Compounded Medication: Questions to Ask Before Your Prescription Is Made

Compounding can meet an important patient-specific need, but it is different from receiving an FDA-approved manufactured drug. Ask clear questions so you understand why the prescription is compounded and how to use it.

Why is this prescription being compounded?

A prescriber may request a compounded preparation when an FDA-approved product does not meet a particular patient need, such as a needed strength or dosage form. Ask what problem the customized prescription is intended to solve.

Is there an FDA-approved option?

FDA explains that compounded drugs are not FDA-approved and therefore are not reviewed by FDA for safety, effectiveness or quality before marketing. That does not mean compounded medications have no role; it means patients should understand why compounding is being used in their case.

What is the dosage form and how should it be measured?

For liquids, creams, capsules or other customized forms, make sure you understand exactly how much to use and which measuring device is appropriate. Ask the pharmacist to clarify any direction that is not obvious.

How should it be stored?

Storage can vary by preparation. Ask whether the product needs refrigeration, protection from light, shaking, or another special step. Also ask what to do during travel or a power outage.

What should I check when I receive it?

Confirm your name, the preparation name or active ingredients, strength, directions and beyond-use information on the label. If the appearance changes unexpectedly or packaging is damaged, call before using it.

How will refills work?

Customized preparations may require lead time. Ask how early to request the next fill and whether a new prescription or prescriber communication will be needed.