Pharmacy General Rules - ORR 2020-128 LR  
Public Comment Summary  
Rules Committee’s Recommendations and Board Response to September 21, 2021, Public Comments  
Testimony/Comments Received:  
Rose M. Baran, PharmD  
Kendra Croker, Manager, Regulatory Affairs, Telepharm  
Deeb D. Eid, PharmD, RPh, Advisor, Pharmacy Regulatory Affairs, CVS Health  
Charlie Mollien  
Julie L. Novak, Chief Executive Officer, Michigan State Medical Society (MSMS)  
Jon Pritchett, Pharm D., RPh., BCSCP, Pharmacy Program Director, Accreditation Commission for Health Care (ACHC)  
Brian Sapita, Director of Government Affairs, Michigan Pharmacists Association (MPA)  
General Comment/Mollien - The General Rules need to be consistent with the Controlled Substances Rules. Any changes made to  
the Controlled Substances Rules should also be considered and appropriately updated in the General Rules for consistency.  
Rule 338.501 Definitions.  
Rule Numbers  
Section (1)  
Commenter  
Mollien  
Comment  
“Written” is used throughout the rules without a definition. Add a definition making it clear that  
“written” allows for paper or electronic forms.  
Rules Committee The Rules Committee agrees with the comment to add a definition of “written” to clarify that it allows for paper or  
Response  
electronic forms.  
Board Response  
The Board agrees with the comment that the term “written” should be added to the definitions with clarification  
that the term allows for paper or electronic forms.  
R 338.501 Definitions.  
Rule 1. (1) As used in these rules:  
October 4, 2021  
(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.  
(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 an individual 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) “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.  
(h) (i) “Manual signature” means a signature that is handwritten or computer-generated if a prescription is electronically transmitted  
as defined in section 17703(7)(8) of the code, MCL 333.17703(7).  
(i) (j) “Practical experience” means professional and clinical instruction in, but not limited to, all of the following areas:  
(i) Pharmacy administration and management.  
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(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) (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.  
(2) Unless otherwise defined in these rules, the The terms defined in the code have the same meaning when used in these rules.  
Rule 338.505  
Rule Numbers  
Section (2)  
Inspection of applicants and licensees.  
Commenter  
Comment  
Sapita  
Regarding R 338.505 subsection 2 which specifies “prelicensure inspection”. Subsection 1  
references both applicants and license holders but subsection 2 now excludes inspections of license  
holders. We suggest removing this language and keeping the original language.  
Rules Committee The Rules Committee agrees with the comment that clarification is needed. The Rules Committee recommends  
Response  
modifying (2) to “Inspections in provision (1) must not extend to any of the following information, however, the  
information is subject to a disciplinary investigation.”  
Board Response  
The Board agrees with the comment that provision (1) and (2) are inconsistent with the addition of  
“prelicensure” in (2) and, therefore, “prelicensure should be deleted, and additional language should be added to  
(2), “Inspections in provision (1) must not extend to any of the following information, however, the information  
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is subject to a disciplinary investigation.”  
R 338.505 Inspection of applicants and licensees.  
Rule 5. (1) The board, board inspector, board agent, or approved 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 make an inspection  
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) The A prelicensure inspection inspections in provision (1) 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.  
Rule 338.523  
Rule Numbers  
Section (2)(a)(ii)  
Pharmacist license by endorsement; requirements.  
Commenter  
Comment  
Sapita  
Regarding Canadian pharmacists, pharmacists throughout the state of Michigan are having a  
difficult time finding jobs in the current job market. We suggest removing subsection (ii).  
Rules Committee The Rules Committee declines the comment as endorsement of Canadian licensees is authorized by the Public Health  
Response  
Code.  
Board Response  
The Board declines the comment as endorsement of Canadian licensees is authorized and required by the Public  
Health Code.  
R 338.523 Pharmacist license by endorsement; requirements.  
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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) that the he He or she is currently licensed holds a license in good standing as a pharmacist in another state and submits the  
NABP licensure transfer report to the department.  
or he or she successfully passed the foreign pharmacy graduate examination administered by NABP and was initially licensed by  
examination in another state.  
(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) 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. 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) Submit the MPJE examination score report and NABP licensure transfer report to the department.  
(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.  
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(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.  
(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.  
Rule 338.531a  
Rule Numbers  
Section (2)(a)  
Remote pharmacy waiver from mileage requirement.  
Commenter  
Comment  
Croker  
Delete the requirement of a map as it is already requested with the application for the remote  
pharmacy.  
Section (2)(b)  
Eid  
Modify as follows: (b) A list and explanation of the services or availability of services that will be  
offered at the remote pharmacy that are different from the services offered at a pharmacy or  
otherwise not readily available to patients located within 10 miles of the proposed remote  
pharmacy.  
Comment: CVS Health supports the addition of language ensuring there is a route for remote  
pharmacies to obtain a waiver from milage requirements. This will increase access to care for  
patients and allow remote pharmacies that otherwise would not be allowed to exist, to provide  
services and patient care. Telepharmacy is nationally accepted by the National Association of  
Boards of Pharmacy (NABP), American Hospital Pharmacists Association (ASHP), and American  
Pharmacist Association (APhA) to create new or maintain current patient access to pharmacy  
services.1,2,3 While the milage restriction is contained in MI statute, it is recommended that the  
Department moves forward with language for a waiver from milage requirements. Many other  
states such as AZ, HI, ID, IL, ND, SD, UT, WV, and WI do not have milage restrictions.4,5,6  
Studies have shown that pharmacy deserts exist in urban areas, amongst minority communities, and  
are not just limited to rural geographies.7 Using an evidenced based law-making philosophy  
showcases that studies have not shown that a milage restriction ensures an increase in patient safety  
or a decrease in patient harm.  
Add in the language above to strengthen the outcome of the rule is suggested.  
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Rationale: Addition of “and explanation” to 2(b) will ensure the Department/Board has a clearer  
understanding of the services that will be offered rather than just a “list”. It is observed that  
statement 2(c)(ii) would be optional since they only need to provide a statement of facts for one of  
more of what is listed in (i-iv). Addition of “or otherwise not readily available to patients” to 2(b)  
ensures the application is inclusive of services that may not be readily available to patients  
currently.  
Section (2)(c)(i)  
Section (2)(c)(i)  
and (ii)  
Sapita  
Croker  
MPA would like to urge the board to define what “limited access” actually means.  
Delete (i) and (ii).  
Section (2)(c)(ii)  
Sapita  
Given the ambiguity of the word “unique”, how would the board verify that the service provided by  
a remote pharmacy is “unique”.  
Rules Committee Section (2)(b) Eid - The Rules Committee agrees with the comment to modify (b) as follows:  
Response  
“A list and explanation of the services or availability of services that will be offered at the remote pharmacy that are  
different from the services offered at a pharmacy or otherwise not readily available to patients located within 10 miles  
of the proposed remote pharmacy.”  
Sections (2)(c)(i) and (ii) Sapita – The Rules Committee declines to define “limited access” or “unique” to avoid  
unintentionally limiting those who may qualify for a waiver.  
Section (2)(a) Croker – The Rules Committee declines to delete the requirement of a map as it is needed with the  
application for the waiver.  
Section (2)(c)(i) and (ii) Croker - The Rules Committee declines to delete (i) and (ii) as they allow for additional reasons  
for a waiver and the Rules Committee does not want to further limit an applicant’s ability to request a waiver.  
Board Response  
Section (2)(b) - The Board agrees with the comment to modify (b) as follows:  
“A list and explanation of the services or availability of services that will be offered at the remote pharmacy that  
are different from the services offered at a pharmacy or otherwise not readily available to patients located within  
10 miles of the proposed remote pharmacy.”  
Sections (2)(c)(ii) and (ii) – The Board declines to define “limited access” or “unique” to avoid unintentionally  
limiting those who may qualify for a waiver.  
Section (2)(a) – The Board declines to delete the requirement of a map as it is needed with the application for the  
waiver.  
Section (2)(c)(i) and (ii) - The Board declines to delete (i) and (ii) as they allow for additional reasons for a  
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waiver and the Board does not want to further limit an applicant’s ability to request a waiver.  
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 that are  
different from the services offered at a pharmacy or otherwise not readily available to patients 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.  
Rule 338.534  
Rule Numbers  
Section (3)  
Inspections.  
Commenter  
Pritchett  
Comment  
We have learned over the course of this year that R 338.534 was modified to require all applicants  
for licensure as a sterile compounding pharmacy to have a physical inspection and corresponding  
report completed within 18 months of application.  
In previous years, the pharmacy was required to submit evidence of current accreditation, or an  
inspection report completed within 18 months of application. My understanding is that this was  
originally put together as an either/or option because procedural differences by which the various  
inspection and accreditation bodies operate.  
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Requiring an inspection within 18 months of application presents a problem with the previously  
approved PCAB process. Accreditations with ACHC are provided on a 36-month cycle, which  
aligns with accreditation programs provided in other areas of the healthcare industry as well as  
requirements issued by the Centers for Medicare and Medicaid Services (CMS). A survey occurs  
prior to each new accreditation cycle, thus a survey roughly every 36 months. This creates a  
misalignment with the Michigan licensure schedule of renewal every 2 years; some pharmacies,  
depending on where they are in their accreditation cycle, will not be scheduled for a survey within  
the 18 months preceding renewal of their licensure.  
In addition, this this challenge, COVID-19 has created an additional burden. Early in 2021  
accreditation organizations were permitted to perform remote surveys in lieu of on-site surveys, of  
which PCAB did many. The current requirement is that a “physical” inspection is to have occurred,  
so a strict reading of the rule would mean that the board-permitted virtual survey would not be  
compliant with the rule.  
Currently, PCAB accredits approximately 100 pharmacies for sterile compounding in Michigan.  
