FDA explanation
Made to order is a different route
The US government agency that reviews medicines for approval is called the Food and Drug Administration (FDA).
A registered compounding facility, a licensed doctor or a licensed pharmacist can prepare compounded medicines.
In its explanation checked September 26, 2026, the FDA says compounding may fit a patient whose medical need cannot be met by an approved medicine.
Ask for the reason in plain words, rather than just “custom”.
Read how the FDA describes compoundingHas the FDA checked the finished medicine?
Compounded medicines lack FDA approval, as of September 26, 2026.
The FDA does not check a compounded medicine’s safety before it is sold.
It also does not check how well it was made or whether it works.
- What patient need calls for this preparation?
- What approved options were considered?
- Who makes it, and what paperwork identifies it?
State compounding rule
Washington still has quality rules
As of September 30, 2026, Washington pharmacy licensees doing compounding must meet the relevant USP standards.
USP is a group that sets medicine quality standards.
The Washington rule includes standards for sterile preparations, meaning medicines made to be free of living germs.
Read Washington’s compounding standardsDoes an FDA registration settle it?
As of September 26, 2026, registering a compounding facility with the FDA does not mean the FDA approves that facility or its products.
- Ask about the actual medicine and the rule that permits its preparation.