- Compounding
- Rather than supply a finished product made in a factory, a pharmacist or doctor prepares the medicine to order.
Why it may come up
A patient may need a preparation that an approved medicine cannot provide. The Food and Drug Administration (FDA) gives a dye allergy and difficulty swallowing a tablet as examples of needs that compounding can address.
Ask which need the proposed preparation would meet. Ask who will make it. The prescriber is the person who decides on a medicine; the compounder is the person or facility that prepares it.
The ingredient matters
For ordinary pharmacy compounding, U.S. law sets rules for the raw ingredient: the substance used to make the medicine.
Where an official drug-quality standard covers the ingredient, both that standard and the pharmacy compounding standards must be met.
Without an official standard, the ingredient has to be a component of a drug with FDA approval.
If neither route applies, the remaining requirement is inclusion on the FDA’s ingredient list for this type of compounding.
These ingredient rules are not a full check of the finished medicine or every rule for the pharmacy.
Ask the prescriber which rule supports this exact ingredient and preparation. A general statement that compounding exists does not answer that question.
U.S. ingredient and prescription rules checked: September 26, 2026.
Ask before agreeing
- Why is a made-to-order medicine being proposed?
- What finished medicine was considered?
- Which pharmacy will prepare it?
- Can that pharmacy answer my questions?
- What written information will come with it?