Nearly 30 were surveyed with an approved virtual survey in 2021, so the question remains as to  
whether or not that will satisfy the licensure requirement for renewal. Of the remaining pharmacies,  
approximately ½ of them would require some sort of off-cycle survey in order to meet the licensure  
window, which presents a considerable unexpected financial strain on the pharmacy as well as a  
resource burden on ACHC.  
ACHC requests that the rule be returned to requiring either evidence on a current accreditation or a  
physical inspection and corresponding report completed within 18 months of application. We would  
also like to see clarification about acceptance of the use of virtual surveys during a public health  
emergency, as the issues surrounding COVID-19 appear to be ongoing.  
Rules Committee The Rules Committee agrees with the comment that the rule should be modified to allow for virtual inspections if the  
Response  
inspection entity determines that it is the best option at the time but declines the suggestion to increase the time between  
inspections to 36 months as the Rules Committee believes allowing more time between inspections is not in the best  
interest of the public.  
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Board Response The Board agrees that virtual inspections should be acceptable as the board approves the entities that provide the  
inspections and can refuse to renew their status as board approved if they do not provide thorough inspections. Further,  
the Board agrees that a pharmacy that has been accredited should not have to submit an inspection within 18 months  
before the date of an application. The Board will add the following language to (3) “unless accredited by a national  
accrediting organization, recognized by the board, an … .”  
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) An Unless accredited by a national accrediting organization, recognized by the board, an applicant for licensure or renewal  
of a an in-state or out-of-state pharmacy that will provide sterile compounded pharmaceuticals in this state shall have all of the  
following:  
(a) An an onsite physical inspection and submit a physical 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 any 1 of the following:  
(i)(a) The department.  
(ii)(b) The national association of boards of pharmacy verified pharmacy program NABP-Verified Pharmacy Program (NABP-  
VPP).  
(iii)(c) An accrediting organization according to R 338.532.  
(iv)(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.  
(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.  
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Rule 338.561  
Pharmacy as wholesale distributor; licensure.  
Rule Numbers  
Commenter  
Comment  
Sections (a) to (d) Mollien  
Do not delete these exemptions. These exemptions remain applicable under 21 USC 353(e)(4).  
Rules Committee The Rules Committee declines the comment to keep (a) through (d) as they are already included in the definition of  
Response “wholesale distribution” under 21 USC 353(e)(4).  
Board Response The Board declines the comment to keep (a) through (d) as they are already included in the definition of “wholesale  
distribution” under 21 USC 353(e)(4).  
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 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).  
(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.  
Rule 338.563  
Rule Numbers  
Section (2)(h)  
Wholesale distributor; wholesale distributor-broker; application for licensure; requirements.  
Commenter  
Mollien  
Comment  
Clarify if this FDA certification requirement is necessary and if it is necessary whether it should  
only apply to distributions of blood and blood products.  
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Rules Committee The Rules Committee agrees that (h) should be deleted as there is no FDA certification for a wholesale distributor who is  
Response distributing biologicals.  
Board Response The Board declines the comment to delete (h) and will add “if required by the FDA” to the rule.  
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 provide all of the following information:  
(a) Provide A a criminal history background check required pursuant to section 17748(6) of the code, MCL 333.17748(6).  
(b) Proof of registration or licensure from every state where the applicant currently holds or has ever held a license or registration.  
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.  
(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.  
(c)(d) Provide Certified certified copies of articles of incorporation or certificates of partnership and assumed names if applicable.  
(d) (e) Provide The the identity and address of each partner, officer, or owner as applicable.  
(e)(f) Provide a A completed compliance checklist.  
(f)(g) Provide a FEIN certificate. list or catalog of all drug products and devices to be distributed.  
(g)(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.  
(h)(i) Unless exempt under section 17748(2) of the code, MCL 333.17748(2), provide 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) Proofproof, in the form of an affidavit, that the facility manager has achieved the following:  
(Ai) A high school equivalency education, or higher, defined as 1 of the following:  
(IA) A high school diploma.  
(IIB) A general education development certificate (GED).  
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(IIIC) A parent-issued diploma for home schooled individuals.  
(IVD) Completion of post-secondary education, including an associate’s, bachelor’s, or master’s degree.  
(Bii) Completion of a training program that includes, but is not limited to, all of the following subjects:  
(IA) Knowledge and understanding of laws in this state and federal laws relating to the distribution of drugs and devices.  
(IIB) Knowledge and understanding of laws in this state and federal laws relating to the distribution of controlled substances.  
(IIIC) Knowledge and understanding of quality control systems.  
(IVD) Knowledge and understanding of the USP standards relating to the safe storage and handling of prescription drugs.  
(VE) Knowledge and understanding of pharmaceutical terminology, abbreviations, dosages, and format.  
(Ciii) Experience equal to either of the following:  
(IA) 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.  
(IIB) 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.  
(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.  
Rule 338.569  
Wholesale distributor and wholesale distributor-broker recordkeeping and policy requirements.  
Rule Numbers  
Commenter  
Comment  
Section (4)  
Mollien  
These rules create a significant public health and safety gap that allows introduction of counterfeit  
medications into the closed distribution supply chain. To close this gap, clarify in this ruleset that  
any purchasing pharmacy using a wholesale distributor-broker to facilitate a transaction from a  
pharmacy not licensed in Michigan shall request the transaction history, transaction statement or  
transaction information for the drugs supplied.  
Section (6)  
Mollien  
Change to “department, board, and …”  
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Rules Committee Section (4) and (6) - The Rules Committee agrees with the comment that a purchasing pharmacy that is using a broker to  
Response  
facilitate the transaction from a pharmacy that is not licensed in Michigan should request the transaction history,  
transaction statement, or transaction information for the drugs supplied, and  
board” should be added to (6).  
Board Response The Board agrees with the comment that a purchasing pharmacy that is using a broker to facilitate the transaction from a  
pharmacy that is not licensed in Michigan should request the transaction history, transaction statement, or transaction  
information for the drugs supplied. The Board also agrees that “board” should be added to (6).  
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, 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.  
14  
(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.  
(4)(6) The records described in subrules (1) and (2) 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, and 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)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.  
(5)(7) A wholesale distributor shall retain theThe records described in this rule must be maintained 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.  
New Rule 583a  
Pharmacy acquisition and distribution records.  
Rule Numbers  
Commenter  
Comment  
Mollien  
The rules are missing the record retention requirements applicable to pharmacies related to non-  
control drug and device acquisition and distribution records.  
15  
ADD  
Pharmacy Acquisition and Distribution Records  
(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.  
(c) The dates of receipt, if applicable, and distribution of the prescription drugs or devices.  
Rules Committee The Rules Committee agrees with the comment that a rule regarding pharmacy acquisition and distribution records  
Response  
should be added.  
Board Response The Board agrees with the comment that for consistency with the controlled substances rules, a rule regarding pharmacy  
acquisition and distribution records should be added.  
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.  
(c) The dates of receipt, if applicable, and distribution of the prescription drugs or devices.  
Rule 338.584  
Rule Numbers  
Section (1)(g)  
Noncontrolled prescriptions.  
Commenter  
Comment  
Change 338.584(1)(g) to “Issue date of the prescription.” The prescriber will not know the date the  
Baran  
16  
prescription was dispensed when issuing a prescription.  
Section (1)(g)  
Novak  
Under subrule (1), MSMS recommends that subrule (1)(g) be deleted. A prescriber does not know,  
at the time he or she is issuing a prescription, the date that it will be dispensed by a pharmacist.  
MSMS believes this language was added in error to Rule 84 or is intended to address another issue  
for which clarifying language is necessary.  
Rules Committee The Rules Committee agrees with the comments and recommends “dispensed” be modified to “issued.”  
Response  
Board Response The Board agrees with the comment to replace “dispensed” with “issued.”  
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:  
(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 dispensed 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 (f)(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 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:  
17  
(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.  
(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) (5) A pharmacy shall keep the original prescription record for 5 years. After 3 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 will becomebecomes 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) (6) This rule does not apply to pharmacy services provided in a medical institution.  
18  
Rule 338.584a  
Rule Numbers  
Section (1)  
Electronic transmission of prescription; waiver of electronic transmission.  
Commenter  
Novak  
Comment  
Under subrule (1), MSMS recommends that the date be consistent with the effective date in the  
statute and that there be consistency on this issue between Rule Set 2020-128 LR and Rule Set  
2020-82 LR.  
(1) Until October 1, 2021, or the date established by the federal Centers for Medicare and Medicaid  
Services for the Medicare electronic transmission requirement, whichever occurs later,…  
Align with controlled substances ruleset. Consider, “Until the enforcement date established by…”.  
MSMS requests the language in subrule (3) be amended to recognize the exceptions to electronic  
transmissions permitted by MCL §333.17754a, as follows:  
Section (1)  
Section (3)  
Mollien  
Novak  
(3) Effective October 1, 2021, or the date established by the federal Centers for Medicare and  
Medicaid Services for the Medicare electronic transmission requirement, whichever occurs later,  
prescribers shall, unless an exception under section 17754a of the code, MCL 333.17754a, applies,  
electronically transmit a prescription for a controlled substance 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 338.3161 are met.  
Section (3)  
Section (4)(b)(iv)  
Mollien  
Novak  
Conform with Rule 84(1).  
MSMS also recommends subrule (4)(b)(iv) be amended to identify examples of qualifying  
“exceptional circumstances, as follows:”  
(iv) The prescriber demonstrates attests to exceptional circumstances including, but not limited to,  
the following:  
A. Prescribing fewer than “X” prescriptions per year.  
B. Intention to cease practice within the next twelve months.  
C. Limited practice due to an illness or other unforeseen event.  
Rules Committee Section (1) and (3) effective date – The Public Health Code mandates electronic transmission of prescriptions as of  
Response  
October 1, 2021 but requires that the Department delay the implementation date of the mandate to the date established by  
the Federal Centers for Medicare and Medicaid Services for electronic transmission of prescription for controlled  
substances. Therefore, the Rules Committee recommends that the effective date be deleted, and the mandate be enforced  
on the date the mandate is enforced by the Federal Centers for Medicare and Medicaid Services.  
