Care briefing
Mixed for a patient, with rules attached.
Compounding means preparing medicine from ingredients to meet a patient’s need, rather than using a ready-made finished product.
FDA is short for Food and Drug Administration, the US agency that reviews medicines.
Compare the product and the reason
Read sourcesReview before use
Ready-made reviewed medicine
FDA approval, as of September 2026, covers a specific finished medicine and its stated use.
Compounded medicine
As of September 2026, compounded medicine has no FDA approval. The agency does not check its quality, benefit or harm before patients receive it.
Why use a mixture?
Ready-made reviewed medicine
Ask whether it can meet the need being treated.
Compounded medicine
The FDA says a mixture may fit when a reviewed medicine cannot meet the patient’s need or is unavailable, as of September 2026.
Ask why the medicine was changed for you. Do not assume a change makes it better.
What the pharmacy type means
As of September 2026, a pharmacy working under the rule called 503A generally compounds for a named patient with a prescription.
“Sterile” describes something with no living germs.
As of September 2026, a site registered under federal rule 503B may make medicine in batches, often for clinics and hospitals. Prescriptions for individual named patients are not required.
A 503B site makes sterile medicine and need not be a licensed pharmacy.
As of September 2026, these registered 503B sites must follow federal drug-factory quality rules and undergo FDA inspections. A 503A pharmacy mixing medicine for a named patient is exempt from those factory rules.
As of September 2026, state pharmacy boards still oversee 503A pharmacies, which must follow standards for preparing medicine.
Ask whether a 503A pharmacy or a registered 503B site makes your medicine. Ask who checks its work and what the latest inspection found. These checks do not mean the FDA has approved your mixture.
The ingredient still has to qualify
As of September 2026, federal compounding rules limit which raw ingredients may be used.
A nomination asks the FDA to add an ingredient to its list for permitted compounding. Taking back that request does not authorize a pharmacy to use the ingredient, as of September 2026.
If a seller says a withdrawn request makes its medicine legal, ask the pharmacist to show which current rule allows it. Have the pharmacist explain how that rule covers the ingredient and the tablet, injection or other version you would receive.
Ask for the patient-specific reason
What need does the mixture address?
Ask what the change does for you that the ready-made option cannot.
Who makes it, and who sends it?
Get the name of the place that makes the medicine and the pharmacy that sends it. Ask whether these differ from the care service’s name.
Sources for this briefing
Choose the source for your question. For a doctor’s licence, use the state licence search. For a medicine’s approval, ask to see the FDA approval and approved label for that exact product.
FDA · Compounding explained
The FDA describes when compounding may serve a patient need and how oversight works.
Read the sourceFDA · Ingredient rules
The FDA explains the requirements for raw ingredients used by patient-specific compounders.
Read the sourceFDA · Registered facilities
The FDA describes facilities that choose to register for batch compounding.
Read the source