Iowa Admin. Code r. 481-552.21 - [Effective 7/16/2025] Labeling
(1)
Ambulatory prescription labeling. The required labeling
elements for a prescription dispensed for an ambulatory patient include:
a. Patient name, except as provided by the
Iowa Code.
b. Prescriber
name.
c. Pharmacy name, address,
and telephone number.
d. Product
name, strength, dosage form, and quantity.
e. Instructions for use.
f. Dispense date.
g. Unique serial number.
h. Manufacturer name or NDC.
(2)
Institutional
patient-specific prescription labeling. The required labeling elements
for a patient-specific supply of prescription medication dispensed for an
institutional patient include:
a. On the
immediate container:
(1) Patient
name.
(2) Drug name, strength, and
dosage form.
b. On outer
packaging, if not present on the immediate container:
(1) Instructions for use.
(2) Pharmacy name, address, and telephone
number unless the pharmacy is located within the institutional
facility.
(3) Dispense
date.
(4) Unique serial
number.
(5) Beyond-use
date.
(3)
Non-patient-specific drug labeling. The required labeling
elements for a non-patientspecific supply of prescription medication include:
a. Drug name, strength, and dosage
form.
b. Drug manufacturer or
NDC.
c. Expiration or beyond-use
date.
(4)
Compounded patient-specific preparation labeling. In addition
to the required labeling identified in subrule 552.21(1) or 552.21(2), as
applicable, a label for a compounded preparation will also include:
a. The name and concentration of each active
ingredient.
b. The date that the
preparation was compounded.
c.
Special storage and handling instructions, if applicable.
d. Except in institutional settings, the
statement "THIS IS A COMPOUNDED DRUG" or a similar statement identifying the
product as a compounded preparation, including the term "STERILE" when
applicable.
e. The batch
identification or control number from which the preparation was dispensed, if
applicable.
f. Beyond-use
date.
(5)
Compounded non-patient-specific preparation labeling-batch compounding
or veterinary office supply. The required labeling elements for a
non-patient-specific supply of a compounded preparation include:
a. Preparation name, strength, dosage form,
and quantity.
b. Name and
concentration of each active ingredient.
c. Pharmacy name, address, and telephone
number, except when batch compounding.
d. Preparation date.
e. Beyond-use date.
f. Storage and handling
instructions.
g. Lot or batch
identification or control number, if applicable.
h. The statement "THIS IS A COMPOUNDED DRUG"
or a similar statement identifying the product as a compounded preparation,
including the term "STERILE" when applicable, except for use within an
institutional setting.
i. The
statement "NOT FOR REDISTRIBUTION" or a similar statement to ensure that use of
the compounded preparation is limited to direct patient administration or
dispensing pursuant to a patientspecific prescription.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.