DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
DIRECTOR'S OFFICE  
PHARMACY - GENERAL RULES  
(By authority conferred on the director of the department of licensing and regulatory  
affairs by sections 16141, 16145, 16148, 16174, 16175, 16178, 16182, 16186, 16204,  
16205, 16215, 16287, 17707, 17721, 17722, 17731, 17737, 17739, 17742a, 17742b,  
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, 333.17746, 333.17748, 333.17748a,  
333.17748b, 333.17748e, 333.17751, 333.17753, 333.17754a, 333.17757, 333.17760,  
333.17767, and 333.17775 and Executive Order Nos. 1991-9, 1996-2, 2003-1, and 2011-  
4, MCL 338.3501, 445.2001, 445.2011, and 445.2030)  
R 338.471 Rescinded.  
History: 1979 AC; 2020 AACS.  
R 338.471a Rescinded.  
History: 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.471b Rescinded.  
History: 2017 AACS; 2020 AACS.  
R 338.472 Rescinded.  
History: 1979 AC; 1980 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.473 Rescinded.  
History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.473a Rescinded.  
History: 1979 AC; 1980 AACS; 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
Page 1  
R 338.473b Rescinded.  
History: 1979 AC; 1980 AACS; 1986 AACS; 2013 AACS; 2020 AACS.  
R 338.473c Rescinded.  
History: 1980 AACS; 1986 AACS; 2020 AACS.  
R 338.473d Rescinded.  
History: 1986 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.474 Rescinded.  
History: 1979 AC; 1980 AACS; 1988 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.474a Rescinded.  
History: 1983 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.475 Rescinded.  
History: 1979 AC; 1980 AACS; 1990 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.476 Rescinded.  
History: 1979 AC; 1980 AACS; 1998-2000 AACS.  
R 338.477 Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 AACS.  
R 338.477a Rescinded.  
History: 1979 AC; 2020 AACS.  
R 338.477b Rescinded.  
Page 2  
History: 1980 AACS; 1986 AACS; 1998-2000 AACS; 2013 AACS; 2020 AACS.  
R 338.477c Rescinded.  
History: 2013 AACS; 2020 AACS.  
R 338.477d Rescinded.  
History: 2013 AACS; 2020 AACS.  
R 338.478 Rescinded.  
History: 1979 AC; 2020 AACS.  
R 338.479 Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.  
R 338.479a Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.  
R 338.479b Rescinded.  
History: 1998-2000 AACS; 2000 AACS; 2007 AACS; 2013 AACS; 2020 AACS.  
R 338.479c Rescinded.  
History: 1998-2000 AACS; 2020 AACS.  
R 338.480 Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 AACS.  
R 338.480a Rescinded.  
History: 1992 AACS; 1998-2000 AACS; 2020 AACS.  
R 338.481 Rescinded.  
Page 3  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2013 AACS; 2020 AACS.  
R 338.482 Rescinded.  
History: 1979 AC; 1980 AACS; 2013 AACS; 2020 AACS.  
R 338.483 Rescinded.  
History: 1979 AC; 1992 AACS.  
R 338.484 Rescinded.  
History: 1979 AC.  
ADMINISTRATIVE HEARINGS  
R 338.485 - R 338.485y Rescinded.  
History: 1979 AC; 1980 AACS.  
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:  
(a) Dispensing medications in a form that minimizes additional preparation before  
administration to the patient, including the admixture of parenterals.  
Page 4  
(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  
policies and procedures to promote safe medication practices, to conduct medication  
utilization review, to approve medications for the medical institution's formulary or  
Page 5  
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 AACS.  
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 AACS.  
R 338.490 Rescinded.  
History: 1979 AC; 1990 AACS; 1998-2000 AACS; 2020 AACS.  
R 338.491 Rescinded.  
Page 6  
History: 1979 AC.  
R 338.492 Rescinded.  
History: 1979 AC.  
R 338.493a Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS; 2020 AACS.  
R 338.493b Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2013 AACS; 2020 AACS.  
R 338.493c Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.  
R 338.493d Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.  
R 338.493e Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.  
R 338.493f Rescinded.  
History: 1979 AC; 1980 AACS; 2020 AACS.  
R 338.493g Rescinded.  
History: 1979 AC; 1980 AACS; 1992 AACS; 2020 AACS.  
R 338.493h Rescinded.  
