A compounded medication is not FDA-approved. FDA does not review that compounded product's safety, effectiveness, or quality before it is marketed.[1]
This distinction matters even when the active ingredient is also used in an FDA-approved drug.
Compounding and generic approval are different
An FDA-approved generic must meet the requirements for generic approval, including establishing therapeutic equivalence to a brand-name drug. A compounded medication has not gone through that process.[1]
Calling a compounded product a generic, the same as an approved brand, or FDA-approved because of its ingredient would misrepresent its status.
Research on an approved drug can help explain an ingredient's known actions and risks. It does not establish that a particular compounded product has the same safety, effectiveness, or quality.
Why compounding exists
Compounding can meet a medical need that an approved product cannot. FDA gives examples such as removing an ingredient a patient is allergic to or preparing a different dosage form when someone cannot use the available one.[1]
That purpose is specific. It does not make compounding a blanket substitute for approved medicines or remove the need to consider available alternatives.
What oversight means
Compounding is subject to applicable law and oversight, which differ by the type of facility. State pharmacy boards generally oversee state-licensed pharmacies day to day; FDA has a larger oversight role for registered outsourcing facilities.[1]
Licensing or facility registration is not FDA approval of the compounded drug.
Poor compounding can lead to contamination or the wrong amount of active ingredient, with potentially serious consequences. Directions and labeling also matter for safe use.[2]
Before using a compounded prescription, the essential information includes why it is needed, which pharmacy prepares it, the exact formulation, and how questions or problems will be handled. The approval disclosure should be easy to find and understand before that decision.
