USP 797 Law – CALIFORNIA

SUMMARY INFORMATION

According to SB 294, pharmacies must be compliant as of 7/2018.

The May 2020 Update entitled “Compounding Requirements Following USP Appeal Decisions” the BOP has reiterated that the 2008 version of USP <797> is in effect.

COVID-19 Note: Business and Professions Code section 4126.8- Waive USP requirements related to the use of personal protective equipment (PPE) in that masks and gowns may be reused by staff performing sterile compounding under specific conditions.

Citations

California Sterile Products Statue

May 2020 BOP Update

ADOPTED BY REFERENCE ONLY? No