Prescribing in the Post-Black Box Era: Navigating FDA-Approved and Compounded Hormones for Menopause

This narrative review compares the safety, efficacy, and clinical utility of FDA-approved versus compounded bioidentical hormone replacement therapies for women in menopause. A comprehensive literature review was conducted using PubMed for studies published between 2016 and 2026, with search terms including “bioidentical hormone replacement therapy,” “compounded hormone replacement therapy,” “menopause,” “menopausal,” “vasomotor,” “estradiol,” “progesterone,” and “testosterone,” alongside an analysis of major medical societies' guidelines and leading menopause telehealth platforms. The findings demonstrate that FDA-approved bioidentical hormone therapies offer superior pharmacokinetic consistency, rigorous regulatory oversight, and robust clinical evidence compared to compounded alternatives, which lack standardized testing and regulatory oversight for routine clinical recommendation. Notably, this review highlights the landmark November 2025 FDA decision to remove black box warnings from approved bioidentical hormones, fundamentally shifting the clinical risk-benefit assessment. Ultimately, FDA-approved bioidentical hormone replacement provides a safer, evidence-based approach to menopause management. These findings have direct implications for physician associates and other practicing providers in primary care and women’s health, as they equip providers with the critical data needed to confidently counsel patients and counter marketing narratives surrounding compounded strategies.