Iowa Admin. Code r. 657-20.16 - [Rescinded effective 7/16/2025] Compounding for hospital use
Compounded preparations distributed or dispensed to a hospital or hospital pharmacy pursuant to this rule shall be administered to an individual patient in the hospital.
(1)
By an FDA-registered outsourcing facility. Only an
FDA-registered outsourcing facility properly licensed in Iowa pursuant to
657-Chapter 41 may distribute human compounded preparations to a hospital or
hospital pharmacy in the absence of a patient-specific prescription. The
compounded preparation shall be labeled in compliance with subrule
20.19(3).
(2)
By a pharmacy
that is not an FDA-registered outsourcing facility. Human compounded
preparations that are not compounded at an FDA-registered outsourcing facility
may be dispensed to a hospital or hospital pharmacy by an Iowa-licensed
pharmacy pursuant to a prescriber's authorization for administration to a
specific patient. The compounded preparation shall be labeled in compliance
with subrule 20.19(2).
Notes
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Compounded preparations distributed or dispensed to a hospital or hospital pharmacy pursuant to this rule shall be administered to an individual patient in the hospital.
(1) By an FDA -registered outsourcing facility . Only an FDA -registered outsourcing facility properly licensed in Iowa pursuant to 657-Chapter 41 may distribute human compounded preparations to a hospital or hospital pharmacy in the absence of a patient-specific prescription. The compounded preparation shall be labeled in compliance with subrule 20.19(3).
(2) By a pharmacy that is not an FDA -registered outsourcing facility . Human compounded preparations that are not compounded at an FDA -registered outsourcing facility may be dispensed to a hospital or hospital pharmacy by an Iowa-licensed pharmacy pursuant to a prescriber's authorization for administration to a specific patient. The compounded preparation shall be labeled in compliance with subrule 20.19(2).