19  
Section (3) – The Rules Committee agrees with the comments that the rules should be amended to recognize the  
exceptions to electronic transmissions permitted by MCL §333.17754a.  
Section (4)(b)(iv) – The Rules Committee agrees with most of the clarifying language regarding “exceptional  
circumstances.” The Rules Committee agrees with adding (B) and (C), however, would suggest deleting (A) as this  
basis is really a claim for economic hardship, which is already in the rule.  
The Rules Committee agrees with the comment to clarify that an attestation will be used to show exceptional  
circumstances.  
For consistency with the Controlled Substances rules and Code, the following are recommended:  
• As the Code requires that if a CMS waiver is granted then the Department shall grant a waiver, provision (4)  
should be modified to allow for this waiver without meeting other requirements. Therefore, (4) will be  
reorganized.  
• The Controlled Substances Rules include the following provision which is not in the Pharmacy General Rules.  
For consistency it should be deleted from the CS rules or added to the General rules unless there is a valid reason  
to differentiate between a CS and non-CS. “This rule does not apply to the use of electronic equipment to  
transmit prescription orders within inpatient medical institutions.”  
Board Response The Board agrees with the following:  
Section (1) and (3) effective date – The Public Health Code mandates electronic transmission of prescriptions as of  
October 1, 2021 but requires that the Department delay the implementation date of the mandate to the date established by  
the Federal Centers for Medicare and Medicaid Services for electronic transmission of prescription for controlled  
substances. Therefore, the Rules Committee recommends that the effective date be deleted, and the mandate be enforced  
on the date the mandate is enforced by the Federal Centers for Medicare and Medicaid Services.  
Section (3) – The rules should be amended to recognize the exceptions to electronic transmissions permitted by MCL  
§333.17754a.  
Section (4)(b)(iv) – The clarifying language regarding “exceptional circumstances” will be added. The Board agrees with  
20  
adding (B) and (C), however, would suggest deleting (A) as this basis is really a claim for economic hardship, which is  
already in the rule.  
The comment to clarify that an attestation will be used to show exceptional circumstances will be added to (4)(b)(iv).  
As the Code requires that if a CMS waiver is granted then the Department shall grant a waiver, provision (4) should be  
modified to allow for this waiver without meeting other requirements. Therefore, (4) will be reorganized.  
The Controlled Substances Rules include the following provision which is not in the Pharmacy General Rules. For  
consistency it should be deleted from the CS rules or added to the General rules unless there is a valid reason to  
differentiate between a CS and non-CS. “This rule does not apply to the use of electronic equipment to transmit  
prescription orders within inpatient medical institutions.”  
R 338.584a Electronic transmission of prescription; waiver of electronic transmission.  
Rule 84a. (1) Until January 1, 2022, or the enforcement date established by the federal Centers for Medicare and Medicaid  
Services for the Medicare electronic transmission requirement, whichever occurs later, a prescription may be electronically  
transmitted, and a pharmacist may dispense the electronically transmitted prescription, if all of the following conditions are  
satisfied:  
(a) The prescription is transmitted to the pharmacy of the patient's choice and occurs only at the option of the patient.  
(b) The electronically transmitted prescription includes all of the following information:  
(i) The name and address of the prescriber.  
(ii) An electronic signature or other board-approved means of ensuring prescription validity.  
(iii) The prescriber's telephone number for verbal confirmation of the  
order.  
(iv) The time and date of the electronic transmission.  
(v) The name of the pharmacy intended to receive the electronic transmission.  
(vi) Unless as otherwise authorized under section 17754(1)(b) of the code, MCL 333.17754, the full name of the patient for  
whom the prescription is issued.  
(vii) All other information that must be contained in a prescription under R 338.584.  
(c) The pharmacist exercises professional judgment regarding the accuracy, validity, and authenticity of the transmitted  
prescription.  
21  
(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 January 1, 2022, or on the enforcement date established by the federal Centers for Medicare and Medicaid  
Services for the Medicare electronic transmission requirement, whichever occurs later, 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 all 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 (b) The  
prescriber also meets 1 of the following:  
(i) The prescriber provides evidence satisfactory to the department that he or she has received a waiver of the Medicare  
requirements for the electronic transmission of controlled substances prescriptions at the federal Centers for Medicare and  
Medicaid Services.  
(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.  
22  
Rule 338.587  
Prescription refill records; manual systems; profile systems; automated pharmacy data systems;  
nonapplicability to medical institution service; record confidentiality; and access.  
Rule Numbers  
Section (4)(e)  
Commenter  
Sapita  
Comment  
We believe the use of “on site” is confusing since after 2 years the prescription information can be  
kept electronically. We suggest that “on site” be removed from this subsection entirely.  
Rules Committee The Rules Committee agrees to delete “on site” in (e).  
Response  
Board Response The Board agrees to delete “on site” in (e).  
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 complies with both of the following  
criteria:  
(a) The amount and date dispensed must be entered on the prescription in an orderly fashion and the dispensing pharmacist initials  
the entry. If the pharmacist only initials and dates the prescription, then the full face amount of the prescription must be 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 complies with all of the following  
criteria:  
(a) Records must be created and maintained in written form. All original and refill prescription information for a particular  
prescription appears on single documents in an organized format. The 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.  
23  
(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. If a pharmacy  
technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must  
be recorded.  
(c) Prescription entries must be made on the record 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 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 complies  
with all of the following criteria:  
(a) All information that is pertinent to a prescription must be entered on the record, including all of the following information:  
(i) The prescription number.  
(ii) The patient's name and address.  
(iii) The prescriber's name.  
(iv) The prescriber's 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. If a pharmacy  
technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must  
be recorded.  
24  
(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. A pharmacy shall keep the original prescription record on site 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 will become the original prescription. The records are subject to inspection by the board or  
its agents. A procedure must be established to facilitate inspections.  
(c) The required information must be entered on the record for all prescriptions filled at the pharmacy, including nonrefillable  
prescriptions. This requirement is in addition to the requirements set forth in R 338.586.  
(d) The recording system must provide adequate safeguards against improper manipulation, the alteration of records, and the loss of  
records.  
(e) The recording system must have the capability of producing a printout of all original and refilled prescription data, including a  
prescription-by-prescription and refill-by-refill audit trial trail for any specified strength and dosage form of a controlled substance by  
either brand or generic name or an audit trail of controlled substance prescriptions written for a particular patient or by a particular  
practitioner. A printout of an audit trail or other required information must be made available to an authorized agent of the board upon  
request. The prescription data must be maintained on site for 5 years. Data older than 16 months 2 years must be provided within 72  
hours of the time the request is first made by the agent. Prescription data for the most current 16 months 2 years must be readily  
retrievable on site and available for immediate review.  
(f) If the automated data processing system is inoperative for any reason, then the pharmacist shall ensure that all refills are  
authorized and that the maximum number of refills is not exceeded. When the automated data processing system is restored to  
operation, the pharmacist shall enter the information regarding prescriptions filled and refilled during the inoperative period into the  
automated data processing system within 48 hours.  
(g) A pharmacy shall make arrangements with the supplier of data processing services or materials to ensure that the pharmacy  
continues to have adequate and complete prescription and dispensing records if the relationship with the supplier terminates for any  
reason. A pharmacy shall ensure continuity in the maintenance of records.  
(h) The automated data processing system must be an integrated system that 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.  
25  
Rule 338.588  
Rule Numbers  
Section (3)  
Automated devices.  
Commenter  
Eid  
Comment  
Modify to: (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. A secured, lockable, and privacy enabled automated  
device located on the premise of the licensed pharmacy may be utilized as a means for  
patient’s or an agent of the patient to pick up prescription medications when and if a  
pharmacy is closed.  
Rationale: As technology continues to advance ensuring that patients can safely and securely pick  
up their medications from a pharmacy is a priority. Patients at times may not be able to get to a  
pharmacy to pick up or may have medications such as antibiotics or other emergent situations they  
need to obtain, but their pharmacy may be closed. Ensuring automated devices which are secured,  
locked, and guarantee privacy could expand access to care after hours or during lunch breaks/other  
closures and ensure patients have a route which is trustworthy to obtain their medications. Yeo et al.  
is a recent study which showcased the benefits of allowing such operational models.1 Other states  
such as AZ, CA, CT, DE, DC, FL, ID, IL, IN, IA, LA, ME, MD, MA, MO, MT, NV, OR, PA, RI,  
SC, SD, TX, WA, WV, and WY allow for such practices within their laws/rules.2,3,4  
Add in clarifying language to allow for use of automated devices as patient pick-up options within  
the premises of a licensed pharmacy is recommended.  
Rules Committee The Rules Committee agrees with the comment as it clarifies that a pharmacy may use an automated device within the  
Response  
pharmacy. The Rules Committee recommends changing the language by deleting “and if a pharmacy is closed.” In  
addition, for clarity with the addition of this language, add “only”, non-controlled, and modify “used” to “under control.”  
Board Response The Board agrees with the comment as it clarifies that a pharmacy may use an automated device within the pharmacy.  
The Rules Committee recommends changing the language by deleting “and if a pharmacy is closed.” In addition, for  
clarity with the addition of this language, add “only”, non-controlled, and modify “used” to “under control.”  
26  
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 only to deliver a non-controlled 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 under the control only by of a pharmacist or his  
or her pharmacy personnel under the personal charge of a pharmacist. A secured, lockable, and privacy enabled automated device  
located on the premise of the licensed pharmacy may be utilized as a means for a patient or an agent of the patient to pick up  
prescription medications.  
