Personalized Hormone Therapy & The Menopause Care Gap

As FDA labeling evolves, telehealth scales, and demand for customized hormone therapy grows, pharmacies and outsourcing facilities face new expectations. The next era of menopause care will depend on infrastructure capable of supporting consistent, well-coordinated, personalized hormone therapy services at scale. Here’s what every 503A pharmacy, 503B outsourcing facility, and telehealth organization needs to anticipate next.

Entering the New Era of Menopause Care: The Rise of Personalized Approaches, Including Compounded Options

With boxed warnings removed from several FDA-approved hormone therapy (HT) products and demand for individualized treatment growing, the industry is being pulled toward data-driven, personalized care models.

The new labeling revisions also signal a move toward more nuanced, evidence-based communication of hormone therapy risks.

Meanwhile, the landscape of menopause care is also being transformed by rising patient expectations and telehealth expansion.

Yet, underdiagnosis and undertreatment of common conditions have left a large gap in care for U.S. women. Despite recent developments, widespread transformation is still in its early stages.

This post serves as a central resource hub for exploring how personalized hormone therapy fits into today’s menopause care landscape from an industry, business, and clinical perspective in 2025 and beyond.

Read our related guides on this topic:

Industry Predictions: The Post–Black Box Era of Menopause Care
Usage Trends: The Changing Landscape of Menopausal Hormone Therapy
Analysis: Makena Withdrawal & Compounded Progesterone Alternatives
Clinical Science: Justifications for Compounded Bioidentical Options

Restore Health Consulting has accurately predicted several major industry shifts before they happened, including that consumer demand for individualized HRT would rise and that telehealth would evolve to ongoing complex care management. We’re now helping organizations operationalize the changes unfolding in real time.

As menopause care evolves, so must the pharmacies and outsourcing facilities that support it. If you're positioning for growth in the new menopause care landscape, connect with us today.

Menopause Market Predictions

Barriers to treatment may explain why the current US market for menopause-related products and services is relatively modest, less than $6 billion. However, there are significant untapped opportunities.

By 2030, 65 million American women will be in one of the three stages of menopause. With higher treatment uptake, the market could grow from under $6 billion today to $40 billion—or even surpass $100 billion, according to some estimates.

Where Compounded Hormone Therapy Fits In

For pharmacies and outsourcing facilities, compounded hormone therapy is sometimes used when prescribers determine that individualized formulations are appropriate and commercially available therapies are not suitable for a particular patient.

This shift is creating new clinical, operational, and regulatory considerations for:

503A pharmacies
503B outsourcing facilities
Telehealth partners

Personalized Hormone Therapy vs. Compounded Bioidentical Hormone Therapy

The backbone of hormone therapy compounding long rested on bioidentical hormones, also known as compounded bioidentical hormone therapy (cBHT).

Compounding has historically included formulations using hormones structurally identical to those produced in the human body.

Many patients still associate compounded hormone therapy with bioidentical hormones only, but the reality is much broader.

Compounding Beyond the “Bioidentical Benefits”

The argument for compounding bioidentical hormones is no longer as useful as it was, given that many FDA-approved topical products and some oral products also contain bioidentical estradiol (E2) and progesterone.

However, pharmacies can also compound other bioidentical hormones that are not found in FDA-approved products. In addition, pharmacies don’t compound only bioidentical hormones—they can compound non-bioidentical hormones too.

Therefore, the differences between FDA-approved therapies and compounded options remain distinct, particularly regarding formulation flexibility.

Clinical Justifications for Compounded Hormone Therapy

Examples of scenarios where a prescriber may choose a compounded hormone therapy option include:

A patient requiring a strength, dosage form, or excipient profile not commercially available
A prescriber determining an FDA-approved therapy is not appropriate
A customized approach being necessary to manage tolerance, titration, or absorption
Telehealth models relying on specialized formulations when prescribers determine they are clinically appropriate

In essence, compounded hormonal replacement therapy (HRT) is a customized treatment prepared or overseen by a pharmacist in accordance with a healthcare provider’s prescription. Compounded formulas are prepared based on a prescriber’s directions, allowing adjustments to hormone types, strengths, excipients, and delivery methods.

