Check the claim
Is TB-500 approved in the United States?
Check FDA approval and pharmacy ingredient rules before treating an online offer as permission to use TB-500.
In the US, medicines are reviewed by the Food and Drug Administration, known as the FDA.
Read the permission records
The approval answer
Approval concerns a specific medicine and use. A product name alone is no proof of it.
- As of September 2026, no TB-500 medicine has FDA approval for any use in the United States.
- On the FDA page dated April 22, 2026, TB-500 appears under requests that were taken back. The group that asked the FDA to let pharmacies use TB-500 as an ingredient withdrew its request.
- Taking that request back did not give FDA approval or let pharmacies make TB-500 medicines to order, as of September 2026.
A meeting did not create approval
An advisory committee gives advice to the FDA. It does not change the ingredient list by itself.
- For the July 2026 committee meeting, FDA staff proposed keeping TB-500 off the list of extra ingredients pharmacies may use.
- The FDA had not posted an official record of the committee's votes as of September 30, 2026.
- As of September 2026, the FDA must propose a rule, invite public comments, and publish a final rule to change that ingredient list. A committee vote alone does not change it.
Notes for this chapter
What an online offer proves
Availability on a page does not answer the approval question.
- In a June 2023 warning letter, the FDA alleged that a seller's TB-500 injections and nasal sprays were unapproved drugs sold in violation of federal law.
- Ask for the source document behind any claim that the status has changed.
- Check the date and distinguish a proposal from a completed decision.