Ohio Admin. Code 4729:5-9-02.8 - Labeling of prescriptions for patients
(A)
All dangerous
drugs dispensed for use by inpatients in an institutional facility, whereby the
drug is not in the possession of the ultimate user prior to administration,
shall meet the following requirements:
(1)
The label of a
single unit package of an individual-dose or unit-dose system of packaging of
drugs shall include:
(a)
The non-proprietary or proprietary name of the
drug;
(b)
Dosage form and route of
administration;
(c)
The strength and volume, where applicable, of the
drug;
(d)
The control number and expiration date;
(e)
National drug
code, universal product code, or formulary code, if applicable, which may be
embedded in a barcode or quick response (QR) code on the label;
(f)
Identification of
the manufacturer, packer or distributor, or, if the repackager is the
dispensing pharmacy, identification of the repackager shall be by name or by
the final seven digits of their terminal distributor of dangerous drugs license
number, and such identification shall be clearly distinguishable from the rest
of the label; and
(g)
Special storage conditions, if
required.
(2)
At least the name of the patient must be placed on all
medication containers too small to bear a complete label and dispensed in a
container bearing a complete label.
(B)
All drugs
dispensed to inpatients for self-administration or dispensed for outpatient use
shall be labeled in accordance with rule
4729:5-5-06 of the
Administrative Code.
(C)
Prior to dispensing, admixtures of parenteral solutions
shall bear a distinctive label indicating:
(1)
The patient's
full name;
(2)
The name and amount of the parenteral
solution;
(3)
The name and amount of the drug(s)
added;
(4)
The expiration date or beyond-use date;
(5)
The name and
address of the institutional pharmacy;
(6)
Cautionary
statements, if required.
(D)
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
Notes
Promulgated Under: 119.03
Statutory Authority: 3715.69, 3719.28, 4729.26
Rule Amplifies: 3715.64, 3719.08
Prior Effective Dates: 09/01/1985, 07/01/1991, 01/10/1996, 03/01/1999, 01/01/2009, 01/01/2010, 09/01/2016
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