{"id":14707,"date":"2025-02-07T10:22:27","date_gmt":"2025-02-07T15:22:27","guid":{"rendered":"https:\/\/whizkid.com\/a4pc\/?p=14707"},"modified":"2025-02-07T10:22:27","modified_gmt":"2025-02-07T15:22:27","slug":"another-california-update","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2025-02\/another-california-update\/","title":{"rendered":"A(nother) California update"},"content":{"rendered":"
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As you may be aware, the California Board of Pharmacy has proposed compounding regulations that include both stability studies and bulk drug testing requirements on Category 1 substances \u2014 requirements that would exceed both USP <797> and FDA requirements.<\/p>\n

APC has been pressing the board on the issue, and we were able to comment during the board\u2019s latest meeting. We expressed our deep concerns about the latest draft of California\u2019s compounding regulations (the third iteration, if you\u2019ve been counting).<\/p>\n

Perhaps most notably, we pointed out that board staff and members seem to have a fundamental misunderstanding of their proposed testing requirements, which carry significant costs \u2014 up to $40,000 per formulation \u2014 that could make compliance nearly impossible for many compounding pharmacies. That would severely limit patient access to specialized therapies like glutathione for inhalation.\u00a0<\/p>\n

We urged the board to reject the current proposal and instead align with USP <795>, <797>, and <800> to protect patient safety without unnecessary barriers to care.<\/p>\n

On that note\u2026<\/span><\/strong><\/h2>\n

The big question here is: How would these regs make patients safer? That\u2019s the very question the Santa Rosa Press Democrat<\/span><\/em> asked<\/span><\/a>, looking specifically at the role compounded glutathione played in saving the lives of firefighters. Reporter Austin Murphy did an excellent job \u2014 with help from APC \u2014 explaining how the actions of a well-meaning but overzealous board of pharmacy could deprive these first responders of a therapy that seems to be helping them amidst the wildfires.<\/p>\n<\/div>\n<\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

APC continues to press the California Board of Pharmacy on its (over-zealous) proposed rules on requirements for compounding Category 1 substances.
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