CA Bus & Prof Code Section 4127.7


On and after July 1, 2005, a pharmacy shall compound sterile injectable products from one or more nonsterile ingredients in one of the following environments:

(a)

An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.

(b)

An ISO class 5 cleanroom.

(c)

A barrier isolator that provides an ISO class 5 environment for compounding.
Last Updated

Aug. 19, 2023

§ 4127.7’s source at ca​.gov