FDA Q&A
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The FDA is currently drawing guidance documents related to compounding. Specifically, the FDA held a workshop in conjunction with CDER on February 2022. The workshop focused on compounding of drugs and discussed what existing guidelines state and to what extent the evolving guidelines hope to address issues. Currently, the 503A is involved in the regulation of compounding. The summary understands that FDA is currently drawing guidance documents and held a workshop recently to discuss this issue.
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