Iowa Admin. Code r. 481-552.22 - [Effective 7/16/2025] Compounding
(1)
USP standards-pharmacies. Preparations compounded pursuant to
21 U.S.C. §
353a (Food, Drug, and Cosmetic Act
§503A) as amended November 27, 2013, will be prepared in accordance with
the standards of USP General Chapter 795 (2023) for nonsterile compounds and
USP General Chapter 797 (2023) for sterile compounds.
(2)
Compounding copies of an approved
drug.
a. The compounding of a
preparation that is essentially a copy of an FDA-approved drug is prohibited
unless:
(1) The compounded preparation is
changed to produce for an individual patient a clinically significant
difference to meet a medical need as documented by the prescriber, or
(2) The FDA-approved product is identified as
currently in shortage on the FDA drug shortages database.
b. The factors that indicate that a
compounded preparation is essentially a copy of an approved drug include:
(1) The compounded preparation has the same
active pharmaceutical ingredient(s) as the commercially available drug
product;
(2) The active
pharmaceutical ingredients have the same, a similar, or an easily substitutable
dosage strength; and
(3) The
commercially available drug product can be used by the same route of
administration as prescribed for the compounded
preparation.
c. A
prescription issued for a compounded preparation that is essentially a copy of
an approved drug will clearly document the relevant change and the significant
clinical difference produced for the patient.
(3)
Compounding for veterinary office
use. A pharmacy may compound preparations for distribution to a
veterinarian for office use, which may include direct patient administration or
dispensing pursuant to a patient-specific prescription.
(4)
Reporting. Annually,
prior to April 1, each licensed pharmacy located in Iowa that dispensed
compounded preparations for human use interstate in the previous calendar year
will report compounding data to the NABP information-sharing network.
(5)
Exemptions. The
combining of commercially manufactured, ready-to-use products is exempt from
USP General Chapter 795 (2023) compounding standards under the following
conditions:
a. No more than four commercially
manufactured, ready-to-use products (that have not been manipulated) are
used.
b. Compounding is not done in
anticipation of medication orders.
c. Preparations are assigned beyond-use dates
in accordance with USP General Chapter 795 (2023).
d. The use of commercially manufactured,
ready-to-use flavoring agents does not exceed 5 percent of the total volume of
the drug to which the flavoring agents are added.
e. The prescription label will comply with
USP General Chapter 795 (2023) and subrule 552.21(4).
(6)
Records. A record for
each compounded preparation will be prepared and maintained and will include:
a. All ingredients used in the preparation,
including manufacturer or NDC, lot number, and expiration date.
b. The compounding steps involved in the
preparation.
c. All personnel
involved in compounding and reviewing the preparation.
Notes
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