Written by William Monroe - January 07, 2023
Bioidentical hormones are made with plant-based, naturally occurring ingredients and are designed to work in the same way as hormones our bodies produce. Though the FDA does not approve bioidentical hormones specifically, they do approve certain drugs that use bioidentical hormone ingredients.
In addition to this, medical compounding pharmacies make custom medications that combine these approved ingredients into products intended to replace lost hormones. As such, it is important to understand how the FDA oversees both commercial medications and compounded medications which contain bioidentical hormone components.
FDA Approvals for Drug Ingredients Containing Bioidentical Hormones
The FDA approves certain drug ingredients which contain bioidentical hormones under their New Drug Application (NDA) program. These include testosterone, estradiol, estriol and progesterone. Though manufacturers need a prescription for producing these drugs, prescriptions must be written on an individual basis in order for them to be used as a component of a compounded medication instead of using an approved commercial product like Premarin or Provera.
Oversight of Compounded Products Containing Bioidenticals
The FDA acts as an overseeing authority when it comes to compounds produced by medical compounding pharmacies that contain bioidenticals and other drug components. Compounded medication's safety and efficacy is judged according to pre-established USP standards set by the United States Pharmacopeia (USP). All compounded products must meet USP Chapter <710> standard for sterility assurance and potency before they can be shipped out or distributed. These requirements are enforced through state board inspections commonly referred to as Joint Commission on Pharmacy Practice Accreditation (JCPPA) or similar organizations recognized by state boards of pharmacy in most states across the country. Thus, medication compounded with bioidenticals must meet all criteria set forth by the JCPPA in order be legally sold or shipped outside a licensed pharmacy setting.
Using Bioidenticals Safely
Just like any other form of hormone replacement therapy, safety should always come first when considering treatment options involving bioidenticals. It’s important to consider any potential risks before beginning a regimen with these types of drugs and consult with your doctor before you start taking them regularly in order ensure safe usage practices are being followed correctly. Additionally its key to find a qualified compounding pharmacy who has experience making customized formulations particularly if your doctor prescribes such treatments using bio identical hormones so that you can get accurate dosages safely every time you need them filled without risking contamination in poorly manufactured products from unlicensed pharmacies practicing without supervision from governing bodies .
At Hormone Treatment Center we adhere strictly to all required guidelines set forth by governing bodies regarding formulation of drugs containing bio identically derived components so you can rest assured that your treatments will always be prepared with utmost quality control standards in mind . Contact us today for more information about our services!