History: 1979 AC; 1980 AACS.  
Page 7  
R 338.494 Rescinded.  
History: 1979 AC; 1982 AACS; 1988 AACS.  
R 338.495 Rescinded.  
History: 1979 AC; 1988 AACS; 1998-2000 AACS.  
R 338.496 Rescinded.  
History: 1979 AC; 1998-2000 AACS.  
R 338.497 Rescinded.  
History: 1981 AACS; 2013 AACS; 2014 AACS.  
R 338.500 Rescinded.  
History: 1995 AACS; 2020 AACS.  
PHARMACY SERVICES IN MEDICAL INSTITUTIONS  
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 (ACPE).  
(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 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.  
(h) “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.  
(i) “Manual signature” means a signature that is handwritten or computer-generated  
if a prescription is electronically transmitted as defined in section 17703(8) of the code,  
MCL 333.17703.  
(j) “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.  
(k) “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.  
(l) “Written” includes both paper and electronic forms.  
Page 9  
(2) Unless otherwise defined in these rules, the terms defined in the code have the  
same meaning when used in these rules.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.503 Prescription drugs and devices; return or exchange for resale  
prohibited.  
Rule 3. (1) Prescription drugs or devices that have been dispensed and have left the  
control of the pharmacist must not be returned or exchanged for resale.  
(2) This rule does not apply to any of the following:  
(a) A pharmacy operated by the department of corrections or under contract with  
the department of corrections or a county jail, as provided in section 17766d of the code,  
MCL 333.17766d.  
(b) A pharmacy or charitable clinic that participates in the program for the  
utilization of unused prescription drugs, as provided in section 17775 of the code, MCL  
333.17775.  
(c) A pharmacy or health facility that participates in the cancer drug repository  
program, as provided in section 17780 of the code, MCL 333.17780.  
(d) Drugs returned when the wrong medication was dispensed to the patient or in  
the instance of a drug recall. Subject to R 338.486(7), in no instance may returned drugs  
be reused or returned to active stock.  
History: 2020 AACS.  
R 338.505 Inspection of applicants and licensees.  
Rule 5. (1) The board, board inspector, board agent, or an entity approved 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 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 distributing 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) 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 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
Page 10  
PART 2. PHARMACIST LICENSES  
R 338.511 Training standards for identifying victims of human trafficking;  
requirements.  
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.  
Page 11  
History: 2020 AACS.  
R 338.513 Educational limited license; application and renewal; practices.  
Rule 13. (1) An applicant for an educational limited license shall submit to the  
department a completed application on a form provided by the department with the  
requisite fee. In addition to satisfying the requirements of sections 16174 and 17737 of  
the code, MCL 333.16174 and MCL 333.17737, the applicant shall establish either 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 Foreign Pharmacy Graduate Examination  
Committee (FPGEC) certification from 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 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 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 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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  
Page 12  
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.  
(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 AACS.  
R 338.517 Preceptor license and responsibilities.  
Rule 17. (1) An applicant for licensure as a pharmacist preceptor shall submit to the  
department a completed application on a form provided by the department.  
(2) The applicant shall satisfy both of the following:  
(a) Have an unrestricted pharmacist license from this state that is in good standing  
for the past year.  
(b) Have been engaged in the practice of pharmacy in this state for at least 1 year.  
(3) A preceptor shall do all of the following:  
(a) Ensure that the pharmacist on duty is supervising not more than 2 pharmacist  
interns at the same time. The approved preceptor is responsible for the overall internship  
program at the pharmacy.  
(b) Determine the degree of the intern’s professional skill on the topics listed in R  
338.501(1)(j) 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)(j) and  
review and discuss the intern’s progress on the topics in R 338.501(1)(j).  
(d) Annually submit to the department training affidavits that include the number  
of internship hours completed by the intern in the practice of pharmacy.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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) 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 longer. An  
applicant who has not achieved a passing score on the NAPLEX may not take the  
NAPLEX more than 3 times in a 12-month period.  
Page 13  
(5) 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 longer.  
(6) If an applicant for licensure fails to pass either of these examinations, 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 he or she failed. After participating in the course or instruction the  
applicant shall provide the department with proof that he or she completed the course or  
instruction.  
(7) An applicant may not sit for the NAPLEX specified in subrule (4) 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 department.  
