DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
DIRECTOR'S OFFICE  
CENTRAL FILL AND SHARED PHARMACY SERVICES  
Filed with the secretary of state on May 19, 2023  
These rules take effect immediately upon filing with the secretary of state unless adopted  
under section 33, 44, or 45a(9) of the administrative procedures act of 1969,1969 PA  
306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections become  
effective 7 days after filing with the secretary of state.  
(By authority conferred on the director of the department of licensing and regulatory  
affairs by sections 16145, 17753, and 17767 of the public health code, 1978 PA 368,  
MCL 333.16145, 333.17753, and 333.17767, and Executive Reorganization Order Nos.  
1991-9, 1996-2, 2003-1, and 2011-4, MCL 338.3501, 445.2001, 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:  
(a) “Board” means the Michigan board of pharmacy, created in section 17721 of the  
code, MCL 333.17721.  
(b) "Central fill pharmacy" means a pharmacy that engages in dispensing functions of  
centralized prescription processing at the request of an originating pharmacy.  
(c) "Code" means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.  
(d) "Deliver," as used in this part, means the actual, constructive, or attempted transfer  
of a prescription drug, including a controlled substance, directly to a patient or a patient's  
agent by the lawful order of a practitioner. Deliver does not include a central fill  
pharmacy that provides a prescription product to another pharmacy for subsequent  
issuance to a patient or a patient's agent.  
(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 agent. The delivering pharmacy must be either  
the originating pharmacy or the central fill pharmacy.  
(g) “Department” means the department of licensing and regulatory affairs (LARA).  
(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 term defined in the code has the same  
meaning if used in these rules.  
February 16, 2023  
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R 338.3052 Central fill and shared pharmacy services rules; prevail over other pharmacy  
rules.  
Rule 2. (1) In addition to these rules, pharmacies must follow all applicable board rules.  
However, to the extent that these rules conflict with other board rules, the provisions in  
these rules must 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.  
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 centralized prescription processing or outsources centralized prescription  
processing to another pharmacy:  
(a) Hold a pharmacy license in this state.  
(b) Share sufficient patient and drug information to minimize the possibility of an  
adverse drug event.  
(c) Maintain records required in R 338.3054, for 5 years from the date of dispensing.  
The pharmacy shall ensure that the records are readily retrievable within 48 hours after  
the department makes a request for the records. If the records are maintained in a digital  
format, a printed copy must be made available to the department or other authorized  
individual 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) A pharmacy engaging in centralized prescription processing is responsible for each  
function of the prescription's processing performed by that pharmacy.  
(5) A delivering pharmacist is responsible for complying with R 338.589(4) regarding  
patient counseling.  
(6) The prescription label for a prescription that was filled by a central fill pharmacy  
must identify each pharmacy that was involved in dispensing and delivering the  
prescription. A 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 central fill pharmacy involved in the processing of the  
prescription.  
(7) A prescription that was not delivered to a patient may be transferred back to the  
pharmacy that filled the prescription, if the transfer records are maintained. A central fill  
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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-dispensed without constituting a violation of R  
338.503(1).  
(8) A pharmacy that performs or contracts for centralized prescription processing shall  
comply with the procedures described in its policies and procedures manual, pursuant to  
section 17753(2) of the code, MCL 333.17753.  
R 338.3054 Records maintenance; requirements for 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 was transmitted to a  
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 central fill pharmacy where the request for centralized  
prescription processing was transmitted.  
(e) The date the delivering pharmacy received the filled prescription from the central  
fill pharmacy.  
(f) The name of the pharmacy employee who accepted the transfer of a filled  
prescription from a 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 central 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 was received from the  
originating pharmacy.  
(b) The name and address of the originating pharmacy where the request for centralized  
prescription processing was received.  
(c) The date the prescription was processed, verified, or filled.  
(d) The identification of the pharmacists who were responsible for processing the  
prescription and shipping athe filled prescription to an originating pharmacy or delivering  
the 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) The 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  
central fill pharmacies.  
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Rule 5. (1) In addition to complying with the requirements of part 1 of these rules, a  
pharmacy that performs or contracts for centralized prescription processing shall comply  
with this rule if 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 central fill pharmacy.  
(3) An originating pharmacy that transmits prescription information for a controlled  
substance to a central 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) The name, address, and the Federal Drug Enforcement Administration (DEA)  
registration number of the central fill pharmacy where the prescription was transmitted.  
(ii) The name of the pharmacist at the originating pharmacy who transmitted the  
prescription.  
(iii) The date of transmittal.  
(b) Ensure that the information that is required on a prescription under 21 CFR 1306.05  
and R 338.3161 is transmitted to the central fill pharmacy, either on the face of the  
original prescription or in the electronic transmission of the prescription.  
(c) Include all of the following in the prescription:  
(i) The number of refills already dispensed.  
(ii) The 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.  
(5) In addition to complying with the requirements in R 338.3054(2)(a), (b), (c), (d), (e),  
(f) and (g), a central fill pharmacy that receives the transmitted prescription shall comply  
with all of the following:  
(a) Maintain records for 5 years after the date of transmittal.  
(b) Maintain 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 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 is the pharmacy responsible to report to the department or the  
department's contractor the information required in R 338.3162b for each controlled  
substance prescription.  
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