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2) Compounding can amplify upstream quality problems In the import alert, FDA notes that API manufacturers are subject to CGMP requirements, but compounders operating under section 503A are exempt from CGMP, including requirements to ensure API meets certain specifications

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Yet, the availability of these medications is limited due to safety concerns, with some being removed from the market due to adverse body health impacts

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[12] Concomitant use with central nervous system depressants-including benzodiazepines, opioids, barbiturates, alcohol, or cannabis-may produce additive sedation, impaired airway reflexes, and respiratory depression