From:  
BPL-BoardSupport  
To:  
Ditschman, Andria (LARA)  
Subject:  
Date:  
FW: Department of Licensing and Regulatory Affairs - Regulatory Impact Statement was approved. Title: Central Fill Pharmacies  
Monday, November 28, 2022 9:00:16 AM  
Attachments:  
Central Fill DraftRule (Public Comment).doc  
From: Mollien, Charlie <Charlie.Mollien@meijer.com>  
Sent: Friday, November 25, 2022 1:14 PM  
To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>  
Cc: Mollien, Charlie <Charlie.Mollien@meijer.com>  
Subject: FW: Department of Licensing and Regulatory Affairs - Regulatory Impact Statement was approved. Title:  
Central Fill Pharmacies  
CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov  
Attached are public comments for Michigan Board of Pharmacy’s proposed ruleset on Central Fill Pharmacies.  
Charlie Mollien  
From: Michigan Department of Licensing and Regulatory Affairs LARA@govsubscriptions.michigan.gov  
Sent: Wednesday, November 2, 2022 2:13 PM  
To: Mollien, Charlie Charlie.Mollien@meijer.com  
Subject: Department of Licensing and Regulatory Affairs - Regulatory Impact Statement was approved. Title:  
Central Fill Pharmacies  
The Regulatory Impact Statement was approved by the Administrative Rules Division for the Department of  
Licensing and Regulatory Affairs - Bureau of Professional Licensing.  
MOAHR ID: 2021-93 LR  
Title: Central Fill Pharmacies  
The Administrative Code for the Department of Licensing and Regulatory Affairs can be viewed by clicking on the  
following link.  
Click Here  
Update your subscriptions, modify your password or email address, or stop subscriptions at any time on your  
Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or  
problems with the subscription service, please contact subscriberhelp.govdelivery.com.  
This service is provided to you at no charge by Michigan Department of Licensing and Regulatory Affairs.  
This email was sent to charlie.mollien@meijer.com using GovDelivery Communications Cloud on behalf of: Michigan Department of Licensing and Regulatory  
Affairs · P.O. Box 30004 · Lansing, MI 48909  
DEPARTMENT OF COMMUNITY HEALTHLICENSING AND REGULATORY  
AFFAIRS  
DIRECTOR'S OFFICE  
CENTRALIZED PRESCRIPTION PROCESSING CENTRAL FILL AND SHARED  
PHARMACY SERVICESPHARMACIES  
Commented [MC1]: These rules appear to regulate both  
central fill pharmacy and shared pharmacy services.  
Consider updating the title to "Central Fill and Shared  
Pharmacy Services".  
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 community health  
department of licensing and regulatory affairs by sections 16145, and 1770117753,  
and 17767 of the public health code, 1978 PA 368, MCL 333.16145, and 333.17701  
333.17753, et seq. and 333.17767, and Executive Reorganization Order Numbers Nos.  
1996-1 1991-9, 1996-2, and 2003-1, and 2011-4, being MCL 330.3101 338.3501,  
445.2001, and 445.2011, and 445.2030)  
R 338.3051, R 338.3052, R 338.3053, R 338.3054, R 338.3055, and R 338.3056 of the  
Michigan Administrative Code are amended, as follows:  
PART 1. GENERAL PROVISIONS  
R 338.3051 Definitions.  
Rule 1. (1) As used in these rules parts 1 and 2 of the centralized prescription  
processing rules, R 338.3051 to R 338.3054:  
(a) “Board” means the Michigan board of pharmacy, created in section 17721 of  
the code, MCL 333.17721.  
(b)(a) "Centralized prescription Central fill pharmacyprocessing center" means a  
pharmacy operated under the direction of a pharmacist that processes information related  
to the practice of pharmacy and engages in dispensing functions of centralized  
prescription processing at the request of an originating pharmacy.  
(b) "Centralized prescription processing" is the term defined in section 17753(3) of the  
code.  
Commented [MC2]: Defining "central fill pharmacy" as  
the all encompassing term for any pharmacy engaged in  
centralized prescription processing incorrectly combines  
industry terms used to delineate between shared pharmacy  
services, a pharmacy engaged in non-dispensing centralized  
prescription processing, and central fill pharmacy, a  
pharmacy that engages in dispensing functions of centralized  
prescription processing.  
