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Source check

Approval and records

# Check the claim at its source.

Being on a government list does not mean a medicine is approved. Ask to see the record behind the claim, check that it names the exact medicine and read its date.

Question to carry

Match the record to the exact product and form.

## Terms to start with

FDA means Food and Drug Administration, the US body that reviews medicines.

NDC stands for National Drug Code. It is a product listing code, not proof of FDA approval.

A clinician is a health professional who reviews your concern and talks through care with you.

Compounding is the preparation of a medicine to order by a pharmacist or doctor.

An FDA-registered medicine-making site can also prepare batches, often for clinics and hospitals.

## A closer look at the words

A listing puts a product in a record. It does not establish approval of that medicine. Ask which record the claim relies on.

Read the offer

## A listing is not an approval

As of September 2026, FDA says an NDC number does not establish approval of the product. [FDA on National Drug Code listings](https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)

As of September 2026, putting a medicine-making site on FDA’s register, or a medicine on its product list, does not give the medicine FDA approval or permission to sell it. [The federal rule on registration](https://www.ecfr.gov/current/title-21/section-207.77)

Ask what is recorded: a product name, a place that makes medicine or approval of a medicine. If the seller claims approval, request the approval record for that exact product.

Match the record to the exact product and form.

Read what the record does and does not establish.

Look more closely

## A discussion does not change the rule

As of September 2026, advice from FDA’s compounding committee does not itself change the permitted-ingredient list; FDA must use a formal rulemaking process. [FDA’s explanation of the ingredient list](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Rulemaking is the formal process for changing a rule, including public comment. A headline about a meeting cannot take the place of the resulting rule.

Ask for the current rule or product record behind a claim. If the reply is only a meeting headline, ask again for the rule before paying.

Ask for the current rule behind a status claim.

Distinguish a proposal from a completed change.

Carry this forward

## Read an FDA letter and later updates

FDA publishes warning letters that describe problems it says a company needs to address. FDA says the situation may change after it and the company exchange more information. [Search FDA’s published letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

A warning letter states FDA’s concerns at that date; it is not a final decision. A company without a letter may simply never have been reviewed. [Read FDA’s context for its letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

For a care decision, return to the license record, the exact product and the clinician’s explanation. Keep the date with any status claim you save.

Read the whole dated record, not a cropped passage.

Ask whether there is a later decision or update.

Keep in mind

## The chapter recap

Use each record for the question it answers. A listing, a registration, a meeting and an approval are different records.

[Check the full cost](/cost-checklist/)

These pages help you weigh care; this guide runs no clinic and sells no medicine.

[Text version](/source-check/index.md)