| (A) brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor;
(B) facility's lot number;
(C) facility's beyond use date; and
(D) quantity of the drug, if the quantity is greater
than one.
(3) Records of prepackaging shall be maintained to
show:
(A) name of the drug, strength, and dosage form;
(B) facility's lot number;
(C) manufacturer or distributor;
(D) manufacturer's lot number;
(E) manufacturer's expiration date;
(F) quantity per prepackaged unit;
(G) number of prepackaged units;
(H) date packaged;
(I) name, initials, or electronic signature of the
prepacker; and
(J) signature or electronic signature of the responsible
pharmacist.
(4) Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(h) Customized patient medication packages.
(1) Purpose. In lieu of dispensing two or more prescribed
drug products in separate containers, a pharmacist may, with the consent
of the patient, the patient's caregiver, or the prescriber, provide
a customized patient medication package (patient med-pak).
(2) Label.
(A) The patient med-pak shall bear a label stating:
(i) the name of the patient;
(ii) 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;
(iii) the name, strength, physical description or identification,
and total quantity of each drug product contained therein;
(iv) the directions for use and cautionary statements,
if any, contained in the prescription drug order for each drug product
contained therein;
(v) if applicable, a warning of the potential harmful
effect of combining any form of alcoholic beverage with any drug product
contained therein;
(vi) any storage instructions or cautionary statements
required by the official compendia;
(vii) the name of the prescriber of each drug product;
(viii) the name, address, and telephone number of the
pharmacy;
(ix) the initials or an identification code of the
dispensing pharmacist;
(x) 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;
(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 and strength of each drug product dispensed;
(-c-) name of the patient; and
(-d-) 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 in a pharmacy.
(1) Automated counting devices. If a pharmacy uses
automated counting devices:
(A) the pharmacy shall have a method to calibrate and
verify the accuracy of the automated counting device and document
the calibration and verification on a routine basis;
Cont'd... |