(c) "Code" means the public health code, 1978 PA 368, MCL 333.1101 et seq. to  
333.25211.  
(d) "Deliver," as used in this part, means the actual, constructive, or attempted  
transfer of to issuea prescription drug, including a controlled substance, directly to a  
patient or a patient's agent by the lawful order of a practitioner. A centralized  
prescription Deliver does not include a central fill processing center pharmacy that  
provides a prescription product to another pharmacy for subsequent issuance to a patient  
or a patient's agent. has not met the definition of deliver as defined in this subrule.  
June 7, 2022  
2
(e) "Delivering pharmacist" means a pharmacist who is responsible for delivering a  
prescription directly to a patient or a patient's agent.  
(f) "Delivering pharmacy" means the pharmacy that delivers the filled or refilled  
prescription to the patient or the patient's authorized representativeagent. The delivering  
pharmacy shallmust be either the originating pharmacy or the centralized prescription  
processing center central fill pharmacy.  
(g) “Department” means the department of licensing and regulatory affairs  
(LARA).  
(g)(h) "Originating pharmacy" means a pharmacy that initially receives a patient's or a  
prescribing practitioner's request to fill or refill a prescription.  
(2) Unless otherwise defined in these rules, a The termsterm defined in the code  
havehas the same meanings meaning whenif used in these rules.  
R 338.3052 Centralized prescription processing Central fill and shared pharmacy  
servicespharmacies rules; prevail  
over other pharmacy rules.  
Rule 2. To(1) In addition to these rules, central fill pharmacies must follow all  
applicable board rules. However, to the extent that any rule in parts 1 and 2 of the  
centralized prescription processing these rules conflicts conflict with other board of  
pharmacy rules, the provisions in parts 1 and 2 of the centralized prescription processing  
these rules shallmust prevail.  
(2) Shared pharmacy services for processing functions of centralized pharmacy  
processing that do not involve the dispensing process, such as completing claims  
adjudication or remote data entry, may be performed under the general supervision  
of a pharmacist. For this subrule, dispensing process means the physical preparing,  
compounding, packaging, or labeling of a drug product intended for delivery to the  
patient.  
Commented [MC3]: Adding this clarification is necessary  
to reflect contemporary practice of pharmacy with shared  
pharmacy services and make clear the application of  
"dispense" as defined by MCL 333.17703(3).  
R 338.3053 Centralized prescription processing; dispensing requirements.  
Rule 3. (1) In addition to complying with the requirements of section 17753 of the code,  
MCL 333.17753, a pharmacy must meet all of the following requirements before it  
either performs may perform centralized prescription processing services or outsource  
outsources these services centralized prescription processing to another pharmacy:.  
Pharmacies that perform or outsource prescription processing services shall meet all of  
the following requirements:  
(a) Be licensed by the Michigan board of pharmacyHold a pharmacy license in this  
state.  
(b) Share sufficient patient and drug information to minimize the possibility of an  
adverse drug event.  
(c) Maintain prescription information or an equivalent record, as prescribed in section  
17752(1) of the code, and the records required in R 338.3054 of this part, for 5 years  
from the date of dispensing. A centralized prescription processing center and an  
original pharmacy The pharmacy shall ensure that the informationrecords isare readily  
retrievable within 48 hours after the board's agent department makes a request for the  
informationrecords. If the records are maintained in a digital format, a printed copy  
3
shallmust be made available to the department or other authorized  
individualimmediately to the board's agent upon request.  
(2) The originating pharmacy shall maintain the original prescription for a period  
of 5 years after the date the prescription was filled.  
(3) Two years after the prescription was filled, the originating pharmacy may  
make an electronic duplicate of the original paper prescription, which becomes the  
original prescription. The originating pharmacy shall present a printed copy of the  
electronic duplicate of the prescription to the department or board upon request.  
(2)(4) A pharmacy engaging in centralized prescription processing shall beis responsible  
for each function of the prescription's processing performed by that pharmacy.  
(3)(5) A delivering pharmacist shall beis responsible for complying with R 338.490(4)  
R 338.589(4) regarding patient counseling.  
