Mich. Admin. Code R. 338.585 - Customized patient medication package
Rule 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.