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Cal. Bus. & Prof. Code § 4127.7

Injectable Sterile Drug Products

Showing this section's text as in effect on January 1, 2011 (in force January 1, 2011 – January 1, 2017). View current text →

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.

Official source: California Legislative Information. Reproduced from public-domain California statutes; confirm against the official source for the current text. Not legal advice.