(8) An applicant may not sit for the MPJE specified in subrule (5) 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 department.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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) Have earned either of the following:  
(i) A professional degree from a school of pharmacy accredited by the ACPE.  
(ii) A FPGEC certification from the NABP. An applicant who has an FPGEC  
certification from NABP has met the English proficiency requirement as the applicant’s  
credentials and English proficiency have been evaluated and determined to be equivalent  
to the credentials required in this state.  
(b) Passed the MPJE and the NAPLEX.  
(c) Completed an internship as set forth in R 338.515.  
(d) Completed 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) Completed a 1-time training in opioids and other controlled substances  
awareness as required in R 338.3135.  
(f) Submitted proof to the department of meeting the English language requirement  
under R 338.7002b and the implicit bias training required in R 338.7004. An applicant  
who has an FPGEC certification from NABP has met the English proficiency  
requirement as the applicant’s credentials and English proficiency have been evaluated  
and determined to be equivalent to the credentials required in this state.  
(3) An applicant who is or has ever been licensed, registered, or certified in a health  
profession or specialty by any other 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.  
Page 14  
(b) Satisfy the requirements of section 16174(2) of the code, MCL 333.16174,  
which includes verification from the issuing entity showing that disciplinary proceedings  
are not pending against the applicant and sanctions are not in force at the time of  
application.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 1 of the following:  
(i) He or she holds a license in good standing as a pharmacist in another state and  
submits the NABP licensure transfer report to the department.  
(ii) He or she holds a pharmacy license in Canada that is in good standing and meets  
all of the following:  
(A) He or she has passed the NAPLEX or both part I and part II of the Pharmacy  
Examining Board of Canada (PEBC) Pharmacists Qualifying Examination.  
(B) He or she 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 (CCAPP).  
(C) If he or she held a pharmacist license for less than 1 year in Canada, he or she  
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) Pass the MPJE as required under R 338.519.  
(c) An applicant who is or has ever been licensed, registered, or certified in a health  
profession or specialty by any other 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,  
which include 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) He or she 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) He or she 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) He or she completes a 1-time training in opioids and other controlled substances  
awareness as required in R 338.3135.  
(g) He or she submits proof to the department of meeting the English language  
requirement under R 338.7002b and the implicit bias training required in R 338.7004.  
Page 15  
(3) An applicant who has an FPGEC certification from NABP has met the English  
proficiency requirement. The applicant’s credentials and English proficiency have been  
evaluated and determined to be equivalent to the credentials required in this state.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 333.16201and 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  
License  
License  
License  
her license lapse in this state and who is lapsed 0-3 years  
not currently licensed in another state or  
a province of Canada:  
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.  
X
X
X
X
X
X
(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  
16174(3) of the code, MCL 333.16174.  
(d) Continuing education: submit  
proof of completing 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
X
X
X
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.  
(e) Pass MPJE: retake and pass the  
MPJE as provided in R 338.519.  
(f) Submit proof of completing a 1-  
time training in identifying victims of  
X
X
X
X
X
Page 16  
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) 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  
of being granted a limited license.  
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  
of being granted a limited license.  
X
(i) Examination: pass the NAPLEX  
within 2 years before applying for  
relicensure, as provided in R 338.519.  
(j) An applicant who is or has ever  
been licensed, registered, or certified in  
a health profession or specialty by any  
other state, the United States military,  
the federal government, or another  
country, shall do both of the following:  
X
X
X
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, which includes 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) 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.  
(4) For a pharmacist who has let his  
or her pharmacist license lapse in this  
state, but who holds a current and valid  
pharmacist license in good standing in  
License lapsed  
more than 3 years,  
but less than 8 years  
License lapsed  
0-3 Years  
License lapsed  
8 or more years  
Page 17  
another state or a Canadian province:  
(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.  
X
X
X
X
X
X
(c) Submit fingerprints: submit  
fingerprints as required under section  
16174(3) of the code, MCL 333.16174.  
X
X
(d) Continuing education: submit  
proof of completing 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 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.  
X
X
X
(f) Examination: retake and pass the  
MPJE as provided in R 338.519.  
X
X
X
(g) An applicant who is or has ever  
been licensed, registered, or certified in a  
health profession or specialty by any  
other state, the United States military, the  
federal government, or another country,  
shall do both of the following:  
X
X
(i) Disclose each license, registration,  
or certification on the application form.  
