What does “compounded” mean for your care?

A custom medicine needs a reason

A ready-made medicine may not meet a patient’s need. For example, it may contain a dye that causes an allergy. A medicine made to order may leave out that dye. A

A compounding pharmacy may legally prepare medicine on a valid prescription naming the patient under the rules as of September 26, 2026. It must also meet the other rules for making that medicine. B

Those rules limit the ingredients it may use and when it may copy ready-made medicines. A prescription alone does not settle those checks. C

A custom order gives no FDA approval

The federal agency reviewing medicines is the Food and Drug Administration (FDA).

As of September 26, 2026, custom-made compounded medicines have no FDA approval. Before patients get them, the agency does not check their quality, whether they work or what harm they may cause. D

Careful work by a pharmacy does not give its medicine FDA approval. D

Ask which kind of place makes the medicine

As of October 6, 2026, Arizona has separate rules for two kinds of medicine maker. One is a pharmacy filling prescriptions for named patients. The other holds a permit to make drugs as a manufacturer. E

The first kind is called a 503A pharmacy. The second is called a 503B outsourcing facility, a place that makes batches. It follows factory quality rules. F

The batch-making facility may make medicine without a prescription naming you. Ask which kind of maker will supply your medicine. G

Arizona may allow a pharmacy to make medicine before an order arrives. Its past work and judgment must support expecting that order. E

It must keep clear labels and store the medicine to protect its quality until supplying it to a named patient. Rules for ingredients and written records still apply. E

Sterile means free from living germs. Making sterile medicine needs extra care with the workspace and equipment. H

Ask about the ingredient as well as the order

Federal rules restrict a compounding pharmacy’s choice of raw ingredients as of September 26, 2026. I

Have the pharmacist name the rule permitting the specific ingredient your medicine contains.

A state permit does not allow every ingredient or product. E