Section 4127.7.

Latest version.

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.

(Added by Stats. 2004, Ch. 695, Sec. 36. Effective January 1, 2005.)

                    
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