Drawers, shelves, and storage cabinets.  
(b) A sink that has hot and cold running water.  
(c) A refrigerator of reasonable capacity located in the pharmacy department.  
(d) Current editions or revisions of the Michigan pharmacy laws and rules, and not  
less than 2 current or revised pharmacy reference texts that pertain to pharmacology, drug  
interactions, or drug composition. A current electronic version of pharmacy laws, rules,  
and pharmacy reference texts, including accessible internet versions, meets the  
requirements of this subrule.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.538 Closing pharmacy.  
Page 21  
Rule 38. (1) A pharmacy that is ceasing operations shall return to the department the  
pharmacy license and the controlled substance license, if applicable, and shall provide the  
department with written notification of all of the following at least 15 days prior to  
closing:  
(a) The effective date of closing.  
(b) The disposition of controlled substances.  
(c) The disposition of non-controlled substances.  
(d) The disposition of records and prescription files.  
(2) A pharmacy shall comply with all applicable federal requirements for  
discontinuing operation as a pharmacy that dispenses controlled substances.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.539 Relicensure.  
Rule 39. (1) An applicant for relicensure of a pharmacy license shall submit to the  
department a completed application on a form provided by the department with the  
requisite fee.  
(2) A pharmacy that has an expired license shall satisfy the requirements of R  
338.531 to be relicensed.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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 pursuant to section 17748(6) of  
the code, MCL 333.17748(6).  
(b) Verification or certification from every state or province where the applicant is  
currently licensed or has ever held a license.  
(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(2), the  
name and license number of the pharmacist designated as the pharmacist in charge (PIC).  
(h) A copy of the FDA certification for the site to be licensed, if an applicant is a  
manufacturer of biologicals.  
Page 22  
(i) An inspection from the manufacturer’s resident state board of pharmacy or  
verified-accredited wholesale distributors (VAWD) accreditation dated not more than 2  
years prior to the application.  
(3) A separate license is required for each location where prescription drugs or  
devices are manufactured.  
(4) A pharmacy is a manufacturer and shall obtain a manufacturer license if it  
prepares or compounds prescription drugs for resale, compounding, or dispensing by  
another person in an amount that exceeds 5% of the total number of dosage units of  
prescription drugs prepared by the pharmacy during a consecutive 12-month period.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.553 Persons to whom prescription drugs or devices may be sold.  
Rule 53. A manufacturer may only supply, distribute, sell, barter, or otherwise  
transfer prescription drugs or devices to persons who are licensed by the board to  
distribute, prescribe, or dispense prescription drugs or devices in or outside this state.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.555 Federal regulation on good manufacturing practice for finished  
pharmaceuticals; adoption by reference; compliance.  
Rule 55. (1) The board approves and adopts by reference the current good  
manufacturing practice for finished pharmaceuticals regulations set forth in 21 CFR  
211.1 to 211.208 (1978).  
(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  
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, MI 48909.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.557 Closure 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 at least 15 days prior to  
closing:  
(a) The effective date of closing.  
(b) The disposition of controlled substances.  
(c) The disposition of non-controlled substances.  
(d) The disposition of records and prescription files.  
Page 23  
(2) A manufacturer shall comply with all applicable federal requirements for  
discontinuing a controlled substance business.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.559 Relicensure.  
Rule 59. (1) An applicant for relicensure of a manufacturer license shall submit to  
the department a completed application on a form provided by the department with the  
requisite fee.  
(2) A manufacturer that has an expired license shall satisfy the requirements of R  
338.551 in order to be relicensed.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
PART 5. WHOLESALE DISTRIBUTOR LICENSE  
R 338.561 Pharmacy as wholesale distributor; licensure.  
Rule 61. A pharmacy that transfers prescription drugs or devices shall obtain a  
wholesale distributor license if it distributes more than 5% of the total dosage units of  
prescription drugs dispensed during any consecutive 12-month period, except in the  
following circumstances:  
(a) The distribution of a drug among hospitals or other health care entities which are  
under common control.  
(b) Intracompany distribution of any drug between members of an affiliate, defined  
pursuant to section 360eee(1) of the Federal Food, Drug, and Cosmetic Act, 21 USC  
section 360eee(1), or within a manufacturer.  
(c) Distribution of a drug by a charitable organization to a nonprofit affiliate of the  
organization, defined pursuant to section 360eee(1) of the Federal Food, Drug, and  
Cosmetic Act, 21 USC section 360eee(1).  
