IMPORTANT INFORMATION ABOUT COMPOUNDED MEDICATIONS
This medication has been compounded (custom-prepared) by a pharmacy. Compounded medications are specially prepared for individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug. These statements have not been evaluated by the FDA.
This compounded preparation:
- Has not been approved by the FDA
- Has not undergone FDA review for safety, effectiveness, or quality
- Is prepared specifically for you based on your prescriber's order
- Individual outcomes may vary
Dosing is determined by the prescribing provider based on patient-specific factors. Always follow your healthcare provider's instructions. Compounded medications are not subject to FDA approval and lack the same safety and efficacy data as FDA-approved commercial medications. This medication should be prescribed and monitored by a licensed healthcare professional familiar with the condition being addressed and the specific applications of the medication.
This compounded medication is only available when the commercially available product is unavailable or when a prescriber determines that there is a clinically significant difference for the patient.
