Made for one person
A compounded medication is prepared by a pharmacy for an individual patient against a prescription, rather than manufactured in batches by a drug company. It is a long-standing and legitimate part of medicine. It is how you get a dose or a form that no manufacturer makes.
What is different about it
Compounded preparations are not FDA-approved in the way a branded medicine is. The FDA approves drug products; it does not approve each compounded preparation. The pharmacy is regulated by the state board, and by the FDA if it is an outsourcing facility, but the preparation itself has not been through the approval process.
That is not a scandal and it is not a loophole. It is simply a different arrangement, and it is worth knowing which one you are being offered.
Questions that are reasonable to ask
- Which pharmacy is compounding this?
- Are they a 503A pharmacy or a 503B outsourcing facility?
- Is the preparation tested, and can I see the certificate of analysis?
- How should it be stored, and how long does it last once it is opened?
None of these are awkward questions. A pharmacy or clinic that treats them as awkward has told you something.
General information, not medical advice, and not a substitute for being assessed by a clinician. Nothing here has been evaluated by the FDA. What is right for you is a decision for a provider who has your history in front of them.
