Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 2 - General Rules
Section 20 CSR 2220-2.145 - Minimum Standards for Multi-Med Dispensing
Universal Citation: 20 MO Code of State Regs 2220-2.145
Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment would expand the authorized beyond-use date for patient med paks and would authorize inclusion of controlled substances as allowed by state and federal controlled substance laws.
(1) In lieu of dispensing two (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 (patient med pak).
(2) A patient med pak is a package prepared by a pharmacist for a specific patient comprising one (1) or more containers and containing two (2) or more prescribed solid oral dosage forms. The patient med pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.
(A) The patient med
pak shall bear a label stating-
1. The name of
the patient;
2. A serial number for
the patient med pak itself and a separate identifying serial number for each of
the prescription orders for each of the drug products contained
therein;
3. The name, strength,
physical description or identification and total quantity of each drug product
contained therein;
4. The
directions for use and cautionary statements if any, contained in the
prescription order for each drug product therein;
5. Any storage instructions or cautionary
statements required by the official compendia;
6. The name of the prescriber of each drug
product;
7. The date of preparation
of the patient med pak and the beyond-use date assigned to the patient med pak
(such beyond-use date shall be not later than ninety (90) days from the date of
preparation);
8. The name, address,
and telephone number of the dispenser; and
9. Any other information, statements, or
warnings required for any of the drug products.
(B) If the patient med pak allows for the
removal or separation of the intact containers therefrom, each individual
container shall bear a label identifying each of the drug products contained
therein.
(C) The patient med pak
shall be accompanied by a patient package insert, in the event that any
medication therein is required to be dispensed with such insert as accompanying
labeling. Alternatively, such required information may be incorporated into a
single, overall, educational insert provided by the pharmacist for the total
patient med pak.
(D) In the absence
of more stringent packaging requirements for any of the drug products contained
therein, each container of the patient med pak shall comply with the 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.
(E) It is the
responsibility of the dispenser, when preparing a patient med pak, to take into
account any applicable compendia requirements or guidelines and the physical
and chemical compatibility of the dosage forms placed within each container, as
well as any therapeutic incompatibilities that may attend the simultaneous
administration of the medications. In this regard, pharmacists are encouraged
to report to United States Pharmacopeia (USP) headquarters any observed or
reported incompatibilities.
(F) In
addition to any individual prescription filing requirements, a record of each
patient med pak shall be made and filed. Each record shall contain, at a
minimum:
1. The name and address of the
patient;
2. The serial number of
the prescription order for each drug product contained therein;
3. The name of the manufacturer or labeler
and lot number for each drug product contained therein;
4. Information identifying or describing the
design, characteristics, or specifications of the patient med pak sufficient to
allow subsequent preparation of an identical patient med pak for the
patient;
5. The date of preparation
of the patient med pak and the beyond-use date that was assigned;
6. Any special labeling instructions;
and
7. The name or initials of the
pharmacist who prepared the patient med pak.
(G) There is no special exemption for patient
med paks from the requirements of the Poison Prevention Packaging Act. Thus the
patient med pak, if it does not meet child-resistant standards, shall be placed
in an outer package that does comply, or the necessary consent of the purchaser
or physician to dispense in a container not intended to be child-resistant,
shall be obtained.
(H) Once a
patient med pak has been delivered to an institution or to a patient it shall
not be returned to the pharmacy, unless the following requirements are met:
1. The med pak is returned to the pharmacy
from which it was originally dispensed;
2. The med pak is modified/repackaged, per
prescription order, for the same patient to whom it was originally
dispensed;
3. The med pak is
labeled in compliance with the requirements of this rule, provided the med pak
shall retain the original beyond-use date assigned to the med pak before
modification/repackaging;
4. The
med pak is assigned a new serial number;
5. The medications removed from the med pak
are destroyed in compliance with state and federal law. In no event shall
medication removed from a med pak be returned to stock/inventory or dispensed
to another patient; and
6.
Licensees shall comply with all applicable record-keeping
requirements.
(I)
Multi-med paks may include controlled substances as allowed by, and in
accordance with, state and federal controlled substance laws and
regulations.
(J) Except as
otherwise allowed in subsection (H) of this section, once a drug has been
commingled with other drugs in a med pak the drug may not be returned to stock,
dispensed, or distributed except for destruction purposes.
*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011 ; 338.059, RSMo 1971, amended 1973, 1978, 1997; and 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 .
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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