The customization of hormone therapy through compounding pharmacies faces significant Compounding Issues regarding quality assurance, dosage accuracy, and regulatory compliance. Unlike commercial, FDA-approved HRT products which must pass rigorous phase 3 trials and adhere to strict Good Manufacturing Practices (GMP), custom-compounded bioidentical hormone preparations are exempt from these federal requirements for safety and efficacy testing.

Studies and regulatory surveys have repeatedly uncovered inconsistencies in the dose and purity of custom-mixed preparations, potentially leading to under-dosing (and lack of symptom relief) or over-dosing (and increased side effect risks, including endometrial hyperplasia). Furthermore, the common practice of dose adjustment based on salivary or serum hormone testing lacks scientific validation, as these tests are poor indicators of hormone action in target tissues. This segment’s lack of oversight means patients are often receiving a product with unproven risks and benefits, a fact that regulatory bodies and medical societies continue to highlight as a public health concern.

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