Second kind: a compounded (made-to-order) medicine
A compounded medicine is prepared for a need that a ready-made product may not meet, but the finished product itself is not FDA-approved.
The usual compounder is an ordinary pharmacy mixing a medicine for a single, named person who holds a prescription. The other kind, an outsourcing facility, is a bigger FDA-registered operation producing germ-free (sterile) medicines by the batch, frequently for clinics and hospitals, and it can work without a prescription made out to you.
If you are offered a compounded medicine, ask which of the two made it and get that maker’s name.