Aside from menopause care, HRT may also be used in other clinical contexts when prescribers determine individualized formulations are appropriate.

Safety and Efficacy

A systematic review meta-analysis of 29 randomized controlled trials (RCTs) found cBHT to have a favorable safety profile with specific symptom benefits, while highlighting the need for future research that reflects personalized dosing.1

The meta-analysis included 1,808 perimenopausal and postmenopausal women. Here’s what they found:

cBHT was not associated with altered lipid profile and glucose metabolism, which are risk factors for cardiovascular disease
The risk of adverse events from cBHT was comparable to placebo, except for a higher risk of androgenic side effects with compounded DHEA
cBHT in the form of vaginal androgens appeared beneficial for vaginal atrophy
Vaginal testosterone cream showed improved sexual function scores
cBHT was not associated with changes in endometrial thickness

As a limitation of this study, no formulations included estrone (E1) or pregnanolone (P5). Many trials also had small numbers of subjects with short durations.

The strength of this study was that it was the first comprehensive review of the safety and efficacy of cBHT in perimenopausal and postmenopausal women using meta-analysis. All studies were RCTs and the majority had a low to moderate risk of bias.

The study could not fully reflect patient-specific dosing regimens due to the complexities of controlled clinical trials. Incorporating personalized dosing is likely to improve patient outcomes, highlighting the need for future trials that may consider interventions that allow certain adjustments.

Addressing Patient Questions and Misconceptions

Many patients wonder:

Are compounded hormones the same as bioidentical?
Is compounded HRT the right choice for me?
How does it compare to FDA-approved hormone therapy options?
Are there different risks I should be aware of with compounded HRT?

Prescribers and pharmacists need to be able to answer these questions and explain the risks and benefits of personalized hormone therapy to their patients carefully, based on the evidence.

Hormones and Dosage Forms

More types of dosage forms of cBHT formulations are available than FDA-approved bioidentical hormone therapy dosage forms. The 10 main hormones (7 unique hormone substances and 3 salt forms) include:

Estrone (E1)
Estradiol (E2)
Estradiol cypionate (Ec)
Estriol (E3)
Dehydroepiandrosterone (DHEA)
Pregnenolone (P5)
Progesterone (P4)
Testosterone (T)
Testosterone cypionate (Tc)
Testosterone propionate (Tp)

A 2025 JAMA review indicates that there are currently more than 20 estrogen-alone and combined estrogen-progestogen products in various doses and formulations.2

As more products become available and patient awareness increases, it’s critical to keep closing clinical and operational gaps to ensure that each patient receives therapy that truly meets their needs.

Personalized Hormone Replacement Therapy: Opportunities for 503A and 503B

As more patients engage in hormone therapy, the subset for whom prescribers select customized formulations may increase.

Professional societies acknowledge that hormone replacement therapy personalization is often needed. For example:

NAMS notes that individualized dose adjustments and alternative delivery systems may be required.
ACOG notes that while FDA-approved formulations should be used when they meet patient needs, certain clinical scenarios (such as excipient intolerance or non-commercial strengths/routes) may warrant a compounded formulation.
The Endocrine Society supports individualized regimens based on patient goals and tolerability.

Opportunities for Compounding Pharmacies

Compounding pharmacies can prepare customized hormone formulations, including:

Bi-Est (a blend of estriol and estradiol)
Tri-Est (estrone, estradiol, and estriol)
Transdermal progesterone or testosterone
Preparations containing other specific customized hormone ratios

The human body produces three primary estrogens: estriol (E3), estradiol (E2), and estrone (E1). Estradiol is dominant during reproductive years, estriol dominates during pregnancy and is present at lower levels in postmenopausal women. Estriol is considered a weaker estrogen, but this doesn’t diminish its significance in Bioidentical Hormone Replacement Therapy (BHRT).

In clinical settings, estriol is often used for localized estrogen support, particularly for women dealing with vaginal dryness, irritation, or urinary symptoms—common concerns in perimenopause and menopause.

