Custom-compounded medications are often sold as "bioidentical hormone replacement therapy" and are not regulated by the FDA. A compounding pharmacy uses your saliva or blood test results to customize a prescription that may contain any variation of hormones, including estrone, estradiol, progesterone and testosterone. However, research has determined that these saliva or blood tests are unreliable because your hormone levels constantly change throughout the day. Women who use custom compounds will not always get the proper dose. Products from compounding pharmacies are not subjected to the same high quality assurance standards that commercially available hormone therapies have to meet. Furthermore, the FDA does not approve any custom compounds. To learn more about the risks of custom compounds, click here.
There is a lot of misinformation about natural, synthetic, bioidentical and compounded hormone therapy. While many women think "natural" hormonal treatments to relieve menopause symptoms are safer, are they? Any product that has an animal, plant or mineral source is technically called "natural." It does not matter if it is a pill, liquid or cream, available over-the-counter or made by a pharmaceutical company and only available by prescription. A soy plant ground into powder and sold as a "natural" supplement to ease your menopause symptoms would not require Food and Drug Administration (FDA) approved safety studies. Soy plants are also extracted in a lab to make FDA-approved synthesized drugs and do go through FDA regulatory approval. Both of these products are considered "natural," but only the latter is regulated. It is important to note that the FDA does not approve any custom-compounded medications and alternative herbal treatments used to treat menopause symptoms.