A field note for your care search
What it means to have medicine mixed for you.
Medicine mixed to order does not get the same review as an approved product.
The mix-up
Made to order means checked like a factory medicine.
The clearer answer
Compounding means preparing medicine to order, work done by a pharmacist or doctor. Source a
Compounding can be legal when it meets the relevant rules. Source a
Before that preparation is sold, the Food and Drug Administration (FDA) neither approves it nor reviews its quality, safety or effectiveness. Source a
U.S. compounding rules as of September 26, 2026.
Ask why a special mixture is being discussed
Why a special mixture is needed
FDA says a custom mixture may help if an approved product fails to meet your medical need or a ready-made version is unavailable. Source a
Have the prescriber explain why your own medical needs call for this mixture.
The exact change
Ask what is being changed from a ready-made product and why that change matters for you.
The pharmacy
Ask which pharmacy will prepare the medicine and where its licence can be checked.
The written information
A compounded medicine may lack some of the directions that accompany an approved product. Source b
Ask for clear written information and a way to ask the pharmacist questions.
Registration does not approve the medicine
A business that mixes medicines can choose to register with FDA. Source c
Registration gives the business no FDA recommendation and gives its medicines no FDA approval. Source c
If a service says FDA registered, ask whether it means the business or the medicine. Ask separately whether FDA has approved the medicine itself.
The rules still matter at a lower price
Federal law restricts custom mixtures that closely copy a drug company’s medicine already on the market. Source d
FDA describes an exception to the copying rules for a change that makes an important difference to one patient’s care. Source d
The person writing the prescription must write down the change and why it makes that difference for the named patient. Source d
FDA’s examples include a patient unable to swallow tablets and a patient with an allergy to dye in a ready-made product. Source a
Rules also limit which raw drug ingredients a pharmacy may use. Source e
Ask what medical need is being addressed before turning to the price.
Sources for this note
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