Custom-made medicine: compare the reason and the route

Ask why the medicine would be made to order

• What need does it address?

  Compounding involves preparing or altering a medicine for an individual patient instead of using a factory’s finished product.

• Why does an approved product not fit?

  The Food and Drug Administration (FDA) says compounding may be appropriate if an approved medicine is unavailable or cannot meet a patient’s medical need.

• Which facility will make it?

  Ask for the full name before trying to check the records.

• What exactly will be supplied?

  Ask for the ingredient, whether it is a pill or an injection, and written information about the medicine.

Who makes the medicine, and where does the prescription fit?

When it meets the law’s conditions, a regular pharmacy may prepare a custom medicine for an identified patient who has a valid prescription.

An outsourcing facility is a place registered with FDA to make batches of medicines that must be free of living germs. It may supply batches without a separate prescription for each named patient. It need not be a licensed pharmacy.

Ask who will supply your own medicine and how your prescription will be handled.

Medicines free of living germs are called sterile.

FDA inspects registered outsourcing facilities, which must follow federal factory-quality rules.

State pharmacy boards, the bodies that license pharmacies, chiefly oversee ordinary pharmacies day to day.

What changes when a product is compounded?

The finished compounded product is not FDA-approved, and FDA does not check its benefits, harms or quality before it goes on sale.

Compounded products may also lack important directions that appear with approved products.

Ask the person writing your prescription and pharmacist to explain the product information and the follow-up plan.

A cheaper copy is not a complete explanation

Federal law limits a regular pharmacy from making copies of an available medicine as a routine business or in large amounts.

Whoever writes your prescription can identify a change with a meaningful medical effect for you. Price savings on their own do not qualify as that medical difference.

Neither semaglutide injections nor tirzepatide injections appeared on FDA’s national shortage list as of September 26, 2026.