Bioidentical Hormones (BHT) are chemically identical to the hormones naturally produced by the human body (estradiol, progesterone, testosterone). They are highly popular among consumers who perceive them as safer and more natural than synthetic hormones. This high demand primarily drives a subset of the compounding pharmacy space, where these hormones are often custom-mixed in various strengths and delivery methods (creams, suppositories).

The main challenge within this segment lies in the regulatory status of custom-compounded BHT. Unlike FDA-approved commercial HRT products, compounded BHT preparations are not subject to the same strict manufacturing standards, quality control, or rigorous clinical testing to prove safety and efficacy. While some BHT products are commercially approved (e.g., certain estradiol gels), the vast majority of personalized formulations fall outside federal quality assurance protocols, raising concerns about dosage accuracy and purity among medical bodies.

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