Understand what is being made
Medicine reviews in the US are the work of the Food and Drug Administration (FDA).
For compounding, a pharmacist or doctor prepares a custom medicine rather than supplying a ready-made product.
As of September 2026, these custom-made medicines had no FDA approval.
The agency did not check how well they worked, how safe they were, or how well they were made before sale.
FDA says custom medicine may address a health need left unmet by an approved drug, or a need for a drug that is unavailable.
Ask why a custom product is needed in your case.
Ask it plainly
What need would this custom product meet that a ready-made drug cannot?
Ask who actually makes it
FDA notes that people getting custom medicines online may not know who made them.
Get the name of the pharmacy or other place making the medicine. Check that name in the state licence record. The care service’s name or logo does not identify the pharmacy that made it.
FDA links to state pharmacy records, but a licence does not prove every medicine decision is proper.
Ask why a pharmacy may make a version of an available medicine
US rules checked in September 2026 could class a custom version of a medicine already available as a copy.
Those rules barred ordinary pharmacies from making such copies regularly or in large amounts.
The limit could allow a changed medicine if the change made an important difference for a named patient’s health.
The prescriber had to decide why the change mattered and put that decision on record.
Making it cheaper did not count as that difference.
An allergy to a dye used in a ready-made medicine can be a reason for a patient to need a custom version.
Ask which part of the medicine has changed and why the change matters for your health. Writing a note alone does not explain the medical need.
FDA’s national shortage list no longer included injections of semaglutide, sold as Ozempic and Wegovy, or tirzepatide, sold as Mounjaro and Zepbound, by September 2026.
After the shortages ended, FDA gave pharmacies extra time before acting on some violations linked to the shortages.
That extra time ended in 2025, so it no longer covered the making of copies.
Ask how the current rules allow the medicine being offered to you.
Do not assume adding a vitamin makes it different enough
In September 2026, FDA said a vitamin added to a similar semaglutide shot could still leave it classed as a copy.
To use the patient-specific exception, the person writing the prescription had to record why the changed medicine mattered for that patient’s health.
Ask why the added ingredient matters for your own health. A different name or a lower price does not explain that.