Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Human Drug Compounding

Human Drug Compounding

                        Compounding Laws and Policies
          Regulatory Policy Information
          Compounding Risk Alerts
          Compounding Oversight and Compliance Actions
          Compounding: Inspections, Recalls, and other Actions
          Information for Outsourcing Facilities
          Registered Outsourcing Facilities
          Bulk Drug Substances Used in Compounding
          Consumer and Health Care Professional Information
          Compounding Information for States
          Compounding Research


                        Compounding Quality Center of Excellence Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Human Drug Compounding
          Compounding Risk AlertsHuman Drug Compounding Compounding Risk Alerts
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintMany serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an Incidents Program to identify and prevent outbreaks through surveillance of adverse events and product quality incidents. This effort has led to many actions by FDA including the issuance of compounding risk alerts to inform health care professionals, compounders and consumers about risks associated with compounded drugs, including information on adverse events, outbreaks or product quality. These are intended to alert stakeholders of the risks so that practitioners can more effectively protect patients from unsafe, ineffective and poor-quality compounded medicines.

Please contact compounding@fda.hhs.gov if you have any questions regarding the information provided in a compounding risk alert below:

FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders (October 10, 2023)
	FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray (February 16, 2022)
	FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions (October 25, 2021)
	FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products (February 4, 2021)
	FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin (August 12, 2020)
	FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables (June 7, 2019)
	Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors (September 24, 2018)
	FDA alerts health care professionals of significant safety risks associated with cesium chloride (July 23, 2018)
	FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product (Update: July 5, 2018)
	Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (Update: March 12, 2019)
	FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection (Updated: March 14, 2018)
	A case of hemorrhagic occlusive retinal vasculitis (HORV) following intraocular injections of a compounded triamcinolone, moxifloxacin, and vancomycin formulation (October 3, 2017)
	FDA investigates two serious adverse events associated with ImprimisRx’s compounded curcumin emulsion product for injection (August 4, 2017)FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program; or
	Download and complete theform, then submit it via fax at 1-800-FDA-0178

                                                                                  Content current as of:
      10/10/2023
              
              
Regulated Product(s)
		 DrugsHuman Drug Compounding

          
                        Compounding Laws and Policies
          Regulatory Policy Information
          Compounding Risk Alerts
          Compounding Oversight and Compliance Actions
          Compounding: Inspections, Recalls, and other Actions
          Information for Outsourcing Facilities
          Registered Outsourcing Facilities
          Bulk Drug Substances Used in Compounding
          Consumer and Health Care Professional Information
          Compounding Information for States
          Compounding Research


                        Compounding Quality Center of Excellence
 SUBSCRIBE
                      Get regular FDA email updates delivered on this topic to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop