April 14, 2023
APC to California BOP: How do proposals protect patients?
APC this week submitted a comment letter expressing concern over the California Board of Pharmacy’s proposed changes to regulations related to sterile compounding. Also included with the comment letter were APC’s detailed comments on specific regulatory changes under consideration by the California board.
From the letter:
APC supports the Board’s statutory mission to protect California consumers, and we believe it’s in the interest of the pharmacy compounding profession to have robust enforcement of reasonable regulation that safeguards patient safety. Yet it is not clear how many of the current proposed changes protect patients. In fact, in some cases, the effect of these proposals will be to eliminate patient access entirely – an action at odds with the agency’s stated mission.
APC’s primary concerns include the lack of enunciated scientific basis for regulatory proposals that exceed USP chapters and FDA guidance, and the risk of immediate loss of access to essential medications for many California patients resulting from some proposals.
APC has asked the board to delay action on these proposals until it can better enunciate a rationale for any resulting proposed regulatory changes.