In addition, compounding pharmacists have a unique and valuable ability to prepare suitable testosterone therapies for women. Testosterone is a hormone made endogenously by both men and women, yet its potential as a hormone replacement therapy for women is often overlooked (Note that there are currently no FDA-approved testosterone replacement therapies specifically indicated for women).

Delivery Formats

503A compounding pharmacies can prepare flexible hormone therapy delivery formats, including:

Oral capsules and suspensions
Troches
Sublingual drops
Rapid Dissolve Tablets (RDTs)
Topical creams and gels
Vaginal formulations

503B outsourcing facilities can also prepare a variety of compounded menopausal hormone therapy formulations, including hormone pellet implants and intramuscular or subcutaneous injections.

The demand for compounded HRT is expected to continue increasing in the coming years due to a growing aging population, growing patient awareness, telehealth expansion, regulatory shifts shaping clinical decisions, and provider shortages.

The Clinical Gaps: Where Menopause Care Is Still Falling Short

The main clinical gaps in menopausal care include:

Limited menopause-trained clinicians and overwhelmed specialist services
Patient stigma and misperceptions about treatment
Regional disparities in therapy availability
Product supply issues and temporary shortages of specific MHT products
Gaps in follow-up care
Research gaps on how menopause affects aging and contributes to age-related diseases

Provider Type and Specialty

According to a 2025 report in Pharmacy Times, provider type and specialty have a major influence on whether women seeking menopause-related care receive prescription treatments. Data from over 5400 women treated between 2016 and 2023 shows that only 17% received medication for menopausal symptoms, with high variability in prescribing across specialties.3,4

“Women were most likely to receive systemic estrogen from obstetrician/gynecologists and least likely to receive it from internal medicine, family medicine, or endocrinology providers,” their findings highlight. Midwives and nurse practitioners were also more likely than physicians to prescribe systemic estrogen.4

These findings emphasize an urgent need for standardized, evidence-based education to ensure all health care professionals can effectively treat patients and menopause-related symptoms.

Perceptions Around the Use of Hormone Therapy

Perceptions, understanding, and use of hormone therapy have improved over the past 5 years. Yet, overall use still remains relatively low.5

There is a slow but steady shift as early misunderstandings of the Women’s Health Initiative results—which initially raised concerns about heart disease and breast cancer—are corrected.

Clinicians and patients are gradually recognizing that hormone therapy can be safe and effective for many women, especially those under 60 or within 10 years of menopause onset, though it may take time for these insights to fully influence practice and decision-making.5

The Attitudes and Usage study of nearly 6,800 U.S. women aged 25 to 65 shows increasing awareness and acceptance of hormone therapy. Key findings include5:

In 2025, 36% of women reported knowing “something” or “a lot” about hormone therapy, up from 28% in 2021
49% felt the benefits outweigh the risks, compared to 38% in 2021
54% were willing to use hormone therapy, up from 40% in 2021
Actual use among women aged 40 to 60 rose from 8% to 13%, with the largest gains among Black, Hispanic, and other underrepresented groups
Topical forms like creams and gels saw the most growth

These results point to a broader cultural and clinical shift toward more informed, positive attitudes about menopause care.

Understanding the Menopause Continuum

We’re finally seeing a shift to understanding menopause as a gradual shift over decades of time, rather than a sudden event. Although the average age of menopause in the U.S. is 52, women can begin to experience symptoms of perimenopause in their 40s.6

Both clinicians and pharmacies need to prepare to support over one billion women who will be in menopause globally by 2030. A better understanding of the hormonal changes that happen during early and late perimenopause can help guide better diagnosis and care.

More advanced telehealth models also show a clear shift away from swipe-and-ship, transactional prescribing toward longitudinal life-stage management.

While clinical gaps define the need for personalized hormone therapy, operational challenges determine whether those therapies reach patients efficiently.

The Operational Gaps: How the Care Model Is Evolving

Telehealth Expansion

Telehealth for menopause care must move beyond quick, low-acuity models to provide ongoing, personalized management, including real-time clinician visits, risk assessment, lab interpretation, symptom tracking, dose adjustments, shared decision-making, and longitudinal follow-up.

