Iowa Admin. Code r. 657-20.16 - 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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