# Wolverine Legal Status: FDA 503A Category and Compounding Access (BPC-157 TB-500) > Wolverine legal status for BPC-157 TB-500: both constituents are FDA 503A Category 2 bulk substances today, with both on a scheduled July 2026 FDA advisory-committee agenda. Present-tense facts, cited to FDA. Access to BPC-157 TB-500 compounding is restricted today and under active FDA review — both constituents are on a scheduled July 2026 advisory-committee agenda as candidates for the 503A bulks list. Where things actually stand, present tense, cited to FDA. ## Access is restricted today — and under active FDA review Wolverine legal status starts with one present-tense fact and one piece of forward momentum. The fact: both constituents of the BPC-157 TB-500 blend are bulk drug substances that the FDA placed in 503A "Category 2" — substances FDA identified as raising significant safety risks — effective with the September 29, 2023 update to the list of substances nominated for use under section 503A [13]. The momentum: that classification is not the end of the story. Access is under active FDA review and may expand, anchored on a scheduled advisory-committee meeting in 2026. Category 2 has a specific consequence. FDA's interim policy does not extend its enforcement-discretion to Category 2 substances; FDA stated it would consider taking action against a compounder for compounding with one [14]. In plain terms, compounding-pharmacy access to these peptides is currently restricted while that status stands. Neither BPC-157 nor TB-500 is an FDA-approved drug, and the Wolverine blend has no approved indication [13]. That is where the present tense ends. What comes next is a scheduled review, not a settled outcome — and the distinction matters, because it is the entire reason the picture is described here as restricted-but-moving rather than simply closed. ## The scheduled July 2026 FDA advisory-committee review The forward-leaning part of this page rests on a single dated, FDA-citable fact: a meeting of the FDA Pharmacy Compounding Advisory Committee (PCAC) is scheduled for July 23-24, 2026, to discuss bulk drug substances being considered for inclusion on the 503A bulks list [15]. Both of the Wolverine blend's constituents are on that agenda. BPC-157 (listed as "BPC-157 (free base)" / "BPC-157 acetate") appears on the published agenda as a substance being considered for inclusion on the 503A bulks list [13][15]. TB-500 (listed as "TB-500 (free base)" / "TB-500 acetate," the LKKTETQ fragment FDA associates with thymosin beta-4) appears on the same agenda, in the same capacity [13][15]. There is no component carve-out: both peptides are currently Category 2, and both are under this one scheduled review. What this meeting is, and is not, has to be stated carefully. Inclusion on a final 503A bulks list is decided by FDA rulemaking informed by the committee; being discussed by the committee is a step in evaluation, not a final listing decision [14]. The meeting may expand access — that is its momentum — but no reclassification has occurred, none is dated, and none is certain. Anyone reading a vendor claim that these peptides were "moved back" or "removed" on a specific 2026 date should treat it as unconfirmed: the fact that both remain on the July 2026 agenda as candidates is consistent with their evaluation being ongoing rather than resolved [15]. ## How legally compounded peptide access works U.S. drug compounding runs through two sections of the Federal Food, Drug, and Cosmetic Act. 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 [14]. In general terms, a legally [compounding pharmacy access](/legal-status#compounding) pathway looks like this [16]: 1. A patient is evaluated by an appropriately licensed prescriber — in person or via a compliant telehealth encounter — who determines whether a compounded preparation is clinically appropriate. 2. If appropriate and lawful, the prescriber issues a valid, patient-specific prescription. 3. The prescription is dispensed by a state-licensed 503A compounding pharmacy, or, for office or batch use, sourced from an FDA-registered 503B outsourcing facility. Telehealth is one channel for the prescriber-evaluation step that begins this pathway — a route to a licensed-prescriber consultation and prescription, not a separate legal status. It does not expand which substances may be compounded and does not remove the need for a legitimate clinical evaluation and a valid prescription [16]. The ingredient-eligibility caveat is the part that bears on these peptides directly. 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 [14]. Substances FDA has flagged for significant safety risks — which is where BPC-157 and TB-500 sit today — are not eligible for routine 503A compounding while that status stands [13][16]. This is general information about the regulatory landscape, not medical or legal advice, and not an offer to supply any substance. ### Is the Wolverine Blend Legal? Neither constituent is an FDA-approved drug, and the blend has no approved indication. Both BPC-157 and TB-500 are 503A Category 2 bulk substances FDA identified as raising significant safety risks, effective the September 29, 2023 list update, so compounding-pharmacy access is currently restricted [13]. Both are on the scheduled July 23-24, 2026 FDA advisory-committee agenda as candidates for the 503A bulks list — a scheduled discussion, not a decision [15]. ### BPC-157 and Compounding Pharmacy Access BPC-157 is in 503A Category 2, which is outside FDA's enforcement-discretion policy, so routine compounding-pharmacy access is restricted while that status stands [13][14]. A lawful compounded preparation requires a licensed-prescriber evaluation, a valid patient-specific prescription, and an eligible ingredient; BPC-157's Category 2 status is the reason the ingredient-eligibility step is currently the binding constraint [16]. ### FDA 503A Status of the Blend Both constituents are 503A Category 2 bulk drug substances, effective the September 29, 2023 update to FDA's nominated-substances list [13]. Category 2 means FDA identified significant safety risks and does not extend enforcement-discretion to the substance [14]. Both BPC-157 and TB-500 are on the scheduled July 23-24, 2026 PCAC agenda as candidates for the 503A bulks list — a scheduled evaluation, not a change in current status [15]. --- An access-and-evidence console for the BPC-157 and TB-500 record — each constituent logged to its own studies, each blend-level gap left visible, with no clinic behind the panel and nothing here to dispense.