# Wolverine Legal Status: FDA 503A Category and Compounding Access for BPC-157 TB-500 > Wolverine legal status, FDA 503A category, and compounding access for BPC-157 TB-500: both constituents are Category 2 today and both are on the FDA's July 2026 PCAC agenda under review. Access is under active FDA review and may expand in 2026 — anchored on a scheduled PCAC meeting, not a decision. As it stands today, both constituents are FDA 503A Category 2. ## Where Wolverine legal status stands today The Wolverine legal status question turns on the FDA 503A category of its two constituents, and the near-term story is one of momentum. Access to compounded BPC-157 TB-500 is under active FDA review and may expand in 2026 — both constituents are on the published agenda of a Pharmacy Compounding Advisory Committee (PCAC) meeting scheduled for July 23-24, 2026, where they are listed as bulk drug substances "being considered for inclusion on the 503A Bulks List" [10]. That is a scheduled evaluation, a real step in the pathway — not a listing decision, not a reclassification, and not an outcome with a date. As the record stands today, both BPC-157 and "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" are in FDA's Category 2 for 503A compounding, effective with the September 29, 2023 update to FDA's list of nominated bulk drug substances [11]. Category 2 means FDA identified each as a bulk drug substance that may present significant safety risks — citing concerns including potential immunogenicity for certain routes of administration and, for BPC-157, complexities with peptide-related impurities and active-ingredient characterization [11]. Category 2 substances are not within FDA's enforcement-discretion policy for 503A compounding, so compounding-pharmacy access to these ingredients is currently restricted [11][12]. Neither constituent is an FDA-approved drug, and the blend has no approved indication [11]. This is general information about the regulatory landscape, not medical or legal advice. ## Why "503A Category 2" matters Under the U.S. Federal Food, Drug, and Cosmetic Act, drug compounding runs through two sections. Section 503A covers traditional, patient-specific compounding by state-licensed pharmacies, federal facilities and licensed 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 [12]. A compounder may use a bulk drug substance — an active ingredient used as a starting material rather than a finished approved drug — only if that substance has an applicable USP/NF monograph, is a component of an FDA-approved drug, or appears on the relevant FDA bulks list [12]. 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 evaluation continues; Category 2 substances were identified as raising significant safety risks and are not covered by that policy, meaning FDA stated it would consider taking action against a compounder for compounding with them [12]. On January 7, 2025, FDA finalized a revised interim policy under which it no longer places newly nominated substances into these numbered categories; substances already in Category 1 may continue within the interim enforcement-discretion policy, while FDA has stated Category 2 substances are not afforded that discretion even if nominations are updated [12]. Both Wolverine constituents sit in Category 2 today [11]. ## Both constituents are on the FDA's July 2026 review agenda There is no component carve-out in the Wolverine blend's regulatory status: both BPC-157 and TB-500 are currently Category 2, and both fall under the same scheduled review. FDA's public calendar lists BPC-157 (the entries "BPC-157 (free base)" / "BPC-157 acetate") and TB-500 ("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 [10][11]. Inclusion on a final bulks list is decided by FDA rulemaking informed by PCAC; being discussed by the committee is a step in evaluation, not a final listing decision, and no outcome should be assumed or dated [12][10]. What this means for the blend: the same single scheduled review covers both legs of the pairing. A reader watching the access picture for BPC-157 TB-500 is watching one meeting and two agenda entries — and watching a process that is, by FDA's own calendar, ongoing rather than resolved [10]. ## How legally compounded peptide access works Separately from any future decision, the lawful pathway for a compounded medication in the U.S. is well-defined and worth understanding in general terms. A legally compounded preparation is made only after an individual patient is evaluated by an appropriately licensed prescriber who determines that a compounded preparation is clinically appropriate, and who then issues a valid, patient-specific prescription [12]. The preparation is dispensed by a state-licensed 503A compounding pharmacy (patient-specific) or, for office or batch use, sourced from an FDA-registered 503B outsourcing facility [12]. Telehealth can serve as the front-end channel for that prescriber evaluation, in person or through a compliant telehealth encounter — but it is a route to a licensed-prescriber consultation, not a separate legal status [12]. Telehealth does not expand which substances may be compounded and does not remove the need for a legitimate clinical evaluation and a valid prescription [12]. And the ingredient-eligibility caveat governs the whole pathway: a compounder may use a requested active ingredient only if that ingredient is eligible under the 503A/503B bulk-substance rules, so an ingredient FDA has flagged for significant safety risks is not eligible for routine 503A compounding while that status stands [12]. That caveat is exactly what applies to both Wolverine constituents today [11]. This page names no specific pharmacy, clinic, telehealth provider or vendor, gives no dosing, and describes the lawful framework only — not any way to obtain a restricted substance outside it. ## Access and safety FAQs #### 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 indication [11]. Both are prohibited by WADA — BPC-157 under the S0 non-approved-substances category and TB-500 / Thymosin Beta-4 under prohibited peptide and tissue-repair categories [5]. As it stands today, FDA placed both constituents in Category 2 for 503A compounding (effective September 29, 2023), so they are not within FDA's enforcement-discretion policy pending further evaluation [11]. #### Can you get BPC-157 from a compounding pharmacy? As the record stands today, BPC-157 is in FDA's Category 2 for 503A compounding (effective September 29, 2023), which means it is not within FDA's enforcement-discretion policy and access through that route is currently restricted [11]. BPC-157 is on the FDA's July 23-24, 2026 PCAC agenda as a substance being considered for inclusion on the 503A bulks list — a scheduled review, not a decision [10]. #### What is the FDA 503A status of Wolverine? Both constituents are FDA 503A Category 2 today — BPC-157 and "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" — effective with the September 29, 2023 list update [11]. Both are on the July 23-24, 2026 PCAC agenda as candidates for the 503A bulks list, under active review with no outcome decided [10]. Neither constituent nor the blend is an approved medicine [11]. --- Two peptides held on one status board — BPC-157 and TB-500 graded against their own studies, the combination row left reading NO-HUMAN-DATA and the 503A status posted as it stands, with no clinic behind the board and nothing here prescribed or sold.