I started bioidentical hormone therapy at the beginning of 2024 and it has made a huge difference in my energy level and overall sense of well being. As a 70 year old woman, I am grateful for the difference it has made in my life.

These hormones are not made from mare's pee but rather plants so they are bioidentical with our bodies. They have been in use safely for years.

I am tired of the medical industry and big Pharma controlling my options for treatment. Their primary motive is profit.

I am humbly asking our government and the FDA to continue to allow access to these life giving therapies. And if you are going to do a study, be sure to include the integrative practitioners and their patients in your research.

I've been struggling for years to try and find answers to the solutions of a multitude of medical issues I've been having as I approached my late 30s. Here are the the most prevalent symptoms that I've been battling over the past 5-6 years:
Sleep disturbance - insomnia
Period changes
Night sweats
Very Dry skin
Joint pain
Bloating
Weight gain
Gallbladder issues
Vaginal dryness
Pain after intercourse
Non existant libdeo/sex drive
Brain fog
Anxiety
Mood swings
Dry eyes
Fatigue
Heart palpitations
Cold hands and feet
Ringing in ears
Itchy ears

Battling these symptoms have been a nightmare and have greatly diminished my quality of life. Every doctor I had seen prior to seeing a HRT practitioner would tell me I'm too young to have hormone issues and they would prescribe me a new medication and not have an answers for why I'm having these issues. By the the time my HRT journey began I was put on 11 different prescription medications. None which addressed the root cause of my symptoms, which was very low hormones, specifically Testosterone. BHRT is life changing for many people including myself. It's critical to patients to have access to BHRT!

After having a partial Hysterectomy when I was 49 years old my body went into perimenopause. Hot flashes, night sweats, loss of sleep, I could go outside in 25-degree weather and still feel too hot. I still had a long life to live, and I happen to be someone who desperately needed hormone replacement because my mother who passed at the age of 92 told me she still was getting hot flashes.
It was affecting everything from my sleep to my daily performance. I got the patch, but it did not address the testosterone nor the progesterone levels. There were testosterone creams for men but not woman and because I had a partial hysterectomy the doctor said I did not need progesterone.

Here I am today at age 68 feeling like my life was given back to me in a troche form and now on capsules. I have energy to carry on life's responsibilities and to feel like living. Because as a woman, these compounds played a vital part in the quality of my life. I did not feel like living with my chemicals in chaos. AND we don't have to live this way.

These compounds are from Yam based ingredients and are safer than any synthetic.

I am writing this story to urge those who would like to disrupt or dispute the necessity of HRT for those women who truly need it to live productive lives. I am one of them.

Congress needs to cooperate to make HRT a choice for women. One affordable and effective. More doctors are specializing in testing and prescribing compounding hormones for women that are in need.

Thank you for your attention in this matter. FDA do not try putting restrictions on a natural product that works. Monitoring HRT is what we do as doctor and patient. Monitoring is what FDA should do. NOT to try RESTRICTING. Hormones are vital for those who need them to live a productive life.

With regards,

Deborah A. Cunningham

I’m grateful for the option of the compound pharmacy, as a physician who is also a patient. I developed obesity and was prescribed weight loss medications. Initially my insurance approved and the local retail pharmacies carried . However , suddenly and without warning , the medicine was not available. I went without for several months, gaining weight back, until I tried a compound pharmacy. As a physician I was very hesitant. However I researched and found a legitimate pharmacy that offered the medication I needed and tried. Based on the results and side effects, the medicine was clearly the same. The local retail pharmacy stocked the medicine again, and I was able to get one more prescription, until my insurance opted to no longer cover he medicine. The prohibitive pricing at the retail pharmacy, and the intermittent and unreliable availability of the medicine have led me to only use the compound pharmacy at this point.

Of note, I am transitioning into menopause. And my Gynocologist is working on getting the right hormone replacement therapy , but it’s not been easy. I have almost no testosterone, but the only way to get testosterone as a woman with an appropriate dose is via one pill option an oral estrogen /testosterone combo pill. However I do not and can not tolerate oral estrogen. I am working with my gynecologist to brainstorm how to get testosterone, and we likely will need to utilize compounding pharmacy.

Limited options to the people only give all the power (and money) to the big pharma monopolies. Please don’t take away options.

If you are really concerned then make sure the pharmacies are licensed and monitor like any pharmacy is monitored. That’s fair, equitable, and allows people choose and ability to access the medication they need.

Thank you.

I am using compound hormones for few years and it made my transition to menopause with no symptoms at all . It's a shame if FDA will restrict compound hormones. Please please please save it.
Thank you

I was unable to tolerate the generic estrogen creams available but having it compounded where I could use the base that was more agreeable to my body made all the difference.

