What you need to know about FDA Approved Bioidentical Hormones versus Compounded Hormones: Are you confused about bioidentical hormones, who makes them and how they are regulated? I’ll dispel some myths about bioidentical compounded hormones and FDA approved bioidentical hormones. Many people believe that there aren’t any FDA approved bioidentical hormones and believe that although compounded hormones are not regulated by the FDA that they are entirely unregulated.
The term bioidentical is not an “official” scientific term. Lay people use this term to distinguish a hormone that has been altered and patented versus something found in nature. Bioidentical hormones are the exact same chemical structure as your body and cannot be patented because they are found in nature. However, pharmaceutical companies can change the delivery system and manufacture FDA approved bioidentical hormones because the delivery system can be patented.
Compounding pharmacies make bioidentical hormones on a small scale for individuals rather than the masses. They are not FDA approved bioidentical hormones because the FDA only oversees large scale manufacturing. State boards of pharmacy regulate compounded medications personalized for individual patients. FDA approved bioidentical hormones are intended for standard doses that are mass-produced by manufacturers. If you need a dose that is higher or lower than what a manufacturer makes, then you must have it compounded to your individual needs.
Names of FDA Approved Bioidentical Hormones
There are 3 types of bioidentical estrogens. The stronger and more active estrogen against menopausal symptoms is called estradiol. Estrone is not useful and another form is estriol that is most beneficial for skin and mucous membranes such as the vagina. So only the names estradiol, estrone and estriol are bioidentical. Testosterone and progesterone are the names of the bioidentical forms. However, in the media, progestins, which are synthetic progesterone are improperly called progesterone. These are generic names and generics are FDA approved bioidentical hormones as well.
FDA approved bioidentical hormones must have the same exact generic name of the hormone to be considered bioidentical.
- Estrogen – Estradiol is an FDA approved bioidentical hormone and is available in brand names such as Vivelle Dot, Climera, Estrogel and more.
- Progesterone – Prometrium given orally, and Endometrin, Cyclogest and Crinone given vaginally are FDA approved bioidentical hormones that contain progesterone. Do not confuse these with progestins that are synthetic. When looking at labels, it should say progesterone, not medroxyprogesterone or any other syllables added.
- Testosterone – Testim, Androgel, Axiron are FDA approved bioidentical hormones that contain testosterone. If there are other syllables added such as testosterone cypionate, they are not bioidentical.
What you need to know about FDA Approved Bioidentical Hormones versus Compounded Hormones: Conclusion
As you see, there are many FDA approved bioidentical hormones to choose from and these are great because they may be covered by insurance. However if you need something other than standard doses, or do not want to take progesterone vaginally. You may want to consider having a compounding pharmacy make the exact dose needed. Work with an anti aging functional medicine doctor who can help you determine what is right for you.
Thanks for this information. There is so much conflicting information out there.