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.
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
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
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.
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
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.
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
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
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.
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