(d) Distribution of a product for emergency medical reasons including a public  
health emergency declaration pursuant to section 319 of the Public Health Service Act,  
42 USC 247d.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.563 Wholesale distributor; application for licensure; requirements.  
Rule 63. (1) An applicant for a wholesale distributor 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 provide all of the following information:  
(a) A criminal history background check required pursuant to section 17748(6) of  
the code, MCL 333.17748(6).  
Page 24  
(b) Proof of registration or licensure from every state where the applicant currently  
holds or has ever held a license or registration.  
(c) Certified copies of articles of incorporation or certificates of partnership and  
assumed names if applicable.  
(d) The identity and address of each partner, officer, or owner as applicable.  
(e) A completed compliance checklist.  
(f) A list or catalog of all drug products and devices to be distributed.  
(g) A copy of the FDA certification for the site to be licensed, if the applicant is  
distributing biologicals.  
(h) Unless exempt under section 17748(2) of the code, MCL 333.17748(2), the  
name and the license number of the pharmacist designated as the pharmacist in charge  
(PIC) or the name of the facility manager. For individuals designated as a facility  
manager, the applicant shall provide the following:  
(i) Proof, in the form of an affidavit, that the facility manager has achieved the  
following:  
(A) A high school equivalency education, or higher, defined as 1 of the following:  
(I) A high school diploma.  
(II) A general education development certificate (GED).  
(III) A parent-issued diploma for home schooled individuals.  
(IV) Completion of post-secondary education, including an associate’s,  
bachelor’s, or master’s degree.  
(B) Completion of a training program that includes, but is not limited to, all of the  
following subjects:  
(I) Knowledge and understanding of laws in this state and federal laws relating  
to the distribution of drugs and devices.  
(II) Knowledge and understanding of laws in this state and federal laws relating  
to the distribution of controlled substances.  
(III) Knowledge and understanding of quality control systems.  
(IV) Knowledge and understanding of the USP standards relating to the safe  
storage and handling of prescription drugs.  
(V) Knowledge and understanding of pharmaceutical terminology,  
abbreviations, dosages, and format.  
(C) Experience equal to either of the following:  
(I) 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.  
(II) Previous or current employment as a designated representative of a  
wholesale distributor certified by the VAWD of NABP.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.565 Persons to whom prescription drugs and devices may be sold.  
Rule 65 A wholesale distributor of prescription drugs or devices may supply,  
distribute, sell, barter, or otherwise transfer prescription drugs or devices only to persons  
who are licensed by the board to distribute, prescribe, or dispense prescriptions drugs or  
devices in or outside this state.  
Page 25  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.567 Wholesale distributor practices; control of prescription drugs or  
devices; inspections.  
Rule 67. (1) A wholesale distributor that does not physically touch prescription  
drugs or devices shall file an affidavit with the department signed by the PIC or facility  
manager attesting to this fact.  
(2) A wholesale distributor that previously filed an affidavit under subrule (1) of this  
rule shall not obtain custody and control of drugs or devices until both of the following  
have occurred:  
(a) The licensee provides written notification to the department of physical  
custody.  
(b) The department conducts an inspection of the premises.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.569 Wholesale distributor recordkeeping and policy requirements.  
Rule 69. (1) A wholesale distributor shall establish and maintain inventories and  
records of transactions regarding the receipt, if applicable, and the distribution or other  
disposition of prescription drugs or devices. These records must include all of the  
following information:  
(a) The source of the prescription drugs or devices, including the name and  
principal address of the seller or transferor and the address from which the prescription  
drugs or devices were shipped.  
(b) The identity and quantity of the prescription drugs or devices received, if  
applicable, and distributed or disposed of.  
(c) The dates of receipt, if applicable, and distribution of the prescription drugs or  
devices.  
(2) A wholesale distributor shall establish and maintain a list of officers, directors,  
managers, and other persons 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 whereby the oldest stock of a prescription drug is distributed first.  
The procedure may permit 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.  
Page 26  
(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 in the event of  
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 will be  
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) The records described in subrules (1) and (2) of this rule must be made available  
for inspection and photocopying by authorized federal, state, or local law enforcement  
agency officials. The records that are kept 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 subrule (5) of this rule. Records that are kept at a  
central location apart from the site must be made available for inspection within 2  
working days of a request.  
