What is a pharmacy-made medicine?

Compounded: made to meet a need

Compounding means making or changing a medicine for a patient’s need. It is done in a pharmacy or another place allowed by law to make it. The result is called a compounded medicine.

FDA (the U.S. drug agency) says this may help when approved medicine cannot meet a patient’s need, for example because the patient is allergic to an added dye.

FDA review: what was checked?

The finished compounded medicine has no FDA approval.

Before a compounded medicine reaches the market, FDA does not review how safe it is, its quality or whether it works.

Compounding can meet a real need, but it must satisfy the rules that apply to that product.

Copy: cheaper is not the whole test

Federal law limits making copies of medicines that are already available to buy. A pharmacy cannot make nearly the same medicine routinely or in large amounts just to offer another version.

The prescriber may judge a change to be important for the care of one particular patient. Under the pharmacy rule, such a changed medicine is not treated as a copy. A cheaper price by itself is not that kind of change.

For example, FDA describes a patient needing a medicine that omits a dye because of an allergy to that dye.

At the September check, semaglutide and tirzepatide injections were off FDA’s national shortage list.

An empty shelf at a local pharmacy is not enough for FDA to list a medicine as being in shortage nationwide.

A useful question for the visit

Ask, “Why do I need this pharmacy-made medicine instead of an approved medicine?”

Then ask who would make it. Ask the prescriber to explain which rule allows that medicine for your need.