California Board of Pharmacy adopts revised compounding regulations after months of debate; public commenters warn of access loss

The California State Board of Pharmacy on March 26 adopted a revised package of regulations governing compounded sterile and nonsterile drug preparations, hazardous drugs and radiopharmaceuticals, voting to accept staff responses to public comments, adopt the fourth modified text and authorize the executive officer to complete the rulemaking process.

The action came after months of meetings, multiple text revisions and a 15-day public-comment period that closed March 21. President Seung Oh, speaking before the vote, said he had “personally voiced my very strong desire to ensure category 1 bulk drug substances remain accessible.”

Why it matters: The regulations are intended to clarify how pharmacies and health-care facilities may compound sterile products and handle hazardous drugs while referencing federal law, federal guidance and the United States Pharmacopeia (USP) standards. Supporters on the board said the fourth modified text streamlines prior drafts and creates a clearer pathway for compliance. Opponents and many public commenters said the changes — and prior enforcement actions — have already reduced access to certain compounded medicines, particularly glutathione and other Category 1 bulk substances used by some patients and first responders.

Board action and procedure

Dr. Maria Serpa moved to: accept staff responses to comments on the fourth modified text, adopt the fourth modified text (identified in the meeting as a February 28, 2025 draft), authorize the executive officer to take all steps necessary to complete the rulemaking, and delegate to the executive officer authority to make technical or non‑substantive changes required by control agencies. Renee Barker seconded the motion. The board recorded seven yes votes, zero nos and one abstention (Ricardo Sanchez), and the motion carried. The board’s president said staff will undertake post‑implementation review and that the text may be revisited in future rulemaking.

Public comment and stakeholder concerns

Dozens of members of the public — including pharmacists, physicians, patients and firefighters who said they have used or rely on compounded products — addressed the board during a lengthy public‑comment period. Speakers described clinical use of compounds such as glutathione, methylcobalamin (a B12 form) and NAD for toxin reduction, chronic illness and post‑fire recovery, and warned that enforcement actions and uncertainty about state rules have already limited patient access.

Marie Kotman, introduced by the board as “a compounding‑only pharmacy owner and PIC for almost 20 years,” told the board that the regulations lacked clarity about how pharmacies would achieve compliance and urged members to “be brave enough today to say no.” Other speakers included physicians, cancer survivors and multiple firefighters who said they relied on compounded products after wildfire exposures.

Several institutional commenters urged the board to pause or withdraw the rulemaking. Lucas Evanson of the California Medical Association said CMA recommended rejecting the rulemaking unless the board adds language clarifying that the regulations do not apply to physicians. John Gray, a registered pharmacist at Kaiser Permanente, urged the board to apply a “mental model” assessing whether the proposed rules would solve the stated problems and warned of negative second‑order effects.

Board members’ remarks

Members described long and detailed deliberations. Several members said the board responded to public input through four rounds of modified text and multiple public meetings. Member Trevor Chandler noted extra meetings were convened in response to public concerns. Maria Serpa and others described substantive changes in the fourth modified text, including removing prescriptive testing requirements and instructing facilities to follow federal law, federal guidance and national standards while maintaining written policies demonstrating how they will comply.

The board also noted several specific textual changes made during the rulemaking process, as summarized at the meeting: expanded flexibility for hospitals and veterinarians in certain circumstances, modified provisions for hazardous drugs (limiting application to facilities that compound hazardous drugs or perform specific hazardous manipulations), adjustments to flavoring‑agent language to permit certain flavoring without prescriber approval, and revisions to provisions on immediate‑use compounding and competency transfers between compounding locations.

Areas of continuing dispute and requested follow‑up

Public commenters repeatedly asked the board to address enforcement practices and to ensure that disciplinary actions have not chilled lawful compounding that other states allow. At the end of the meeting a physician and cancer survivor, Dr. Seha, asked the board to “really focus on enforcement,” noting concerns that prior enforcement actions had limited access. Several board members suggested follow‑up work: possible education seminars for licensees, exploring a voluntary registry of pharmacies and services, and further public communication to explain how the new regulatory text is intended to operate.

