Current through Register Vol. 46, No. 19, March 20, 2024
The label, or attached auxiliary labeling if necessary, affixed
to the container of any compounded preparation dispensed or distributed into or
within Iowa shall contain at least the information identified in one of the
following subrules, as applicable.
(1)
General pharmacy or outpatient dispensing. The label shall
meet the labeling requirements of 657-subrule 6.10(1) and shall include the
following additional information:
a. The name
and concentration of each active ingredient.
b. The date that the preparation was
compounded.
c. The beyond-use date
of the compounded preparation.
d.
Special storage and handling instructions, if applicable.
e. The statement "COMPOUNDED PREPARATION" or
a reasonable comparable alternative statement that prominently identifies the
drug as a compounded preparation.
f
If the compounded preparation is sterile, the word "STERILE."
g. If the compounded preparation was prepared
from batch preparation compounding, the batch identification or control number.
(2)
Hospital
pharmacy or inpatient administration. The label shall meet the
labeling requirements of 657-subrule 22.1(3) and shall include the following
additional information:
a. The name and
concentration of each active ingredient.
b. The date that the preparation was
compounded.
c. The beyond-use date
of the compounded preparation.
d.
If the compounded preparation was prepared from batch preparation compounding,
the batch identification or control number.
e. Special storage and handling instructions,
if applicable.
(3)
Outsourcing facility distribution or dispensing. The label, or
auxiliary labeling if necessary, shall include the following information:
a. The statement "THIS IS A COMPOUNDED DRUG"
or a reasonable comparable alternative statement that prominently identifies
the drug as a compounded preparation.
b. The name, address, and telephone number of
the outsourcing facility that compounded the preparation.
c. The established name of the
preparation.
d. The dosage form and
strength.
e. The quantity of the
preparation.
f. The date that the
preparation was compounded.
g. The
beyond-use date of the compounded preparation.
h. Storage and handling instructions.
i. The lot or batch identification
or control number.
j. The national
drug code number, if available.
k.
The statement "Not for resale" and, if the preparation is dispensed or
distributed other than pursuant to a patient-specific prescription, the
statement "OFFICE USE ONLY."
l. The
following additional information, which can be included on the labeling of a
container (such as a plastic bag containing individual product syringes) from
which individual units of the drug are removed for dispensing or for
administration if there is not space on the label for such information:
(1) Directions for use including, as
appropriate, dosage and administration;
(2) A list of the active and inactive
ingredients, identified by established name and quantity or proportion of each
ingredient;
(3) FDA contact
information (www.fda.gov/medwatch and 1-800-FDA-1088 or successor Web site or
telephone number) to facilitate adverse event reporting.
m. If the preparation is compounded pursuant
to a prescription for a specific patient, the label shall also include the
label requirements in 657-subrule 6.10(1).
n. If the preparation is compounded for
office use, the label shall also include the label requirements in subrule
20.15(4).