# Wolverine Legal Status, FDA 503A Category, and Compounding Access (BPC-157 TB-500) > Wolverine legal status, plainly: BPC-157 TB-500 components are FDA 503A Category 2 bulk substances today, and both are on the scheduled July 23-24, 2026 PCAC agenda as candidates under active review. General information, cited to FDA. Both of the blend's components are under active FDA review, with a Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026 — and both currently sit in 503A Category 2. Here is exactly where the record stands, cited to FDA. ## What the Wolverine legal status is, right now The momentum is real: access to the Wolverine blend's component peptides is under active FDA review and may expand in 2026, anchored on a concrete, scheduled event — an FDA Pharmacy Compounding Advisory Committee (PCAC) meeting is scheduled for July 23-24, 2026 to discuss these peptides as candidates for the Section 503A bulks list [14]. That is the forward-looking fact, and it is a scheduled discussion, not a decision. The Wolverine legal status today is precise. The blend is not a single regulated entity; its legal standing is the standing of its two components, BPC-157 and TB-500. Neither is an FDA-approved drug, and the assembled blend has no approved therapeutic indication anywhere. Both components are currently classified by the FDA as 503A 'Category 2' bulk drug substances — substances FDA identified as potentially presenting significant safety risks — effective with the September 29, 2023 update to the list of nominated substances [12][13]. Because they are Category 2, they are not within FDA's enforcement-discretion policy for 503A compounding, which means compounding-pharmacy access for these substances is currently restricted [11]. ## FDA 503A Category 2: what it means and why it applies The Federal Food, Drug, and Cosmetic Act governs drug compounding 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 may compound larger batches under cGMP-style oversight. 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 the relevant FDA bulk drug substances list [11]. Under FDA's interim policy, nominated substances were sorted into categories. Category 1 substances may be eligible for the bulks list and are covered by enforcement discretion while FDA evaluates them. Category 2 substances are those FDA identified as raising significant safety risks; they are not afforded that discretion, and FDA has stated it would consider taking action against a compounder for compounding with a Category 2 substance [11]. FDA placed both BPC-157 ('BPC-157 (free base)' and 'BPC-157 acetate') and 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' in Category 2, citing concerns including potential immunogenicity for certain routes of administration and complexities with peptide-related impurities and active-ingredient characterization [12][13]. FDA's own list entry establishes the relationship between the names: TB-500 is the LKKTETQ fragment associated with Thymosin Beta-4 [13]. ## Active review: the scheduled July 2026 PCAC meeting What is genuinely in motion is an evaluation, not a reclassification. FDA's public advisory-committee calendar lists a Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026 [14]. Both of Wolverine's components are on that agenda. 'BPC-157 (free base)' and 'BPC-157 acetate' appear as substances being considered for inclusion on the 503A bulks list; 'TB-500 (free base)' and 'TB-500 acetate' — the thymosin beta-4 fragment LKKTETQ — appear on the same agenda as candidates being considered for the same list [12][13][14]. There is no component carve-out. Both legs of the blend are currently Category 2, and both are under this one scheduled review at the same meeting. A PCAC discussion is advisory and is a step in evaluation, not a final FDA decision; being discussed by PCAC is not the same as being listed [11]. No outcome of the July 2026 meeting should be assumed, and none is stated here — only that the review is scheduled and that both components are on its agenda. Whether access expands, and on what terms, is a matter the meeting will inform, not one it has resolved. ## How legally compounded peptide access works In the United States, a legally compounded medication is prepared only after an individual patient is evaluated by an appropriately licensed prescriber who determines a compounded preparation is clinically appropriate and issues a valid, patient-specific prescription [11]. The preparation is then made either by a state-licensed 503A compounding pharmacy (patient-specific) or, for larger volumes, by an FDA-registered 503B outsourcing facility. Telehealth can serve as the front-end channel for that prescriber evaluation — a route to a licensed-prescriber consultation and prescription [11]. It does not change which substances are eligible to be compounded, and it does not remove the need for a legitimate clinical evaluation and a valid prescription. One ingredient-eligibility caveat governs the whole pathway: the compounder may use a requested active ingredient only if that ingredient is eligible under the 503A/503B bulk-substance rules. Substances FDA has flagged for significant safety risks — which is where BPC-157 and TB-500 currently sit — are not eligible for routine 503A compounding while that status stands [11][12][13]. This is general information about the regulatory landscape, not medical or legal advice, and not an offer to sell or supply any substance. ## WADA prohibition and the access record in brief Beyond the compounding question, both constituents are prohibited in sport. The World Anti-Doping Agency prohibits BPC-157 under its S0 non-approved-substances category, and TB-500 / Thymosin Beta-4 under prohibited peptide and growth-factor categories — in and out of competition for the relevant classes. The access record, then, reads consistently across every source: no FDA drug approval for either component, both currently in 503A Category 2 with compounding access restricted, both under one scheduled PCAC review in July 2026, and both WADA-prohibited. For the safety questions that sit alongside this record, see the [WADA prohibition status and compounding access](/legal-status) points above and the regulatory items in the FAQ. --- A bento board of the BPC-157 TB-500 record — each peptide read against its own studies in its own cell, the join between them left empty because no combination trial exists, and the FDA 503A status set in its own panel; no clinic behind the grid and nothing here dispensed.