Section 338.479c. Customized patient medication packages (CPMP).

c. (1) In place of dispensing 2 or more prescribed drug products in separate containers, a pharmacist may, with the consent of the  patient,  the patient’s caregiver, or a prescriber, provide a customized patient medication package (CPMP). A CPMP is a package which is prepared by a pharmacist for a specific patient and which 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, then all of  the  following conditions shall be met:

(a)      Each CPMP shall bear a clearly readable label that states all of the following information:

(i)     A serial number for the CPMP itself 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 shall 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 shall be accompanied by a patient package insert in case any medication in the CPMP is required to be dispensed with an insert as accompanying labeling. 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)       In the absence of more stringent packaging requirements for any of the drug products contained in the CPMP, each CPMP shall be in compliance with the United States pharmacopeia (USP) and national formulary, as defined in section 17706(2) of the code, for moisture permeation requirements for a class b single- unit or unit-dose container. Each container shall be either not reclosable or so designed as to show evidence of having been opened. All provisions of the poison prevention packaging act, as  defined  in  section 17761(2) of the code, shall be complied with.

(d)        When preparing a CPMP, the dispenser shall take into account 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 shall 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 shall not be packaged together in the same CPMP.

(f)       Medications that have been 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 shall be prepared for the patient.

(g)     In addition to all individual prescription filing requirements, a record of each CPMP dispensed shall be made and filed. At  a   minimum  each record, shall 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. History:  1998-2000 AACS.