Iowa Admin. Code r. 657-20.16

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 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).

Iowa Admin. Code r. 657-20.16

Adopted by IAB October 14, 2015/Volume XXXVIII, Number 08, effective 11/18/2015

Amended by IAB August 2, 2017/Volume XL, Number 3, effective 9/6/2017