The risks associated with using compounded medications include:
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Risk of contamination: Because compounding pharmacies are not regulated by the FDA to the same degree as commercial drug manufacturers, compounded drugs can be contaminated with bacteria, fungi, or other harmful substances. A notable example is the 2012 fungal meningitis outbreak caused by contaminated steroid injections from a compounding pharmacy, which resulted in nearly 800 infections and 64 deaths.
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Inconsistent dosing: Dosing errors are more common with compounded drugs because they are not standardized like FDA-approved drugs. This can lead to patients receiving too much or too little of the active ingredient, causing serious side effects or reduced effectiveness. For example, compounded versions of certain injectables have led to dosing mistakes resulting in hospitalizations.
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Lack of FDA evaluation: Compounded medications are not clinically evaluated by the FDA for safety, efficacy, or quality. They do not have standard labeling or prescribing information with safety instructions. This absence increases the potential for preparation errors and adverse effects.
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Potential for misbranded or adulterated products: Some compounded drugs have been found to contain ingredients not approved by the FDA or to have less active ingredient than advertised. This can compromise treatment outcomes and patient safety.
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Limited oversight: Most compounding pharmacies are overseen by state boards rather than the FDA, except for certain registered outsourcing facilities. This limits consistent quality assurance and adverse event reporting.
For these reasons, compounded medications should only be used when an FDA-approved drug is not suitable or available and under careful medical supervision.