(ii) Satisfy the requirements of  
section 16174(2) of the code, MCL  
Page 18  
333.16174, which includes verification  
from the issuing entity showing that  
disciplinary proceedings are not pending  
against the applicant and sanctions are  
not in force at the time of application.  
(5) If relicensure is granted and it is determined that a sanction has been imposed by  
another state, the United States military, the federal government, or another country, the  
disciplinary subcommittee may impose appropriate sanctions under section 16174(5) of  
the code, MCL 333.16174.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
PART 3. PHARMACY LICENSES  
R 338.531  
Pharmacy license; remote pharmacy license; applications;  
requirements.  
Rule 31. (1) An applicant for a pharmacy license or a remote pharmacy license shall  
submit to the department a completed application on a form provided by the department  
together with the requisite fee.  
(2) An applicant shall submit all of the following information:  
(a) Certified copies of articles of incorporation or partnership certificates and  
certified copies of assumed name certificates, if applicable.  
(b) Submission of fingerprints for the purpose of a criminal history background  
check required under section 17748(6) of the code, MCL 333.17748.  
(c) A federal employer identification number (FEIN) certificate.  
(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,  
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.  
(k) 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.  
Page 19  
(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.  
(l) If the applicant is or has ever been licensed, registered, or certified as a  
pharmacy by any other state, the United States military, the federal government, or  
another country, the applicant shall do both of the following:  
(i) Disclose each license, registration, or certification on the application form.  
(ii) Submit verification from the issuing entity showing that disciplinary proceedings  
are not pending against the applicant and sanctions are not in force at the time of  
application.  
(3) The department shall issue only 1 pharmacy license per address. If an applicant  
has more than 1 location at which drugs are prepared or dispensed, each address location  
must obtain a separate license.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.531a Remote pharmacy waiver from mileage requirement.  
Rule 31a. (1) An applicant seeking a remote pharmacy license may apply to the  
board for a waiver from the prohibition of locating a remote pharmacy within 10 miles of  
another pharmacy in section 17742a(2)(c) of the code, MCL 333.17742a, by submitting a  
completed application to the department, on a form provided by the department.  
(2) The applicant shall submit the following with the application:  
(a) A map showing the location of any existing pharmacies within 10 miles of the  
proposed remote pharmacy if the remote pharmacy will not be located at a hospital or  
mental health facility.  
(b) A list and explanation of the services or availability of services that will be  
offered at the remote pharmacy or otherwise not readily available to patients that are  
different from the services offered at a pharmacy located within 10 miles of the proposed  
remote pharmacy.  
(c) A statement of facts to support the statement of 1 or more of the following:  
(i) The proposed remote pharmacy is located in an area where there is limited  
access to pharmacy services.  
(ii) The proposed remote pharmacy will offer a service or the availability of a  
service that is unique from other pharmacies in the 10-mile radius from the remote  
pharmacy and the service will satisfy an unmet need of the surrounding community.  
(iii) There exists a limitation on travel that justifies waiving the requirement.  
(iv) There are other compelling circumstances that justify waiving the  
requirement.  
(3) If the waiver is denied, the application is considered closed unless within 30  
days of receipt of the denial, the applicant notifies the department that it is requesting a  
hearing on the matter.  
History: 2022 MR 4, Eff. Feb. 22, 2022.  
Page 20  
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  
date, whichever is later, the accreditation is void, and a pharmacy shall obtain  
accreditation or an inspection from an organization that satisfies subrule (1) of this rule.  
History: 2020 AACS.  
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, Maryland, 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 no  
cost at http://www.usp.org/compounding, or at a cost of 10 cents per page from the Board  
of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and  
Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing,  
Michigan, 48909.  
(3) 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.  
Page 21  
(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 (2021).  
(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 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.  
(7) An outsourcing facility may compound drugs that appear on an FDA shortage  
list, if the bulk drug substances used to compound the drugs comply with the criteria  
specified in this rule.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 from the date of application.  
(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) Unless accredited by a national accrediting organization, recognized by the  
board, an applicant for licensure or renewal of an in-state or out-of-state pharmacy 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-Verified Pharmacy Program (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.  
Page 22  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 of 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(3), is approved by the department, and is accredited or an organization satisfying  
the requirements of R 338.532(1) verifies that the pharmacy is USP compliant.  
