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Federal Prosecution and the Section 503A/503B Compounding Framework Compounding pharmacies provide a vital service by preparing customized medications, but their ability to work with raw active pharmaceutical ingredients (APIs) is heavily restricted by federal statute

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In September 2025, the Food and Drug Administration issued over 50 Warning Letters to companies for marketing compounded GLPs as generic versions or that make comparative claims to FDA-approved versions

Instead, use anatomical modifiers to distinguish their repeat procedures

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