Approved

An FDA approval means a specific product completed clinical development: controlled trials in a named indication, a reviewed manufacturing process, and labeling that states what the evidence supports. The approval belongs to the product and its indication, not to the molecule in every use a seller can imagine for it.

Four molecules in this index hold approvals. For each, the approved product is the lawful supply route; under section 503A, a pharmacy may not compound what is essentially a copy of a commercially available drug unless a prescriber documents a clinical difference for an individual patient, and the FDA has rejected price as such a difference.

The monographs above carry each product's record and its trial evidence; the compoundable page covers the molecules a pharmacy may prepare without an approved product behind them.