I have had low testosterone for 15 years. I was able to use compounded bioidentical hormones in a very low dose for many many years without having these compounded hormones. My quality of life would’ve been much worse. Without being overly dramatic, having normal Testosterone has allowed me to maintain an active lifestyle while battling a serious chronic disease. Please don’t cave to the pharmaceutical industries desire to eliminate all competition. Compounding pharmacies use USP Quality hormones, and, at least my pharmacy, has higher quality standards than The pharmaceutical companies.

My thyroid was completely removed. I've tried every synthetic thyroid drug imaginable and I was sick for years! Natural thyroid saved my life and helped me feel human again! Please for the love of God, do not ban it or make it more expensive!

I've had severe perimenopause symptoms and the FDA approved menopause treatments have all made me feel even worse, which I didn't think was possible. My only saving grace has been compounded hormones in a cream. Not all of us are one size fits all. I've worked for a variety of federal agencies, and see the unethical ways departments operate, so I do not hold the FDA and their options to mean anything.

I have spent the last 12 years of my career changing the lives of men for the better. This has been the result of the personal relationships I have developed with pharmacists at compound pharmacies and the products they can specialize for my patients. Hormone replacement therapy is not "cookie cutter" medicine. Each individual has a different uptake and metabolism of these vital hormone replacements. Yes men and women could live out their lives without hormone replacement therapy. But do we want to just exist or do we want to LIVE. The individualized utilization of compounded hormones and other adjunctive therapies allows my practice to help these LIVE and not just exist. The ramnifications of their improved lives radiates out to their colleagues, their families and their community. Big Pharma creates medications with very little capability, manipulate dosing, remove additives that can cause reactions in many patients or combining intone single delivery method to improve compliance. Please support compound pharmacies and take away some of the control Big Pharma has over our society and the practice of individualized medicine which is the way medicine should be practiced.
Jason Schmidthuber PA-C

I've tried different approaches to treat my hypothyroidism, including T4 , T4 plus compounded T3 but nothing works for me other than NDT. Without NP tgtrood I am basically bed ridden, unable to work and support myself. I don't know what would happen to me if NDT meds are taken out of circulation or the cost increases and I become unable to cover its cost6.

I have tried other kinds of creams that have negatively affected my overall emotional health more than my physical issues affected by my hormone imbalances. With the bio identical compounded medication I am able to have over all higher quality of life emotionally and physically. It has helped stop the reoccurring UTIs I was having as well as increased my libido and mental focus. I find I am able to sleep better too.

I am 52 years female who just entered the menopause and started BHRT from compounding pharmacy a few months ago. Within those few months from having severe hot flashes and night sweats, living on 3-4 hours of sleep every night, while trying to teach middle school students during the day. Now since starting the compounded BHRT, ALL my symptoms disappeared, I can finally sleep and be myself again, I feel strong and full of energy! I can not support compounding pharmacies enough! This is truly life saving!!! I went from becoming delusional due to lack of sleep, to thriving again. I am sharing the information about the hormones with all my female friends who is about to enter this period of life. I can not imagine living the next 30-40 years of my life in misery that I was before! Hormones that I receive from the compounding pharmacy gave me my life back! Thank you!!!

I was diagnosed with low testosterone over a year ago and have been treated with compounded TRT ever since. The symptom improvement has been life changing for the better. My lab markers have improved as well, including cardiac risk markers and HBA1c. I can’t imagine a country where the FDA would stop compounded hormone therapy from being a reality. I think that would be a disaster for patient care.

Sincerely,

Dave Hall

I went through menopause in my fifties and have been dealing with th e symptoms of low Estrogen, Progesterone and testosterone ever since.
I have been continually exhausted and in a depressed state for at least four years.
I understand that taking oral estrogen and progesterone can be dangerous to my health long term and chose to use the bio identical compounds instead. I am just beginning to see a difference and it gives me hope that as a 65 year old woman I may be able to live life with vigor and even sexual pleasure again.
Please don’t take this away from me.

Bioidentical hormones have given me my life back! Combining this therapy with healthy lifestyle changes has given me back my vitality, along with other health benefits. Access to compounded bioidentical hormone therapy is critical for patients!

Utilizing bioidentical hormones absolutely transformed my life in a way that traditional hormone therapy could not. Bioidentical hormone therapy is a safe and effective therapy that should remain available as a treatment choice. I have personally seen it transform numerous lives, not just my own.

After having a hysterectomy at a young pre-menopausal age, my doctor and I decided that it would be good for me to take a compounded estrogen hormone therapy called bi-est. It worked well for me for several years.
I certainly respect doctors and pharmacists who are familiar with compounded medicines and prescribe and mix them for individual patients. I very much hope the FDA is not planning to restrict or take away this option for people. Not everyone can take the medications pharmaceutical companies put out on the market.

My compounded cream is not hormone therapy but it is compounded for me to use on my skin by my dermatologist. Nothing else on the marked that I used helped my various keratoses, but the compounded-for-me creme helped substantially