# Wolverine Legal Status: BPC-157 TB-500 FDA 503A Category and Access > Wolverine legal status for the BPC-157 TB-500 blend: both components are FDA Category 2 bulk substances, currently restricted for 503A compounding, and under active FDA review at a July 2026 PCAC meeting. General information, cited to FDA. Access is under active FDA review and may expand in 2026 — but as of today both of Wolverine's components sit in FDA Category 2, and compounding-pharmacy access is restricted. General information, not medical or legal advice. ## Access is under active review — and that is the lead The most movement on Wolverine legal status in years is happening right now. Both of the blend's components — BPC-157 and TB-500, the thymosin beta-4 fragment LKKTETQ — are on the published agenda of an FDA Pharmacy Compounding Advisory Committee (PCAC) meeting scheduled for July 23-24, 2026, listed as bulk drug substances "being considered for inclusion on the 503A Bulks List" [15]. Access to legally compounded peptide preparations could expand depending on how that review unfolds. That is the forward-leaning part, and it has to be read with a hard boundary around it. A PCAC discussion is a scheduled step in evaluation, not a decision and not a reclassification — it is advisory, and inclusion on a final 503A bulks list is decided by separate FDA rulemaking under the agency's interim compounding policy [13][14][15]. No outcome of the July 2026 meeting should be assumed, and no date should be attached to a predicted result. What can be stated today is the present-tense status, which is the next section. ## The current FDA status: Category 2, restricted As of today, both of Wolverine's components are FDA Category 2 bulk drug substances, and compounding-pharmacy access is restricted. This is the present-tense fact, and it is the one that governs [12]. The U.S. Federal Food, Drug, and Cosmetic Act governs compounding through two sections. Section 503A covers traditional, patient-specific compounding by state-licensed pharmacies and physicians, pursuant to a valid prescription for an individual patient. Section 503B covers FDA-registered "outsourcing facilities" that compound larger batches under cGMP-style oversight [13]. 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 bulks list; otherwise the substance must be nominated and evaluated by FDA [13]. Under FDA's interim policy, Category 2 bulk drug substances are those nominated with sufficient information to evaluate but that FDA has identified as raising significant safety risks. Category 2 substances are not covered by the enforcement-discretion policy that applies to Category 1, and FDA stated it would consider taking action against a compounder for compounding with a Category 2 substance [13]. - BPC-157 was identified by FDA as a bulk drug substance that may present significant safety risks and placed in Category 2 for 503A compounding, effective with the September 29, 2023 update to the nominated-substances list, citing concerns including potential immunogenicity for certain routes of administration and complexities with peptide-related impurities and active-ingredient characterization [12]. - TB-500 is listed by FDA as "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" — the thymosin beta-4 fragment that is the TB-500 leg of this blend — and was likewise placed in Category 2, effective with the September 29, 2023 update, citing potential immunogenicity for certain routes and a lack of important safety information [12]. Neither component is an FDA-approved drug, and the blend has no approved therapeutic indication [12]. There is no component carve-out: both BPC-157 and TB-500 are currently Category 2, and both are under the single scheduled July 23-24, 2026 review [12][15]. ## How legally compounded peptide access works Legally compounded access in the U.S. follows a defined pathway, and it is worth describing in general terms because it is the framework any future change would operate within. A compounded medication is prepared only after an individual patient is evaluated by a licensed prescriber who determines a compounded preparation is appropriate and issues a valid, patient-specific prescription. The preparation is then made by a state-licensed 503A compounding pharmacy or, for larger volumes, an FDA-registered 503B outsourcing facility [13]. The steps, in order: a patient is evaluated by an appropriately licensed prescriber, in person or through a compliant telehealth encounter; if appropriate and lawful, the prescriber issues a valid prescription; the prescription is dispensed by a 503A pharmacy or sourced from a 503B facility [13]. Telehealth is one channel for the prescriber-evaluation step that begins this pathway — a route to a licensed-prescriber consultation, not a separate legal status. It does not expand which substances may be compounded, and it does not remove the need for a legitimate clinical evaluation and a valid prescription [13]. The binding caveat is ingredient eligibility. A compounder may lawfully use a requested active ingredient only if that ingredient is eligible under the 503A/503B bulk-substance rules. Ingredients FDA has flagged for significant safety risks — which currently includes both of Wolverine's components — are not eligible for routine 503A compounding while that status stands [13]. This page describes the regulatory landscape in general terms. It is not medical or legal advice, names no pharmacy, clinic, or provider, and gives no dosing or administration instructions. ## WADA status and the regulatory FAQ Both constituents are also prohibited in sport by the World Anti-Doping Agency: BPC-157 under the S0 non-approved-substances category, and TB-500 / thymosin beta-4 under prohibited peptide and growth-factor categories [11]. The blend is banned in and out of competition for the relevant classes. ### Is Wolverine legal? The Wolverine blend is not an approved product, and its two components are FDA Category 2 bulk substances currently restricted for routine 503A pharmacy compounding [12]. Neither BPC-157 nor TB-500 is an FDA-approved drug, and both are prohibited in sport by WADA [11][12]. Both components are on the agenda of a July 23-24, 2026 FDA PCAC meeting as candidates for the 503A bulks list — a scheduled review, not a change in current status [15]. ### Can you get BPC-157 from a compounding pharmacy? As of today, BPC-157 is an FDA Category 2 bulk drug substance, which means it is not within FDA's enforcement-discretion policy for routine 503A compounding while that status stands [12][13]. Legally compounded access generally requires a licensed-prescriber evaluation and a valid, patient-specific prescription filled by a 503A pharmacy or 503B facility — but only for ingredients eligible under the bulk-substance rules, which BPC-157 currently is not [13]. BPC-157 is on the July 2026 PCAC agenda for evaluation [15]. ### What is the FDA 503A status of Wolverine? Wolverine has no status of its own — it is a two-peptide blend, not a single substance — but both of its components are FDA Category 2 for 503A compounding, effective with the September 29, 2023 update to the nominated-substances list, on safety-risk grounds [12]. Category 2 substances are not covered by FDA's enforcement-discretion policy [13]. Both BPC-157 and TB-500 appear on the July 23-24, 2026 PCAC agenda as substances being considered for inclusion on the 503A bulks list — a scheduled evaluation, not a listing decision [15]. ### Are BPC-157 and TB-500 FDA approved or banned by WADA? Neither is FDA-approved for human use, and the blend has no approved therapeutic indication. In 2023 FDA placed BPC-157 in Category 2 — bulk drug substances not eligible for routine 503A compounding pending further evaluation — and the thymosin beta-4 fragment (LKKTETQ) known as TB-500 was placed in Category 2 in the same update [12]. Both constituents are prohibited by WADA: BPC-157 under S0, and TB-500 / thymosin beta-4 under prohibited peptide and growth-factor categories [11]. --- Two peptides set on one studio table and shown straight — BPC-157 and TB-500 lit specimen by specimen, the Thymosin Beta-4 tumor signal and the 503A status left in plain view, with no clinic behind the lens and nothing here dispensed.