(5) The records described in this rule must be maintained for a minimum of 2 years  
after the disposition of the prescription drugs or devices.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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 for 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 have been 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 will provide protection against theft  
and diversion. When appropriate, the security system must provide protection against  
theft or diversion that is facilitated or hidden by tampering with computers or electronic  
records.  
Page 27  
(2) All prescription drugs or devices must be stored at temperatures and under  
appropriate conditions pursuant to the label requirements or pursuant to the requirements  
set forth in the current edition of the USP compendium. If storage requirements are not  
established for a prescription drug, the drug may be held at a controlled room temperature  
to help ensure that its identity, strength, quality, and purity are not adversely affected.  
Appropriate manual, electromechanical, or electronic temperature and humidity recording  
equipment devices, or logs must be utilized to document the proper storage of  
prescription drugs or devices.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.573 Examination of materials; returned, damaged and outdated  
prescription drugs or devices.  
Rule 73. (1) A wholesale distributor shall comply with both of the following  
provisions that pertain to the examination of materials:  
(a) Each outside shipping container must be visually examined upon receipt for the  
identity of the prescription drug or devices and to prevent the acceptance of contaminated  
prescription drugs or devices or prescription drugs or devices otherwise unfit for  
distribution. The examination must be adequate to reveal container damage that would  
suggest possible contamination or other damage to the contents.  
(b) Each outgoing shipment must be visually inspected for identity of the  
prescription drug products and to ensure that prescription drugs or devices that have been  
damaged in storage or held under conditions that are inconsistent with USP compendium  
standards are not delivered.  
(2) All of the following provisions apply to returned, damaged, and outdated  
prescription drugs or devices:  
(a) Prescription drugs or devices that are outdated, damaged, deteriorated,  
misbranded, or adulterated, must be quarantined and physically separated from other  
prescription drugs or devices until they are destroyed or returned to the supplier.  
(b) Any immediate or sealed outer or sealed secondary containers of any  
prescription drugs or devices that have been opened or used must be identified as such  
and the drugs or devices must be quarantined and physically separated from other  
prescription drugs or devices until they are either destroyed or returned to the supplier.  
(c) If the conditions under which a prescription drug has been returned cast doubt  
on the drug’s safety, identity, strength, quality, or purity, then the drug must be destroyed  
or returned to the supplier, unless examination, testing, or other investigation proves that  
the drug meets appropriate standards of safety, identity, strength, quality, and purity. In  
determining whether the conditions under which the drug has been returned cast doubt on  
the drug’s safety, identity, strength, quality, or purity, the wholesale distributor shall  
consider the conditions under which the drug has been held, stored, or shipped before or  
during its return and the condition of the drug and its container, carton, or labeling as a  
result of storage or shipping.  
(3) The recordkeeping requirements of R 338.569 must be followed.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
Page 28  
R 338.575 Closing a wholesale distributor.  
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 shall provide the department with written notification of all of the  
following at least 15 days prior to closing:  
(a) The effective date of closing.  
(b) The disposition of controlled substances.  
(c) The disposition of noncontrolled substances.  
(d) The disposition of records and prescription files.  
(2) A wholesale distributor shall comply with all applicable federal requirements for  
discontinuing a business that handles a controlled substance.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.577 Relicensure.  
Rule 77. (1) An applicant for relicensure of a wholesale distributor license shall  
submit to the department a completed application on a form provided by the department  
with the requisite fee.  
(2) An applicant for relicensure of a wholesale distributor license that has expired  
must satisfy the requirements of R 338.563 in order to be relicensed.  
PART 6. PRACTICE OF PHARMACY  
R 338.582 Prescription drug labeling and dispensing.  
Rule 82. (1) All labeling of prescription drugs must comply with the requirements of  
the code and sections 351 to 399f of the Federal Food, Drug, and Cosmetic Act, 21 USC  
351 to 399f.  
(2) All containers in which prescription medication is dispensed must bear a label  
that contains, at a minimum, all of the following information:  
(a) Pharmacy name and address.  
(b) Prescription number.  
(c) Patient's name.  
(d) Date the prescription was most recently dispensed.  
(e) Prescriber's name.  
(f) Directions for use.  
(g) The name of the medication and the strength, unless the prescriber indicates "do  
not label."  
(h) The quantity dispensed, if applicable.  
(i) The name of the manufacturer or supplier of the drug if the drug has no brand  
name, unless the prescriber indicates “do not label.”  
