A Brooklyn care briefing
Compounded medicines lack FDA approval
Compounded describes a medicine made specially to order. A doctor, pharmacist or registered drug-making facility prepares it in place of a finished product supplied by a drug company. [a]
These medicines do not have approval from FDA, the US medicine agency. This approval information was checked on September 26, 2026. [a]
What is being prepared?
FDA says compounding may help when ready-made approved medicines cannot meet a patient’s medical need. It may also be an option when the approved product is not available to buy. [a]
- What need would this preparation meet?
- Why would an approved product not meet it?
- Which pharmacy or facility would make it?
What has not been reviewed?
Before sale, the compounded product has not gone through FDA’s review of whether it works, its quality or its safety. [a]
- Custom is not a substitute for that review.
- Ask how the preparation is meant to address something specific about your care.
Why a cheaper copy needs another question
Federal rules limit making medicines to order that are near copies of ready-made medicines already available. Copying rules checked: September 26, 2026. [b]
For a regular compounding pharmacy, the prescriber decides whether the proposed change makes a significant difference for that named patient. A medicine changed in that way is not treated as a copy under this rule. [b]
A lower price alone does not count as that significant difference for the patient.
The shortage list matters because a national shortage can allow certain compounding that would otherwise be restricted. [b]
The national shortage list held by FDA contained no listing for semaglutide injections or tirzepatide injections on September 26, 2026. [c]
- What change would be made to the medicine, and why would it matter for my medical need?
- Keep the price comparison separate from the explanation of why it can be compounded.