Compounding can meet a real clinical need—for example, when an approved formulation cannot be used by a particular patient. But the word is often presented online as if it were a synonym for individualized, improved or FDA-approved. It is none of those things by default.

The central distinction

FDA-approved drugs undergo agency review for safety, effectiveness and manufacturing quality before marketing. Compounded drugs are not FDA approved, and the agency does not verify those three attributes before they reach patients.

That does not make every compounded medicine inappropriate. It does mean readers need to understand why it was selected, who produced it and which assurances do—and do not—apply.

THE BOTTOM LINE

Compounding may address an individual medical need, but compounded drugs are not FDA-approved substitutes by default.

Primary sourceFDA compounding questions and answers

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Medical note

This article provides general information, not diagnosis or treatment advice. Decisions about peptides, compounded drugs or other therapies belong with a qualified clinician who knows your history.