(3) If a drug is dispensed that is not the brand prescribed, the pharmacy shall notify  
the purchaser and the prescription label must indicate both the name of the brand  
prescribed and the name of the brand dispensed. If the dispensed drug does not have a  
Page 29  
brand name, the prescription label must indicate the name of the brand prescribed  
followed by the generic name of the drug dispensed. This subrule does not apply if the  
prescriber indicates "do not label."  
(4) If drug product selection takes place, the brand name or the name of the  
manufacturer or supplier of the drug dispensed must be noted on the prescription.  
(5) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.583 Prescription drug receipts.  
Rule 83. (1) The purchaser of a prescription drug shall receive, at the time 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 most recently dispensed.  
(h) The name of the prescriber.  
(i) The name of the patient for whom the drug was prescribed.  
(j) The price for which the drug was sold to the purchaser.  
(2) Notwithstanding R 338.582, the information required in this rule must appear on  
either the prescription label or on a combination label and receipt.  
(3) For prescription services that are covered by a third-party pay contract, the price  
included in the receipt is the amount paid by the patient.  
(4) A pharmacist shall retain a copy of the receipt for a period of 90 days. The  
inclusion of the information required in this rule in the automated data processing system  
or on the written prescription form and the retention of the form constitutes retaining a  
copy of the receipt. The physical presence of the prescription form in the pharmacy or the  
ability to retrieve the information from the automated data processing system constitutes  
compliance with the requirement of having the name and address of the pharmacy on the  
form.  
(5) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.584 Noncontrolled prescriptions.  
Rule 84. (1) A prescriber who issues a prescription for a noncontrolled prescription  
drug shall date the prescription; provide a manual signature on the prescription, as  
defined in R 338.501(1)(h) of these rules; and ensure that the prescription contains all of  
the following information:  
Page 30  
(a) The full name of the patient for whom the drug is being prescribed.  
(b) The prescriber’s printed name and address.  
(c) The drug name and strength.  
(d) The quantity prescribed.  
(e) The directions for use.  
(f) The number of refills authorized.  
(2) A prescriber shall ensure that a prescription is legible and that the information  
specified in subrule (1)(c) to (f) of this rule is clearly separated.  
(3) A prescriber shall not prescribe more than either 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 from the date the prescription was issued.  
(5) A prescriber may electronically transmit a noncontrolled substance prescription  
to the pharmacy of the patient’s choice by utilizing a system that includes all of the  
following:  
(a) A combination of technical security measures such as, but not limited to, those  
listed in security standards for the protection of electronic protected health information  
set forth in 45 CFR 164.312 (2013) that implements the Federal Health Insurance  
Portability and Accountability Act of 1996 (HIPAA), to ensure all of the following:  
(i) Authentication of an individual who prescribes or dispenses.  
(ii) Technical non-repudiation.  
(iii) Content integrity.  
(iv) Confidentiality.  
(b) An electronic signature as defined in R 338.501(1)(g). An electronic signature  
is valid when it is used to sign a noncontrolled prescription.  
(c) Appropriate security measures to invalidate a prescription if either the  
electronic signature or prescription record to which it is attached or logically associated is  
altered or compromised following transmission by the prescriber. The electronic  
prescription may be reformatted to comply with industry standards provided that no data  
is added, deleted, or changed.  
(6) The electronic prescription must meet all requirements of the HIPAA.  
(7) The electronic prescription must permit the prescriber to instruct the pharmacist  
to dispense a brand name drug product provided that the prescription includes both of the  
following:  
(i) The indication that no substitute is allowed, such as “dispense as written” or  
“DAW.”  
(ii) The indication that no substitute is allowed and that it is a unique element in the  
prescription.  
(8) If the prescription is transmitted electronically, the prescriber shall generate and  
transmit the prescription in a format that can be read and stored by a pharmacy in a  
retrievable and readable form. The electronic prescription must identify the name of the  
pharmacy intended to receive the transmission, and must include the information  
identified in subrule (1) of this rule.  
Page 31  
(9) The electronic prescription must be preserved by a licensee or dispensing  
prescriber for not less than 5 years. A paper version of the electronic prescription must  
be made available to an authorized agent of the board upon request. A secured copy must  
be retained for a minimum of 1 year by the transaction service vendor for record-keeping  
purposes and must be shared only with the parties involved in the transaction except as  
otherwise permitted by state or federal law.  
(10) An electronic signature that meets the requirements of this rule has the full  
force and effect of a handwritten signature on a paper-based written prescription.  
