The FDA is continuing its efforts to build and leverage strong working relationships with state regulators in our collective efforts to oversee drug compounding. With the 2023 Intergovernmental Working Meeting on Drug Compounding scheduled for Nov. 7-8, 2023, FDA is reporting on how it has addressed action items identified during last year’s meeting, held on November 1-2, 2022. This meeting between the FDA and state regulators has occurred annually since 2014. To learn more about FDA’s interactions with states on the regulation of drug compounding, see the FDA Compounding Information for States webpage.
Action Item: FDA will continue to work on streamlining its inspection review process to reduce timeframes and improve information available to states concerning inspections of compounding facilities.
Response: FDA has implemented several process improvements since 2019. We have achieved a 53.3 percent reduction over four years on the average number of days from the end of inspection to certain actions, including warning letters, untitled letters, warning letter closeouts, state referral letters, state hand off letters, FMD-145s (which release establishment inspection reports), and regulatory meetings. From FY2019 to FY2020, there was a 16.7 percent reduction in timeframe, from FY2020 to FY2021, a 25.6 percent reduction, and from FY2021 to FY2022, a 24.7 percent reduction. FDA continues to work on streamlining, standardizing and improving the inspection review processes.
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: In April 2023, the Office of Compounding Quality and Compliance (OCQC) issued an email alert to over 2,600 compounding stakeholders to remind them of the potential health hazard of bulk ingredients contaminated with diethylene glycol (DEG) or ethylene glycol (EG). Additionally, OCQC revised the FDA to Compounders: Know Your Bulks and Excipients Suppliers webpage to include historical and recent examples of DEG or EG contamination and provide resources to assist compounders in establishing practices that prevent the use of drug components that are contaminated with DEG or EG to prevent future incidents of poisoning.
On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms of semaglutide in compounded products. On Oct. 10, 2023, FDA sent additional letters to the National Association of Boards or Pharmacy and the Federation of State Medical Boards expressing similar concerns. The letters also explain the conditions under which compounded semaglutide products may be permissible under the law and note that compounded drugs are not FDA-approved or evaluated before marketing for safety and effectiveness.
In May, the FDA published a webpage, Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss, to provide state-licensed compounders, healthcare professionals, and state regulators with easy access to relevant compounding policies and agency concerns about compounded semaglutide, and to increase awareness of adverse events associated with compounded semaglutide. FDA also published the Drug Compounding and Shortages webpage to inform stakeholders, including state regulators, about what state-licensed pharmacies can compound during shortages. FDA has also responded to numerous media inquiries about compounded semaglutide and compounding other drugs in shortages.
In October 2023, FDA published a compounding risk alert to alert patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. This alert addresses compounded dosage forms of ketamine provided through telemedicine platforms and compounders, noting that the ability to obtain these drug products for at-home use may be attractive to some patients. However, the lack of monitoring for adverse events, such as sedation and dissociation, by an onsite health care provider may put patients at risk. The alert also emphasizes that safe and effective dosing of ketamine for any psychiatric disorder has not been established because ketamine is not FDA-approved for these uses.
FDA continues to notify and request information from state regulatory authorities about incidents received by FDA related to compounded drugs. In FY2023, the Compounding Incidents Program issued 48 notification letters to 20 states. State regulatory authorities in receipt of these letters included boards of barbering and cosmetology, boards of medical examiners, boards of pharmacy, boards of medicine, boards of nursing, and divisions of consumer affairs.
In FY2023, the Compounding Incidents Program issued 47 correspondence letters to 15 states to notify and request information from state regulatory authorities. State regulatory authorities in receipt of these letters included boards of medicine, boards of naturopathic medicine, boards of nursing, boards of pharmacy, boards of podiatric medicine, divisions of professional licensing, occupational safety and health administrations, and osteopathic boards.
Action Item: FDA will explore pathways to facilitate additional collaboration and dialogue between federal and state regulators on non-pharmacist compounding and IV hydration clinics.
Response: FDA joined the National Association of Boards of Pharmacy, the Federation of State Medical Boards, and the National Council of State Boards of Nursing for a panel discussion for state regulators, Intravenous (IV) Hydration Clinics: Federal and State Perspectives, on July 26, 2023, to discuss risks associated with IV hydration services being offered to the public. Approximately 700 state regulators attended this virtual meeting. Panelists discussed regulatory perspectives on these businesses, and opportunities for more effective oversight. For example, panelists discussed state boards of medicine, state boards of pharmacy, and state boards of nursing conducting joint inspections of IV hydration clinics. Read more on the Federation of State Medical Boards website.
Action Item: FDA will consider providing additional training for state regulators and inspectors on FDA guidance documents.
Response: Throughout FY2023, FDA has provided several training opportunities for compounders and associated stakeholders that include discussion of FDA guidance documents.
- On Dec. 14, 2022, FDA presented a Small Business and Industry Assistance program webinar, What to Expect after an Inspection: 483s, Responses and Beyond.
- On Feb. 14, 2023, FDA held a briefing on the newly published guidance on compounding certain ibuprofen oral suspensions for hospitals and health systems for administration within the hospital or health system and/or state-licensed pharmacies.
- On July 14, 2023, FDA held a webinar to provide an overview of the newly published Draft Guidance: Prohibition on Wholesaling Under Section 503B of the FD&C Act.
- Throughout FY2023, FDA sent monthly listserv messages to compounding stakeholders on training opportunities offered by the FDA Compounding Quality Center of Excellence.
- More than 90 participants from 25 states completed instructor-led and self-guided online trainings offered by the FDA Compounding Quality Center of Excellence during FY2023.
- The FDA Compounding Quality Center of Excellence posted video recordings of its 2022 annual conference, held Sept. 6-8, 2022, on the conference webpage. This includes a video link and slides session for the session on FDA’s draft guidance on Hospital and Health System Compounding.