# BPC-157 TB-500 Regulatory Status: FDA, WADA, and the Research-Chemical Channel

> BPC-157 TB-500 regulatory status: neither peptide is FDA-approved, both are prohibited by WADA, FDA placed both in 503A Category 2, and the blend moves through an unregulated channel where identity and purity are unverified.

The BPC-157 TB-500 regulatory status, read as a clearance ledger: neither constituent is an approved drug, both are on the WADA Prohibited List, both sit in FDA's 503A Category 2, and the blend ships through an unregulated channel.

## The clearance ledger: where BPC-157 TB-500 stands

The BPC-157 TB-500 regulatory status is best read as a clearance ledger with no green lights. Neither component is approved by the FDA for human use, and the blend has no approved therapeutic indication anywhere [15]. Both constituents are on the World Anti-Doping Agency Prohibited List. And FDA has identified both as bulk drug substances that may present significant safety risks, placing each in "Category 2" for pharmacy compounding under section 503A — a status detailed on the [Wolverine legal status and 503A compounding](/legal-status) page [16].

Because neither peptide is an approved medicine, the material moves through unregulated research-chemical and veterinary-context channels. In that channel, product identity, purity, and the actual BPC-157:TB-500 ratio are not verified outside formal studies — which is why a regulatory page and a handling caveat end up describing the same problem from two directions [6].

## WADA: both peptides are prohibited in sport

Both constituents of the blend are prohibited by the World Anti-Doping Agency. BPC-157 falls under the S0 non-approved-substances category — the catch-all for substances with no current approval for human therapeutic use by any government health authority. TB-500 / Thymosin Beta-4 falls under prohibited peptide, growth-factor, and tissue-repair categories [14]. The pairing is therefore banned in and out of competition for the relevant classes; combining them does not change either status.

The analytical infrastructure to enforce this is mature. Doping-control chemists synthesized and characterized the N-terminal acetylated 17-23 fragment of Thymosin Beta-4 — TB-500 itself — as a reference standard [15], and developed liquid-chromatography-mass-spectrometry methods to detect the parent peptide and its metabolites in equine plasma and urine at limits of detection around `0.01-0.02 ng/mL` [14]. Those studies also anchor TB-500's chemical identity as `Ac-LKKTETQ`, distinct from the full-length protein.

## FDA: not an approved drug, and flagged for compounding

Neither BPC-157 nor TB-500 is an FDA-approved drug. FDA approval of a finished drug is a separate question from whether a bulk substance may be used in compounding, and neither peptide clears either bar [16]. Under the Federal Food, Drug, and Cosmetic Act, a compounder may use a bulk drug substance only if it has an applicable USP/NF monograph, is a component of an FDA-approved drug, or appears on FDA's 503A bulks list [16].

FDA placed both BPC-157 and the Thymosin Beta-4 fragment (LKKTETQ, also known as TB-500) in Category 2 — bulk substances FDA identified as raising significant safety risks — effective with the September 29, 2023 update to the nominated-substances list [16]. Category 2 substances are not covered by FDA's enforcement-discretion policy for 503A compounding. The full mechanics of that status, and how legally compounded access works, are on the [Wolverine legal status and 503A compounding](/legal-status) page.

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A two-lane dispatch manifest on the BPC-157 and TB-500 record — every constituent finding logged to its study, every blend-level claim cleared as no-human-data, with no clinic behind the console and nothing here routed for sale.