A PWN commentary: Compounding bioidentical hormones – Not the safest thing you can do

By Jorge D Faccinetti – cofounder – San Francisco, CA – May 2016 – A recent article from the Journal of Clinical Endocrinology and Metabolism (JCEM) on Compounded Bioidentical Hormones in Endocrinology Practice caught our attention because of its wide use despite some real risks associated with the practice.

The article, authored by leading clinical endocrinologists and investigators, Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton was published in JCEM Volume 101, Issue 4.

By way of background, the Food and Drug Administration (FDA) defines compounding as “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient”.

The article from JCEM focuses on several hormones that are generally prescribed by doctors and mixed by compound pharmacies according to a physician’s specific direction.

The article in question, Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement, cautions about this practice. It reiterates there is a general lack of standards and quality controls regarding “how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, and/or contamination.” The abstract specifically mentions cases of contamination leading to considerable patient harm and even death.

This is not a new problem, several recent related articles by the Endocrine Society’s Hormone Health Network, report on the well known fact that compounding (mixing) practices are not well regulated and monitored by the FDA and offer an increase quality risk due to a lack of safety and efficacy data for non-FDA regulated custom-compounded bioidentical hormones.


It is important to note that there is nothing wrong with bioidentical hormones, which are prescribed by physicians in accordance with FDA guidelines and labeling indications.   The issue is when these bioidentical hormones are mixed in unregulated, untested environments.


In its conclusion, the Endocrine’s Society Scientific Statement finds no reason, or rational, for prescribing these potentially harmful unregulated compounded bioidentical hormones and urges patients to avoid them. We urge you to do the same and approach these practices with extreme caution.

For other articles on “things that sound too good to be true” click on this link.

You can read the abstracts to the articles mentioned by clicking on the highlighted text links. You can download the complete text by following Endocrine Society site’s instructions.

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