TB-500 FDA & Regulatory Status (2026)
Published reporting only; not an independently verified live regulatory determination. Sources and review dates are shown for each field.
Author: Chad E. · Last reviewed: 2026-10-17
- FDA compounding category
- Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post
Reviewed: 2026-10-17 - PCAC review and vote
- July 23, 2026: recommended for inclusion, 8–6. The vote is advisory. Source post
Reviewed: 2026-10-17 - 503A bulks list status
- The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post
Reviewed: 2026-10-17 - FDA-approved drug
- Not yet reviewed
- WADA status
- Not yet reviewed
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Sourced questions
What FDA category is TB-500 in?
Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement.
What did the PCAC vote on TB-500?
July 23, 2026: recommended for inclusion, 8–6. The vote is advisory.
Is TB-500 on the 503A bulks list?
The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition.
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