(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 under the control of the dispensing prescriber. A pharmacy shall not own, control, or operate  
an automatic dispensing device in a dispensing prescriber's office, unless the prescriber’s office is affiliated with a hospital consistent  
with section 17760 of the code, MCL 333.17760, and subrule (2)(h) of this rule. All of the following apply to the use of an automated  
device in a dispensing prescriber's office:  
(a) If a dispensing prescriber delegates the stocking of the automated device, then technologies must be in place and utilized to  
ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that  
complies with R 338.3154.  
(b) A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in that  
device as well as removed from that device.  
27  
(c) If any medication or device is dispensed from an automated device in a dispensing prescriber’s office, then documentation as to  
the type of equipment, serial numbers, content, policies, procedures, and location within the facility must be maintained by the  
dispensing prescriber for review by an agent of the board. This documentation must include at least all of the following information:  
(i) Manufacturer name and model.  
(ii) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.  
(iii) Policy and procedures for system operation that addresses, at a minimum, all of the following:  
(A) Accuracy.  
(B) Patient confidentiality.  
(C) Access.  
(D) Data retention or archival records.  
(E) Downtime procedures.  
(F) Emergency procedures.  
(G) Medication security.  
(H) Quality assurance.  
(5) An automated device that is to be used for furnishing medications for administration to registered patients in any hospital, county  
medical care facility, nursing home, hospice, or any other skilled nursing facility, as defined in section 20109(4) of the code, MCL  
333.20109(4), must be supplied and controlled by a pharmacy that is licensed in this state. The use of an automated device in these  
locations is not limited to the provisions of subrule (3) of this rule. If a pharmacist delegates the stocking of the device, then  
technologies must be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing bar-  
coding or another board-approved error-prevention technology. Each automated device must comply with all of the following  
provisions:  
(a) A pharmacy operating an automated device is responsible for all medications that are stocked and stored in that device as well as  
removed from that device.  
(b) If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial  
numbers, content, policies, procedures, and location within the facility must be maintained by the pharmacy for review by an agent of  
the board. The documentation must include at least all of the following information:  
(i) Name and address of the pharmacy responsible for the operation of the automated device.  
(ii) Name and address of the facility where the automated device is located.  
(iii) Manufacturer name and model number.  
(iv) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.  
(v) Policy and procedures for system operation that address, at a minimum, all of the following:  
28  
(A) Accuracy.  
(B) Patient confidentiality.  
(C) Access.  
(D) Data retention or archival records.  
(E) Downtime procedures.  
(F) Emergency procedures.  
(G) Medication security.  
(H) Quality assurance.  
(I) Ability to provide on demand to an agent of the board a list of medications qualifying for emergency dose removal without  
pharmacist prior review of the prescription or medication order.  
(6) An automated device that is operated at a location affiliated with a hospital, but not at the same physical address as the pharmacy,  
that is owned and operated by the hospital, must comply with section 17760 of the code, MCL 333.17760.  
(7) Records and electronic data kept by automated devices must meet all of the following requirements:  
(a) All events involving access to the contents of the automated devices must be recorded electronically.  
(b) Records must be maintained for 5 years by the pharmacy or dispensing prescriber and must be retrievable on demand for review  
by an agent of the board. The records must include all of the following information:  
(i) The unique identifier of the automated device accessed.  
(ii) Identification of the individual accessing the automated device.  
(iii) The type of transaction.  
(iv) The name, strength, dosage form, quantity, and name of the manufacturer of the drug accessed.  
(v) The name of the patient for whom the drug was ordered.  
(vi) Identification of the pharmacist responsible for the accuracy of the medications to be stocked or restocked in the automated  
device.  
(8) Policy and procedures for the use of the automated device must include a requirement for pharmacist review of the prescription or  
medication order before system profiling or removal of any medication from the system for immediate patient administration. This  
subrule does not apply to the following situations:  
(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R  
338.486(4)(j).  
(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c).  
29  
(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R  
338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to  
review the medication order.  
(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize  
any further dispensing within 48 hours.  
(e) The automated device is located in a dispensing prescriber's office.  
(9) A copy of all policies and procedures related to the use of an automated device must be maintained at the pharmacy responsible  
for the device's specific location or at the dispensing prescriber's office and be available for review by an agent of the board.  
30  
September 21, 2021  
Department of Licensing and Regulatory Affairs  
Bureau of Professional Licensing  
Boards and Committees Section  
PO Box 30670  
Lansing, MI 48909-8170  
Dear Policy Analyst,  
The Michigan Pharmacists Association (MPA) would like to thank the Michigan Board of Pharmacy within the  
Michigan Department of Licensing and Regulatory Affairs for allowing us to submit our comments on the  
proposed administrative rules 2020-128 LR, Pharmacy – General Rules governing the rules for pharmacy  
professionals. MPA represents pharmacists, pharmacy technicians, and student pharmacists across the state.  
We are strong proponents of offering increased access to care to all Michiganders in a safe and effective way.  
We would like to take this opportunity to changes to these rules.  
1. Regarding R 338.505 subsection 2 which specifies “prelicensure inspection”. Subsection 1 references  
both applicants and license holders but subsection 2 now excludes inspections of license holders. We  
suggest removing this language and keeping the original language.  
2. Regarding R 338.523 regarding Canadian pharmacists. Pharmacists throughout the state of Michigan  
are having a difficult time finding jobs in the current job market. We suggest removing subsection  
(ii).  
3. Regarding R 338.531a  
a. subsection 2(c)(i) which specifies “limited access to pharmacy services”. MPA would like to  
urge the board to define what “limited access” actually means.  
b. Subsection 2(c)(ii) which specifies “service that is unique from other pharmacies…”. Given  
the ambiguity of the word “unique”, how would the board verify that the service provided  
by a remote pharmacy is “unique”.  
4. Regarding R 338.586 subsection 4(e). which specifies “on site”. We believe the use of “on site” is  
confusing since after 2 years the prescription information can be kept electronically. We suggest that  
“on site” be removed from this subsection entirely.  
Again, the Michigan Pharmacists Association would like to thank you for taking the time to review our  
concerns. If you have any additional questions, I can be reached at the information below.  
Sincerely,  
Brian Sapita  
Director of Government Affairs  
Ph: 517-377-0254  
Email: Brian@MichiganPharmacists.org  
From: Jon Pritchett Pharm.D., RPh., BCSCP  
To: Ditschman, Andria (LARA)  
Subject: Board of Pharmacy - comments of rules revision - R 338.534  
Date: Friday, September 17, 2021 4:50:09 PM  
Attachments: image002.png  
image003.png  
image004.png  
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image006.png  
CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov  
Hello,  
I am the Pharmacy Program Director with Accreditation Commission for Health  
Care (ACHC), which provides sterile compounding accreditation through the  
Pharmacy Compounding Accreditation Board (PCAB) nationally and  
internationally, and is approved in the state of Michigan as an  
accreditation/inspection entity for the purpose of assessing compliance with  
USP standards (see https://www.michigan.gov/lara/0,4601,7-154-  
89334_72600_72603_27529_27548_91200-366832--,00.html).  
We have learned over the course of this year that R 338.534 was modified to  
require all applicants for licensure as a sterile compounding pharmacy to have a  
physical inspection and corresponding report completed within 18 months of  
application. The following excerpt was provided to ACHC by several  
Michiganlicensed  
pharmacies:  
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.  
In previous years, the pharmacy was required to submit evidence of current  
accreditation or an inspection report completed within 18 months of application.  
My understanding is that this was originally put together as an either/or option  
because procedural differences by which the various inspection and  
accreditation bodies operate.  
Requiring an inspection within 18 months of application presents a problem  
with the previously-approved PCAB process. Accreditations with ACHC are  
provided on a 36-month cycle, which aligns with accreditation programs  
provided in other areas of the healthcare industry as well as requirements issued  
by the Centers for Medicare and Medicaid Services (CMS). A survey occurs prior  
to each new accreditation cycle, thus a survey roughly every 36 months. This  
creates a mis-alignment with the Michigan licensure schedule of renewal every 2  
years; some pharmacies, depending on where they are in their accreditation  
cycle, will not be scheduled for a survey within the 18 months preceding renewal  
of their licensure.  
In addition this this challenge, COVID-19 has created an additional burden. Early  
in 2021 accreditation organizations were permitted to perform remote surveys in  
lieu of on-site surveys, of which PCAB did many. The current requirement is that  
a “physical” inspection is to have occurred, so a strict reading of the rule would  
mean that the board-permitted virtual survey would not be compliant with the  
rule.  
Currently, PCAB accredits approximately 100 pharmacies for sterile  
compounding in Michigan. Nearly 30 were surveyed with an approved virtual  
survey in 2021, so the question remains as to whether or not that will satisfy the  
licensure requirement for renewal. Of the remaining pharmacies, approximately  
½ of them would require some sort of off-cycle survey in order to meet the  
licensure window, which presents a considerable unexpected financial strain on  
the pharmacy as well as a resource burden on ACHC.  
ACHC requests that the rule be returned to requiring either evidence on a  
current accreditation or a physical inspection and corresponding report  
completed within 18 months of application. We would also like to see  
clarification about acceptance of the use of virtual surveys during a public health  
emergency, as the issues surrounding COVID-19 appear to be ongoing.  
Thank you for allowing ACHC to submit comments on this rule. If I can provide  
further information or clarification I can be reached at this email or my mobile at  
919.621.1310.  
