Section R. 338.585 - Customized patient medication packageRule 85.
(1) A pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a CPMP. 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 individual that 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 comply with the USP and National Formulary, 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 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) If preparing a CPMP, the dispenser shall 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.(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 are dispensed in CPMP packaging may 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.Mich. Admin. Code R. 338.585
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024