Why Aren’t “Bio-Identicals” FDA-Approved?
Bio-identical drugs are made by pharmacy operations in a process called “pharmacy compounding,” instead of being manufactured the way most drugs are. In this process, the pharmacist alters or changes a drug that had previously been approved by the FDA. However, when the drug is modified in the compounding process, it is no longer FDA-approved.4 The goal of pharmacy compounding used to be to allow a medical prescription to be customized for a particular patient, typically to dilute a particular drug, or to make a medicine made without certain ingredients that cause allergic reactions. In many cases, this kind of compounding is beneficial to the patient, but it is not without risks.4 However, pharmacy compounding can allow untested drugs to be widely sold to millions of people. When FDA-approved drugs are changed during the compounding process, serious problems can arise because the production standards of compounding are not required to be regulated or monitored.4 After compounding, con
