The short answer
Letters in the Food and Drug Administration (FDA) record, checked in September 2026, identify a seller’s BPC-157 and TB-500 products as unapproved new drugs.
What that finding does and does not say
In the United States, BPC-157 has no FDA-approved medicine as of September 2026.
Its letters describe allegations about particular businesses, rather than rulings made by a court.
Ask about the exact preparation being proposed to you. Do not let a discussion about a name stand in for a discussion about the actual product.
A withdrawn request is not clearance
BPC-157 and TB-500 are listed under withdrawn compounding requests on an FDA page whose current-as-of date is April 22, 2026.
A withdrawn request means the group that asked for the ingredient to be considered took that request back.
Compounding means making a medicine to order.
As of September 2026, withdrawing a request does not give a pharmacy permission to use the ingredient.
A meeting headline is not a change in the rules
As of September 2026, an FDA advisory meeting had discussed both substances, but no FDA record of the committee’s votes was available.
An advisory committee offers advice; its vote alone cannot change the compounding list.
Ask which current rule supports the proposed preparation. A reference to a meeting or a withdrawn request leaves that question open.
Carry this forward
Check the preparation and the rule being cited, rather than relying on a familiar name.