Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed.

Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate quality standards – such as if a drug is contaminated or contains too much active ingredient – it could cause serious injury or death. Additionally, the labels on compounded drugs may not include important information such as adequate directions to help ensure the drugs are used safely.

The agency seeks to strike a balance between preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not produced in accordance with applicable federal law.

FDA continues to investigate many reports of serious adverse events associated with contaminated or otherwise poor-quality compounded drugs. The agency continues to identify insanitary conditions at drug compounding facilities during inspections. Insanitary conditions can cause drugs to become contaminated and lead to serious patient injury and death.

Risk-based oversight, providing information about compounding regulation, policy development and fostering collaboration with states and stakeholders are vital to achieving broader compliance with the provisions of federal law intended to help protect patients.

Email us: compounding@fda.hhs.gov

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