(4)(6) The prescription label for a prescription that was filled by a centralized  
prescription processing center central fill pharmacy shallmust identify each pharmacy  
that was involved in preparingdispensing and delivering athe prescription. A centralized  
prescription processing center central fill pharmacy may be identified on a prescription  
label by use of a unique identifier that is recognized by the delivering pharmacist. A  
central fill pharmacy shall create and maintain a unique identifier and  
communicate the unique identifier to all pharmacies that use its services. As used in  
this subrule, "unique identifier" means a unique combination of letters, numbers, or  
symbols that allows the delivering pharmacy to identify the specific centralized  
prescription processing center central fill pharmacy involved in the processing of the  
prescription. A centralized prescription processing center shall create and maintain a  
unique identifier and shall communicate the unique identifier to all pharmacies that use  
its services.  
(5)(7) A prescription that was not delivered to a patient may be transferred back to the  
pharmacy that filled the prescription, provided thatif the transfer records are maintained.  
A centralized prescription processing center central fill pharmacy and an originating  
pharmacy shall establish procedures for the disposition of prescription medication that  
was not delivered to patients. This medication may be returned to stock and may be re-  
delivered re-dispensed without constituting a violation of R 338.472(1) 338.503(1).  
(6)(8) A pharmacy that performs or contracts for centralized prescription processing  
services shall comply with the procedures described in its policies and procedures  
manual, as provided inpursuant to section 17753(2) of the code, MCL 333.17753.  
R 338.3054 Records maintenance; requirements for centralized prescription processing  
central fill pharmacies.  
Rule 4. (1) An originating pharmacy shall maintain records that indicate all of the  
following:  
(a) The date the request for centralized prescription processing services was transmitted  
to a centralized prescription processing center central fill pharmacy.  
(b) The method of transmittal.  
(c) The identification of the pharmacist responsible for the transmission.  
(d) The name and address of the centralized prescription processing center central fill  
pharmacy to which where the request for centralized prescription processing services  
was transmitted.  
4
(e) The date the delivering pharmacy received the filled prescription from the  
centralized prescription processing centercentral fill pharmacy.  
(f) The name of the pharmacy employee who accepted the delivery transfer of a filled  
prescription from a centralized prescription processing center central fill pharmacy.  
(g) The identification of the pharmacist who was responsible for delivering the  
prescription to the patient or the patient's agent.  
(2) A centralized prescription processing centercentral fill pharmacy that receives the  
transmitted prescription shall maintain records that indicate all of the following, as  
applicable to its function:  
(a) The date the request for centralized prescription processing services was received  
from the originating pharmacy.  
(b) The name and address of the originating pharmacy from whichwhere the request for  
centralized prescription processing services was received.  
(c) The date the prescription was processed, verified, or filled.  
(d) The identification of anythe pharmacistpharmacists who waswere responsible for  
processing the prescription and shipping athe filled prescription to an originating  
pharmacy or delivering athe filled prescription to a patient or a patient's agent.  
(e) The date the filled prescription was shipped to the originating pharmacy or was  
shipped or delivered to the patient or the patient's agent.  
(f) If shipped, theThe name and address of the patient to whom the filled prescription  
was shipped, if shipped.  
(g) The method of delivery, such as private, common, or contract carrier, if shipped.  
(3) If a prescription was not delivered to a patient and was transferred back to the  
pharmacy that filled the prescription, that pharmacy shall maintain the transfer records.  
PART 2. CONTROLLED SUBSTANCES PRESCRIPTIONS  
R 338.3055 Schedule 2, 3, 4, or 5 controlled substances prescriptions; requirements for  
centralized prescription processing central fill pharmacies.  
Rule 5. (1) In addition to complying with the requirements of Partpart 1 of these rules, a  
pharmacy that performs or contracts for centralized prescription processing services shall  
comply with this rule whenif processing a prescription for a schedule 2, 3, 4, or 5  
controlled substance.  
(2) Prescriptions for controlled substances may be transmitted electronically, including  
by facsimile, from an originating pharmacy to a centralized prescription processing center  
central fill pharmacy.  
