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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. [\[a\]](#source-a)

These medicines do not have approval from FDA, the US medicine agency. This approval information was checked on September 26, 2026. [\[a\]](#source-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. [\[a\]](#source-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. [\[a\]](#source-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. [\[b\]](#source-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. [\[b\]](#source-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. [\[b\]](#source-b)

The national shortage list held by FDA contained no listing for semaglutide injections or tirzepatide injections on September 26, 2026. [\[c\]](#source-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.

## The records behind the compounding questions

<a id="source-a"></a>

[a] [FDA’s compounding questions and answers](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)

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[b] [FDA’s account of the copying rules](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)

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[c] [The federal drug-shortage records](https://www.accessdata.fda.gov/scripts/drugshortages/)

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