I went into menopause very early. I did not understand what was happening to my body. All I knew was that my emotions were on a constant roller coaster. For over a decade I lived this way. Every year I was worse. At 50 I could no longer function. I was in severe depression. The minute I woke up it descended on me. I sat and cried and struggled my way through every day. I could not sleep at night. I would toss and turn and be restless all night. My health is declining! I was scared of my future! I wanted to die. After having blood work done with my holistic doctor we found that I was literally living on no hormones at all. Then my experience with hormone replacement therapy began. I was able to have testosterone pellets as well as progesterone. Within weeks my life completely turned around. Now I wake up after a good night's sleep, my sex drive has returned, and I’m starting my own business. I’m in fear of what will happen if they take away the ability to have hormone replacement therapy! Please please please fight this!

I’m a 74-year-old woman who has taken hormonal compounding for around 30 years. Part of the reason I take them is for bone density. Hormonal compounding, as I believe, is a much safer choice in hormonal therapy.

If hormonal compounding is taken away, I have no choice. Also, my OB/GYN is very supportive of them.

It would be absolutely reprehensible for the FDA to meddle unnecessarily with cBHT compounding. I am a 71-year-old man who has had a bioidentical testosterone cream prescribed for me for about four years. The positive improvement it has made in my sexual and physical life has been immeasurable. Without it, my life would be significantly affected in a negative direction.

In conclusion, the FDA should back out of this area. They should complete an unbiased study so they can acknowledge the immense amount of well-being (physically, psychologically, and emotionally) compounded hormones do for people.

I just went on my Facebook group last night and learned about the risk to compounded hormones. This news caused a chain reaction, I had trouble sleeping last night and I feel sick today after hearing about this threat. I had already been on anti-depressants and when I hit menopause, and they no longer worked. I am a mother to two school-age kids and I was suicidal. These compounded hormones literally saved my life as the conventional medications did not come in high enough doses (estrogen), and the oral progesterone did not work for me. Unfortunately, these hormones have been termed "reproductive" hormones but I can tell you from first-hand experience that I need them to keep myself alive, and secondarily to be a productive member of society. I would end up needing government disability and a lot of health care without these hormones which keep me healthy and functioning. Please take my plea to not end our access to compounded hormones very seriously. If any elected officials are reading this, I'm not exaggerating in the least when I say access to compounding is life-changing.

My naturopath MD recommended bioidentical hormones while I was going through perimenopause. I had no hot flashes or any other discomfort. My sister died at 44 of breast cancer, and my mom of heart disease so I wouldn’t have risked pharmaceutical hormones. So I’m glad I had the bioidentical option!

I have been using physician-prescribed bioidentical hormones for over 20 years. They got me gracefully through a difficult menopause, restoring mental acuity, physical strength, and energy to care for the aging and share my medical knowledge with others. At 74 I remain strong and vital, pursuing health, hobbies, writing coherently and persuasively. I attribute this to my wholly natural supplementation with bioidentical hormones. Without them, I'd be a helpless wreck and a liability to my society. Please do not take this possibility away from the women you love and cherish.

I tried using pharmaceutical testosterone gel but could not adjust the dose properly for my needs. Since then, I have been using a compounded testosterone cream for about 15 years.

I am a patient who utilizes Bioidentical hormone replacement. I have also been in the medical field for 18 years. I thrive on medical research and have spent countless hours trying to find relief from the multiple life-disrupting symptoms I was having. I finally found relief with bio-identical hormone replacement. I am not exaggerating when I say this gave me my life back. For many years I suffered from abdominal pain, terrible menses, and infertility. When I was finally able to get pregnant I had a rough pregnancy, was on bed rest, and had multiple wary delivery scares. After delivery, my symptoms worsened. Long story, short, I ended up with a hysterectomy at age 40 after many issues. I was already struggling with postpartum depression and anxiety and this abrupt change just added to my misery. I also had impossible weight gain (even though I have always been healthy and fit). Working out even more and restrictive dietary changes only made it worse. I ended up on multiple medications, hardly able to function day-to-day, and losing my job.
After finding a doctor that would listen to me and actually take me seriously and after some blood work, I was started on bioidentical hormones. The results have been amazing! I am my old self again. I have lost the weight, I am off of other medication, my depression and anxiety lifted, I can sleep, and my chronic pain has greatly alleviated. I am finally able to be fully present for my family and I am back to working 2 jobs. These treatments have given me my life back! Please let doctors be doctors and let patients have choices for their health. We are not all the same and with informed consent should be able to make our own medical choices. Bioidentical hormone replacement needs to stay available for everyone.

Compounding provides a level of precision and delivery that is necessary to achieve comfort for many, many people.. Especially in the case of hormones, too much or too little can be the difference between function and not. As a nurse, I would feel that my patients would be adversely affected if compounding pharmacies are restricted. Their amazing professionalism and methods of dosage are of great value to my patients.

I have watched countless women and men over the last thirteen years renew their vitality, restore intimacy, control bladder health, improve bone density, regain mental acuity, regulate their emotions, enjoy sound sleep, get stronger and restore their relationships with compounded hormones. Compounding pharmacists are not sitting back dispensing a cancerous death or debilitating side effects via hormone replacement. In fact, we are dispensing a reversal from descent via compounded hormones and joyfully supporting our patients as they take back their lives and live them well.