(11) A pharmacy shall keep the original prescription record for 5 years. After 3  
years, a pharmacy may make an electronic duplicate of the original paper prescription,  
which will become the original prescription. A pharmacy shall present a paper copy of  
the electronic duplicate of the prescription to an authorized agent of the board upon  
request.  
(12) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.585 Customized patient medication package.  
Rule 85. (1) A pharmacist may, with the consent of the patient, or the patient’s  
caregiver, or a prescriber, provide a customized patient medication package (CPMP). A  
CPMP is a package that is prepared by a pharmacist for a specific patient and that  
contains 2 or more prescribed solid oral dosage forms. 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 person who 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  
Page 32  
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 be in compliance with the United States  
Pharmacopeia (USP) and national formulary, as defined in section 17706(2) of the code,  
MCL 333.17706(2), 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 having been opened. Each CPMP must comply with all of the  
provisions of the poison prevention packaging act of 1970, 15 USC 1471 to 1477.  
(d) When preparing a CPMP, the dispenser shall take into account 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.  
(f) Medications that have been dispensed in CPMP packaging shall not be returned  
to stock or dispensed to another patient when returned to the pharmacy for any reason. If  
a prescription for any drug contained in the CPMP is changed, then a new appropriately  
labeled CPMP must be prepared for the patient.  
(g) In addition to all individual prescription filing requirements, a record of each  
CPMP dispensed must be made and filed. At a minimum, each record must contain all of  
the following information:  
(i) The name and address of the patient.  
(ii) The serial number of the prescription order for each drug product contained in  
the CPMP.  
(iii) Information identifying or describing the design, characteristics, or  
specifications of the CPMP sufficient to allow subsequent preparation of an identical  
CPMP for the patient.  
(iv) The date of preparation of the CPMP and the expiration date assigned.  
(v) Any special labeling instructions.  
(vi) The name or initials of the pharmacist who prepared the CPMP.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
R 338.586 Prescription records; nonapplicability to inpatient medical institution  
service.  
Rule 86. (1) A prescription must be numbered, dated, and initialed or electronically  
initialed by the pharmacist who performs the final verification prior to dispensing at the  
time of the first filling at the pharmacy.  
Page 33  
(2) 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.  
(3) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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 is in  
compliance 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  
deemed dispensed.  
(b) If the drug that is dispensed is other than the brand prescribed or if the  
prescription is written generically, then the name of the manufacturer or supplier of the  
drug dispensed must be indicated on the prescription.  
(3) A pharmacy may utilize a uniform system of recording refills if the system is in  
compliance 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 pharmacy shall preserve the records for 5 years. 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 federal drug enforcement administration (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 upon 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.  
(c) Prescription entries must be made on the record at the time the prescription is  
first filled and at the time of 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  
Page 34  
or refill without reentering the information. The dispensing pharmacist is responsible for  
the completeness and accuracy of the entries and must 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 is in compliance 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 federal 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 upon 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.  
(b) Prescription entries must be made on the record at the time the prescription is  
first filled and at the time of 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. The pharmacy shall preserve the records  
on-site for 5 years. 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 trial 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  
upon request. The prescription data must be maintained for 5 years. Data older than 16  
months must be provided within 72 hours of the time the request is first made by the  
agent. Prescription data for the most current 16 months must be readily retrievable on site  
and available for immediate review.  
Page 35  
(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 is  
capable of complying with all of the requirements of these rules.  
(5) This rule does not apply to pharmacy services provided in a medical institution.  
(6) Records that are created under subrule (2), (3) or (4) of this rule are subject to the  
same requirements regarding confidentiality and access that apply to original  
prescriptions.  
History: 2020 MR 24, Eff. Dec 22, 2020.  
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 provided that 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 defined in section 20109(4) of the code, MCL  
333.20109(4).  
(g) An office of a dispensing prescriber.  
(h) A location affiliated with a hospital, but not at the same physical address as the  
pharmacy, that is owned and operated by the hospital, consistent with section 17760 of  
the code, MCL 333.17760.  
(3) A pharmacy that operates an automated device under this section to deliver a  
drug or device directly to an ultimate user or health care provider shall notify the  
department of the automated device’s location on a form provided by the department. An  
automated device located within a licensed pharmacy must be used only by a pharmacist  
or his or her pharmacy personnel under the personal charge of a pharmacist.  
(4) If an automated device is used in a dispensing prescriber's office, the device  
must be used only to dispense medications to the dispensing prescriber's patients and only  
Page 36