| (xi) either on the prescription label or the written
information accompanying the prescription, the statement "Do not flush
unused medications or pour down a sink or drain." A drug product on
a list developed by the Federal Food and Drug Administration of medicines
recommended for disposal by flushing is not required to bear this
statement; and
(xii) any other information, statements, or warnings
required for any of the drug products contained therein.
(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 product contained
therein.
(C) The dispensing container is not required to bear
the label as specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an
ultimate user who is institutionalized in a licensed health care institution
(e.g., nursing home, hospice, hospital);
(ii) no more than a 90-day supply is dispensed at one
time;
(iii) the drug is not in the possession of the ultimate
user prior to administration;
(iv) the pharmacist-in-charge has determined that the
institution:
(I) maintains medication administration records which
include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration
of the drug(s); and
(III) provides for appropriate safeguards for the control
and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) name of the patient; and
(-c-) name and strength of each drug product dispensed;
(-d-) name of the patient; and
(-e-) name of the prescribing practitioner of each
drug product, or the pharmacist who signed the prescription drug order;
(II) the date after which the prescription should not
be used or beyond-use-date. Unless otherwise specified by the manufacturer,
the beyond-use-date shall be one year from the date the med-pak is
dispensed or the earliest manufacturer's expiration date for a product
contained in the med-pak if it is less than one-year from the date
dispensed. The beyond-use-date may be placed on the prescription label
or on a flag label attached to the bottle. A beyond-use-date is not
required on the label of a prescription dispensed to a person at the
time of release from prison or jail if the prescription is for not
more than a 10-day supply of medication; and
(III) for each drug product sets forth the directions
for use and cautionary statements, if any, contained on the prescription
drug order or required by law.
(3) Labeling. The patient med-pak shall be accompanied
by a patient package insert, in the event that any drug contained
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.
(4) Packaging. 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 official packaging
standards. Each container shall be either not reclosable or so designed
as to show evidence of having been opened.
(5) Guidelines. It is the responsibility of the dispensing
pharmacist when preparing a patient med-pak, to take into account
any applicable compendial 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 drugs.
(6) Recordkeeping. In addition to any individual prescription
filing requirements, a record of each patient med-pak shall be made
and filed. Each record shall contain, as a minimum:
(A) the name and address of the patient;
(B) the unique identification number for the patient
med-pak itself and a separate unique identification number for each
of the prescription drug orders for each of the drug products contained
therein;
(C) the name of the manufacturer or distributor and
lot number for each drug product contained therein;
(D) 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;
(E) the date of preparation of the patient med-pak
and the beyond-use date that was assigned;
(F) any special labeling instructions; and
(G) the initials or an identification code of the dispensing
pharmacist.
(7) The patient med-pak label is not required to include
the initials or identification code of the dispensing pharmacist as
specified in paragraph (2)(A) of this subsection if the identity of
the dispensing pharmacist is recorded in the pharmacy's data processing
system. The record of the identity of the dispensing pharmacist shall
not be altered in the pharmacy's data processing system.
(i) Automated devices and systems.
(1) Automated compounding or counting devices. If a
pharmacy uses automated compounding or counting devices:
(A) the pharmacy shall have a method to calibrate and
verify the accuracy of the automated compounding or counting device
and document the calibration and verification on a routine basis;
(B) the devices may be loaded with bulk or unlabeled
drugs only by a pharmacist or by pharmacy technicians or pharmacy
technician trainees under the direction and direct supervision of
a pharmacist;
(C) the label of an automated compounding or counting
device container shall indicate the brand name and strength of the
drug; or if no brand name, then the generic name, strength, and name
of the manufacturer or distributor;
(D) records of loading bulk or unlabeled drugs into
an automated compounding or counting device shall be maintained to
show:
(i) name of the drug, strength, and dosage form;
(ii) manufacturer or distributor;
(iii) manufacturer's lot number;
(iv) manufacturer's expiration date;
(v) date of loading;
(vi) name, initials, or electronic signature of the
person loading the automated compounding or counting device; and
(vii) signature or electronic signature of the responsible
pharmacist; and
(E) the automated compounding or counting device shall
not be used until a pharmacist verifies that the system is properly
loaded and affixes his or her signature to the record as specified
in subparagraph (D) of this paragraph.
(2) Automated pharmacy dispensing systems.
(A) Authority to use automated pharmacy dispensing
systems. A pharmacy may use an automated pharmacy dispensing system
to fill prescription drug orders provided that:
(i) the pharmacist-in-charge is responsible for the
supervision of the operation of the system;
(ii) the automated pharmacy dispensing system has been
tested by the pharmacy and found to dispense accurately. The pharmacy
shall make the results of such testing available to the board upon
request; and
(iii) the pharmacy will make the automated pharmacy
dispensing system available for inspection by the board for the purpose
of validating the accuracy of the system.
(B) Quality assurance program. A pharmacy which uses
an automated pharmacy dispensing system to fill prescription drug
orders shall operate according to a written program for quality assurance
of the automated pharmacy dispensing system which:
(i) requires continuous monitoring of the automated
pharmacy dispensing system; and
(ii) establishes mechanisms and procedures to test
the accuracy of the automated pharmacy dispensing system at least
every six months and whenever any upgrade or change is made to the
system and documents each such activity.
(C) Policies and procedures of operation.
(i) When an automated pharmacy dispensing system is
used to fill prescription drug orders, it shall be operated according
to written policies and procedures of operation. The policies and
procedures of operation shall:
(I) provide for a pharmacist's review, approval, and
accountability for the transmission of each original or new prescription
drug order to the automated pharmacy dispensing system before the
transmission is made;
Cont'd... |