The most successful telehealth platforms in menopause care will be defined not by marketing, but by clinical rigor and operational discipline. Strong integration with pharmacies and 503B facilities will be essential.

As telehealth expands, compounding will be expected to deliver consistent quality, predictable turnaround times, thorough documentation, and high traceability. Clear prescriber-pharmacy communication and GMP-level reliability will also be critical.

Operational excellence in these areas is a key competitive advantage.

Bridging the Care Gap

Aligning telehealth with pharmacy and 503B operations creates a data-driven ecosystem capable of delivering truly personalized hormone therapy.

By standardizing workflows, tracking outcomes, and integrating feedback loops, this model ensures patients receive the right formulation, dose, and follow-up at the right time.

Ultimately, these operational improvements can support more consistent workflows, clearer communication, and improved service coordination.

503A and 503B Roles in Menopause Care

The increased demand for personalized hormone therapy, telehealth expansion, and regulatory changes rely on the complementary roles of 503A compounding pharmacies and 503B outsourcing facilities. Each plays a distinct operational role in delivering personalized hormone therapy to patients.

How 503A Pharmacies Can Support Personalization

503A compounding pharmacies specialize in preparing medications based on individual patient prescriptions. These facilities are ideal for highly personalized hormone therapy regimens, offering flexibility in hormone types, doses, excipients, and delivery methods.

Operationally, 503As are governed primarily by state boards of pharmacy and adhere to USP standards, allowing them to quickly adapt formulations to meet unique patient needs. They typically produce smaller batches (e.g., up to 250 sterile units per batch), which supports individualized care but limits large-scale distribution of a lot.

Key contributions of 503As to personalized menopause care include:

Customized formulations tailored to patient physiology, tolerance, and preferences
Rapid iteration of doses and delivery methods based on clinician feedback
Direct patient consultation opportunities, enhancing shared decision-making
Ability to source certain compounds from 503B facilities when needed, maintaining continuity of care

This focus on personalization supports prescribers when individualized formulations are appropriate and FDA-approved options are not suitable.

How 503B Facilities Can Support Shortages and Standardized Demand

503B outsourcing facilities operate on a larger, more industrial scale. They are FDA-registered, must comply with federal cGMP regulations, and can produce medications in bulk for distribution to healthcare providers. While they do not focus on patient-specific prescriptions, 503Bs provide consistency, quality control, and scale.

In the context of menopause care, 503Bs enable:

Large-volume production of sterile hormone formulations, ensuring steady supply during high-demand periods
Distribution to healthcare providers and telehealth partners for office-administered or direct-to-patient use
Support for 503As by providing ready-to-dispense compounded medications when specialized formulations are needed

By bridging supply gaps and ensuring quality at scale, 503Bs help support availability of standardized compounded preparations, especially as patient volumes grow.

Operational Collaboration Between 503A and 503B

The 503A/503B framework allows compounding facilities to complement each other:

503As deliver patient-specific personalization and formulation adaptation
503Bs provide standardized compounds in sufficient quantities to meet predictable demand and mitigate shortages
503As may purchase 503B-prepared compounds for individual patient prescriptions (subject to state and federal regulations), extending the range of treatment options

Together, these facilities contribute to the operational infrastructure that supports individualized approaches to menopause-related prescribing.

Workflow and Inventory Challenges

As demand for personalized hormone therapy grows, both 503A and 503B facilities face unique operational pressures around workflow efficiency and inventory management.

Ensuring that patients receive the right dose, formulation, and delivery method on time requires precise coordination between clinicians, telehealth providers, and pharmacies.