Regards,  
Jon Pritchett, Pharm.D., RPh., BCSCP  
Program Director  
T (855) 937-2242 x233  
F (919) 785-3011  
VIA email at BPL-BoardSupport@michigan.gov  
September 21, 2021  
Department of Licensing and Regulatory Affairs  
Bureau of Professional Licensing– Boards and Committees Section  
Attention: Policy Analyst  
P.O. Box 30670  
Lansing, MI 48909-8170  
Re: Administrative Rules for Pharmacy – General Rules – Rule Set 2020-128 LR  
Dear Policy Analyst:  
I am writing on behalf of the Michigan State Medical Society’s (MSMS) 15,000 members regarding  
proposed Rule Set 2020-128 LR (Pharmacy – General Rules) (the “Proposed Rule Set”) which  
provides several updates to the Administrative Rules including requirements for the electronic  
transmission of non-controlled substances. MSMS’s comments are related to Rules 84 and 84a  
and align with comments submitted by MSMS on Rule Set 2020-82 LR (Pharmacy – Controlled  
Substances) on September 9, 2021.  
MSMS offers the following comments to the Proposed Rule Set:  
R 338.584 Noncontrolled Prescriptions  
Under subrule (1), MSMS recommends that subrule (1)(g) be deleted. A prescriber does not know,  
at the time he or she is issuing a prescription, the date that it will be dispensed by a pharmacist.  
MSMS believes this language was added in error to Rule 84 or is intended to address another  
issue for which clarifying language is necessary.  
R 338.584a Electronic Transmission of Prescription; Waiver of Electronic Transmission  
Under subrule (1), MSMS recommends that the date be consistent with the effective date in the  
statute and that there be consistency on this issue between Rule Set 2020-128 LR and Rule Set  
2020-82 LR.  
(1) Until October 1, 2021, or the date established by the federal Centers for Medicare and  
Medicaid Services for the Medicare electronic transmission requirement, whichever occurs  
later,…  
Additionally, MSMS requests the language in subrule (3) be amended to recognize the exceptions  
to electronic transmissions permitted by MCL §333.17754a, as follows:  
(3) Effective October 1, 2021, or the date established by the federal Centers for Medicare  
and Medicaid Services for the Medicare electronic transmission requirement, whichever  
September 21, 2021  
Department of Licensing and Regulatory Affairs  
Bureau of Professional Licensing– Boards and Committees Section  
Page 2  
occurs later, prescribers shall, unless an exception under section 17754a of the code,  
MCL 333.17754a, applies, electronically transmit a prescription for a controlled  
substance 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 338.3161 are met.  
MSMS also recommends subrule (4)(b)(iv) be amended to identify examples of qualifying  
“exceptional circumstances, as follows:”  
(iv) The prescriber demonstrates attests to exceptional circumstances including, but not  
limited to, the following:  
A. Prescribing fewer than “X” prescriptions per year.  
B. Intention to cease practice within the next twelve months.  
C. Limited practice due to an illness or other unforeseen event.  
Thank you for your consideration.  
Should you have any questions regarding our  
recommendations, please contact Stacey P. Hettiger, MSMS Senior Director of Medical and  
Regulatory Policy, at shettiger@msms.org. MSMS appreciates the opportunity to provide  
comment.  
Sincerely,  
Julie L. Novak  
Chief Executive Officer  
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
DIRECTOR'S OFFICE  
PHARMACY - GENERAL RULES  
Filed with the secretary of state on  
These rules take effect immediately upon filing with the secretary of state unless  
adopted under section 33, 44, or 45a(6)(9) of the administrative procedures act of 1969,  
1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections  
become effective 7 days after filing with the secretary of state.  
(By authority conferred on the director of the department of licensing and regulatory  
affairs by sections 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 338.501, R 338.505, R 338.513, R 338.517, R 338.519, R 338.521, R 338.523,  
R 338.525, R 338.531, R 338.533, R 338.534, R 338.535, R 338.536, R 338.537,  
R 338.538, R 338.539, R 338.551, R 338.555, R 338.557, R 338.559, R 338.561,  
R 338.563, R 338.569, R 338.575, R 338.577, R 338.582, R 338.583, R 338.584,  
R 338.585, R 338.586, R 338.587, and R 338.588 of the Michigan Administrative Code  
are amended, and R 338.531a and R 338.584a are added, as follows:  
DMINISTRATIVE HEARINGS PHARMACY SERVICES IN  
MEDICAL INSTITUTIONS  
PART 1. GENERAL PROVISIONS  
R 338.501 Dinitions.  
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.  
August 24, 2021  
2
(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.  
(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 an individual  
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) “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.  
(h) (i) “Manual signature” means a signature that is handwritten or computer-generated  
if a prescription is electronically transmitted as defined in section 17703(7)(8) of the  
code, MCL 333.17703(7).  
(i) (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.  
(j) (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.  
3
(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) Unless otherwise defined in these rules, the The terms defined in the code have the  
same meaning when used in these rules.  
R 338.505 Inspection of applicants and licensees.  
Rule 5. (1) The board, board inspector, board agent, or approved 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 make an inspection  
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) The A prelicensure 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.  
PART 2. PHARMACIST LICENSES  
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 he or shethe applicant is actively enrolled in, or is within 180 days of having  
graduated fromcompleting, an approved educational program.  
(b) That he or she has successfully passed the foreign pharmacy graduate equivalency  
examination administered by the applicant has received a Foreign Pharmacy  
Graduate Examination Committee (FPGEC) certification from the national  
association of boards of pharmacy National Association of Boards of Pharmacy  
(NABP) Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville Dr.,  
Mount Prospect, IL Illinois, 60056, https://nabp.pharmacy/programs/fpgec/.)  
(2) The educational limited license must be renewed annually as follows:  
4
(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  
fromcompleting, 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.  
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)(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)(i) (j) and  
review and discuss the intern’s progress on the topics in R 338.501(1)(i)(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. 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.  
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.  
5
(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.  
(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.  
(4) (6) If an applicant for licensure fails to pass either of these examinations, within 3  
attempts, he or she 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 boarddepartment, after the  
third attempt and prior to retesting, with certification proof 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. that he  
or she completed the course or instruction.  
(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  
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 may not sit for the NAPLEX specified in subrule (5)(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  
boarddepartment.  
(8) An applicant shall may not sit for the MPJE specified in subrule (6)(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 boarddepartment.  
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 Have earned either of the following:  
(i) A professional degree from a school of pharmacy accredited by the American  
council of pharmaceutical education ACPE.  
(ii) A foreign pharmacy graduate examination committee certificate FPGEC  
certification administered by from the NABP. An applicant who has an FPGEC  
certification from NABP has met the English proficiency requirement as the  
6
applicant’s credentials and English proficiency have been evaluated and determined  
to be equivalent to the credentials required in this state.  
(b) Successfully passed 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’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. 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.  
(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.  
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) that the he He or she is currently licensed holds a license in good standing as a  
pharmacist in another state and submits the NABP licensure transfer report to the  
department.  
or he or she successfully passed the foreign pharmacy graduate examination administered  
by NABP and was initially licensed by examination in another state.  
(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.  
7
(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) 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. 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) Submit the MPJE examination score report and NABP licensure transfer report to  
the department.  
(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.  
(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.  
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 the provisions of sections 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 lapsed 0- License lapsed  
License lapsed 8  
or more years  
license lapse in this state and who is not 3 years  
currently licensed in another state or a  
province of Canada:  
more than 3  
years, but less  
than 8 years  
X
(a) Application and fee: submit to  
X
X
8
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  
16174(3) of the code, MCL  
333.16174(3).  
(d) Continuing education: submit  
proof of having completed 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  
X
X
X
X
X
X
X
X
requirements have been met.  
(e) Pass MPJE: retake and pass the  
MPJE as provided in R 338.519.  
(f) Submit proof of having  
X
X
X
X
X
completed both completing 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, 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  
applying for relicensure of being  
granted a limited license.  
X
(h) Practical experience: complete  
400 hours of practical experience under  
the personal charge of a currently  
X
9
licensed Michigan pharmacist in or  
outside of Michigan, within 6 months of  
applying for relicensure of being  
granted a limited license.  
(i) Examination: pass the NAPLEX  
within 2 years before applying for  
relicensure, as provided in R 338.519.  
(h) (j) Proof of license verification from  
another state: An applicant’s license  
must be verified by the licensing agency  
of all other states of the United States in  
which the applicant ever held a license  
as a registered professional nurse.  
Verification must include the record of  
any disciplinary action taken or pending  
against the applicant. 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  
X
X
X
X
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 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.  
License lapsed 0-3 License lapsed  
License lapsed 8 or  
(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  
another state or a Canadian province:  
Years  
more than 3 years, more years  
but less than 8 years  
X
(a) Application and fee: submit to the  
X
X
10  
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  
16174(3) of the code, MCL  
333.16174(3).  
X
X
X
X
X
(d) Continuing education: submit  
proof of having completed 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 having completed  
both completing 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, 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.  
(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. An applicant who is or has  
ever been licensed, registered, or  
certified in a health profession or  
X
X
X
X
X
11  
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 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.  
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(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. 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(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.  
12  
(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.  
(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  
shall must obtain a separate license.  
R 338.531a Remote pharmacy waiver from mileage requirement.  
Rule 31a. (1) An applicant seeking a remote pharmacy license may apply to the  
board for a waiver from the prohibition of locating a remote pharmacy within 10  
miles of another pharmacy in section 17742a(2)(c) of the code, MCL 333.17742a, by  
submitting a completed application to the department, on a form provided by the  
department.  
(2) The applicant shall submit the following with the application:  
(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 of the services or availability of services that will be offered at the  
remote pharmacy 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.  
13  
(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.  
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 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 cost , 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, MIMichigan, 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 (19782021).  
(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.”  
14  
(e) Ensure that bulk drug substances used for compounding meet specified FDA  
criteria.  
(7) An outsourcing facility may compound drugs that appear on an FDA shortage list, if  
the bulk drug substances used to compound the drugs comply with the criteria specified  
in this rule.  