(4) An outsourcing facility shall not start or resume providing sterile compounding  
services in this state until the outsourcing facility is approved by the department and  
verifies that it is compliant with the requirements of R 338.533(4) to (7).  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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. A pharmacy  
department must be locked when the pharmacist is not on the premises.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
Page 23  
R 338.537 Professional and technical equipment and supplies.  
Rule 37. A pharmacy must be equipped with both of the following:  
(a) The necessary facilities, apparatus, utensils, and equipment to permit the  
pharmacy to provide prompt and efficient services.  
(b) Current print, electronic, or internet accessible editions of the Michigan  
pharmacy laws and rules, and at least 2 current pharmacy reference texts that pertain to  
pharmacology, drug interactions, or drug composition.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.538 Closing pharmacy.  
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 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) How controlled substances will be disposed.  
(c) How non-controlled substances will be disposed.  
(d) The location where records and prescription files will be stored.  
(2) A pharmacy shall comply with all applicable federal requirements for  
discontinuing operation as a pharmacy that dispenses controlled substances.  
(3) Records must be maintained for the same amount of time that is required if the  
pharmacy remained open.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.539 Relicensure and renewal.  
Rule 39. (1) An applicant with an expired license may apply for relicensure of a  
pharmacy license by submitting to the department a completed application on a form  
provided by the department, satisfying all the requirements for licensure in part 3 of these  
rules, R 338.531 to R 338.539, and paying the requisite fee.  
(2) A pharmacy that renews its license during the license renewal period submit to  
the department a completed application, on a form provided by the department, together  
with the requisite fee.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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:  
Page 24  
(a) A criminal history background check required pursuant to 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. 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 general education development certificate (GED).  
(C) A parent-issued diploma for home schooled individuals.  
(D) Completion of post-secondary education, including either an associate’s degree,  
a bachelor’s degree, or a master’s degree.  
(ii) Completion of a training program that includes, but is not limited to, all of the  
following subjects:  
(A) Knowledge and understanding of laws in this state and federal laws relating to  
the distribution of drugs and devices.  
(B) Knowledge and understanding of laws in this state and federal laws relating to  
the distribution of controlled substances.  
(C) Knowledge and understanding of quality control systems.  
(D) Knowledge and understanding of the USP standards relating to the safe storage  
and handling of prescription drugs.  
(E) Knowledge and understanding of pharmaceutical terminology, abbreviations,  
dosages, and format.  
(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 manufacturer’s resident state board of pharmacy or  
verified-accredited wholesale distributors (VAWD) accreditation dated not more than 2  
years prior to the application.  
(j) An applicant that is or has ever been licensed, registered, or certified as a  
manufacturer by any other state, the United States military, the federal government, or  
another country, shall do both of the following:  
Page 25  
(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)(i) of this rule to the department within 30 days of the  
change.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.553 Persons to whom prescription drugs or devices may be sold.  
Rule 53. A manufacturer may only supply, distribute, sell, barter, or otherwise  
transfer prescription drugs or devices to persons who are licensed by the board to  
distribute, prescribe, or dispense prescription drugs or devices in or outside this state.  
History: 2020 AACS.  
R 338.555 Federal regulation on good manufacturing practice for finished  
pharmaceuticals; adoption by reference; compliance.  
Rule 55. (1) The board approves and adopts by reference the current good  
manufacturing practice for finished pharmaceuticals regulations set forth in 21 CFR  
211.1 to 211.208 (2021).  
(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, Michigan, 48909.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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) 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.  
Page 26  
(2) A manufacturer shall comply with all applicable federal requirements for  
discontinuing a controlled substance business.  
(3) Records must be maintained for the same amount of time that is required if the  
manufacturer remains open.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 3 of these  
rules, R 338.531 to R 338.539, and paying the requisite fee.  
(2) A manufacturer that renews its license during the license renewal period shall  
submit to the department a completed application on a form provided by the department  
together with the requisite fee.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
PART 5. WHOLESALE DISTRIBUTOR AND  
WHOLESALE DISTRIBUTOR-BROKER LICENSE  
R 338.561 Pharmacy as wholesale distributor; licensure.  
