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  1. Human Drug Compounding

Background

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

Risks Related to Compounded Drugs

Date Alert Description
June 5, 2024 FDA alerts health care professionals, compounders and patients of potential safety risks associated with sulfite-containing compounded drugs
May 21, 2024 Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors
October 10, 2023 FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders
February 16, 2022 FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray
October 25, 2021 FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions
February 4, 2021 FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products
August 12, 2020 FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin
June 7, 2019 FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables
March 12, 2019 Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
July 23, 2018 FDA alerts health care professionals of significant safety risks associated with cesium chloride
July 5, 2018 FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product
March 14, 2018 FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection
October 3, 2017 A case of hemorrhagic occlusive retinal vasculitis (HORV) following intraocular injections of a compounded triamcinolone, moxifloxacin, and vancomycin formulation
August 4, 2017 FDA investigates two serious adverse events associated with ImprimisRx’s compounded curcumin emulsion product for injection

MedWatch Reporting Information

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: 

 

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