R 338.534 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) An applicant for licensure or renewal of a an in-state or out-of-state pharmacy that  
will provide sterile compounded pharmaceuticals in this state shall have all of the  
following:  
(a) An an onsite physical inspection and submit a physical 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 any 1 of the following:  
(i)(a) The department.  
(ii)(b) The national association of boards of pharmacy verified pharmacy program  
NABP-Verified Pharmacy Program (NABP-VPP).  
(iii)(c) An accrediting organization according to R 338.532.  
(iv)(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.  
(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.  
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 providing sterile compounding services in this  
state until the pharmacy submits to the department an inspection report as required  
15  
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.  
(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.  
(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).  
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.  
R 338.537 Professional and technical equipment and supplies.  
Rule 37. A pharmacy must be equipped with both all of the following:  
(a) Drawers, shelves, and storage cabinets. The necessary facilities, apparatus,  
utensils, and equipment to permit the pharmacy to provide prompt and efficient  
services.  
(b) A sink that has hot and cold running water.  
(c) A refrigerator of reasonable capacity located in the pharmacy department.  
(d) (b) Current print, electronic, or internet accessible editions or revisions of the  
Michigan pharmacy laws and rules, and not less than at least 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.  
R 338.538 Closing pharmacy.  
16  
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 How controlled substances will be disposed.  
(c) The disposition of How non-controlled substances will be disposed.  
(d) The disposition of 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.  
R 338.539 Relicensure and renewal.  
Rule 39. (1) An applicant with an expired license may apply for relicensure of a  
pharmacy license shall by submit 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 with the requisite fee.  
(2) A pharmacy that renews its license during the license renewal period has an  
expired license shall satisfy the requirements of R 338.531 to be relicensed submit to the  
department a completed application, on a form provided by the department,  
together with the requisite fee.  
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. 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(2), the name  
and license number of the pharmacist designated as the pharmacist in charge (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:  
17  
(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:  
(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 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.  
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.  
R 338.555 Federal regulation on good manufacturing practice for finished  
pharmaceuticals; adoption by reference; compliance.  
18  
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 (19782021).  
(2) A manufacturer shall comply with the standards adopted in subrule (1) of this rule.  
(3) The standards adopted by reference in subrule (1) of this rule are available at no cost  
at  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=21  
1, or at 10 cents per page , 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, Michigan, 48909.  
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 How controlled substances will be disposed.  
(c) The disposition of How non-controlled substances will be disposed.  
(d) The disposition of The location where records and prescription files will be  
stored.  
(2) A manufacturer shall comply with all applicable federal requirements for  
discontinuing a controlled substance business.  
(3) Records must be maintained for the same amount of time that is required if the  
manufacturer remains open.  
R 338.559 Relicensure and renewal.  
Rule 59. (1) An applicant with an expired license may apply for relicensure of a  
manufacturer license shall by submit 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 with the  
requisite fee.  
(2) A manufacturer that renews its license during the license renewal period has an  
expired license shall satisfy the requirements of R 338.551 in order to be relicensed  
submit to the department a completed application on a form provided by the  
department together with the requisite fee.  
PART 5. WHOLESALE DISTRIBUTOR AND  
WHOLESALE DISTRIBUTOR-BROKER LICENSE  
R 338.561 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:  
19  
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).  
) 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.  
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 provide all of the following information:  
(a) Provide A a criminal history background check required pursuant to section  
17748(6) of the code, MCL 333.17748(6).  
(b) Proof of registration or licensure from every state where the applicant currently  
holds or has ever held a license or registration. 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.  
(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.  
(c)(d) Provide Certified certified copies of articles of incorporation or certificates of  
partnership and assumed names if applicable.  
(d) (e) Provide The the identity and address of each partner, officer, or owner as  
applicable.  
(e)(f) Provide a A completed compliance checklist.  
(f)(g) Provide a FEIN certificate. list or catalog of all drug products and devices to be  
distributed.  
(gh) Provide a copy of the FDA certification for the site to be licensed, if the  
applicant is distributing biologicals.  
(h)(i) Unless exempt under section 17748(2) of the code, MCL 333.17748(2), provide  
the name and the license number of the pharmacist designated as the pharmacist in charge  
20  
(PIC) or the name of the facility manager. For individuals designated as a facility  
manager, the applicant shall provide the following:  
(i) Proofproof, in the form of an affidavit, that the facility manager has achieved the  
following:  
(Ai) A high school equivalency education, or higher, defined as 1 of the following:  
(IA) A high school diploma.  
(IIB) A general education development certificate (GED).  
(IIIC) A parent-issued diploma for home schooled individuals.  
(IVD) Completion of post-secondary education, including an associate’s,  
bachelor’s, or master’s degree.  
(Bii) Completion of a training program that includes, but is not limited to, all of the  
following subjects:  
(IA) Knowledge and understanding of laws in this state and federal laws relating  
to the distribution of drugs and devices.  
(IIB) Knowledge and understanding of laws in this state and federal laws relating  
to the distribution of controlled substances.  
(IIIC) Knowledge and understanding of quality control systems.  
(IVD) Knowledge and understanding of the USP standards relating to the safe  
storage and handling of prescription drugs.  
(VE) Knowledge and understanding of pharmaceutical terminology, abbreviations,  
dosages, and format.  
(Ciii) Experience equal to either of the following:  
(IA) 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.  
(IIB) 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.  
(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.  
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:  
21  
(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.  
(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.  
(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.  
(4)(6) The records described in subrules (1) and (2) to (5) of this rule and section of  
17748e of the code, MCL 333.17748e, must be made available for inspection and  
photocopying by the dpartment and authorized federal, state, or local law enforcement  
22  
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)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.  
(5)(7) A wholesale distributor shall retain theThe records described in this rule must  
be maintained for a minimum of 2 years after the disposition of the prescription drugs or  
devices.  
R 338.575 Closing a wholesale distributor or wholesale distributor-broker.  
Rule 75. (1) A wholesale distributor that is ceasing operations shall return the wholesale  
distributor license and controlled substance license, if applicable, to the department, and  
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 How controlled substances will be disposed.  
(c) The disposition of How noncontrolled substances will be disposed.  
(d) The disposition of 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.  
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  
wholesale distributor license shall by submit submitting to the department a completed  
application on a form provided by the departmentsdepartment, satisfying all the  
requirements for licensure in part 3 of these rules, and paying with the requisite fee.  
(2) An applicant for relicensure of a wholesale distributor license that renews its license  
during the license renewal period has expired must shall satisfy the requirements of R  
338.563 in order to be relicensed. 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.  
PRT 6. PRACTICE OF PHARMACY  
23  
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 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.  
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.  
24  
(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.  
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:  
(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 dispensed.  
(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 (f)(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 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.  
25  
(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.  
(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) (5) A pharmacy shall keep the original prescription record for 5 years. After 3 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 will  
becomebecomes 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) (6) This rule does not apply to pharmacy services provided in a medical  
institution.  
R 338.584a Electronic transmission of prescription; waiver of electronic  
transmission.  
Rle 84a. (1) Until January 1, 2022, or the date established by the federal Centers  
for Medicare and Medicaid Services for the Medicare electronic transmission  
requirement, whichever occurs later, 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.  
26  
(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.  
(Effective January 1, 2022, or the date established by the federal Centers for  
Medicare and Medicaid Services for the Medicare electronic transmission  
requirement, whichever occurs later, prescribers shall 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 all of the following requirements:  
(a) The prescriber is unable to meet the requirements of section 17754a(1) or (2)  
of the code, MCL 333.17754a.  
(b) The prescriber meets 1 of the following:  
(i) The prescriber provides evidence satisfactory to the department that he or  
she has received a waiver of the Medicare requirements for the electronic  
transmission of controlled substances prescriptions at the federal Centers for  
Medicare and Medicaid Services.  
(ii) The prescription is dispensed by a dispensing prescriber.  
(iii) The prescriber demonstrates economic hardship or technological limitations  
that are not within the control of the prescriber.  
(iv) The prescriber demonstrates exceptional circumstances.  
(v) 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.  
R 338.585 Customized patient medication package.  
27  
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  
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 comply 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 being opened. Each CPMP must comply with all of the  
provisions of the poison prevention packaging act of 1970, 15 USC 1471 to 1477.  
(d) When preparing a CPMP, the dispenser shall take into account consider any  
applicable compendial requirements or guidelines, the physical and chemical  
compatibility of the dosage forms placed within each container, and any therapeutic  
incompatibilities that may attend the simultaneous administration of the medications.  
Medications must not be dispensed in CPMP packaging in any of the following  
situations:  
(i) The USP monograph or official labeling requires dispensing in the original  
container.  
(ii) The drugs or dosage forms are incompatible with packaging components or each  
other.  
(iii) The drugs are therapeutically incompatible when administered simultaneously.  
(iv) The drug products require special packaging.  
28  
(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 shallmay not be  
returned to stock or dispensed to another patient when returned to the pharmacy for any  
reason. If a prescription for any drug contained in the CPMP is changed, then a new  
appropriately labeled CPMP must be prepared for the patient.  
(g) In addition to all individual prescription filing requirements, a record of each  
CPMP dispensed must be made and filed. At a minimum, each record must contain all of  
the following information:  
(i) The name and address of the patient.  
(ii) The serial number of the prescription order for each drug product contained in the  
CPMP.  
(iii) Information identifying or describing the design, characteristics, or specifications  
of the CPMP sufficient to allow subsequent preparation of an identical CPMP for the  
patient.  
(iv) The date of preparation of the CPMP and the expiration date assigned.  
(v) Any special labeling instructions.  
(vi) The name or initials of the pharmacist who prepared the CPMP.  
R 338.586 Prescription records; nonapplicability to inpatient medical institution service.  
Rule 86. (1) A Each prescription must be chronologically numbered, and the  
pharmacist performing final verification before dispensing must record, manually  
or electronically, the prescription number, dispensing dateddate, and his or her  
initialed initials or electronically initialed by the pharmacist who performs the final  
verification prior to dispensing at the time of the first filling at the pharmacy.  