Rule 61. A pharmacy shall obtain a license as a wholesale distributor under this part  
if the total number of dosage units of all prescription drugs distributed by the pharmacy  
to a person during any consecutive 12-month period is more than 5% of the total number  
of dosage units of prescription drugs distributed and dispensed by the pharmacy during  
the same 12-month period. The calculation of this 5% threshold must not include a  
distribution of a prescription drug that is exempt from the definition of wholesale  
distribution under 21 USC 353(e)(4).  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 pursuant to 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 any other state, the United States military, the  
federal government, or another country.  
Page 27  
(c) Satisfy the requirements of section 16174(2) of the code, MCL 333.16174,  
which include 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) Provide a copy of the FDA certification, if a certification is required by the  
FDA, for the site to be licensed, if the applicant is distributing biologicals.  
(i) 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. For individuals designated as a facility manager, the applicant shall  
provide proof, in the form of an affidavit, that the facility manager has achieved the  
following:  
(i) A high school equivalency education, or higher, defined as 1 of the following:  
(A) A high school diploma.  
(B) A GED.  
(C) A parent-issued diploma for home schooled individuals.  
(D) Completion of post-secondary education, including an associate’s, bachelor’s,  
or master’s degree.  
(ii) Completion of a training program that includes, but is not limited to, all of the  
following subjects:  
(A) Knowledge and understanding of laws in this state and federal laws relating to  
the distribution of drugs and devices.  
(B) Knowledge and understanding of laws in this state and federal laws relating to  
the distribution of controlled substances.  
(C) Knowledge and understanding of quality control systems.  
(D) Knowledge and understanding of the USP standards relating to the safe  
storage and handling of prescription drugs.  
(E) Knowledge and understanding of pharmaceutical terminology, abbreviations,  
dosages, and format.  
(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 VAWD of NABP or of a wholesale distributor-broker.  
(iv) Current employment with the applicant.  
(j) Provide a list or catalog of all drug products and devices to be distributed, if a  
wholesale distributor.  
(k) Submit an affidavit, at the time of the application for initial licensure, that the  
applicant facilitates deliveries or trades for at least 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, if a wholesale distributor-broker.  
Page 28  
(3) A wholesale distributor or wholesale distributor-broker that changes its facility  
manager shall submit all of the information required in subrule (2)(i) of this rule to the  
department within 30 days of the change.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.565 Persons to whom prescription drugs and devices may be sold.  
Rule 65 A wholesale distributor of prescription drugs or devices may supply,  
distribute, sell, barter, or otherwise transfer prescription drugs or devices only to persons  
who are licensed by the board to distribute, prescribe, or dispense prescriptions drugs or  
devices in or outside this state.  
History: 2020 AACS.  
R 338.567 Wholesale distributor practices; control of prescription drugs or  
devices; inspections.  
Rule 67. (1) A wholesale distributor that does not physically touch prescription  
drugs or devices shall file an affidavit with the department signed by the PIC or facility  
manager attesting to this fact.  
(2) A wholesale distributor that previously filed an affidavit under subrule (1) of this  
rule shall not obtain custody and control of drugs or devices until both of the following  
have occurred:  
(a) The licensee provides written notification to the department of physical  
custody.  
(b) The department conducts an inspection of the premises.  
History: 2020 AACS.  
R 338.569  
Wholesale distributor and wholesale distributor-broker  
recordkeeping and policy requirements.  
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,  
Page 29  
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.  
(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) A wholesale distributor-broker shall establish and maintain a list of officers,  
directors, managers, and other persons 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 at least 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 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 subrules (5) and (7) 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.  
(7) A wholesale distributor shall retain the records described in this rule for a  
minimum of 2 years after the disposition of the prescription drugs or devices.  
(8) A purchasing pharmacy using a wholesale distributor-broker to facilitate a  
transaction from a pharmacy that is not licensed in Michigan shall request the transaction  
history, transaction statement or transaction information for the drugs supplied.  
Page 30  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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.  
(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 AACS.  
R 338.573 Examination of materials; returned, damaged and outdated  
prescription drugs or devices.  
Rule 73. (1) A wholesale distributor shall comply with both of the following  
provisions that pertain to the examination of materials:  
(a) Each outside shipping container must be visually examined upon receipt for the  
identity of the prescription drug or devices and to prevent the acceptance of contaminated  
prescription drugs or devices or prescription drugs or devices otherwise unfit for  
distribution. The examination must be adequate to reveal container damage that would  
suggest possible contamination or other damage to the contents.  
