FDA, the Food and Drug Administration, handles U.S. drug review.
Compounding is the name for preparing your medicine to order. The finished product does not come ready-made from a drug company. A pharmacist, doctor or drug-making site registered with FDA can do this.
The U.S. approval and legal information below is current to September 26, 2026.
| Type | What the status means | Ask the clinician |
|---|---|---|
| An approved drug product | FDA approval concerns a particular product and use; some peptides are approved medicines. | What is this product approved to treat, and is that the use being discussed? |
| A compounded preparation | This preparation has no FDA approval. For a compounded drug, the quality, benefit and safety have not been verified by FDA before sale. | Why does my need call for this preparation rather than an approved product? |
| A chemical labelled for laboratory research | A research-only label describes a chemical for lab work. FDA warning letters have alleged illegal sales of unapproved drugs when sellers used such labels but promoted the products for people. | Why is a chemical labelled for lab work being offered as care for me? |
Custom preparation has limits
Compounding can help with an allergy to a dye that an otherwise suitable approved drug contains.
As of September 26, 2026, the law also limits the ingredients a regular compounding pharmacy may use.
So ‘custom’ leaves a question open. Ask for the ingredient, the reason for using it and the pharmacy’s name. A prescription alone does not answer all of those questions.
A registration claim is not a product answer
Registering a drug-making site with FDA does not mean FDA has approved the site or its drugs. This rule was checked September 26, 2026.
Ask what a badge or registration actually refers to. Keep the answer beside the product name.
Sources and when we checked them
FDA approval and registration: September 26, 2026. Finding a pharmacy’s state licence record: September 17, 2026.