Federal fact file dated September 26, 2026.
Made for a patient does not mean reviewed
Compounding means preparing medicine to order. Ask why you need it and which rules the person making it follows.
Separate a patient need from an approval claim
FDA refers to the U.S. medicines regulator, the Food and Drug Administration.
For the finished preparation, there is no FDA approval. FDA does not review it before sale to check whether it works, is safe or is made well.
Read the FDA answer about pre-sale review
FDA gives dye allergy as an example of a need compounding may address.
Ask what need is being addressed in your case. Ask whether an approved product could meet it instead.
Know which preparation route is being discussed
For a pharmacy or doctor preparing medicine for a named patient, the law has a section called 503A. It requires a valid prescription for that person. A prescription alone does not meet every requirement in that section.
Read the rules for preparation under 503A
Sterile means free of living germs.
A different section, 503B, covers a facility registered with FDA to prepare sterile medicines. It is called an outsourcing facility and often makes batches for clinics or hospitals. It can prepare those batches without prescriptions naming the patients who will receive them.
Read the FDA explanation of outsourcing facilities
This batch rule concerns the maker. It does not let a service supply a prescription medicine to you without the required prescription.
Ask who made the medicine and whether they follow 503A or 503B. Ask why it is needed for you. The copy limits below are another check.
Those labels name legal routes, not a promise that a preparation works for the use being offered.
A custom label does not erase copy limits
A pharmacy or doctor following 503A cannot regularly make, or make excessive amounts of, copies or very similar versions of ready-made medicines already being sold. A separate copy limit also applies to facilities following 503B.
Read the federal answer on copies of available drugs
For 503A, the person prescribing must find an important difference for the named patient in the changed medicine. The change cannot qualify just because it saves money.
One example of a need for medicine prepared to order is an allergy to a dye in a ready-made product.
Ask for the reason in plain words. Do not let the word custom stand in for it.