Check these points
Ask why a made-to-order medicine is proposed
The FDA, or Food and Drug Administration, handles federal reviews of medicines.
As of September 26, 2026, the FDA says a compounded medicine may address a medical need that an approved product cannot meet.
Ask what that need is in your case, and what approved options were considered.
Ask who actually prepares it
Ask for the name of the pharmacy or business that makes the medicine before agreeing to a plan.
As of September 26, 2026, compounded drugs have no FDA approval or FDA check of their quality, safety and effectiveness before marketing.
Ask which rules allow the preparation
Federal law restricts regularly making copies of medicines already available to buy, as of September 26, 2026. For a pharmacist or doctor, a change may qualify for an exception if the person prescribing decides it makes a significant difference for you.
Ask what change you need and why it makes that difference. Ask which rule allows your medicine to be made and get the explanation in writing.
Notes that explain the checks
“Registered” is a different word
As of September 26, 2026, a larger compounding business can choose to put itself on the FDA’s registered-business list. That listing does not mean the FDA recommends the business or approves its medicines.
These larger businesses make batches, often for clinics and hospitals. They must follow federal factory quality rules, and the FDA inspects them, as of September 26, 2026.
Registration answers: is this business on the FDA’s list? A state licence answers: what work has the state given it permission to do? Product approval answers: has the FDA reviewed this particular medicine for a named use?
Boston adds a pharmacy check
As of September 30, 2026, Massachusetts requires an extra sterile-compounding licence or registration for compounded injections sent in from another state.
Sterile means free of living germs.
Ask for the exact licence category, not just the pharmacy’s name.