Compounded vs. brand-name: what actually differs

If you are prescribed a compounded medication you should understand exactly what that means. Most providers gloss over it. We would rather be direct.

Brand-name

Manufactured by the original developer, FDA-approved for a specific indication, produced under FDA-inspected manufacturing standards with batch-level consistency. Every dose is what the label says.

Compounded

Prepared by a state-licensed compounding pharmacy for an individual patient. Compounded formulations are not FDA-approved and have not been evaluated by the FDA for safety, efficacy or quality. Pharmacies are licensed and regulated, but the product itself does not carry FDA approval.

Why compounded formulations get used

• Availability — brand supply has been constrained at various points
• Cost — usually significantly lower
• Customisation — doses or combinations not available commercially
• Ingredient issues — avoiding a component a patient reacts to

What to ask before accepting one

1. Which pharmacy is compounding it, and in which state are they licensed?
2. Is it a 503A or 503B facility? 503B outsourcing facilities are subject to additional FDA oversight.
3. Is third-party potency and sterility testing performed?
4. What exactly is in it — is it the active ingredient alone, or combined with something else?

Any provider who cannot answer those four questions is not one you should be buying prescription medication from.