According to the agency’s Fact Sheet, after a comprehensive review of the scientific literature, an expert panel consultation and a public comment period, the FDA is requesting labeling updates to remove references to cardiovascular disease, breast cancer and probable dementia from the highest-level warning for most systemic menopausal hormone therapies. Importantly, the agency is not seeking to remove the boxed warning that remains for endometrial cancer risk in systemic estrogen-alone products. Nature+3HHS+3U.S. Food and Drug Administration+3
This regulatory shift is a change for practices and patients alike — and at Wells Pharmacy Network (WPN), we are proactively managing this change to provide our partners with clear, effective, evidence-based support and to optimize patient care.
Why this is important
For nearly a quarter-century the boxed warning on menopausal hormone therapies has cast a long shadow. First introduced after early studies such as the Women’s Health Initiative (WHI) indicated potential elevated risks of breast cancer, stroke and heart disease, the high-visibility warning led many clinicians and patients to avoid hormone therapy altogether. Nature+1
Emerging data — especially for women initiating therapy within 10 years of menopause onset or under age 60 — suggest that the benefit-to-risk profile for many women is much more favorable than previously believed. According to the HHS/FDA fact sheet: women starting HRT in this earlier window saw reductions in all-cause mortality, fractures, even cardiovascular disease and dementia risk in some analyses. HHS
By removing the blanket fear associated with the boxed warning and replacing it with nuanced, individualized risk-benefit discussion, we expect:
- Better shared-decision-making between clinicians and patients.
- Reduced hesitancy to initiate appropriate hormone therapy for symptomatic menopausal women.
- A shift in practice towards earlier, tailored intervention rather than default avoidance.
How Wells Pharmacy Network is managing the change
At WPN, our approach is multi-faceted:
1. Education and alignment with practices.
We are updating our provider communications, training modules and clinical-support materials so that prescribers understand the new regulatory landscape, the nuances of patient candidacy (e.g., timing of therapy initiation, individual risk factors) and the role of compounded/customized hormone solutions in the post-warning era.
2. Integration of compliance, quality and safety.
As a licensed 503A + FDA-registered 503B compounding pharmacy, we emphasize rigorous standards in formulation, packaging, labeling and provider-directed patient education. With the boxed warning removal, clarity around indication, dosing, monitoring and consent is more important than ever.
3. Expanding product options and delivery innovations.
We already specialize in a broad portfolio of hormone-related therapies including BHRT creams, pellets and other delivery systems. With this regulatory “opening,” we’re poised to offer practices safe, flexible, customized compounding solutions tailored to patient needs (while always ensuring compliance and appropriate risk-assessment).
4. Patient-centric support and follow-up.
We provide materials for clinics to share with patients: symptom-assessment tools, educational brochures on bio-identical hormone therapy (BHRT), monitoring checklists and guidance on follow-up labs and safety surveillance. We believe that the real benefit of this regulatory change is translated when practices and pharmacies partner to deliver individualized care.
How this benefits practices
Practices working with WPN stand to gain in multiple ways:
- Confidence in prescribing: With the regulatory burden easing, clinicians may feel more comfortable discussing hormone therapy options when guided by up-to-date science and supported by a pharmacy partner experienced in customized compounding.
- Differentiation in women’s health care: Offering tailored BHRT options (creams, pellets, etc) positions practices at the forefront of mid-life women’s wellness — an important and underserved market.
- Workflow support: WPN’s streamlined ordering, compounding, provider-portal access and shipping infrastructure help practices to reduce logistical friction while focusing on patient care.
- Improved patient engagement and retention: When patients receive treatment that supports symptoms associated with hot flashes, night sweats, mood changes, bone/heart/cognitive health in a proactive way, it may enhance satisfaction, referrals and practice growth.
Featured Therapies: BLT Cream, BHRT Cream and Pellets
BLT Cream – This is a compounded topical delivery containing bio-identical estrogen, progesterone and testosterone (often abbreviated “BLT”). The cream offers flexibility: daily application, easy titration, and an option for patients who prefer non-invasive delivery. Topical delivery also avoids first-pass hepatic metabolism and may support symptoms such as low libido, mood changes and vaginal/genitourinary atrophy.
BHRT Cream – More broadly, bio-identical hormone replacement therapy (BHRT) creams use hormones chemically identical to endogenous hormones (typically estradiol, progesterone, testosterone). They can be compounded to patient-specific doses, applied to various skin locations, and adjusted over time under provider supervision. While the FDA-approved formulations of bioidentical hormones exist, compounded BHRT requires careful monitoring and doesn’t carry the same standardized clinical trial base as conventional HRT. Cleveland Clinic
Pellets – Subcutaneous hormone pellets are small implants (about rice-sized) that deliver consistent levels of estradiol or testosterone over several months (commonly 3–6 months) after insertion under the skin. They provide convenience (no daily dosing) and more stable hormone levels versus creams or patches. Art of Medicine Direct+1 Because they release steadily, they help minimize undulating hormone levels which can contribute to symptom recurrence. Practices empowered with pellet solutions can address compliance challenges, day-to-day dose variation and offer a more “set-and-forget” option.
At WPN, our compounding expertise enables us to produce high-quality pellet and cream formulations for BHRT and BLT protocols — supporting clinician customization while emphasizing safety, documentation and monitoring. We provide the foundation; your practice brings the patient-centered dialogue and care.
Conclusion
The FDA’s decision to remove the black-box warning from most menopausal hormone therapies is more than regulatory housekeeping — it is a signal of a paradigm shift in women’s mid-life care. For too long the fear of outdated risk labels limited meaningful options. At Wells Pharmacy Network, we are excited to partner with practices to turn this shift into more meaningful care discussions: enabling timely, individualized hormone therapy (including BLT creams, BHRT creams and pellets), backed by rigorous compounding practices, clinician support and patient education. Together, we can help women navigate menopause with our custom compounding solutions .
References
1.) Food and Drug Administration. (2025, November 10). HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy [Press release]. U.S. Department of Health and Human Services. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy U.S. Food and Drug Administration+1
2.) Peeples, L. (2025, November 11). Is HRT in menopause healthy? US label change triggers debate. Nature. https://doi.org/10.1038/d41586-025-03687-0 Nature
National Breast Cancer Coalition. (2025, November 12). NBCC Statement on FDA Hormone Replacement Therapy (HRT) Black Box Warning Removal. https://www.stopbreastcancer.org/nbcc-statement-fda-hrt-black-box/ National Breast Cancer Coalition
3.) Cleveland Clinic. (2022, April 15). Bioidentical Hormones: Therapy, Uses, Safety & Side Effects. https://my.clevelandclinic.org/health/treatments/15660-bioidentical-hormones Cleveland Clinic
4.) Art of Medicine Direct. (2024, November 16). Hormone pellets vs. cream: The pros and cons for treating imbalances. https://www.artofmedicinedirect.com/hormone-pellets-vs-cream/ Art of Medicine Direct
