CHA News Article

Hospitals Reminded of New Requirements for Sterile Compounding Pharmacy Clean Rooms

In January 2017, the California Board of Pharmacy (BoP) established new requirements for hospitals performing sterile compounding. In addition, the Office of Statewide Health Planning and Development’s Facilities Development Division and the California Department of Public Health (CDPH) Licensing and Certification Program must review physical plant and program changes that hospitals must make to comply with the new BoP requirements.

In May, CDPH released an All Facilities Letter clarifying requirements for new or remodeled pharmacy clean rooms and use of mobile sterile compounding units in general acute care hospitals. According to the letter, hospitals must obtain CDPH approval for all new or remodeled pharmacy clean rooms under the hospital’s license. Hospitals must also obtain CDPH approval — including program flexibility approval — to temporarily use mobile sterile compounding units. CDPH advises hospitals to submit applications to the Centralized Applications Unit 120 days prior to when they anticipate completion of the new or remodeled pharmacy, and to clearly mark that the application is for sterile compounding. In addition, CDPH advises hospitals to contact the CDPH Pharmacy Consultant Unit at LNCPharmCleanRoom@cdph.ca.gov 90 days prior to anticipated completion.

Additional resources to assist hospitals in complying with the new requirements were previously shared in CHA News.

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