There is a lot of confusion and misunderstanding about compounding medicines and compounding pharmacies.
First of all, compounding is used all over the country to make many types of medications (from diaper rash creams to cough syrups to topical anesthetics) and to a greater or lesser degree is done by MOST pharmacies. These medications are used in hospitals and most clinics all over the country.
“Compounding” in essence means that a pharmacist combines two or more products in order to improve the effectiveness or convenience of the product. Medications strengths or delivery methods can be customized for each individual’s needs. There are many benefits of compounded medications.
Some advantages are improving patient compliance and by decreasing side effects – by changing the dosage strengths of medication with the approval of the physician, removing dyes and/or fillers, or changing the medication delivery system (sublingual troches or triturates, suspensions, injectables, transdermal gels and creams, etc.).
Often a source of confusion is that the FDA does not ‘approve’ the products coming out of compounding pharmacies. This is actually a technicality when it comes to bio identical hormones. Pharmacists at specialty pharmacies, such as Bloomington Drug use estradiol (estrogen), progesterone and testosterone that ARE FDA approved. It is the act of mixing these FDA approved products with something else like a vanishing cream, transdermal gel, etc. that makes the product ‘not FDA approved.’ In the case of the weaker estrogen estriol (E3), which is often use in conjunction with estradiol to make Biest cream, the FDA has not thoroughly investigated it. Ironically, all of the science to date has suggested estriol (E3) is the safest estrogen and appears to have anti-inflammatory and anti-breast cancer effects.
The FDA approval process is intended for mass-produced drugs made by manufacturers. Because compounded medications are personalized for individual patients, it is not possible for each formulation to go through the FDA’s drug approval process, which takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.
The Bioidentical hormone therapies compounded can be used to treat the following conditions or symptoms: Menopause, Perimenopause, PMS, Andropause, Thyroid and Adrenal Fatigue.
– Dr. Rich Sinda