# Wolverine Legal Status: FDA 503A Category and Compounding Access for BPC-157 TB-500 > Wolverine legal status for BPC-157 TB-500, filed plainly: both constituents are in FDA 503A Category 2, both on the July 2026 PCAC agenda under active review, with compounding access currently restricted. Both BPC-157 and TB-500 currently sit in FDA 503A Category 2, so compounding access is restricted — and both are on the FDA advisory committee's July 2026 agenda, which means the status is under active review. ## Where BPC-157 TB-500 stands today, and where it may be heading The Wolverine legal status question is, for BPC-157 TB-500, a single picture with two halves: access is restricted today, and that status is in motion. The forward-looking half first. Both peptides are scheduled for discussion at an FDA Pharmacy Compounding Advisory Committee (PCAC) meeting on July 23-24, 2026, where they appear on the published agenda as substances "being considered for inclusion on the 503A Bulks List" [15]. Compounding access for these peptides is under active FDA review and may expand in 2026. That is momentum, not a decision: a PCAC discussion is advisory, and no reclassification has occurred, been dated, or been guaranteed. The present-tense half second. The FDA has identified both of the blend's constituents as bulk drug substances that may present significant safety risks and placed them in 503A "Category 2," effective with the September 29, 2023 update to its nominated-substances list [13]. BPC-157 (listed as "BPC-157 (free base)" and "BPC-157 acetate") and "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500" are both named in that Category 2 listing [13]. Neither is an FDA-approved drug, and the Wolverine blend has no approved therapeutic indication. There is no component carve-out: both legs of the blend carry the same Category 2 status, and both are on the July 2026 agenda. ## FDA 503A Status of the Blend Under the U.S. Federal Food, Drug, and Cosmetic Act, drug compounding runs through two sections. Section 503A covers patient-specific compounding by state-licensed pharmacies and physicians pursuant to a valid prescription; Section 503B covers FDA-registered outsourcing facilities compounding larger batches [14]. 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 FDA's 503A bulks list [14]. Category 2 is the relevant marker for this blend. Per FDA's interim policy, Category 2 substances were nominated with enough information to evaluate but were identified by FDA as raising significant safety risks; they are not covered by the enforcement-discretion policy that applies to Category 1, and FDA stated it would consider taking action against a compounder using a Category 2 substance [13][14]. For BPC-157 and TB-500, FDA's published rationale cites concerns including potential immunogenicity for certain routes of administration and complexities with peptide-related impurities and active-ingredient characterization [13]. Inclusion on a final bulks list is decided by FDA rulemaking informed by PCAC — being discussed by PCAC is a step in evaluation, not a listing decision [14][15]. ## BPC-157 and Compounding Pharmacy Access How does [compounding pharmacy access](/legal-status#compounding) actually work for unapproved peptides? In general terms, 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 [14]. The preparation is then made by a state-licensed 503A compounding pharmacy (patient-specific) or, for larger volumes, sourced from an FDA-registered 503B outsourcing facility [14]. Telehealth can serve as the front-end channel for the prescriber evaluation, but it does not change which substances are eligible to be compounded or remove the need for a legitimate clinical evaluation and a valid prescription [14]. The binding caveat is ingredient eligibility. A compounder may use a requested active ingredient only if that ingredient is permitted under the 503A/503B framework — and ingredients FDA has flagged for significant safety risks are not eligible for routine 503A compounding while that status stands [14]. With BPC-157 and TB-500 currently in Category 2, that eligibility gate is the operative restriction. This page is general information about the regulatory landscape, not medical or legal advice, and not an offer to supply any substance. --- A curated property-portal listing of the BPC-157 TB-500 record — each constituent finding, dose parameter, and FDA 503A access mark filed as its own cited entry, with no clinic, pharmacy, or prescription behind the keyline.