# Wolverine Legal Status, FDA 503A Category & Compounding Access | BPC-157 TB-500

> Wolverine legal status: BPC-157 TB-500 both sit in FDA's 503A Category 2 and are on the July 23-24, 2026 PCAC agenda as bulks-list candidates. Access is under active FDA review and may expand in 2026.

Both BPC-157 and TB-500 currently sit in FDA's 503A Category 2 — and both are on the FDA Pharmacy Compounding Advisory Committee's July 23-24, 2026 agenda as bulks-list candidates. The register is open; the outcome is not decided.

## Wolverine legal status: where the two records stand today

Wolverine legal status is a status story, and the momentum is forward. Access to compounded BPC-157 TB-500 is under active FDA review, and it may expand in 2026 — because the FDA Pharmacy Compounding Advisory Committee (PCAC) has a meeting scheduled for July 23-24, 2026 at which both of the blend's components are listed as bulk drug substances being considered for inclusion on the 503A Bulks List [12]. That is the live development worth leading with.

The present-tense fact underneath it is narrower. Today, both constituents of the Wolverine blend are research peptides in FDA's 503A "Category 2" — bulk substances that FDA has identified as potentially presenting significant safety risks — effective with the September 29, 2023 update to the nominated-substances list [10][11]. Category 2 substances are not covered by FDA's enforcement-discretion policy for 503A compounding, so compounding-pharmacy access is currently restricted [10]. Neither peptide is an FDA-approved drug, and the blend has no approved therapeutic indication.

Both things are true at once: the current classification restricts routine compounding, and that classification is precisely what is under scheduled review. Nothing here predicts the meeting's outcome. A PCAC discussion is advisory — a step in evaluation, not a final listing decision [12].

## What FDA 503A Category 2 means for BPC-157 and TB-500

Under the Federal Food, Drug, and Cosmetic Act, compounding runs through two sections. Section 503A covers traditional, patient-specific compounding by state-licensed pharmacies and physicians, generally pursuant to a valid prescription for an individual patient. Section 503B covers FDA-registered "outsourcing facilities" that compound larger batches under cGMP-style oversight [10]. 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; otherwise it must be nominated and evaluated by FDA, with input from PCAC [10].

FDA's interim policy sorted nominated substances into categories. Category 1 substances "may be eligible" for the bulks list and are covered by FDA's enforcement-discretion policy while under evaluation. Category 2 substances were nominated with enough information to evaluate but were identified by FDA as raising significant safety risks — and FDA stated it would consider taking action against a compounder for compounding with a Category 2 substance [10]. Both BPC-157 and TB-500 are in Category 2, with FDA citing concerns including potential immunogenicity for certain routes of administration and complexities with peptide-related impurities and active-ingredient characterization [11].

Inclusion on a final 503A bulks list is decided by FDA rulemaking informed by PCAC. Being discussed by PCAC is a step in that evaluation — not a final listing decision, and not a change in current status [12].

## Both components are on the July 23-24, 2026 PCAC agenda

There is no component carve-out in the Wolverine blend. Both records are under the same scheduled review. FDA's public advisory-committee calendar lists the BPC-157 entries ("BPC-157 (free base)" / "BPC-157 acetate") and the TB-500 entries ("TB-500 (free base)" / "TB-500 acetate") among the bulk drug substances being considered for inclusion on the 503A Bulks List at the July 23-24, 2026 PCAC meeting [12].

FDA's own Category 2 list also establishes the identity of the second record: it names the entry "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" — the same `Ac-LKKTETQ` heptapeptide that is one of the two peptides in this blend [11]. So both BPC-157 and TB-500 (the thymosin beta-4 fragment, LKKTETQ) are currently Category 2, and both are on this one scheduled agenda as bulks-list candidates.

What the agenda does not do is decide anything. The outcome of the July 2026 meeting is unknown; FDA's calendar confirms only that these substances are scheduled for discussion as candidates [12]. No reclassification has occurred, none is dated, and none is certain.

## How legally compounded peptide access works

Independent of any single substance's status, the lawful pathway for a compounded medication in the U.S. is well defined. A patient is first evaluated by an appropriately licensed prescriber — in person or through a compliant telehealth encounter — who determines whether a compounded preparation is clinically appropriate [13]. Telehealth is one channel for that prescriber-evaluation step; it is a route to a licensed-prescriber consultation, not a separate legal status, and it does not change which substances may be compounded [13].

If a compounded preparation is appropriate and lawful, the prescriber issues a valid, patient-specific prescription. The preparation is then made by a state-licensed 503A compounding pharmacy (patient-specific) or, for larger volumes, an FDA-registered 503B outsourcing facility [13].

The ingredient-eligibility caveat is the gate. A compounder may use a requested active ingredient only if it is eligible under the 503A/503B bulk-substance rules — and ingredients FDA has flagged for significant safety risks are not eligible for routine 503A compounding while that status stands [13]. That is the current position for both BPC-157 and TB-500. This page is general information about the regulatory landscape, not medical or legal advice, and not an offer to supply any substance.

## WADA status of both constituents

Outside the compounding question, both constituents are prohibited in sport. The World Anti-Doping Agency lists BPC-157 under its S0 non-approved-substances category, and TB-500 / Thymosin Beta-4 falls under prohibited peptide, growth-factor, and tissue-repair categories. For athletes subject to anti-doping rules, the blend is banned in and out of competition for the relevant classes. This is a status fact, not a recommendation; the page does not advise on use.

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Two peptides logged as two records on one console — BPC-157 and TB-500 each weighed against its own studies and its 503A status, the combination row left reading NO-HUMAN-DATA, with no clinic behind the panel and nothing here dispensed.