A compounded medication may meet a medical need that an FDA-approved product cannot. It also has a different regulatory status: compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before marketing.[1]
Why this preparation?
FDA says compounded drugs should be used when a patient's medical needs cannot be met by an approved drug. Examples include removing an ingredient that causes an allergy or preparing a dosage form the patient can use.[1]
The prescriber should explain the relevant need. A lower price or an added ingredient does not, on its own, explain why an approved option is unsuitable.
What exactly is supplied?
Identify the active ingredient, dosage form, and concentration. The finished preparation matters even when its ingredient name is familiar.
A compounded drug is different from an FDA-approved generic. Research or approval associated with another product does not establish equivalence for the compounded one.[1]
Which pharmacy supplies it?
Check the pharmacy's name and state licensure. FDA's online-pharmacy guidance also recommends checking that it requires a prescription, has a U.S. address, and makes a licensed pharmacist available for questions.[2]
Keep those contact details with the label and instructions. The service handling the order may be a different organization from the pharmacy.
Are the instructions clear?
The preparation's storage, use, and relevant dates should be understandable. If the label, concentration, or supplied equipment is unfamiliar, clarify it with the prescriber or pharmacist before use.
FDA identifies contamination, incorrect amounts of active ingredient, and inadequate directions among the risks associated with compounded drugs.[3]
