Current through all regulations passed and filed through September 16, 2024
(A)
As used in this rule, "repackaging" means the act of
taking a finished drug product from the container in which it was distributed
by the original manufacturer and placing it into a different container without
further manipulation of the drug. Repackaging also includes the act of placing
the contents of multiple containers (e.g., vials) of the same finished drug
product into one container, as long as the container does not include other
ingredients. If a drug is manipulated in any other way, including if the drug
is reconstituted, diluted, mixed, or combined with another ingredient, that act
is not considered repackaging.
(B)
The following
rule applies to dangerous drugs repackaged by an institutional pharmacy. The
rule does not apply to any of the following:
(1)
Repackaging drug
products for use in animals;
(2)
Repackaging
non-dangerous drug products;
(3)
Radiopharmaceuticals as defined in Chapter 4729:5-6 of the
Administrative Code;
(4)
Repackaging conducted by outsourcing facilities or
repackagers licensed in accordance with section
4729.52 of the Revised
Code;
(5)
Removing a drug product from the original container at
the point of care (e.g., patient's bedside) for immediate administration to a
single patient after receipt of a valid patient-specific prescription or order
for that patient (e.g., drawing up a syringe to administer directly to the
patient);
(6)
Upon receipt of, or in anticipation of, a valid
patient-specific prescription or medication order, a licensed pharmacy removing
from one container the quantity of non-sterile drug products (e.g., oral dosage
forms) necessary to fill the prescription and placing it in a different
container to dispense directly to the patient; and
(7)
Investigational
new drugs being studied under an investigational new drug
application.
(C)
Drugs repackaged by an institutional pharmacy shall
comply with the following:
(1)
Unless otherwise specified in the individual monograph
or in the absence of stability data to the contrary, the beyond-use date shall
be not later than the expiration date on the manufacturer's container or
one-year from the date the drug is repackaged, whichever is earlier. Sterile
compounded drug preparations shall comply with paragraph (C)(2) of this
rule.
(2)
Sterile compounded drug preparations shall comply with
United States pharmacopeia chapter <797> as referenced in rule
4729:7-1-01 of the
Administrative Code.
(D)
Labels of drugs
repackaged by and stored within a pharmacy prior to being dispensed shall
contain, but not be limited to, the following:
(1)
Name of drug,
strength, and dosage form;
(2)
National drug
code or universal product code, if applicable, which may be embedded in a
barcode or quick response (QR) code on the label;
(3)
The
identification of the repackager by name or by the final seven digits of their
terminal distributor of dangerous drugs license number;
(4)
Pharmacy control
number; and
(5)
The beyond-use date of the repackaged drug in
accordance with the guidance listed in paragraph (C) of this
rule.
(E)
All drugs dispensed to inpatients for
self-administration or dispensed for outpatient use shall also be labeled in
accordance with rule
4729:5-5-06 of the
Administrative Code.
(F)
A record of all drugs repackaged and stored within a
pharmacy prior to being dispensed shall be kept for at least three years or one
year past manufacturer's expiration date, whichever is greater. This record
shall include, at a minimum, the following:
(1)
Name of drug,
strength, dosage form, and quantity;
(2)
National drug
code or universal product code (UPC), if applicable, which may be embedded in a
barcode or quick response (QR) code on the label;
(3)
Manufacturer's or
distributor's control number;
(4)
Manufacturer's or
distributor's name, if a generic drug is used, or if not using NDC or
UPC;
(5)
Pharmacy control number;
(6)
Manufacturer's or
distributor's expiration date;
(7)
The pharmacy's
beyond-use date in accordance with the guidance listed in paragraph (C) of this
rule;
(8)
The positive identification of the individual
responsible for the repackaging of the drug; and
(9)
The positive
identification of the pharmacist conducting the final verification of the
repackaged drug to confirm the accuracy of the drug and conformity to the
requirements of this rule prior to dispensing or
distribution.
(G)
Supplemental labels created by a pharmacy that contain
a barcode or QR code for the purpose of identifying a drug shall contain a
means of identifying the positive identification of the pharmacist responsible
for:
(1)
Association of the barcode to the drug
product;
(2)
Association of the label to the drug product.
Replaces: 4729-17-10
