Check a care route
What does “compounded” mean?
A medicine made to order is a preparation method. It is not a shortcut around the rules for its ingredients.
Made to order
When a doctor or pharmacist compounds a medicine, they make it to order rather than use a finished product from a drug company.
It can address a patient's need that an approved medicine leaves unmet, such as avoiding a particular dye.
Compounded medicines have no FDA approval under the rules reviewed on September 26, 2026.
FDA does not review these medicines for quality, benefit or safety before patients receive them.
The ingredient matters too
For a pharmacy making medicine to order for one patient, the rules checked on September 26, 2026 restrict which raw ingredients it may use.
These are legal conditions, not tests of whether the medicine helps. The ingredient rule has three possible routes:
- If there are official quality rules written for the ingredient, it must meet those rules and the rules for making medicine.
- If no such quality rules exist, the ingredient must be part of a medicine that has FDA approval.
- If the first two conditions do not apply, the ingredient must be on FDA's special list of allowed ingredients.
FDA's July 2026 review found no such written quality rules for Semax and no approved medicine containing it.
As checked on September 30, 2026, Semax was also missing from that special ingredient list.
A registration is a different check
FDA registration puts a business in FDA's records. A drug can also be listed in those records. The rules reviewed on September 26, 2026 say that neither entry means FDA approval.
Ask what is being claimed: a pharmacy licence, a business recorded with FDA, or FDA approval of a medicine. Ask to see the record for that claim.