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  1. Human Drug Compounding

FDA is concerned about the risk to patients from compounded drugs that do not meet the conditions in sections 503A or 503B or the requirements in other applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For example, during inspections FDA investigators have identified many compounders that were not registered as outsourcing facilities, but were engaged in large-scale, non-patient specific compounding like a conventional manufacturer, without complying with premarket approval, labeling, and current good manufacturing practice (GCMP) requirements for their drugs, or compounders that prepared, packed, or held drugs under insanitary conditions.

When appropriate, FDA has taken steps to encourage compounders to voluntarily comply with the FD&C Act, such as by issuing warning letters. However, during follow-up inspections FDA has found that some compounders continue to fail to comply with applicable requirements of the law. FDA may consider enforcement action such as seizure or injunction.

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