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What "not FDA-approved" actually means for compounded medications When a compounded medication is described as "not FDA-approved," that means the FDA hasn't reviewed that specific compounded formulation for safety, effectiveness, or manufacturing quality before dispensing

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Our May 22, 2025 guidance regarding the use of the estimated allowed amount was an important first step towards requiring the disclosure of the actual prices of items and services, not estimates, and ensuring pricing information is standardized and easily comparable across hospitals and health plans