**Compounded medications are:
- Prepared by pharmacies that operate under state law, United States Pharmacopeia (USP) requirements, and USP Good Compounding Guidelines.
- Available by prescription from licensed pharmacies that are equipped to compound drugs
- Not reviewed by the FDA or State Boards of Pharmacy for safety and efficacy.
- Not approved by the FDA for any indication and do not contain FDA reviewed package inserts that may explain usage, contraindications, warnings, precautions, adverse reactions, and drug incompatibilities.
We wish to emphasize that the FDA has not reviewed compounded medications for safety and efficacy via the New Drug Application process.
Additionally, the patient should be advised that the compounded medication:
- Is provided based upon the medical need of the individual patient.
- Is prepared by a licensed pharmacy.
- Has not undergone the FDA’s New Drug Application process and has not been reviewed or approved by the FDA for safety or efficacy.
Disclaimer:
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Every effort has been made to provide accurate, complete, and updated information on this website. However, our content is not intended to substitute for professional medical advice regarding your unique situation and health needs. Always consult your doctor or other qualified health practitioners with medical questions and before starting or changing any treatment, medication, dietary or nutritional supplement, or herbal or homeopathic product.
