Board of Pharmacy adopts revised compounding regulations after months of debate

SACRAMENTO — The California State Board of Pharmacy voted on March 26 to adopt a fourth modified text of regulations covering compounded drug preparations, hazardous drugs and radiopharmaceuticals and authorized the executive officer to complete the rulemaking process.

The action, carried by a 7–0 vote with one abstention, accepted staff responses to comments received during a 15-day public-comment period and adopted the version of the text dated Feb. 28, 2025. Licensee member Maria Serpa moved to "accept the board staff recommended responses to the comments on the fourth modified text... adopt the fourth modified text that was dated 2/28/25, and authorize the Executive Officer to take all steps necessary to complete the rulemaking process," and the board seconded the motion and voted to approve it.

Why it matters: the package affects how pharmacies compound sterile products in California and how the board oversees hazardous-drug handling and radiopharmaceuticals. Dozens of public commenters — including firefighters, physicians and patients — urged the board not to finalize language they said would limit access to patient-specific compounded medicines such as glutathione and methylcobalamin. Other commentators, and several board members, argued the revised text clarifies standards and creates a pathway aligned with federal law and national United States Pharmacopeia (USP) standards.

Board action and vote Board President Seung Oh opened the vote after members discussed the regulation revisions and public testimony. Maria Serpa made the motion; Renee Barker seconded. The roll call vote recorded the following: President Seung Oh — yes; Trevor Chandler — yes; Renee Barker — yes; Jeff Hughes — yes; Ricardo Sanchez — abstain; Satinder Sandhu — yes; Maria Serpa — yes; Nicole Tibo — yes. The board recorded the outcome as approved and delegated to the executive officer authority to complete regulatory filing and make technical, non‑substantive changes required by control agencies.

What the adopted text says and what changed The board said the fourth modified text removes some previously proposed prescriptive facility testing requirements and instead instructs regulated facilities to follow federal law, federal guidance and applicable USP standards, and to document policies showing how they will comply. The board highlighted specific changes made during the rulemaking process, including revised provisions for compounding for animal patients, expanded day‑supply allowances to veterinarians, added flexibility for hospitals to compound commercially available drug products and expanded "immediate use" provisions for certain urgent situations. Board materials and remarks noted other changes to hazardous‑drug handling language and to flavoring-agent provisions.

Members emphasized that the adopted regulations do not, on their face, ban so‑called FDA Category 1 bulk drug substances, and the board repeatedly told the public that the package is intended to clarify and implement federal and USP requirements rather than to prohibit particular substances. President Seung Oh said the board "has been very thoughtful in its consideration of comments" and that the board will perform post‑implementation review and may update the rules again in the future.

Public comment: access, enforcement and safety concerns Public testimony consumed a large portion of the meeting. Dozens of callers and in-person commenters — including firefighters who participated in recent wildfire responses, physicians who treat chronic and post‑infectious conditions, and patient advocates — pleaded to preserve access to compounded sterile products. Many speakers said glutathione and related sterile compounds have been used to treat toxin exposure and chronic conditions and said enforcement actions and changing practice requirements have already reduced access in California.

Marie Kotman, a compounding-only pharmacy owner and pharmacist in charge, told the board: "Please make a motion to repeal the relevant compounding sections as listed in the fourth modified text without the addition of any revision or additional rules." Doctor Chris Holder, a toxicology specialist, said he can no longer write patient‑specific prescriptions for many firefighters as he had in prior years. Patient speaker Sarah Johnson said the rules "function as a de facto ban" for some patients and called the process a "legal failure, a public health failure, and a moral failure." Other callers urged adherence to federal guidance and USP standards while maintaining patient access.

Industry groups and clinicians also submitted formal comments during the 15‑day period. The Alliance for Pharmacy Compounding urged the board "not to move forward with the proposed compounding regulations in their current form," while Kaiser Permanente urged the board to vote down the motion and instead consider repealing the board's existing compounding rules and allowing the proposal to expire.

Board responses and next steps Board members and staff repeatedly said the regulatory package had been substantially modified in response to comments and that the fourth modified text included numerous concessions to address concerns about access and implementation. Licensee member Renee Barker and other members described specific technical points — for example, differences in beyond‑use dating tied to USP compounding categories (Renee Barker noted that some segregated compounding areas permit maximum room‑temperature beyond‑use limits such as roughly 12 hours and refrigerated limits such as roughly 24 hours, versus longer dating when full clean‑room suites or 503B manufacture with validated stability data are in place).

Several public speakers urged the board to focus more on enforcement practices and on outreach to pharmacies to reduce a "chilling effect" they said followed enforcement actions against some compounding operations. Physician commenter Doctor Seha requested that the board "really focus on enforcement" and examine whether enforcement and penalties have contributed to reduced patient access.

After the vote the board said staff will complete the regulatory filing and the executive officer was authorized to make technical or non‑substantive edits required by control agencies. President Oh also said the board will conduct a post‑implementation review and that the text is likely to be revisited in the future.

Votes at a glance - Motion to accept staff responses, adopt fourth modified text (dated Feb. 28, 2025) and delegate authority to the executive officer: mover — Licensee member Maria Serpa; second — Licensee member Renee Barker; outcome — approved; roll call: Seung Oh (yes), Trevor Chandler (yes), Renee Barker (yes), Jeff Hughes (yes), Ricardo Sanchez (abstain), Satinder Sandhu (yes), Maria Serpa (yes), Nicole Tibo (yes).

What the meeting did not do The board did not state that it removed or changed federal USP standards; it instructed regulated entities to follow federal law and USP standards. The board did not adopt any separate enforcement actions at this meeting beyond delegating administrative authority to the executive officer to complete rulemaking filings. The transcript records many claims about enforcement practices and alleged pharmacy closures; the board acknowledged those concerns and signaled plans for post‑implementation review and additional outreach rather than taking immediate enforcement policy changes at this session.

Looking ahead The executive officer will handle final rulemaking steps and any technical edits required by control agencies. The board said it will evaluate the regulations after implementation and consider updates. Staff and members suggested follow‑up work on public education, outreach to pharmacies, and possible registry or voluntary reporting to clarify where patients can obtain compounded sterile products. The board recessed and resumed other agenda items after the vote.