regulatory landscape

FDA category status, WADA prohibited list, compounding pharmacy rules, and international legal frameworks

Legal Gray Zones

TB-500 is not FDA-approved, sits on the FDA's "do not compound" list, and has been WADA-prohibited under S2 since 2013. It is still unscheduled in most countries and sold openly as a "research chemical."

The 2023 FDA compounding decision pushed quality-tested supervised use off the table. LC-MS/MS detection keeps improving, with TB4 metabolites trackable for days after the last dose.

2013

added to WADA S2

Cat 2

FDA compounding placement (2021)

FDA-approved human indications

4 yr

longest doping ban on record

legal warning: Not approved for human use anywhere. Possession or administration outside research settings can carry civil or criminal penalties depending on jurisdiction.

where can you actually get it?

click any jurisdiction for its current status.

regulatory status by jurisdiction

Compare the Agencies

FDA, WADA, DEA, and import rules side by side.

regulatory status comparison

Knowledge Check

Test what you've learned in this unit.

Practice Exercises

Reinforce your understanding.