Are Bio-Identical Hormones FDA Approved? The answer, and my opinion, might surprise you.
by Emily Sadri
What Are Bio-Identical Hormones?
You may have heard some back and forth in the perimenopause and menopause community about the types of hormones being used in Hormone Replacement Therapy.
What does Bio-identical mean in relation to hormones? How important is FDA approval? It can be hard to sift through all the information out there. Today I'll give you my view on the topic and help you feel confident in your choice of HRT.
Bio-identical hormones (BHRT) are structurally identical to the hormones your body already produces. They mimic the composition of the hormones moving around in your body—hormones like estradiol, progesterone, and testosterone.
Unlike synthetic hormone therapies such as Premarin (derived from pregnant mare’s urine) or synthetic progestins like medroxyprogesterone acetate, bio-identical hormones are designed to interact with the body in the same way as its own hormones.
This structural similarity is the key reason why many practitioners, including me and the team at Aurelia, favor bio-identical hormone replacement therapy (BHRT) over traditional hormone therapy.
But what about their regulation? Are they FDA approved? Let’s break this down systematically.
Understanding the FDA and What FDA Approval Means
The Food and Drug Administration (FDA) is the governing body responsible for ensuring the safety, efficacy, and quality of drugs, biologics, and medical devices in the United States.
A drug earns FDA-approval when:
It has undergone rigorous clinical trials to demonstrate safety and effectiveness.
The manufacturing process adheres to strict quality control standards.
The product is consistently produced in a manner that meets FDA regulations.
So, when we ask if bio-identical hormones are FDA approved, we should look at two specific products available to women right now: commercially available bio-identical hormone products and compounded bio-identical hormones.
FDA-Approved Bio-Identical Hormone Products
Yes, some bio-identical hormone products are FDA-approved. These include commercially manufactured, standardized formulations that have met the FDA’s requirements.
Examples of FDA-Approved Bio-Identical Hormones
Estradiol
Estrace® (oral estradiol)
Vivelle-Dot® (estradiol transdermal patch)
Estrogel® (estradiol gel)
Divigel® (estradiol gel)
Progesterone
Prometrium® (micronized progesterone capsules)
Crinone® (progesterone gel)
Endometrin® (progesterone vaginal insert)
Testosterone (primarily FDA-approved for men but sometimes used in women off-label)
Androgel® (testosterone gel)
Testim® (testosterone gel)
Natesto® (testosterone nasal gel)
These FDA-approved bio-identical hormones are available by prescription at commercial pharmacies and are produced under standardized conditions to ensure consistent dosing.They are usually covered by insurance.
Compounded Bio-Identical Hormones: Why Aren’t They FDA Approved?
Many women seek compounded bio-identical hormones because they allow for individualized dosing, routes of administration, and combinations of hormones (although we don’t like to combine hormones at Aurelia) that are not available in standardized, FDA-approved formulations.
However, compounded formulations themselves are not FDA-approved. Here’s why:
1. Customization and Lack of Standardized Testing
Unlike commercial pharmaceutical drugs, compounded medications are custom-made for individual patients based on a provider’s prescription. Because these formulations vary from patient to patient, they cannot be subjected to the large-scale clinical trials required for FDA approval.
2. Regulatory Oversight of Compounding Pharmacies
Compounded bio-identical hormones are made in specialized pharmacies known as compounding pharmacies. These pharmacies are regulated at the state level and overseen by the U.S. Pharmacopeia (USP) and state pharmacy boards, rather than the FDA. While the ingredients used in compounded formulations may be FDA-approved, the final compounded product does not go through FDA approval processes, because it is not a large-scale drug product. I like to think of it as small-batch.
3. Safety Concerns and Controversy
The FDA and some medical organizations, such as the The Menopause Society (formerly NAMS) and the Endocrine Society, have raised unfounded concerns about compounded hormones due to:
Variability in potency and purity across different batches
Lack of large-scale clinical trials to support efficacy and long-term safety
Potential for contamination in some poorly regulated compounding pharmacies
However, when obtained from high-quality, accredited compounding pharmacies, compounded bio-identical hormones are a safe, effective, and personalized treatment option.
The pharmacy that we partner with at Aurelia is dually accredited by The Pharmacy Compounding Accreditation Board (PCAB) and the National Association of Boards of Pharmacy (NABP). They also batch test every single batch of medications they make to ensure accurate potency and quality.
