Read what compounding adds to the offer

What compounding describes

Compounding means preparing a medicine: a pharmacist can mix it for a patient, while an FDA-registered facility can make batches.

Ask what patient need the proposed preparation is meant to address. Ask why an approved product is not being proposed instead.

What it does not establish

The federal rules described here were checked on September 26, 2026.

Medicines made this way receive no FDA approval. These prepared medicines go on sale without FDA checking their safety, the quality of the preparation or how well they work.

Federal law allows this kind of medicine making only when the maker, prescription arrangements and ingredients meet the relevant rules.

Those rules also restrict the raw ingredients used to make a medicine.

Ask which kind of medicine maker is involved

503A is the federal rule for a medicine prepared for a particular patient on a valid prescription, with further conditions.

A facility following the other federal rule, 503B, registers with FDA and prepares sterile medicine in batches, often for hospitals or clinics.

Sterile means free of living germs.

People call it an outsourcing facility; preparing a batch does not require prescriptions that name all the future patients.

That describes the maker’s work. Ask separately who decides whether to prescribe for you. Ask the maker which ingredient rule it relies on and how this product meets it. Get the answer in writing.