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FDA and USP compounding resources repeatedly emphasize that sterile compounding exists to reduce contamination, infection, and patient harm, and FDA has documented outbreaks, infections, and deaths associated with contaminated compounded drugs and insanitary conditions

Death was determined based on standardized criteria including the absence of respiration, absence of heartbeat, loss of pupillary light reflex, and absence of reflexes, with scavenging and operator protection measures in place

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