June 21, 2024

APC to CA BOP: How does this make patients safer?

The California Board of Pharmacy has proposed several new regulations for pharmacy compounding, some of which, to put it bluntly (and we did put it bluntly), are not rooted in science or evidence.

APC Chief Advocacy Officer Tenille Davis outlined our objections to these proposals in a presentation at a CA BOP public hearing this week. Her comments were a summary of APC’s comment letter to the agency about the proposal.

“In total we identify 57 specific places where the proposed regulations exceed what is required in federal law and by the compounding chapters of the U.S. Pharmacopeia,” she told the board. “In none of those instances has the board demonstrated how these excessive regulations make patients safer.”

Those 57 include California’s proposed prohibition on compounding with FDA Interim Bulks list items in Category 1, which includes glutathione, methylcobalamin, and DMPS; and stringent regulations on allergenic extract compounding that will adversely affect patient access.

In some cases, she explained, the proposed regulations would be difficult to comply with because they don’t match industry standards: “For example, excipient suppliers that must be FDA registered manufacturers, and the printed original manufacturer name and address being printed on the certificate of analysis of the API.”

You can listen to Tenille’s testimony here (4-minute MP3) or read it here (PDF).