When can you compound commercially available products?

• A. You can always compound
• B. Never compound
• C. You can’t unless there is a shortage
• D. Only with a patient consent on file

Answer: (C)

This question hinges on the regulatory boundary between compounding and manufacturing. Compounding is meant to prepare medications tailored to an individual patient’s prescription, not to routinely produce drugs that are already available commercially. Because of that, you’re generally not allowed to compound a commercially available product unless there is a shortage or unavailability of the drug in the needed form, strength, or route of administration. In shortage situations, compounding may be permitted under proper oversight, documentation, and adherence to applicable standards and laws. Merely having patient consent on file does not authorize compounding a drug that is readily available; the shortage or unavailability must exist for compounding to be appropriate.