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FDA Compounding Oversight

Meaning

FDA Compounding Oversight refers to the comprehensive regulatory framework established by the U.S. Food and Drug Administration (FDA) to supervise the preparation of customized medications, known as compounded drugs, by licensed pharmacists or physicians. This oversight is crucial because compounded drugs are not FDA-approved, meaning they have not undergone the agency’s rigorous premarket review for safety, efficacy, and quality standards. The regulations aim to strike a critical balance between allowing patients access to necessary, individualized therapies, particularly in hormonal health, and mitigating the inherent public health risks associated with non-standardized pharmaceutical production. Compliance ensures patient protection from substandard, contaminated, or sub-potent preparations.