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Compounders Question FDAs Rationale and Evidence Pointing to Safety Concerns On October 27, 2023, APC urged FDA via letter addressed to Gail Bormel, Director of the FDA's Office of Compounding Quality and Compliance, for transparency regarding the recent inclusion of substances into Category 2

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It may be the right thing to do in many clinical situations, but we dont have data to say that with certainty, so we cant endorse it, said Robert McLean, MD, a rheumatologist with Northeast Medical Group in New Haven, Conn., and associate clinical professor at the Yale School of Medicine: One reason is that theres no placebo-controlled evidence establishing the right target