What does "compounded" mean? Is my formula FDA-approved?

Two distinct things to separate.

• The active ingredients in your formula — tretinoin, hydroquinone, clindamycin, azelaic acid, eflornithine, niacinamide, and others — are FDA-recognized and individually have decades of clinical evidence behind them.
• The combined compounded formula is not a single FDA-approved finished product the way a brand-name medication off a pharmacy shelf is. Compounded medications are individually prepared by a 503A compounding pharmacy under a specific prescription for a specific patient, regulated under federal compounding rules and state pharmacy boards.

What that means for you:

• A compounded formula is legal, regulated, and prescribed by a licensed clinician — but it is not the same as picking up a sealed bottle of tretinoin 0.025% with an FDA-approved manufacturer's label.
• The compounding pharmacy is required to operate under USP standards for sterility, potency, and identity testing on the active ingredients.
• The combination, ratios, and supporting actives in your specific formula are tailored to you, which is the whole point of compounding — but it is also the reason the finished product is not labeled with an FDA approval number.

If you specifically need an FDA-approved finished product (for example, for an FSA or HSA documentation requirement, or for travel through a country that requires it), tell your dermatologist — they can sometimes prescribe a brand-name FDA-approved alternative as a substitute, depending on your case.