Why would medicine be made to order?
Through compounding, medicine is made for one patient rather than supplied as a ready-made drug product.
The US Food and Drug Administration, known as FDA, explains that compounding can meet a patient’s medical need when an approved medicine cannot.
Its consumer explanation gives two examples: a patient with a dye allergy, or one unable to swallow a tablet.
Has FDA checked that finished medicine?
As of September 2026, compounded medicines did not have FDA approval. FDA does not evaluate these medicines for safety, effectiveness or quality before they go on sale.
A licence tells you the pharmacy is allowed to operate. Drug approval tells you about the medicine, so check both.
Who checks the place making my medicine?
For an ordinary pharmacy that makes medicine to order, the state pharmacy board is the main body checking its work. For a place registered with FDA to make batches of these medicines, FDA is the main body checking its work.
That second kind of place is called an outsourcing facility. The medicines it makes in batches are sterile: they have no living germs.
As of September 2026, registering such a facility does not mean FDA has approved it or its products.
Can a cheaper copy be made on request?
As of September 2026, US law limits how often a pharmacy can make copies of ready-made medicines and how much it can make.
The person prescribing must judge whether the medicine’s proposed change would make an important difference to you. A cheaper price by itself does not satisfy this requirement.
An allergy to a dye or trouble swallowing a tablet are examples of needs that medicine made to order may address.
Ask the prescriber to explain the change you need and why it matters in your case.
Can a drug shortage allow pharmacies to make copies?
A national shortage can allow pharmacies to make copies under the shortage rules.
Semaglutide and tirzepatide are ingredients in medicines used for diabetes or weight loss, such as Ozempic (semaglutide) and Zepbound (tirzepatide).
As of September 2026, injections with those ingredients were absent from FDA’s national shortage list.
One pharmacy running out of stock does not amount to a national shortage listing.
Where to read more
- FDA: the compounding questions
Explains why a patient may need medicine made to order, who checks the pharmacy and why FDA does not check the finished medicine before sale.
- FDA: copies after the shortages
Explains why a past drug shortage does not keep allowing pharmacies to make copies after it ends.
Plain word notes
- Telehealth
Care that takes place by video, phone or an online form.
- Compounding
A medicine prepared to order for an individual patient.