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 outpatient 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 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 outpatient pharmacy shall comply
with the following:
(1)
"Repackaging of Certain Human Drug Products by
Pharmacies and Outsourcing Facilities" guidance issued by the United States
food and drug administration (January 2017) and any other subsequent
repackaging guidance issued by the food and drug administration that is
approved by the board;
(2)
For sterile compounded drug preparations, 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 bar
code or quick response (QR) code on the label;
(3)
The
identification of the repackager by name or by the final seven digits of the
terminal distributor of dangerous drugs license number;
(4)
Pharmacy control
number;
(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 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 in a readily retrievable manner
for at least three years or one year past manufacturer's expiration date,
whichever is greater. This record shall include the following:
(1)
Name of drug,
strength, dosage form, and quantity;
(2)
National drug
code or universal product code, if applicable, which may be embedded in a bar
code 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;
(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)
A pharmacy that
uses supplemental labels that contain a bar code or QR code for the purpose of
identifying a repackaged drug shall capture the positive identification of the
pharmacist responsible for the following:
(1)
Association of
the bar code to the drug product; and
(2)
Association of
the label to the drug product.
Replaces: 4729-9-20