I have been using bio-identical hormone therapy from a compounding pharmacy for 5 years. I chose this route as the commercial products did not work for me. 1. I cannot tolerate corn oil, which is what the generic Prometrium contains. 2. I cannot tolerate the adhesive of the only estradiol topical option that is available. Generic pharmaceuticals are limited in not only their dose options but also their delivery methods. I have had breast and GYN surveillance since using these compounded products and there are no problems. They have saved my marriage and many other health issues. Before using compounded hormones, I could not sleep as I suffered from night sweats, depression, and anxiety. Compounded hormones have helped so much, they have saved me from having to take many other unnecessary drugs.
Although every woman could benefit from hormone therapy, not every woman is the same. The ability to have options for dosing and application are very important.
Don't take away our right to choose options in healthcare.
Sincerely
Kelly Parcell

I was suffering.. from debilitating anxiety and panic, Raynaud's disease, massive bone loss, hair loss, sleep disorder, thyroid dysfunction, and was prescribed potent pharmaceuticals that could not help me. Since I have been on BHRT my entire life has turned around. I was able to wean off all anti-anxiety meds after 25+ yrs. I have grown my hair back, my bones are feeling somewhat better as I'm not losing mass any longer, my Raynaud's has gone away. I sleep and I have no more anxiety, heart palpitations, or mood disorders. Please please listen to the people. We should be allowed to determine what is right for our bodies and not be given a death sentence by a governmental agency. It's unfair and unjust. The FDA needs to do the right thing. They can't keep approving dangerous pharmaceuticals while denying us life-saving choices. Thank you for your time.

I am a Babyboomer born in the first year of that generation. In my mid-60s, I developed some vaginal discomfort and urinary issues. The Urologist took one look at that area of my body and said, "classic estrogen deficiency". She prescribed Estrace vaginal cream. The cream cleared up all of my problems with a minimum, localized dose of estrogen. Each time I refilled my prescription after that, about once every 9 months, the price increased. After a few years, it began increasing substantially each time. 
I finally was recommended to check out the local compounding pharmacy. It is well established in this community and has been so for years with an excellent reputation. They do provide the cream with an easier applicator than I had been provided with at the regular pharmacy. 
My compounding pharmacy has only raised the price once in the 7 or so years I have been getting it from them, and they apologized for the small increase.

Prior to using hormones, I was unbalanced. My life was in a downward spiral. Since my doctor prescribed hormones, my life has improved significantly!! I am a different person and I am happy.

I have a lifelong history of hypothyroidism. Over the years, I have taken many forms of thyroid medications, somewhat of necessity as the different brands become ineffective or unavailable.
At the moment, I am taking a cBHT prescribed for me by my naturopath. Of all the supplements I have used, this is by far the best. My doctor monitors my blood test and discusses my symptoms and adjusts the prescription accordingly. The ability to adjust the different components of thyroid medication is a huge benefit over standard medications. There is ongoing communication between my doctor and I, and there is real and objective data via blood tests, as well as my subjective feedback. As a result, I have felt better than I have in years. As a patient, my daily life is impacted by the freedom we have to use cBHT. I wake early and easily, something every thyroid patient knows is a blessing. My energy is constant throughout the day, also a blessing as I have an aging father to care for and 3 grandsons who need time with their "Nana." If it weren't for my compounded thyroid medication, my days would be a slog. I simply can't afford to be less than the best I can be. Life is too busy and too short.
Please consider this testimony as proof of the need for the continued availability of cBHT. The government should not have the right to interfere in the lives of its citizens. Health decisions such as this are not the purview of government.

Thank you for your consideration.

Sincerely,
Cynthia Seaney

At 52 years old I had never really been sick a day in my life. One morning I was dizzy, started having ringing in my ears, and by nightfall was deaf in my right ear. Suddenly I found myself crying all the time. My back hurt, my legs were restless when I laid down and my anxiety was out the roof. I couldn't sleep a wink and I couldn't eat. I lost weight from 140 lbs, which is not that much for me as I am 5' 9", down to 115 lbs. I felt like I was dying. If they had not given me Ativan at the ER, to help me sleep, I might have died.

My OBGYN gave me estrogen, but no progesterone because I'd had my uterus removed. Nothing really helped but the Ativan. I was horrified I would become addicted and only took about half what was prescribed.

A doctor prescribed an SSRI and I was finally able to get on that and quit worrying about addiction. Although the SSRI helped and I was able after a year to go back to work somewhere, I was still not myself.

I had always been a health food fan and I went to this Naturopath that was also an MD to find out natural means that might help me. While I was there, I asked him if he could write me a refill for my estrogen. He said he could and he could also give me something that didn't cause heart attack, cancer, and stroke and could add progesterone to it, which could make it more calming. I was scared to death to do anything that might upset the applecart, but I did it and in one month I was off the SSRI I had been on for three years, which, by the way, was new and had caused liver problems and even death to one woman.

I have recommended the bioidentical hormones to many women that were going through similar circumstances and all have been helped.

Please don't take our bioidentical hormones away from us. Which is better, to spend the rest of my life on SSRIs, which only barely made me functional, or something natural that makes me feel like my old self again and has no side effects?

Thank you for your time.

Sheila Turney

I started taking CBHT about 8 months ago after miserable side effects from other hormone therapies. I am a 39-year-old female and had a full hysterectomy at 22 years old due to PCOS and other gynecological issues. Taking the CBHT was my last option to try for hormone replacement. This medication has given me back my youth and changed my life. I was having severe symptoms from early menopause that were making my life feel like I was living in a nightmare. I was not able to be active with my son or be intimate with my husband due to severe pain. I have a renewed life now because of this therapy. Not being able to take this would make my newfound youth fade away again. I feel that this therapy can be so beneficial for many women that are facing similar issues. I thank God each day for this blessing and I ask that it continue for not only me but other women.

Access to hormones has helped me through menopause.

There should be less regulation, not more. It should not be difficult or expensive to work with your doctor to prescribe treatments that are necessary for better health and quality of life.

Thank you,

Ann Annunziata

Compounded BIHR has spared me from having to have urogyn surgery with safe, personalized, minimal therapeutic dosing. BIHR should not be one size fits all.