FDA-Approved and Compounded Medications: What Is Different?

What FDA approval means

For an FDA-approved drug, FDA reviews safety, effectiveness, and quality before the product is marketed, including whether it is manufactured in a way that ensures consistent drug quality and whether its label is complete and accurate. The approved labeling contains a summary of the essential scientific information needed for the safe and effective use of that product.

Approval does not mean a drug is right for every person. A licensed clinician still has to consider the individual patient's history and the approved labeling.

What compounding means

Drug compounding generally involves combining, mixing, or altering ingredients to create a preparation for an identified patient need. FDA states that compounded drugs are not FDA-approved, so the agency does not review their safety, effectiveness, or quality before they are marketed.

FDA also notes that compounded drugs can serve an important medical need for some patients. That fact does not make a compounded preparation equivalent to an FDA-approved product.

Why labeling and instructions deserve attention

FDA-approved products have approved labeling. FDA warns that labels on compounded drugs may not include the same information or adequate directions. Patients should receive clear, product-specific instructions from the prescriber or dispensing pharmacy.

If the product name, concentration, instructions, or packaging differs from what you expected, pause and contact the dispensing pharmacy or prescriber before using it.

Questions to ask before a decision

• Is this exact product FDA-approved or compounded?
• If compounded, what patient-specific need is being addressed?
• Which pharmacy will prepare or dispense it, and where is that pharmacy licensed?
• Where are the directions, warnings, and contact details for questions?