(3) An originating pharmacy that transmits prescription information for a controlled  
substance to a centralized prescription processing centercentral fill pharmacy shall  
comply with all of the following:  
(a) Ensure that the words "CENTRAL FILL" are on the face of the original prescription  
and the originating pharmacy shall record all of the following information:  
(i) theThe name, address, and the federal drug enforcement administration (dea)  
Federal Drug Enforcement Administration (DEA) registration number of the  
centralized prescription processing center central fill pharmacy to which where the  
prescription had beenwas transmitted;.  
5
(ii) theThe name of the pharmacist at the originating pharmacy who transmitted the  
prescription;.  
(iii) and, theThe date of transmittal.  
(b) Ensure that all the information that is required to be on a prescription pursuant  
tounder the provisions of 21 CFRC.F.R. § 1306.05 and R 338.3161 is transmitted to the  
centralized prescription processing centercentral fill pharmacy, either on the face of the  
original prescription or in the electronic transmission of the prescription information.  
(c) Indicate Include all of the following in the prescription information that is  
transmitted,:  
(i) theThe number of refills already dispensed.  
(ii) and theThe number of refills remaining.  
(d) Maintain the original prescription for a period of 5 years from the date the  
prescription was filled.  
(4) Two years after the prescription was filled, the originating pharmacy may  
make an electronic duplicate of the original printed prescription, which becomes the  
original prescription. A pharmacy shall present a printed copy of the electronic  
duplicate of the prescription to the department or board upon request.  
(4)(5) In addition to complying with the requirements in R 338.3053338.3054(2)(a), (b),  
(c), (d), (e), (f) and (g), a centralized prescription processing centercentral fill pharmacy  
that receives the transmitted prescription shall comply with bothall of the following:  
(a) Maintain records for 5 years after the date of transmittal.  
(b) KeepMaintain a copy of the prescription if it was sent via facsimile or an electronic  
record of all the information transmitted by the originating pharmacy, including the  
name, address, and dea DEA registration number of the originating pharmacy that  
transmitted the prescription.  
(c) Maintain a record of the date the filled prescription was dispensed and the  
method of dispensing.  
R 338.3056 Reporting to the electronic system for monitoring controlled substances.  
Rule 6. As used in this part, the pharmacy that uses its stock to fill a prescription for a  
controlled substance shall beis the pharmacy responsible to report to the department or  
the department's contractor the information required in R 338.3162b for each controlled  
substance prescriptionof a controlled substance.  
Central Fill Pharmacies Rules - ORR 2021-093 LR  
Public Comment Summary  
Rules Committee’s Recommendations to December 14, 2022, Public Comments  
Testimony/Comments Received:  
Charlie Mollien  
Title  
Rule Numbers  
Title  
Commenter  
Mollien  
Comment  
The rules appear to regulate both central fill pharmacies and shared pharmacy services. Consider  
updating the title to “Central Fill and Shared Pharmacy Services”.  
Rules Committee The Rules Committee agrees with the comment to modify the title to include both Central fill and Shared Pharmacy  
Response  
Services.  
Board Response  
The Board agrees with the comment to modify the title to include both Central fill and Shared Pharmacy  
Services.  
CENTRALIZED PRESCRIPTION PROCESSING PHARMACIES CENTRAL FILL AND SHARED PHARMACY SERVICES  
Rule 338.3051  
Rule Numbers  
Section (1)(b)  
Definitions.  
Commenter  
Mollien  
Comment  
Defining "central fill pharmacy" as the all-encompassing term for any pharmacy engaged in  
centralized prescription processing incorrectly combines industry terms used to delineate between  
shared pharmacy services, a pharmacy engaged in non-dispensing centralized prescription  
processing, and central fill pharmacy, a pharmacy that engages in dispensing functions of  
centralized prescription processing. Modify to:  
(b)(a) "Centralized prescription Central fill pharmacyprocessing center" means a pharmacy  
operated under the direction of a pharmacist that processes information related to the practice of  
pharmacy and engages in dispensing functions of centralized prescription processing at the  
February 16, 2023  
request of an originating pharmacy.  
