Compounded bioidentical hormones (cBHT) are an essential medical therapy for millions of women who suffer the debilitating effects of hormone imbalance. For these patients, compounded hormones aren't an alternative to manufactured hormones, they are the only available option. And now there is a significant threat to patient access of this important therapy.
The FDA has signaled that it may consider new regulations that, if implemented, will deny access to a critically important, life-changing medical therapy to millions of people.
The FDA has said it will base its decisions on a deeply flawed report that it commissioned from the National Academies of Science, Engineering and Medicine (NASEM). The report is neither a complete or accurate representation of compounded hormones and is tainted by bias, conflicts of interest and bad science.
Marked by pre-menstrual syndrome, depression, sleep disorders, menstrual migraines, infertility, osteoporosis, reduced libido
Testosterone deficiency causing depressed mood, erectile dysfunction, loss of bone mass and sleep disruption.
Vaginal atrophy (atrophic vaginitis) is thinning, drying and inflammation of the vaginal walls that may occur when your body has less estrogen.
Specialized care for individuals to ensure that sexual characteristics align with the person's gender identity.
Condition where thyroid gland doesn't produce enough thyroid hormone.
Vulvodynia can be so uncomfortable that some activities can feel unbearable, such as sitting for long periods of time or having sex.
Physicians have been prescribing and patients have been taking compounded hormones for decades. The FDA-funded NASEM study ignores mountains of research on successful patient outcomes. It excludes the insights of both physicians and pharmacists who have extensive, patient-facing cBHT experience. The NASEM committee only included a fraction of the available data on the topic, which means that their report does not reflect a complete or accurate understanding of compounded hormones.Learn more about the Flaws behind the FDA's Actions
It also ignored the practical experiences of patients whose lives have been transformed by compounded hormones, as well as physicians and physicians and pharmacists with extensive, patient-facing experience.
Our campaign to protect access to compounded hormones needs your support. We need your involvement. We need your voice. And, yes, we need your financial support as well.
"I am a 59 y/o family physician who has struggled with perimenopause and menopause for the past 15 years at least and finally found much needed relief in the form of a cBHT troche from a locally owned compounding pharmacy.
We need to move beyond the idea that the same pill/med will fix every woman.
On this page, we can only touch on the data that shows the importance of compounded hormones to millions of women in this country.
While an FDA effort to restrict this vital therapy for patients and physicians may prove profitable for the big pharmaceutical companies, it will be disastrous for patients for whom those same pharmaceutical companies' manufactured hormones are not suited!
With your help, we can show members of Congress how many of their constituents are benefiting from compounded hormones, educate them about those therapies, and engage them in preserving access.
We encourage the appropriate committees in both the House and Senate to hold hearings on this critical issue.
Preserve access to compounded hormones.
Explore our interactive map that demonstrates the importance of compounded hormones to patients all across the country. Filter these first-hand accounts by state to see just how vital compounded hormones are.