The Draft Legislation will likely undergo significant revisions before its adoption — if it is adopted at all. What is clear, however, is that the FDA is moving toward regulating compounding practices that have traditionally been regulated by state agencies. Federal intervention will likely come to fruition in the near future, and many compounders who are not currently subject to the FDCA’s GMPs and other requirements will be faced with the challenge of having to comply with new regulations and additional oversight. Accordingly, it is important that compounding entities become familiar with and track the Draft Legislation as it progresses as it appears that increased federal oversight is imminent.
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