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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

Some of the released molecules, referred to as damage-associated molecular patterns (DAMPs) like heme and its derivatives, ATP, heat shock protein (HSP70), or interleukin-33 (IL-33), are capable of triggering the immune response, amplifying inflammation [62, 63]