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5 Companies receiving warning letters have 15 working days to respond with a corrective action plan or a justification

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A safer drug supply The FDA was pretty clear in their December 19, 2024 letter when they wrote: Although compounded drug products can provide treatment options for patients during a drug shortage, compounded drugs have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process