Page 31  
(b) Each outgoing shipment must be visually inspected for identity of the  
prescription drug products and to ensure that prescription drugs or devices that have been  
damaged in storage or held under conditions that are inconsistent with USP compendium  
standards are not delivered.  
(2) All of the following provisions apply to returned, damaged, and outdated  
prescription drugs or devices:  
(a) Prescription drugs or devices that are outdated, damaged, deteriorated,  
misbranded, or adulterated, must be quarantined and physically separated from other  
prescription drugs or devices until they are destroyed or returned to the supplier.  
(b) Any immediate or sealed outer or sealed secondary containers of any  
prescription drugs or devices that have been opened or used must be identified as such  
and the drugs or devices must be quarantined and physically separated from other  
prescription drugs or devices until they are either destroyed or returned to the supplier.  
(c) If the conditions under which a prescription drug has been returned cast doubt  
on the drug’s safety, identity, strength, quality, or purity, then the drug must be destroyed  
or returned to the supplier, unless examination, testing, or other investigation proves that  
the drug meets appropriate standards of safety, identity, strength, quality, and purity. In  
determining whether the conditions under which the drug has been returned cast doubt on  
the drug’s safety, identity, strength, quality, or purity, the wholesale distributor shall  
consider the conditions under which the drug has been held, stored, or shipped before or  
during its return and the condition of the drug and its container, carton, or labeling as a  
result of storage or shipping.  
(3) The recordkeeping requirements of R 338.569 must be followed.  
History: 2020 AACS.  
R 338.575 Closing a wholesale distributor or wholesale distributor-broker.  
Rule 75. (1) A wholesale distributor that is ceasing operations shall return the  
wholesale distributor license and controlled substance license, if applicable, to the  
department, and 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) How controlled substances will be disposed.  
(c) How noncontrolled substances will be disposed.  
(d) The location where records and prescription files will be stored.  
(2) A wholesale distributor shall comply with all applicable federal requirements for  
discontinuing a business that handles a controlled substance.  
(3) A wholesale distributor-broker that is ceasing operations shall return the  
wholesale distributor-broker license and provide the department with written notification  
of the location where records will be stored at least 15 days prior to closing.  
(4) Records must be maintained for the same amount of time that is required if the  
wholesale distributor or wholesale distributor-broker remained open.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
Page 32  
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 3 of these rules, 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 at  
least 50 qualified pharmacies and that each pharmacy holds a license in good standing as  
a pharmacy from the state in which it is located at the time of renewal.  
History: 2022 MR 4, Eff. Feb. 22, 2022.  
PART 6. PRACTICE OF PHARMACY  
R 338.582 Prescription drug labeling and dispensing.  
Rule 82. (1) All labeling of prescription drugs must comply with the requirements of  
the code and sections 351 to 399f of the Federal Food, Drug, and Cosmetic Act, 21 USC  
351 to 399f.  
(2) All containers in which prescription medication is dispensed must bear a label  
that contains, at a minimum, all of the following information:  
(a) Pharmacy name and address.  
(b) Prescription number.  
(c) Patient's name.  
(d) Date the prescription was dispensed.  
(e) Prescriber's name.  
(f) Directions for use.  
(g) The name of the medication and the strength, unless the prescriber indicates "do  
not label."  
(h) The quantity dispensed, if applicable.  
(i) The name of the manufacturer or supplier of the drug if the drug has no brand  
name, unless the prescriber indicates “do not label.”  
(3) If a drug is dispensed that is not the brand prescribed, the pharmacy shall notify  
the purchaser and the prescription label must indicate both the name of the brand  
prescribed and the name of the brand dispensed. If the dispensed drug does not have a  
brand name, the prescription label must indicate the name of the brand prescribed  
followed by the generic name of the drug dispensed. This subrule does not apply if the  
prescriber indicates "do not label."  
(4) If drug product selection takes place, the brand name or the name of the  
manufacturer or supplier of the drug dispensed must be noted on the prescription.  
(5) This rule does not apply to pharmacy services provided in a medical institution.  
Page 33  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
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 dispensed.  
(h) The name of the prescriber.  
(i) The name of the patient for whom the drug was prescribed.  
(j) The price for which the drug was sold to the purchaser.  