(2) If final product verification is completed by a pharmacy technician, both the  
initials of the pharmacy technician and delegating pharmacist must be recorded.  
(2) (3) 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)(4) This rule does not apply to pharmacy services provided in a medical institution.  
R 338.587 Prescription refill records; manual systems; profile systems; automated  
pharmacy data systems; nonapplicability to medical institution service; record  
confidentiality; and access.  
Rule 87. (1) A pharmacist shall record prescription refills using only 1 of the systems  
described in subrule (2), (3), or (4) of this rule and in compliance with the provisions of  
subrule (2), (3), or (4) of this rule, as applicable.  
(2) A pharmacy may utilize a manual system of recording refills if the system is in  
compliance complies with both of the following criteria:  
(a) The amount and date dispensed must be entered on the prescription in an orderly  
fashion and the dispensing pharmacist initials the entry. If the pharmacist only initials and  
dates the prescription, then the full face amount of the prescription must be deemed  
dispensed.  
29  
(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 complies with all of the following criteria:  
(a) Records must be created and maintained in written form. All original and refill  
prescription information for a particular prescription appears on single documents in an  
organized format. The 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. If a pharmacy technician performs final product  
verification, the identification of the delegating pharmacist and pharmacy  
technician must be recorded.  
(c) Prescription entries must be made on the record 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 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 complies with all of the following criteria:  
(a) All information that is pertinent to a prescription must be entered on the record,  
including all of the following information:  
(i) The prescription number.  
(ii) The patient's name and address.  
(iii) The prescriber's name.  
(iv) The prescriber's federal DEA number, if appropriate.  
(v) The number of refills authorized.  
(vi) Whether the drug must be dispensed as written.  
30  
(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. If a pharmacy technician performs final product  
verification, the identification of the delegating pharmacist and pharmacy  
technician must be recorded.  
(b) Prescription entries must be made on the record 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. A pharmacy shall keep the original prescription record on site 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 will become the original prescription. The records are subject to inspection by  
the board or its agents. A procedure must be established to facilitate inspections.  
(c) The required information must be entered on the record for all prescriptions filled at  
the pharmacy, including nonrefillable prescriptions. This requirement is in addition to the  
requirements set forth in R 338.586.  
(d) The recording system must provide adequate safeguards against improper  
manipulation, the alteration of records, and the loss of records.  
(e) The recording system must have the capability of producing a printout of all  
original and refilled prescription data, including a prescription-by-prescription and refill-  
by-refill audit 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 on site for 5 years. Data older  
than 16 months 2 years must be provided within 72 hours of the time the request is first  
made by the agent. Prescription data for the most current 16 months 2 years must be  
readily retrievable on site and available for immediate review.  
(f) If the automated data processing system is inoperative for any reason, then the  
pharmacist shall ensure that all refills are authorized and that the maximum number of  
refills is not exceeded. When the automated data processing system is restored to  
operation, the pharmacist shall enter the information regarding prescriptions filled and  
refilled during the inoperative period into the automated data processing system within 48  
hours.  
(g) A pharmacy shall make arrangements with the supplier of data processing services  
or materials to ensure that the pharmacy continues to have adequate and complete  
prescription and dispensing records if the relationship with the supplier terminates for any  
reason. A pharmacy shall ensure continuity in the maintenance of records.  
(h) The automated data processing system must be an integrated system that is capable  
of complying with all of the requirements of these rules.  
31  
(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.  
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 under  
the control of the dispensing prescriber. A pharmacy shall not own, control, or operate an  
automatic dispensing device in a dispensing prescriber's office, unless the prescriber’s  
office is affiliated with a hospital consistent with section 17760 of the code, MCL  
333.17760, and subrule (2)(h) of this rule. All of the following apply to the use of an  
automated device in a dispensing prescriber's office:  
(a) If a dispensing prescriber delegates the stocking of the automated device, then  
technologies must be in place and utilized to ensure that the correct drugs are stocked in  
their appropriate assignment utilizing a board-approved error prevention technology that  
complies with R 338.3154.  
(b) A dispensing prescriber operating an automated device is responsible for all  
medications that are stocked and stored in that device as well as removed from that  
device.  
(c) If any medication or device is dispensed from an automated device in a dispensing  
prescriber’s office, then documentation as to the type of equipment, serial numbers,  
content, policies, procedures, and location within the facility must be maintained by the  
32  
dispensing prescriber for review by an agent of the board. This documentation must  
include at least all of the following information:  
(i) Manufacturer name and model.  
(ii) Quality assurance policy and procedure to determine continued appropriate use  
and performance of the automated device.  
(iii) Policy and procedures for system operation that addresses, at a minimum, all of  
the following:  
(A) Accuracy.  
(B) Patient confidentiality.  
(C) Access.  
(D) Data retention or archival records.  
(E) Downtime procedures.  
(F) Emergency procedures.  
(G) Medication security.  
(H) Quality assurance.  
(5) An automated device that is to be used for furnishing medications for administration  
to registered patients in any hospital, county medical care facility, nursing home, hospice,  
or any other skilled nursing facility, as defined in section 20109(4) of the code, MCL  
333.20109(4), must be supplied and controlled by a pharmacy that is licensed in this  
state. The use of an automated device in these locations is not limited to the provisions of  
subrule (3) of this rule. If a pharmacist delegates the stocking of the device, then  
technologies must be in place and utilized to ensure that the correct drugs are stocked in  
their appropriate assignment utilizing bar-coding or another board-approved error-  
prevention technology. Each automated device must comply with all of the following  
provisions:  
(a) A pharmacy operating an automated device is responsible for all medications that  
are stocked and stored in that device as well as removed from that device.  
(b) If any medication or device is dispensed from an automated device, then  
documentation as to the type of equipment, serial numbers, content, policies, procedures,  
and location within the facility must be maintained by the pharmacy for review by an  
agent of the board. The documentation must include at least all of the following  
information:  
(i) Name and address of the pharmacy responsible for the operation of the automated  
device.  
(ii) Name and address of the facility where the automated device is located.  
(iii) Manufacturer name and model number.  
(iv) Quality assurance policy and procedure to determine continued appropriate use  
and performance of the automated device.  
(v) Policy and procedures for system operation that address, at a minimum, all of the  
following:  
(A) Accuracy.  
(B) Patient confidentiality.  
(C) Access.  
(D) Data retention or archival records.  
(E) Downtime procedures.  
(F) Emergency procedures.  
33  
(G) Medication security.  
(H) Quality assurance.  
(I) Ability to provide on demand to an agent of the board a list of medications  
qualifying for emergency dose removal without pharmacist prior review of the  
prescription or medication order.  
(6) An automated device that is operated at a location affiliated with a hospital, but not  
at the same physical address as the pharmacy, that is owned and operated by the hospital,  
must comply with section 17760 of the code, MCL 333.17760.  
(7) Records and electronic data kept by automated devices must meet all of the  
following requirements:  
(a) All events involving access to the contents of the automated devices must be  
recorded electronically.  
(b) Records must be maintained for 5 years by the pharmacy or dispensing prescriber  
and must be retrievable on demand for review by an agent of the board. The records must  
include all of the following information:  
(i) The unique identifier of the automated device accessed.  
(ii) Identification of the individual accessing the automated device.  
(iii) The type of transaction.  
(iv) The name, strength, dosage form, quantity, and name of the manufacturer of the  
drug accessed.  
(v) The name of the patient for whom the drug was ordered.  
(vi) Identification of the pharmacist responsible for the accuracy of the medications to  
be stocked or restocked in the automated device.  
(8) Policy and procedures for the use of the automated device must include a  
requirement for pharmacist review of the prescription or medication order before system  
profiling or removal of any medication from the system for immediate patient  
administration. This subrule does not apply to the following situations:  
(a) The system is being used as an after-hours cabinet for medication dispensing in the  
absence of a pharmacist as provided in R 338.486(4)(j).  
(b) The system is being used in place of an emergency kit as provided in R  
338.486(4)(c).  
(c) The system is being accessed to remove medication required to treat the emergent  
needs of a patient as provided in R 338.486(4)(c). A sufficient quantity to meet the  
emergent needs of the patient may be removed until a pharmacist is available to review  
the medication order.  
(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a  
pharmacist shall review the orders and authorize any further dispensing within 48 hours.  
(e) The automated device is located in a dispensing prescriber's office.  
(9) A copy of all policies and procedures related to the use of an automated device must  
be maintained at the pharmacy responsible for the device's specific location or at the  
dispensing prescriber's office and be available for review by an agent of the board.  
From: Mollien, Charlie  
To: Ditschman, Andria (LARA)  
Subject: RE: Draft General Rules Public Comment 9.21.21 Public Hearing  
Date: Tuesday, September 21, 2021 4:00:40 PM  
CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov  
Andria,  
One additional comment. The General Rules need to be consistent with the Controlled Substances  
Rules. Any changes made to the Controlled Substances Rules should also be considered and  
appropriately updated in the General Rules for consistency.  
Charlie Mollien  
From: Mollien, Charlie  
Sent: Tuesday, September 21, 2021 3:48 PM  
To: Ditschman, Andria (LARA) <DitschmanA@michigan.gov>  
Subject: Draft General Rules Public Comment 9.21.21 Public Hearing  
Andria,  
Please see attached comments for 2020-128-LR related to the Pharmacy General Rules.  
