The term “FDA Approved Drug” has caused some confusion in the marketplace. FDA approved drugs go through an approval process that can often take many years and millions of dollars to complete. Only the final product consisting of specific ingredient(s) at specified strength(s) and a dosage form for a defined indication are considered FDA approved.
The individual Active Pharmaceutical Ingredients (APIs) used by FDA-approved products or even in compounds, by their very nature, are not FDA approved. Recently, some insurance companies have taken the stance that they will not reimburse for a compounded medication because either the compound or the API is not FDA approved. While FDA approved medication(s) make up the majority of the drugs that are commercially available in the market today, it may be surprising to some that there are drugs that are commercially manufactured that did not go through the FDA approval process.
These drugs are critically important to patients and practitioners and are still prescribed frequently. Insurance companies may be applying an inconsistent policy if they reimburse for any of the drugs listed and not for compounded medications.
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