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Compounding Pharmacy Risks

Meaning

Compounding Pharmacy Risks encompass the potential safety and efficacy concerns associated with medications that are custom-prepared by a pharmacist for an individual patient, contrasting with mass-produced, FDA-approved drugs. These risks primarily center on product quality issues, notably dose inconsistency, which is a critical failure where the actual amount of active ingredient deviates significantly from the labeled quantity. Other concerns include a lack of sterility in non-sterile preparations, potential contamination with foreign substances, and the absence of robust, manufacturer-level quality control testing. The variability in product quality and the lack of comprehensive clinical endpoint data for customized formulations present a significant consideration for patient safety and therapeutic reliability.