The board did not adopt additional emergency or access‑specific measures at the meeting; members said they expect to conduct post‑implementation review and to return to the text if needed.

Votes at a glance

- Motion: Adopt staff responses to comments on fourth modified text; adopt fourth modified text dated February 28, 2025; authorize executive officer to complete rulemaking and make technical changes. Mover: Dr. Maria Serpa. Second: Renee Barker. - Outcome: Approved. - Vote (recorded): Seung Oh, president — yes; Trevor Chandler — yes; Renee Barker — yes; Jeff Hughes — yes; Ricardo Sanchez — abstain; Satinder (Sandhu) — yes; Maria Serpa — yes; Nicole Tipo — yes.

What the adopted text says about Category 1 substances

Board members emphasized the adopted text does not ban compounding with FDA Category 1 bulk substances. Instead, the fourth modified text, as described in materials and at the meeting, instructs facilities to follow federal law, federal guidance and USP standards and to maintain written policies showing how they will meet those standards. Several commenters disputed that this approach preserves access in practice, citing enforcement actions and business decisions that have already reduced the number of pharmacies willing to make certain compounded sterile products.

Next steps and oversight

The board delegated technical editing authority to the executive officer and authorized staff to complete the administrative steps needed to file the regulations. President Oh also said the board will undertake post‑implementation review and that the rules may be revisited sooner than a typical multi‑year cycle. Several members asked staff to explore education and outreach options for licensees and possible mechanisms to report or register pharmacies that offer compounded sterile products.

Speakers

President Seung Oh — President, California State Board of Pharmacy Dr. Maria Serpa — Licensee member, California State Board of Pharmacy Renee Barker — Licensee member, California State Board of Pharmacy Trevor Chandler — Public member, California State Board of Pharmacy Jeff Hughes — Public member, California State Board of Pharmacy Ricardo Sanchez — Public member, California State Board of Pharmacy Satinder Sandhu — Licensee member, California State Board of Pharmacy Nicole Tipo — Licensee member, California State Board of Pharmacy Marie Kotman — Compounding‑only pharmacy owner and PIC (public commenter) Dr. Chris Holder — Physician, toxicology specialist (public commenter) Dr. Seha — Physician and cancer survivor (public commenter) Sarah Johnson — Patient (public commenter) Lucas Evanson — California Medical Association (public commenter) John Gray — Registered pharmacist, Kaiser Permanente (public commenter) Additional public commenters included firefighters, patients with long COVID or ME/CFS, and patient‑advocacy speakers recorded in the meeting transcript.

Clarifying details

- Fourth modified text: identified in meeting materials as dated February 28, 2025 (as stated by the motion maker). - 15‑day comment period on the fourth modified text closed March 21, 2025 (noted by the board chair). - The board reported that it had discussed the proposed regulations across seven meetings and produced four rounds of modified text during rulemaking (remarks by President Oh and members). - Motion included delegation to the executive officer to make technical or nonsubstantive changes required by control agencies.

Community relevance

The adopted regulations were the subject of sustained comment from patients and first responders across California who said they rely on compounded sterile products (examples cited in public comment: firefighters exposed during wildfires, patients with long COVID, ME/CFS, Lyme disease and other chronic conditions). Commenters and some board members also raised concerns about pharmacy closures and business decisions (including effects of USP updates) that may affect local access.

Sources and provenance

Transcript excerpts in the meeting record support the account above: the agenda item introducing the proposed regulatory package (agenda item 2) and staff review begins midmeeting; public comment for the item spans repeated callers; the motion and roll‑call vote are recorded in the transcript. See provenance entries below for the first and last transcript blocks cited as evidence.

Ending

Board members said they expect continued oversight, public engagement and a post‑implementation review of the adopted regulations. Several members and public commenters urged the board to pursue additional education and clearer public communication about how the rules are intended to work and how enforcement will be applied.