# Wolverine Legal Status: BPC-157 TB-500 FDA 503A Category and Access > Wolverine legal status: the BPC-157 TB-500 components are FDA 503A Category 2 bulk substances today, and both are on the July 23-24, 2026 PCAC agenda as 503A bulks-list candidates. Access under active review. Cited to FDA. Both peptides are 503A Category 2 today and both are on a scheduled FDA advisory-committee agenda for 2026 — momentum is real, the outcome is not decided. General information, not legal or medical advice. ## Where Wolverine Legal Status Stands — and Where It Is Heading The Wolverine legal status question has real forward momentum: access to its component peptides is under active FDA review and may expand in 2026. Anchoring that momentum is a concrete, scheduled fact — the FDA's Pharmacy Compounding Advisory Committee (PCAC) is set to meet on July 23-24, 2026 to discuss these peptides as candidates for the Section 503A Bulks List [13]. That is the honest leading edge of this story, and it is a scheduled discussion, not a decision. The present-tense fact has to be stated plainly alongside it. Both of Wolverine's components are currently classified by the FDA as 503A "Category 2" bulk drug substances — substances FDA identified as ones that may present significant safety risks — effective with the FDA's September 29, 2023 update to the list of nominated substances [12]. Category 2 substances are not covered by the enforcement-discretion policy that applies to Category 1, which means compounding-pharmacy access to these peptides is currently restricted. Neither peptide is an FDA-approved drug, and the blend has no approved indication [12]. So both things are true at once. The current category is restrictive; the trajectory is open. The blend's [WADA prohibition status](/legal-status) is covered below, and none of what follows is medical or legal advice — it is general information about the regulatory landscape. ## What 503A Category 2 Means for Both Components Under the Federal Food, Drug, and Cosmetic Act, drug 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 [12]. 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; substances not yet listed are evaluated by FDA through a public nomination process with input from PCAC [12]. Within that framework, FDA's interim policy sorted nominated substances into Category 1 (covered by enforcement discretion while under evaluation) and Category 2 (identified as raising significant safety risks, and not covered by that discretion) [12]. Both of Wolverine's components sit in Category 2 today, with no component carve-out: - BPC-157 (evaluated as "BPC-157 (free base)" and "BPC-157 acetate") is in Category 2 for 503A compounding, effective with the September 29, 2023 list update, with FDA citing concerns including potential immunogenicity for certain routes and complexities with peptide-related impurities and active-ingredient characterization [12]. - TB-500 — listed by FDA as "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" — is in Category 2 for 503A compounding, effective with the same September 29, 2023 update, with FDA citing concerns including potential immunogenicity for certain routes and a lack of important safety information [12]. FDA's own list entry establishes the relationship between the marketed name and the fragment: TB-500 is the LKKTETQ fragment associated with Thymosin Beta-4 [12]. ## The July 2026 Advisory-Committee Review Both components are on the published agenda of the FDA Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026, listed as bulk drug substances "being considered for inclusion on the 503A Bulks List" [13]. There is no carve-out: BPC-157 and TB-500 are both currently Category 2 and both are under this one scheduled review. What that meeting is, precisely: a scheduled, advisory discussion of substances under evaluation. Inclusion on a final 503A 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 [12]. The outcome of the July 23-24, 2026 meeting is not known, and nothing on this page should be read as asserting a reclassification, a listing, or a removal as already done, dated, or certain. The momentum is genuine and the date is real; the result is still ahead. ## How Legally Compounded Peptide Access Works In the U.S., a legally compounded medication is prepared only after an individual patient is evaluated by an appropriately licensed prescriber who determines a compounded preparation is appropriate and issues a valid, patient-specific prescription [12]. 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 [12]. Telehealth can serve as the front-end channel through which a patient is evaluated and a prescription issued — it is a route to a licensed-prescriber consultation, not a separate legal status, and it does not change which substances are eligible to be compounded [12]. The eligibility caveat is the part that currently binds for these peptides. A compounder may use a requested active ingredient only if that ingredient is permitted under the 503A/503B bulk-substance rules; ingredients FDA has flagged for significant safety risks are not eligible for routine 503A compounding while that status stands [12]. As long as BPC-157 and TB-500 remain in Category 2, that is the operative constraint. This is general information about how the pathway works, not a route to obtain a restricted substance and not medical or legal advice. --- A glazed-tile reading panel on the BPC-157 TB-500 blend — each tendon, wound, and angiogenesis study set in its own tile beside the FDA 503A and access record, with no clinic behind the panel and nothing here dispensed.