Rules Committee The Rules Committee agrees with the comment to clarify that a central fill pharmacy is a pharmacy that is handling  
Response  
dispensing functions versus shared pharmacy services that describes a pharmacy engaged in processing functions of  
centralized pharmacy processing.  
Board Response The Board agrees with the comment to clarify that a central fill pharmacy is a pharmacy that handles dispensing  
functions versus shared pharmacy services.  
R 338.3051 Definitions.  
Rule 1. (1) As used in these rules parts 1 and 2 of the centralized prescription processing rules, R 338.3051 to R 338.3054:  
(a) “Board” means the Michigan board of pharmacy, created in section 17721 of the code, MCL 333.17721.  
(b)(a) "Centralized prescription Central fill pharmacyprocessing center" means a pharmacy operated under the direction of a  
pharmacist that processes information related to the practice of pharmacy and engages in dispensing functions of centralized  
prescription processing at the request of an originating pharmacy.  
(b) "Centralized prescription processing" is the term defined in section 17753(3) of the code.  
(c) "Code" means the public health code, 1978 PA 368, MCL 333.1101 et seq. to 333.25211.  
(d) "Deliver," as used in this part, means the actual, constructive, or attempted transfer of to issuea prescription drug,  
including a controlled substance, directly to a patient or a patient's agent by the lawful order of a practitioner. A centralized  
prescription Deliver does not include a central fill processing center pharmacy that provides a prescription product to another  
pharmacy for subsequent issuance to a patient or a patient's agent. has not met the definition of deliver as defined in this subrule.  
(e) "Delivering pharmacist" means a pharmacist who is responsible for delivering a prescription directly to a patient or a patient's  
agent.  
(f) "Delivering pharmacy" means the pharmacy that delivers the filled or refilled prescription to the patient or the patient's  
authorized representativeagent. The delivering pharmacy shallmust be either the originating pharmacy or the centralized prescription  
processing center central fill pharmacy.  
(g) “Department” means the department of licensing and regulatory affairs (LARA).  
(g)(h) "Originating pharmacy" means a pharmacy that initially receives a patient's or a prescribing practitioner's request to fill or  
refill a prescription.  
(2) Unless otherwise defined in these rules, a The termsterm defined in the code havehas the same meanings meaning whenif  
used in these rules.  
2
Rule 338.3052  
Centralized prescription processing Central fill pharmacies and shared pharmacy services rules; prevail  
over other pharmacy rules.  
Rule Numbers  
Title  
Commenter  
Mollien  
Comment  
The rules appear to regulate both central fill pharmacies and shared pharmacy services. Consider  
updating the title to “Central Fill and Shared Pharmacy Services rules; prevail over other  
pharmacy rules”.  
Mollien  
Mollien  
Divide rule into (1) and (2). Adding this clarification is necessary to reflect contemporary practice  
of pharmacy with shared pharmacy services and make clear the application of "dispense" as defined  
by MCL 333.17703(3).  
Delete “central fill” in first line.  
(1) Delete central fill from (1)  
(2) Shared pharmacy services for processing functions of centralized pharmacy processing  
that do not involve the dispensing process, such as completing claims adjudication or remote  
data entry, may be performed under the general supervision of a pharmacist. For this  
subrule, dispensing process means the physical preparing, compounding, packaging, or  
labeling of a drug product intended for delivery to the patient.  
Modify (1) and  
Add (2)  
Rules Committee Title: The Rules Committee agrees with the comment to modify the title to include both central fill and shared pharmacy  
Response  
services.  
(1) and (2): The Rules Committee agrees with the comment that the rule should be divided into two provisions, and  
accepts the language recommended in (1) and (2) above, to reflect that central fill involves dispensing versus other  
shared services for processing functions of centralized pharmacy processing that does not involve dispensing.  
Board Response Title: The Board agrees with the comment to modify the title to include both central fill and shared pharmacy services.  
(1) and (2): The Board agrees with the comment that the rule should be divided into two provisions, and accepts the  
language recommended in (1) and (2) above, to reflect that central fill involves dispensing versus other shared services  
for processing functions of centralized pharmacy processing that does not involve dispensing.  
R 338.3052 Centralized prescription processing Central fill pharmacies rules; prevail over other pharmacy rules.  
