California Board of Pharmacy opens 15‑day comment period on revised compounding rules after months of debate

The California State Board of Pharmacy on March 6 approved sending a fourth modified draft of proposed regulations on sterile and nonsterile compounding, hazardous drugs and radiopharmaceuticals out for a 15‑day public comment period and delegated to staff and two board members authority to review any additional comments.

The decision, made after more than two hours of discussion and more than three hours of public testimony, passed on a recorded vote of 7‑2. The motion approved staff responses to comments on the third modified text; approved the board's fourth modified text dated Feb. 28, 2025, for a 15‑day comment period; and delegated authority to the executive officer and to board members Maria Serpa and Renee Barker to review non‑substantive changes and any comments received during that period and return recommendations to the full board.

The vote followed a staff presentation and a lengthy review by Enforcement Committee chair Maria Serpa and member Renee Barker of changes the board is proposing to Title 16 of the California Code of Regulations. The proposed changes aim to clarify when ‘‘immediate use’’ compounding is allowed, to update procedures for compounding with category 1 bulk drug substances that appear on the FDA interim list, and to revise standard operating procedure (SOP) requirements for evaluating active pharmaceutical ingredients and components used in sterile compounding.

"In reviewing each of these comments, consideration and reflection of the board's consumer protection mandate was at the forefront of the assessment and the recommendation," Maria Serpa said while walking members through the fourth modified text. Serpa emphasized that the board began the rulemaking in 2019, resumed work in 2023 after USP finalized compounding chapters, and sought to align certain requirements with USP while clarifying state expectations.

Why it matters: The changes affect how pharmacies across California may compound medications for home and clinic use, including preparations for inhalation and other sterile products. The board’s decision to proceed with a fourth modified text and to open a new 15‑day comment period keeps the rulemaking active and preserves the board's option to revise the text again before a formal adoption vote.

What the draft changes say and why they drew comment

• Immediate use and reporting. The draft narrows language about when immediate‑use compounding may be used and adds clarifying language about when reporting is required. Maria Serpa told members the text does not expand immediate use beyond the board’s prior intent but clarifies conditions for reporting when sterile compounding equipment or environments fail.

• Category 1 bulk drug substances and API evaluation. The proposed edits to section 17.36.9 incorporate language consistent with USP chapters requiring certificates of analysis (COA) and methods to evaluate suitability and quality of APIs, and direct facilities to include SOPs describing processes for determining API quality. The board removed explicit cross‑references to some USP chapters from the regulation text but retained requirements that parallel USP expectations.

• SOPs and gloves. The draft strengthens SOP requirements for approving components (including category 1 bulk substances) and incorporates glove requirements that mirror USP language in certain areas.

Public testimony skewed heavily toward access concerns, especially for nebulized glutathione and methylcobalamin. Hundreds of callers and in‑person speakers—including firefighters, clinicians, patients and advocacy groups—urged the board to align with USP or the FDA interim enforcement policy and to preserve patient access to compounded nutrients and other sterile preparations. Testimony included personal accounts from first responders who said nebulized or IV glutathione improved symptoms following wildfire smoke exposure.

"We strongly urge the board to delay moving forward with the proposed compounding regulations," said Tenille Davis of the Alliance for Pharmacy Compounding, who urged the board to resolve enforcement and clarity issues before finalizing new state rules.

Clinical systems and large health systems offered a contrasting view: Kaiser Permanente and Sutter Health urged the board not to exceed USP compounding chapters and said the board lacked empirical evidence supporting a more prescriptive state framework. John Gray, a registered pharmacist at Kaiser Permanente, said the organization continued to believe the USP chapters provide evidence‑based standards and urged the board to withdraw the state package and rely on existing federal and compendial requirements.

Flavoring and ‘‘simple’’ compounding also produced focused comment. FlavorRx and other speakers asked the board to allow limited exemptions for flavoring commercially available preparations without triggering full compounding requirements; staff and board members said they were trying to strike a narrow compromise that would preserve access while respecting USP definitions that treat flavoring as compounding.

Enforcement, professional judgment and ambiguity

Several speakers raised concerns about enforcement and whether a pharmacist's professional judgment under a less prescriptive approach would expose compounders to inconsistent inspection outcomes. Board staff explained that inspectors document findings, investigations are reviewed by pharmacists and management, and outcomes can range from education and correction to formal discipline depending on the facts, license history and risk to patients.

Corinne (board counsel) clarified the limits of the board's jurisdiction when commenters suggested the board might regulate physicians or doctor's offices. She pointed to Business and Professions Code provisions that assign enforcement authority over healing‑arts licensees to their respective boards and reiterated that outsourcing facilities operating under section 503B have a defined role under federal law and may compound for office stock and individual prescriptions in some circumstances.

Votes at a glance

• Motion: Accept staff recommended responses to comments on the third modified text; approve fourth modified text dated 02/28/2025 for a 15‑day public comment period; delegate authority to the executive officer and board members Maria Serpa and Renee Barker to review additional comments and to make technical or non‑substantive changes. • Mover: Maria Serpa, Enforcement Committee chair. • Seconder: Renee Barker. • Vote: Yes — Seung Oh (president), Trevor Chandler, Renee Barker, KK John, Jay (public member), Satinder Sandhu, Maria Serpa. No — Jeff Hughes, Nicole Thiebaud. Outcome: approved (motion passes).

Next steps and implementation

With the board's vote the fourth modified text will be posted for a 15‑day comment period. Board members Serpa and Barker and the executive office have authority to review additional comments and recommend further changes before the board's next full consideration. Board staff said the board is likely to reconvene on March 26 for further consideration of the compounding package; members and staff also said the rules will be revisited after implementation if changes are needed.

What was not decided

The board did not adopt final rules at this meeting. Members deferred further detailed drafting questions — including a number of technical clarifications and the precise interaction of state language with USP and FDA guidance — to the delegated review process and future meetings.

Documents and legal framework referenced

The discussion and draft language referenced Title 16 of the California Code of Regulations (multiple sections proposed for repeal and addition), USP compounding chapters (as the national standards), the FDA interim policy on compounding with bulk drug substances, and federal distinctions between section 503A (traditional compounding) and 503B (outsourcing facilities). Counsel also cited Business and Professions Code provisions that define the limits of the board's jurisdiction.

Reporting: The board will accept written comments during the posted 15‑day period and delegated reviewers will return recommended edits, if any, for future board action.

Ending

The board's action keeps the rulemaking active while providing a narrow route for additional public input and staff review. Stakeholders on both sides of the debate signaled continued engagement: hospital systems and pharmacy‑practice groups urged the board not to exceed USP requirements, while patient groups, firefighters and clinicians pressed for unrestricted access to specific compounded nutrient therapies and clearer paths for community pharmacies to produce them. The board set a further meeting date to continue its review and implementation planning.