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Are bioidentical hormones regulated?

Written by John Matthews - January 29, 2023

Bioidentical hormones are a type of hormone therapy that uses hormones that are identical in molecular structure to the hormones naturally produced by the human body. The hormones are derived from plants such as soy or yams and compounded into an individualized treatment plan based on the unique needs of each patient.

The safety and efficacy of bioidentical hormone replacement therapy (BHRT) has been researched and debated for many years. In short, these hormones are regulated by the FDA, but because they’re combined with other ingredients to create compounds customized for specific patients, there is no oversight concerning their safety and efficacy.

The FDA does regulate bioidentical hormone products in some ways. All products must meet FDA good manufacturing practices, which mandate that materials used to create them be appropriate for use in any combination at all times. Additionally, manufacturers must maintain accurate records stating how the product was made, including who produced it and when.

In addition to these regulations set forth by the FDA, some states have additional regulations governing BHRT products. For example, New York State requires that pharmacies engaged in compounding bioidentical hormone products use non-sterile compounding procedures established by national USP standards and current FDA guidance documents relating to non-sterile compounding activities for human drugs.

Despite regulation from both state governments and the FDA, it’s important to note that compounded bioidentical hormone therapies have not yet been approved or regulated by either government entity as a whole. This means that individuals seeking BHRT treatments should discuss options thoroughly with a healthcare professional before deciding what form of treatment is best suited for their needs.

At Hormone Treatment Center we offer personalized bioidentical hormone replacement therapy tailored to your individual needs and backed up by research studies showing improved health outcomes associated with our programs. Our specialists are trained experts in managing hormonal issues related to menopause, perimenopause, adrenal dysfunction/fatigue syndromes, thyroid disorders as well as other endocrine imbalances associated with aging/lifestyle habits such as poor diet or lack of exercise. We believe you deserve better care than the quick prescriptions found so often at traditional doctors' offices - so call us today!

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