THE SHORT ANSWER
FDA approval concerns a specific drug product and its approved uses. Compounding involves preparing a medication for particular needs; compounded drugs are not FDA approved. Off-label prescribing refers to using an approved drug outside its approved labeling. These terms describe different issues and should not be treated as interchangeable.
What to keep in mind
- Ask which description applies to the exact product.
- A compounded medicine is not an FDA-approved generic.
- Discuss the evidence and alternatives for the proposed use.
What is a compounded medication?
Compounding can involve combining, mixing, or altering ingredients to create a medication suited to an individual need. FDA does not review compounded drugs for safety, effectiveness, and quality before marketing as it does approved drug products.
How is off-label prescribing different?
Off-label use concerns how an approved medicine is prescribed—for example, for a condition outside its approved labeling. It does not turn an unapproved compounded product into an approved one. Ask your clinician which distinction applies and why the proposed approach is appropriate.
Sources: NIDDK: Prescription medications to treat overweight and obesity
What should I ask about a proposed compound?
Ask why an approved product cannot meet your particular medical needs, which ingredients are included, and what evidence supports the proposed formulation. For compounded GLP-1 products, FDA highlights concerns that include dosing errors and misleading claims of equivalence to approved drugs.
- What is the exact product and intended use?
- What alternatives can we consider?
- Which pharmacy would prepare or dispense it?
- What instructions, risks, and monitoring should I understand?
How can I keep the decision clear?
Write down the product name and the purpose discussed with your clinician. Keep the prescription and pharmacy instructions together, and ask before using a medicine if the label or directions are unclear.
A website’s medication selector can help compare formulations and prices. It cannot establish clinical suitability or replace a conversation about the exact product. Use the secure portal for personal questions, and do not substitute a product or dosing schedule on your own.
Common questions
Does adding an approved ingredient make a compound FDA approved?
No. Approval of an ingredient in a particular drug product is not approval of every compounded formulation containing it.
Are all off-label prescriptions compounded?
No. Off-label prescribing and compounding describe different things.
Sources & context
Sources checked September 18, 2026. This is general education, not a diagnosis or individualized treatment advice. Medication examples do not establish availability or suitability.
