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.
Disclaimer:
Compounded medications are specially prepared for individual patient needs based on a valid prescription and, as such, are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. These statements have not been evaluated by the FDA.
This information is for educational and informational purposes only. It is not medical advice, diagnosis, or treatment recommendation. Always consult your healthcare provider before starting any new medication to determine whether it is appropriate for your individual circumstances. Contact your healthcare provider with any questions regarding a medical condition.
References
- Progesterone. (2025). In Lexi-Drugs. UpToDate Lexidrug. UpToDate Inc. Retrieved June 3, 2025, from https://online.lexi.com
- Spark MJ, Willis J. Systematic review of progesterone use by midlife and menopausal women. Maturitas. 2012 Jul;72(3):192-202. doi: 10.1016/j.maturitas.2012.03.015. Epub 2012 Apr 25. PMID: 22541358.
- Nagy B, Szekeres-Barthó J, Kovács GL, Sulyok E, Farkas B, Várnagy Á, Vértes V, Kovács K, Bódis J. Key to Life: Physiological Role and Clinical Implications of Progesterone. Int J Mol Sci. 2021 Oct 13;22(20):11039. doi: 10.3390/ijms222011039. PMID: 34681696; PMCID: PMC8538505.