Are the Ingredients in Compounded Bio-Identical Hormones FDA Approved?
Yes. While the final compounded product is not FDA-approved, the individual ingredients used in compounding are derived from FDA-approved sources.
For example:
Estradiol USP (bio-identical estradiol) is FDA-approved when used in commercial drugs.
Progesterone USP (micronized progesterone) is an FDA-approved ingredient.
Testosterone USP is the same testosterone found in FDA-approved formulations.
Thus, compounding pharmacies are using the same bio-identical hormones found in FDA-approved medications, but in customized dosages, combinations, and delivery methods.
Denouncing the Fear-Mongering Around “Non-FDA Approved” Options
One of the biggest disservices in the hormone therapy conversation is the fear-mongering around the term “non-FDA approved.” This label is often used as a scare tactic, making it seem as though compounded bio-identical hormones are dangerous, unregulated, or inferior to their commercial counterparts. This black-and-white thinking is misleading and fails to account for the nuanced reality of medical care.
First, let’s put the numbers into perspective. Compounded medications account for only about 3% of all prescriptions written by medical providers each year. Despite their relatively small market share, compounded medications fill an essential gap in personalized medicine, particularly in fields like endocrinology, dermatology, and—yes—hormone therapy. More importantly, the number of adverse events reported with compounded medications is significantly lower than those associated with commercially manufactured drugs.
The reality is that compounded bio-identical hormones are prescribed by highly trained medical professionals who understand their safety and efficacy. They are formulated in licensed, accredited compounding pharmacies that follow strict regulatory guidelines, including those set by the U.S. Pharmacopeia (USP), state pharmacy boards, and the Pharmacy Compounding Accreditation Board (PCAB). While the FDA does not approve final compounded formulations (because each one is unique to the patient), this does not mean they are unsafe or ineffective.
Dismissing compounded bio-identical hormones as “unapproved” without context ignores their critical role in patient care. Women deserve access to both standardized FDA-approved options and individualized compounded solutions—without fear, misinformation, or unnecessary alarmism. Many of the providers propagating such fear-mongering have financial or business interests in online telehealth platforms that do not utilize compounded medications whatsoever - their experience, thus, is limited, and their recommendations are biased.
Our experience with the industry’s best compounding pharmacies is that they share our common interest in patient outcomes, education, and high-touch care. We only partner with the best at Aurelia.
Why Aurelia Favors Compounded Bio-Identical Hormones
At Aurelia, we prioritize personalization in hormone replacement therapy. While we prescribe FDA-approved bio-identical hormone products when they meet a patient's needs, we favor compounded formulations because they allow for:
Custom dosing that matches a woman’s individual hormone levels.
More advanced regimens such as Physiologic HRT protocols.
Alternative routes of administration, such as sublingual troches, topical creams, or vaginal suppositories.
Avoidance of unnecessary additives found in some commercial formulations.
Compounded bio-identical hormones allow us to tailor treatment to each woman’s unique hormonal landscape—a level of precision that commercial products often cannot provide.
Keep in mind that many of the providers who denounce compounded hormones also do not advocate for testing hormone levels, and monitoring response to therapy. That approach may be sufficient for some women, but the women we treat at Aurelia expect a higher level of care - we call this: precision hormone medicine.
Compounded vs. FDA-Approved Bio-Identical Hormones: Pros and Cons
Conclusion: The Best of Both Worlds
So, are bio-identical hormones FDA-approved? The answer is yes and no:
Yes, FDA-approved bio-identical hormone products exist (like Estrace, Prometrium, and Androgel).
No, compounded bio-identical hormone formulations are not FDA-approved, but their ingredients are.
At Aurelia, we use both FDA-approved bio-identical hormone therapies and high-quality, compounded bio-identical hormones to provide the safest, most effective, and personalized hormone replacement therapy available.
For women who need a one-size-fits-all approach, FDA-approved bio-identical hormones offer a regulated and standardized option. But for those who need precision, personalization, and flexibility, compounded bio-identical hormones provide a superior alternative.
If you’re unsure which option is best for you, Aurelia is here to help. Our hormones-first™ approach ensures that every woman receives customized, evidence-based hormone therapy tailored to her unique needs.
Let’s Do Midlife Better™—together.
