Americans for Safe and Effective Medicines (ASEM) commends the Medical Board of California for taking action against a San Diego medical office accused of compounding and administering injectable semaglutide and tirzepatide in unsafe conditions.
According to the Board, the facility lacked basic safeguards necessary for sterile drug production, including a certified cleanroom, appropriate air filtration, and written operating procedures. The products were also allegedly mislabeled, dispensed without child-resistant packaging, and missing tracking numbers and expiration dates — posing major safety risks to patients.
Compounded drugs are not FDA-approved and do not undergo the same premarket review for safety, effectiveness, and quality as FDA-approved medicines. When compounded products are produced or administered outside established safeguards, decisive oversight is essential to protect patients and preserve trust in the health care system.
The Board’s action to seek revocation of the medical license for the San Diego office’s physician who allowed unsafe compounding practices demonstrates what strong state-level oversight looks like. By investigating potential misconduct, documenting alleged violations, and pursuing accountability, the Board is sending a clear message that patient safety standards cannot be ignored.
This type of leadership is needed across the country. State medical boards are uniquely positioned to hold licensed professionals accountable and ensure that patients are not exposed to improperly prepared or deceptively presented compounded drugs.
We encourage medical boards in other states to follow California’s lead by leaning into their oversight responsibilities, closely examining large-scale and high-risk compounding practices within clinical settings, and taking action when patient safety may be compromised.
Thank you for your commitment to protecting California patients and for demonstrating the important role state medical boards can play in addressing unsafe compounding practices. ASEM stands ready to support continued efforts to strengthen transparency, accountability, and patient protections in California and nationwide.