March 24, 2023
California BOP compounding proposals out of sync with national standards
The California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding.
During the four-hour-long meeting, APC legislative and regulatory counsel David Pore shared concerns about how proposed changes to regulations will impact patients in the state. Notably, the proposals are inconsistent with USP 797, aim to make USP Chapters 1000 and above enforceable in California – something USP itself clearly does not recommend – and state that items on FDA’s interim list for bulk substances may not be compounded.
APC is submitting a formal comment letter addressing our serious concern that the proposals are well out of sync with nationally recognized standards, will sow confusion among licensees and dampen their ability to serve patients.
“Patient access is the real issue here,” says APC’s Scott Brunner. “These policies aren’t rooted in any particular science and well exceed national standards like USP and FDA guidance. The California BOP has not demonstrated how patients are made safer by these proposals. Instead, this is a state agency charged with protecting the public that is pursuing restrictions that will ultimately disadvantage California patients who rely on compounded medications to live normal lives.”