Key Workflow Challenges

Prescription Complexity: Personalized HRT often requires multiple hormones, unique excipients, or non-standard doses, increasing compounding complexity and the need for careful verification at each step
Lab Integration: Clinicians increasingly rely on lab data to guide titration. Providers must track prescriptions in parallel with lab results to support ongoing dose adjustments
Telehealth Coordination: With remote prescribing, communication between prescribers, pharmacies, and patients must be seamless, requiring robust workflow systems to avoid errors or delays
Regulatory Compliance: Both 503A and 503B facilities must maintain rigorous documentation for every batch, compounding step, and patient-specific order, which can strain operational capacity without strong digital systems

Inventory Challenges

Limited Stock Flexibility (503A): Small-batch production and patient-specific prescriptions make predicting demand difficult. Facilities must carefully manage raw materials to avoid shortages without overstocking, which can lead to wastage due to short Beyond Use Dates (BUDs)
Bulk Management (503B): While 503Bs can produce at scale, they must forecast demand accurately to maintain continuous supply across multiple healthcare providers, balancing shelf-life, storage capacity, and quality assurance
Supply Chain Variability: Hormone APIs, excipients, and delivery materials can be subject to delays, price fluctuations, or regulatory restrictions. Both 503As and 503Bs need contingency plans to maintain uninterrupted patient care
Integration Between 503A and 503B: When 503As rely on 503B-prepared compounds to supplement their personalized workflows, precise tracking, labeling, and compliance with state and federal regulations are critical to avoid errors or regulatory risk

Addressing these workflow and inventory challenges requires advanced operational systems, predictive analytics, and cross-functional coordination.

Facilities that invest in robust inventory management, clear process mapping, and seamless telehealth integration will be best positioned to scale personalized menopause care while maintaining safety and compliance.

Prepare For the New Era of Menopause Care

Compounded HRT continues to be used when prescribers determine individualized formulations are appropriate. The future of menopause management is increasingly collaborative, with telehealth, pharmacies, 503B facilities, and clinicians working together to close the care gap.

Explore our resources and connect with our experts to streamline workflows, stay compliant, and deliver well-coordinated, compliant, individualized hormone therapy services.

If you’re ready to play an active role in shaping the future of personalized menopause care, schedule your free consultation today.

Book a Free Consult

References:

1. Liu Y, Yuan Y, Day AJ, et al. Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. Menopause. 2022;29(4):465-482. Published 2022 Feb 14. doi:10.1097/GME.0000000000001937

2. Makary MA, Nguyen CP, Høeg TB, Tidmarsh GF. Updated Labeling for Menopausal Hormone Therapy. JAMA. Published online November 10, 2025. doi:https://doi.org/10.1001/jama.2025.22259

3. McGovern G. Recapping TMS 2025: Evolving Insights and Future Directions in Menopause Care. Pharmacytimes.com. Published November 18, 2025. Accessed December 4, 2025. https://www.pharmacytimes.com/view/recapping-tms-2025-evolving-insights-and-future-directions-in-menopause-care

4. McGovern G. Menopause Care Varies by Provider, Highlighting Need for Standardized Education. Pharmacytimes.com. Published October 25, 2025. Accessed December 4, 2025. https://www.pharmacytimes.com/view/menopause-care-varies-by-provider-highlighting-need-for-standardized-education

5. McGovern G. Hormone Therapy Use, Understanding, and Perceptions Have Positively Shifted From 2021 to 2025. Pharmacytimes.com. Published October 24, 2025. Accessed December 4, 2025. https://www.pharmacytimes.com/view/hormone-therapy-use-understanding-and-perceptions-have-positively-shifted-from-2021-to-2025

6. Strelow B, O'Laughlin D, Anderson T, Cyriac J, Buzzard J, Klindworth A. Menopause Decoded: What's Happening and How to Manage It. J Prim Care Community Health. 2024;15:21501319241307460. doi:10.1177/21501319241307460

Disclaimer:

The information provided on this website does not, and is not intended to, constitute clinical or legal advice; instead, all information, content, and materials available on this site are for general informational purposes only. Information on this website may not constitute the most up-to-date clinical, legal or other information. Readers of this website should contact their doctor or attorney to obtain advice with respect to any particular clinical or legal matter.

503A, 503BAna AleksicDecember 9, 2025cHRT, Menopause, Compounding, Pharmacy Compounding, Telehealth