Approval and a withdrawn request are different matters.

The US approval answer

As recorded on September 30, 2026, TB-500 had no FDA approval for treating any condition in the United States.

Using an approved medicine for a purpose its official instructions do not list is called off-label use. TB-500 is different: there is no FDA-approved TB-500 medicine or official product label to start from.

What the withdrawn request means

The FDA ingredient page marked current April 22, 2026 lists TB-500 among requests that were taken back. Someone had asked the FDA to consider letting pharmacies use TB-500 as a raw ingredient, then took that request back.

Taking the request back gave no approval or permission to use TB-500. The FDA still shows its safety concerns beside the entry. The page does not say when TB-500 moved from the safety-risk list to the list of requests taken back. That move did not give pharmacies new permission to use it.

The committee did not rewrite the rule

FDA staff proposed against adding TB-500 to the pharmacy ingredient list in July 2026. By the September 30, 2026 check, the FDA had posted no record of the advisory committee’s votes.

An advisory committee gives advice. The rules checked September 26, 2026 require more than a committee vote to change the ingredient list. For an ingredient-list change, the FDA has to publish its proposal, then allow comments from the public.

A headline about a meeting, a table change or a request can sound decisive. Read what the record actually changes and what it leaves in place. Keep the date beside any answer you receive.