Board approves another 15‑day comment period on compounding regulations after heated public remarks on access to glutathione

The California State Board of Pharmacy voted 7–2 on Feb. 5 to publish a third modified text of proposed regulations on sterile and nonsterile compounding, hazardous drugs and radiopharmaceuticals for another 15‑day public comment period.

The motion directs staff to post the recommended third modified text, to accept the staff responses to comments from the prior 15‑day period and to delegate to members Maria Serpa and Renee Barker the authority to review comments received during the new 15‑day period and return recommendations to the board. The board also delegated to the executive officer authority to make non‑substantive, technical edits.

Why it matters: The measure moves a long‑running rulemaking effort forward after years of updates to U.S. Pharmacopeia (USP) chapters and multiple public hearings. Board staff and members said the additional comment period will allow them to refine language about where state regulations restate or clarify federal law, USP standards and inspection expectations — and to respond to repeated public concerns that the proposed rules could reduce patient access to certain compounded products.

Board staff presented the package as an effort to clarify California requirements around compounding rather than to create new federal standards. “The board's proposed regulation provides a pathway that navigates federal law and federal guidance related to the use of bulk substances and ... USP requirements,” said Maria Jacobs, a board staff member who led the presentation.

Board members and staff spent several hours reviewing proposed edits across articles for nonsterile compounding, sterile compounding, hazardous drugs and radiopharmaceuticals. Discussion highlighted several recurring points raised during the 15‑day comment period and earlier meetings: how pharmacists should document a clinical review before dispensing a compounded product, whether consultation language should use “offer” or “provide,” documentation for cleaning agents and final rinse water, how to treat facilities that only add a flavoring agent, and the extent of stability and bulk‑API testing that should be required.

Legal context and agency guidance

Board counsel Noreen (last name on file) reminded the board and members of the public that FDA statements cited in the discussion are an enforcement‑discretion posture, not FDA approval. “The FDA's interim policy regarding these substances ... is an enforcement‑discretion policy. So, it's not the same as saying that FDA has approved or authorized these substances,” she said during the meeting.

Public comments: access and safety concerns

Public comment ran more than an hour and the board heard scores of callers and in‑room commenters. Multiple speakers representing firefighters, long‑term patients and compounding pharmacies urged the board to avoid language that would make commonly sought compounded preparations, especially nebulized glutathione and methlycobalamin injections, effectively unavailable in California.

Jackie Jorgensen of the Volunteer Fire Foundation told the board bluntly: “If you take 1 thing away from this meeting, please know that nebulized glutathione is not available to firefighters.” She and several firefighters who spoke said they had received treatment through pop‑up clinics and reported respiratory improvement after smoke exposure.

Representatives of industry and pharmacy groups asked the board for clearer guidance on what counts as acceptable verification and documentation when a pharmacist dispenses an “essentially a copy” compounded product. Mark Johnston of CVS Health asked whether routine, low‑complexity compounding such as flavoring “magic mouthwash” would be covered by the flavoring exemption; staff and board members acknowledged the language was a source of confusion and said they would try to make it clearer.

Costs and testing availability

Board staff provided two pieces of cost information cited during the meeting: a vendor estimate that per‑lot testing for certain APIs could run about $16.10 per vial for a 250 mg glutathione vial and $8.06 per vial for methylcobalamin and that one‑time stability studies often run in the $5,000–$10,000 range, but noted many such studies already exist in the marketplace and can be referenced rather than repeated.

Board response and next steps

Board members expressed concern about both patient access and safety. Several members described the issue as complex because federal guidance, FDA enforcement policy and USP chapters intersect and because USP and federal guidance are themselves evolving. One line of debate focused on whether the proposed text should explicitly restate federal guidance and USP provisions (which some commenters had asked for to reduce ambiguity) or remain concise and point licensees to the federal and USP materials.

The motion approved by the board sends the third modified text to a 15‑day comment period and gives Serpa and Barker delegated authority to work with staff on responses to any new comments that arrive during that window. The board will review the record and any recommended edits at a future public meeting.

Votes at a glance

- Motion: Approve staff responses and the recommended third modified text for a 15‑day public comment period; delegate authority to members Serpa and Barker to review comments with staff and to delegate non‑substantive technical edits to the executive officer. (Text as presented at the Feb. 5 meeting.) - Vote: Yes — Jesse Crowley, Trevor Chandler, Renee Barker, KK John, Jay Nuo, Satinder Sandhu, Maria Serpa. No — Jeff Hughes, Nicole Thiebaud. Tally: 7 yes, 2 no. Outcome: approved.

What the board did not do

The board did not adopt final regulations; it did not change federal FDA guidance or USP chapters; and it did not approve an exemption or carve‑out that would override federal guidance. Staff reiterated that the proposed regulations are intended to clarify state requirements and how they relate to USP and FDA guidance.

What to watch next

The board will post the third modified text for 15 days and accept comments. Serpa and Barker will have delegated authority to review comments and return recommendations to the full board. Board staff said they will incorporate non‑substantive edits and prepare a revised packet for the board's next public meeting.