M Hormones are essential for regulating major processes in the body, such as metabolism, reproduction and development. Hormonal imbalance can lead to numerous symptoms and create life-altering complications that threaten the health and well-being of millions of patients.
This typically affects women in perimenopause and menopause, but it also affect women with other medical conditions, transpersons and men suffering a variety of conditions. Not all patients suffer the same symptoms or in the same intensity, but the more common manifestations of hormonal imbalance including
Hormone replacement therapy has been a powerful treatment that allows millions of people to live normal lives. But the typical FDA-approved therapies can't serve all people.
For example, there are no manufactured bioidentical hormone therapy products available on the market for certain diseases, such as female sexual dysfunction (“FSD”) and gender dysphoria.
Many patients need customized medications. Some patients may be allergic to a component in an FDA-approved drug, such as lactose, gluten or a dye. Patients who cannot swallow a tablet or capsule (e.g., elderly patients, children) may need a compounded medicine in a liquid dosage form. A patient may need an exact strength or dosage form that is not commercially available. A patient may need a drug that has been discontinued by the manufacturer.
Federal law recognizes that it is impossible for drug manufacturers to meet every conceivable patient need, and that certain patients cannot be treated even with an FDA-approved medication. Meaning compounding pharmacy plays an essential role in keeping people healthy.
Source Material
The foundation of this website is an independent analysis of the original NASEM report, The Panel Put Policy-Making Before Patient Need, written and published by The Berkeley Research Group. You can download the analysis here.