Thank you,  
Charlie Mollien  
Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398  
September 20th, 2021  
Andria Ditschman, JD  
Senior Policy Analyst  
Bureauof ProfessionalLicensing, MichiganDepartment of Licensing and RegulatoryAffairs (LARA)  
611 W. Ottawa St. PO Box 30670 Lansing, MI 48909  
Telephone: 517-241-9255  
DitschmanA@michigan.gov  
Re: CVS Health Comments Rules Public Hearing for Pharmacy GeneralRules (MOAHR #2020-128 LR)  
Dear Andria and BoardMembers:  
I amwriting to you in my capacityas Advisor of RegulatoryAffairs for CVS Healthand its family of pharmacies. CVS  
Health, the largest pharmacyhealth care provider in the United States, is uniquely positioned to provide diverse  
access points of care to patients in Michiganthrough our integratedofferings across the spectrumof pharmacy care.  
CVS Healthappreciates the opportunity to submit comments on the proposed rules for PharmacyGeneralRules  
regulations. We would also like to thank the Department andBoard for their vigilance to continuously improve the  
laws and regulations that guide pharmacists, pharmacyinterns, andpharmacytechnicians serving Michigan’s  
patients.  
CVS Healthsupports the majority of updates the Department and Boardhave proposed to streamline and modernize  
the Generalrules. These changes include licensing for pharmacists, pharmacies, andthe practice of pharmacy.  
There are a few sections we suggest couldbe strengthenedto better align withnational trends, improve patient  
safety, and overall outcomes. These recommended changes canbe found in the Appendixsection whichhighlights  
the rules, comments, proposed language, andany citations or additional information or questions to consider.  
CVS Healthappreciates the opportunity to submit comments for the Board’s review. Please contact me directly at  
616-490-7398 if you have any questions.  
Sincerely,  
DeebD. Eid, PharmD, RPh  
Advisor, PharmacyRegulatory Affairs  
CVS Health  
deeb.eid@cvshealth.com  
Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398  
Appendix  
1. SuggestedRule Language Changes:  
Part 3 Pharmacy Licenses  
R338.531a Remote Pharmacywaiver from milage requirement  
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 oflocating 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 formprovided by the  
department.  
(2) The applicant shallsubmit the following with the application:  
(a) A map showing the location ofany existing pharmacies within 10 miles of the proposed remote pharmacy if  
the remote pharmacy will not be located at a hospitalor mentalhealth facility.  
(b) A list and explanation ofthe services or availability of services that will be offered at the remote pharmacy  
that are different from the services offered at a pharmacy or otherwise not readily available to patients located  
within 10 miles of the proposedremote pharmacy.  
(c) A statement offacts to support the statement of1 or more ofthe following:  
(i) The proposedremote pharmacyis located in an area where there is limited access to pharmacy services.  
(ii) The proposed remote pharmacy willoffer a service or the availability of a service that is unique fromother  
pharmacies in the 10-mile radius from the remote pharmacy and the service will satisfy an unmet need ofthe  
surrounding community.  
(iii) There exists a limitation on travelthat justifies waiving the requirement.  
(iv) There are other compelling circumstancesthat justify waiving the requirement.  
(3) If the waiver is denied, the application is consideredclosedunless within 30 days ofreceipt ofthe denial, the  
applicant notifies the department that it is requesting a hearing on the matter.  
Comment: CVS Healthsupports the addition of language ensuring there is a route for remote pharmacies to obtain a  
waiver from milage requirements. This will increase access tocare for patients and allow remote pharmacies that  
otherwise would not be allowed to exist, to provide services andpatient care. Telepharmacyis nationally acceptedby  
the NationalAssociationof Boards of Pharmacy (NABP), AmericanHospitalPharmacists Association(ASHP), and  
AmericanPharmacist Association(APhA) to create new or maintain current patient access topharmacy services.1,2,3  
While the milage restrictionis contained in MI statute, it is recommended that the Department moves forward with  
language for a waiver from milage requirements. Manyother states suchas AZ, HI, ID, IL, ND, SD, UT, WV, andWI do  
not have milage restrictions.4,5,6 Studieshave shownthat pharmacydeserts exist in urban areas, amongst minority  
communities, and are not just limited to ruralgeographies.7 Using anevidenced basedlaw-making philosophy  
showcases that studies have not shown that a milage restrictionensures an increase in patient safetyor a decrease in  
patient harm.  
Adding in the language in green above to strengthen the outcome of the rule is suggested.  
Rationale: Addition of “and explanation” to 2(b) will ensure the Department/Boardhas a clearer understanding of the  
services that will be offered rather thanjust a “list”. It is observed that statement 2(c)(ii) would be optional since they  
only need to provide a statement offacts for one of more of what is listedin (i-iv). Addition of “or otherwise not  
readily available topatients” to 2(b) ensures the application is inclusive of services that may not be readily available  
to patients currently.  
Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398  
Citations:  
1. AmericanSociety of Health-SystemPharmacists. The consensus ofthe Pharmacy Practice Model Summit. Am  
J Health-Syst Pharm. 2011; 68:1148-52. http://www.ajhp.org/content/68/12/1148.full.pdf (Accessed2021  
Sept 21).  
2. National Associationof Boards of Pharmacy. The Model State PharmacyAct and Model Rules of the National  
Associationof Boards of Pharmacy(Model Act). 2021. Available from: https://nabp.pharmacy/publications-  
reports/resource-documents/model-pharmacy-act-rules/. (Accessed2021 Sept 21).  
3. APhA Policy Manual. House of Delegates Policyand Procedure Manual.  
https://aphanet.pharmacist.com/policy-manual?key=telepharmacy&op=Search. (Accessed2021 Sept 21).  
4. Arizona State Boardof PharmacyST 32-1961.01 Pharmacies; Remote Dispensing. Available from:  
https://pharmacy.az.gov/ (Accessed2021 Sept 21).  
5. Illinois State Board of Pharmacy ADC 68-1330.510 Telepharmacy. Available from:  
https://www.idfpr.com/profs/pharm.asp (Accessed2021 Sept 20).  
6. Idaho State Boardof Pharmacy24.36.01.302 Drug Outlets That Dispense Drugs toPatients without anOnsite  
Pharmacist or Prescriber. Available from: https://bop.idaho.gov/(Accessed2021 Sept 15).  
7. Qato DM et. al. 'Pharmacy deserts' are prevalent in Chicago's predominantly minority communities, raising  
medication access concerns. HealthAff(Millwood). 2014 Nov;33(11):1958-65. doi:  
10.1377/hlthaff.2013.1397. PMID: 25367990.  
2. SuggestedRule Language Changes:  
Part 6 Practice of Pharmacy  
Rule 88.  
R338.588 Automateddevices  
(3) A pharmacy that operates an automateddevice under this sectionto deliver a drug or device directly to an  
ultimate user or health care provider shall notify the department of the automateddevice’s location on a form  
provided by the department. An automateddevice located within a licensed pharmacymust be used only by a  
pharmacist or his or her pharmacypersonnel under the personal charge of a pharmacist. A secured, lockable, and  
privacy enabled automateddevice locatedon the premise ofthe licensed pharmacy may be utilized as a means for  
patient’s or an agent ofthe patient to pick up prescription medications when andifa pharmacy is closed.  
Rationale: As technology continues to advance ensuring that patients can safelyand securelypick up their  
medications from a pharmacy is a priority. Patients at times may not be able to get to a pharmacyto pick up or may  
have medications such as antibiotics or other emergent situations they need to obtain, but their pharmacy may be  
closed. Ensuring automateddevices which are secured, locked, and guarantee privacycould expand access tocare  
after hours or during lunch breaks/other closures and ensure patients have a route which is trustworthyto obtain  
their medications. Yeoet al. is a recent study which showcasedthe benefits of allowing such operational models.1  
Other states suchas AZ, CA, CT, DE, DC,FL, ID, IL, IN, IA, LA, ME, MD, MA, MO, MT, NV, OR, PA, RI, SC, SD, TX, WA,  
WV, and WY allow for such practices within their laws/rules.2,3,4  
Adding in clarifying language to allow for use of automated devices as patient pick-up options within the premises  
of a licensed pharmacy is recommended.  
Citations/Evidence:  
1. Yeo YL, Chang CT, Chew CC, Rama S. Contactless medicine lockers in outpatient pharmacy: A safe dispensing  
systemduring the COVID-19 pandemic. Res Social Adm Pharm. 2021;17(5):1021-1023.  
doi:10.1016/j.sapharm.2020.11.011  
Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398  
2. Arizona ADC R4-23-614 Automated Storage and DistributionSystem.  
https://qa.azsos.gov/public_services/Title_04/4-23.htm  
3. California ADC 16-1713 Receipt and Delivery of Prescriptions and PrescriptionMedications Must be To or  
From Licensed Pharmacy. https://www.pharmacy.ca.gov/laws_regs/1711_1713_1715_1_oa.pdf  
4. Montana ADC 24.174.839 Alternate delivery of prescriptions.  
https://rules.mt.gov/gateway/ruleno.asp?RN=24%2E174%2E839  
From:  
BPL-BoardSupport  
To:  
Ditschman, Andria (LARA)  
Subject:  
Date:  
Attachments:  
FW: Public Comment on Pharmacy General Rules 2020-128 LR  
Thursday, September 2, 2021 11:40:31 AM  
Comments on General Rules.docx  
From: Rose M Baran <RoseBaran@ferris.edu>  
Sent: Thursday, September 2, 2021 11:39 AM  
To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>  
Subject: Public Comment on Pharmacy General Rules 2020-128 LR  
CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov  
Attention: Policy Analyst  
Please find attached public comment on Pharmacy General Rules 2020-128 LR.  
Thanks,  
Rose Baran  
This email message and any attachments are for the confidential use of the intended recipient.  
Please notify me if you have received this message by mistake and delete this message and  
any attachments.  
Comments on Board of Pharmacy General Rules 2020-128 LR  
Rose Baran Pharm. D.  
Comments on General Rules  
Rule 338.584  
Change 338.584(1)(g) to “Issue date of the prescription.” The prescriber will not know the date  
the prescription was dispensed when issuing a prescription.  
;