Know what is being prepared
In compounding, a pharmacist, doctor, or registered facility prepares or changes the medicine instead of supplying an approved product that is ready-made.
As of September 2026, compounding could meet a patient need under the law’s conditions; it was not automatically unlawful.
FDA, the Food and Drug Administration, says a compounded drug can meet a need that an approved product leaves unmet.
Compounded medicines had no approval from FDA as of September 2026.
Before these medicines are offered, FDA does not check their safety, their quality, or how well they work.
A copy needs more than a lower price
As of September 2026, federal law limited pharmacies making repeated copies of ready-made approved medicines that were available.
When a pharmacy prepares medicine for an identified patient, the prescriber must judge whether changing it makes an important difference to that person. If so, the changed medicine may fall outside that limit on copies.
A dye allergy, for example, may leave a patient needing medicine with that dye removed.
Being cheaper is not, by itself, an important difference for the patient.
- What need would this preparation meet for me?
- How will the preparation change, and what makes that change matter?
- Which pharmacy or facility makes it?
- What written product information will I receive?
- What approved options could meet the same need?
Ask the clinician to explain the product’s status in plain words. A prescription is part of the conversation, not its end.
Notes behind the answers
- FDA · why medicine is compounded
The source for compounding’s role and its lack of product approval.
- FDA · what has not been reviewed
The basis for the limits of product review.
- Federal law · pharmacy copies for a named patient
Read when a change that matters for a particular patient can fall outside the limit on copies.