Rule 2. (1) ToIn addition to these rules, central fill pharmacies must follow all applicable board rules. However, to the extent  
that any rule in parts 1 and 2 of the centralized prescription processing these rules conflicts conflict with other board of pharmacy  
rules, the provisions in parts 1 and 2 of the centralized prescription processing these rules shallmust prevail.  
3
(2) Shared pharmacy services for processing functions of centralized pharmacy processing that do not involve the dispensing  
process, such as completing claims adjudication or remote data entry, may be performed under the general supervision of a  
pharmacist. For this subrule, dispensing process means the physical preparing, compounding, packaging, or labeling of a drug  
product intended for delivery to the patient.  
Rule 338.3053  
Rule Numbers  
Title  
Centralized prescription processing; requirements.  
Commenter  
Comment  
Mollien  
Add “dispensing” to title.  
Centralized prescription processing; dispensing requirements.  
Rules Committee The Rules Committee agrees with the comment to add “dispensing” to the title.  
Response  
Board Response The Board agrees with the comment to add “dispensing” to the title.  
R 338.3053 Centralized prescription processing; dispensing requirements.  
Rule 3. (1) In addition to complying with the requirements of section 17753 of the code, MCL 333.17753, a pharmacy must meet all  
of the following requirements before it either performs may perform centralized prescription processing services or outsource  
outsources these services centralized prescription processing to another pharmacy:. Pharmacies that perform or outsource  
prescription processing services shall meet all of the following requirements:  
(a) Be licensed by the Michigan board of pharmacyHold a pharmacy license in this state.  
(b) Share sufficient patient and drug information to minimize the possibility of an adverse drug event.  
(c) Maintain prescription information or an equivalent record, as prescribed in section 17752(1) of the code, and the records required  
in R 338.3054 of this part, for 5 years from the date of dispensing. A centralized prescription processing center and an original  
pharmacy The pharmacy shall ensure that the informationrecords isare readily retrievable within 48 hours after the board's agent  
department makes a request for the informationrecords. If the records are maintained in a digital format, a printed copy shallmust  
be made available to the department or other authorized individualimmediately to the board's agent upon request.  
(2) The originating pharmacy shall maintain the original prescription for a period of 5 years after the date the prescription  
was filled.  
(3) Two years after the prescription was filled, the originating pharmacy may make an electronic duplicate of the original  
paper prescription, which becomes the original prescription. The originating pharmacy shall present a printed copy of the  
electronic duplicate of the prescription to the department or board upon request.  
4
(2)(4) A pharmacy engaging in centralized prescription processing shall beis responsible for each function of the prescription's  
processing performed by that pharmacy.  
(3)(5) A delivering pharmacist shall beis responsible for complying with R 338.490(4) R 338.589(4) regarding patient counseling.  
(4)(6) The prescription label for a prescription that was filled by a centralized prescription processing center central fill pharmacy  
shallmust identify each pharmacy that was involved in preparingdispensing and delivering athe prescription. A centralized  
prescription processing center central fill pharmacy may be identified on a prescription label by use of a unique identifier that is  
recognized by the delivering pharmacist. A central fill pharmacy shall create and maintain a unique identifier and communicate  
the unique identifier to all pharmacies that use its services. As used in this subrule, "unique identifier" means a unique  
combination of letters, numbers, or symbols that allows the delivering pharmacy to identify the specific centralized prescription  
processing center central fill pharmacy involved in the processing of the prescription. A centralized prescription processing center  
shall create and maintain a unique identifier and shall communicate the unique identifier to all pharmacies that use its services.  
(5)(7) A prescription that was not delivered to a patient may be transferred back to the pharmacy that filled the prescription, provided  
thatif the transfer records are maintained. A centralized prescription processing center central fill pharmacy and an originating  
pharmacy shall establish procedures for the disposition of prescription medication that was not delivered to patients. This medication  
may be returned to stock and may be re-delivered re-dispensed without constituting a violation of R 338.472(1) 338.503(1).  
(6)(8) A pharmacy that performs or contracts for centralized prescription processing services shall comply with the procedures  
described in its policies and procedures manual, as provided inpursuant to section 17753(2) of the code, MCL 333.17753.  
5
;