(2) Notwithstanding R 338.582, the information required in this rule must appear on  
either the prescription label or on a combination label and receipt.  
(3) For prescription services that are covered by a third-party pay contract, the price  
included in the receipt is the amount paid by the patient.  
(4) A pharmacist shall retain a copy of the receipt for a period of 90 days. The  
inclusion of the information required in this rule in the automated data processing system  
or on the written prescription form and the retention of the form constitutes retaining a  
copy of the receipt. The physical presence of the prescription form in the pharmacy or the  
ability to retrieve the information from the automated data processing system constitutes  
compliance with the requirement of having the name and address of the pharmacy on the  
form.  
(5) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.583a Pharmacy acquisition and distribution records.  
Rule 83a. (1) A pharmacy must keep and make available for inspection all  
acquisition and distribution records for prescription and non-prescription drugs and  
devices, such as 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.  
Page 34  
(c) The dates of receipt, if applicable, and distribution of the prescription drugs or  
devices.  
History: 2022 MR 4, Eff. Feb. 22, 2022.  
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; 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, then 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 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 pharmacy shall keep the original prescription record for 5 years. After 2 years  
from 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 upon request.  
(6) This rule does not apply to pharmacy services provided in a medical institution.  
History: 2020 AACS; 2022 MR 4, Eff. Feb. 22, 2022.  
R 338.584a Electronic transmission of prescription; waiver of electronic  
transmission.  
Rule 84a. (1) Until the enforcement date established by the federal Centers for  
Medicare and Medicaid Services for the Medicare electronic transmission requirement a  
prescription may be electronically transmitted, and a pharmacist may dispense the  
electronically transmitted prescription, if all of the following conditions are satisfied:  
(a) The prescription is transmitted to the pharmacy of the patient's choice and  
occurs only at the option of the patient.  
Page 35  
(b) The electronically transmitted prescription includes all of the following  
information:  
(i) The name and address of the prescriber.  
(ii) An electronic signature or other board-approved means of ensuring prescription  
validity.  
(iii) The prescriber's telephone number for verbal confirmation of the  
order.  
(iv) The time and date of the electronic transmission.  
(v) The name of the pharmacy intended to receive the electronic transmission.  
(vi) Unless as otherwise authorized under section 17754(1)(b) of the code, MCL  
333.17754, the full name of the patient for whom the prescription is issued.  
(vii) All other information that must be contained in a prescription under R  
338.584.  
(c) The pharmacist exercises professional judgment regarding the accuracy,  
validity, and authenticity of the transmitted prescription.  
(d) All requirements in section 17754 of the code, MCL 333.17754, are met.  
(2) An electronically transmitted prescription that meets the requirements of subrule  
(1) of this rule is the original prescription.  
(3) Effective the enforcement date established by the federal Centers for Medicare  
and Medicaid Services for the Medicare electronic transmission requirement prescribers  
shall, unless an exception under section 17754a of the code, MCL 333.17754a, applies,  
electronically transmit a prescription consistent with both of the following requirements:  
(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.  
(b) All the requirements in R 338.584 are met.  
(4) A prescriber applying for a waiver from section 17754a of the code, MCL  
333.17754a, shall submit a completed application to the department, on a form provided  
by the department, and shall satisfy either of the following requirements:  
(a) The prescriber provides evidence satisfactory to the department that the  
prescriber has received a waiver of the Medicare requirement for the electronic  
transmission of controlled substances prescriptions from the federal Centers for Medicare  
and Medicaid Services.  
(b) The prescriber is unable to meet the requirements of section 17754a(1) or (2) of  
the code, MCL 333.17754a, and also meets 1 of the following:  
(i) The prescription is dispensed by a dispensing prescriber.  
(ii) The prescriber demonstrates economic hardship or technological limitations  
that are not within the control of the prescriber.  
(iii) The prescriber demonstrates by attesting to exceptional circumstances, including,  
but not limited to, the following:  
(A) Intention to cease practice within the next twelve months.  
(B) Limited practice due to an illness or other unforeseen event.  
(iv) The prescriber issues prescriptions from a non-profit charitable medical  
clinic.  
(5) A waiver is valid for 2 years and is applicable to the specific circumstances  
included in the application. A waiver may be renewed by application to the department.  
History: 2022 MR 4, Eff. Feb. 22, 2022.  
Page 36