FDA Responses to Action Items Identified in 2023 Intergovernmental Working Meeting on Drug Compounding

FDA and state pharmaceutical regulators meet regularly to advance their collective efforts to improve the quality of compounded drugs and protect consumers from unsafe compounded drugs. In the most recent Intergovernmental Working Meeting on Drug Compounding, Nov. 7-8, 2023, FDA and state regulators identified three actions items. Below is a summary of those action items and how FDA has responded. 

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Action item: FDA will continue to work with states and the National Association of Boards of Pharmacy to identify, understand and enhance pathways for information sharing about adverse events, complaints and product quality issues related to compounded drugs.

Response: FDA issued two compounding risk alerts on adverse events related to compounded drugs. The first, issued on June 5, 2024, alerted healthcare professionals and patients to the risks of serious allergic-type reactions to sulfite-containing compounded drugs. The second, issued on July 26, 2024, warned healthcare professionals and patients about adverse events related to compounded semaglutide dosing errors. 

Additionally, FDA sent letters in July 2024 about the dosing and titration schedule of compounded semaglutide and tirzepatide to several state regulatory and industry associations including the National Association of Boards of Pharmacy, the Federation of State Medical Boards, the National Council of State Boards of Nursing, the Alliance for Pharmacy Compounding and the Outsourcing Facility Association. The letters described adverse events due to prescriptions indicating higher than recommended starting doses, more frequent than recommended dosing and faster than recommended titration of doses. 

FDA also updated its webpage, FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, to provide more information on adverse events associated with compounded GLP-1 drugs and to recommend that patients obtain a GLP-1 prescription from their doctor and fill the prescription at a state-licensed pharmacy. 

Throughout 2024, FDA continued to issue correspondence letters to notify and request information concerning drug compounding from state regulatory authorities. 

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Action item: FDA will work with outsourcing facilities and other stakeholders to understand barriers to producing products that appear on FDA’s drug shortages list.

Response: FDA hosted several listening sessions in May 2024 with outsourcing facilities, pharmacy professional and industry associations, hospital and health system associations, public health advocacy groups, medical associations and health benefits/insurance industry associations. In these sessions, FDA staff asked attendees about their barriers to compounding drugs that appear on FDA’s drug shortages list. Members of the FDA drug shortages staff and compounded drug regulatory staff were available to respond to questions from attendees. Visit compounding when drugs are on FDA’s Drug shortages list> for more information. 

FDA announced in July 2024 that it intends to publish new guidance for outsourcing facilities on considerations related to drug shortages. Feedback from outsourcing facilities, pharmaceutical professional associations and industry groups has provided valuable perspectives for FDA policy staff on compounding drugs in shortage. 

FDA hosted 10 meetings in October 2024 with representatives of several trade associations, an outsourcing facility and a medical products manufacturer in response to the closure of a critical supplier of intravenous (IV) and peritoneal dialysis solutions. The supplier, Baxter’s western North Carolina manufacturing plant, had produced approximately 60% — or 1.5 million bags — of the IV solutions used daily in the United States. The plant closed due to damage caused by Hurricane Helene.

FDA issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, on Oct. 11, 2024, describing temporary enforcement discretion for IV solutions in shortage to enable compounders to help fill in gaps in the supply of IV solutions.

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Action item: FDA will work to strengthen collaboration with federal agency partners and state regulators outside of boards of pharmacy.  

Response: On April 19, 2024, FDA participated in a panel discussion, Addressing IV Hydration, Ketamine, and Other Unregulated Treatments, at the Federation of State Medical Boards annual conference in Nashville. FDA had previously issued compounding risk alerts on compounded IV hydration services and compounded ketamine drugs. FDA continues to encourage state boards of nursing, state medical boards and state boards of pharmacy to work together to address the risks of compounded IV hydration solutions used in clinics and med spas.

On Nov. 13, 2024, FDA convened a day-long meeting with staff from 12 other federal agencies with an interest in drug compounding, including the Veterans Affairs, the Indian Health Service, the Bureau of Prisons, the Drug Enforcement Agency, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention and others. The intent was to improve collaboration and strengthen partnerships across federal agencies whose work is related to compounded drugs. During the meeting, FDA staff gave presentations on compounding basics, compounding policy, inspection trends, insanitary conditions, compounded drug incidents, FDA educational opportunities and drug shortages. The meeting highlighted the need for federal agencies to continue collaborating with each other to improve the safety and quality of compounded drugs. 

Visit FDA Compounding Information for States webpage to learn more about FDA’s interactions with states on the regulation of drug compounding.