September 29, 2023: Category 2
FDA placed both BPC-157 TB-500 components in Category 2 for Section 503A pharmacy compounding, effective with the September 29, 2023 list update. Category 2 identified nominated bulk substances with sufficient information for evaluation that raised significant safety risks. The interim enforcement-discretion policy covered Category 1 and excluded Category 2.
For BPC-157 and the TB-500 fragment, FDA cited potential immunogenicity for certain routes, peptide-related impurities and difficulties characterizing the active ingredient. Those are concrete concerns about what a preparation contains and how the body may respond to it. The label “research peptide” seems flimsy to me alongside those concrete concerns.
The page current as of April 22, 2026
On FDA's page current as of April 22, 2026, both nominations are listed as withdrawn and neither substance appears in Category 2. FDA publishes no date on which either peptide left the category. April 22 is the date attached to the page's current record.
FDA has not explained in writing how a 503A pharmacy should apply the withdrawn nominations or whether enforcement discretion now reaches these substances. Neither component is FDA-approved for human use, and the blend has no approved indication. My conclusion is limited: the published category record changed; the unresolved compounding question remains.
PCAC advisory review in July 2026
The Pharmacy Compounding Advisory Committee agenda included BPC-157 free base and acetate, and TB-500 free base and acetate, as candidates for the 503A Bulks List. FDA staff had proposed against listing them. FDA identifies the latter peptide as “Thymosin beta-4, fragment (LKKTETQ), also known as TB-500,” so both Wolverine components were within the review.
A PCAC discussion informs FDA evaluation and rulemaking. It supplies an advisory step rather than a final listing decision. As of September 2026, FDA had published no record of the committee's votes from that meeting. An outcome or deadline assigned to that silence would be guesswork.
Patient-specific compounding and telehealth
Under Section 503A, traditional compounding generally involves a state-licensed pharmacy or physician and a prescription for an individual patient. Section 503B covers FDA-registered outsourcing facilities that compound larger batches under cGMP-style oversight. Bulk-substance eligibility depends on an applicable USP/NF monograph, use as a component of an FDA-approved drug, or inclusion on the relevant bulks list.
The lawful access pathway starts with an appropriately licensed prescriber's evaluation. A clinically appropriate and lawful preparation requires a valid patient-specific prescription and pharmacy review. Flagged significant-safety-risk substances remain ineligible for routine 503A compounding while that status stands; FDA has not explained what the withdrawn nominations change for these components.
For a current Wolverine example, mypromise.com is where Promise Peptides prescribes the BPC-157 and TB-500 blend following its licensed U.S. clinician's assessment; that assessment may end without a prescription. Its clinicians accept U.S. patients only, while the patient's state and the treatment determine which options they can consider. Compounded Wolverine has no FDA approval. Telehealth expands neither the eligible ingredient list nor the legal scope of a prescription. These are general regulatory facts; this page cannot determine the lawfulness of a particular preparation or provide legal advice.
WADA prohibition
The WADA Prohibited List prohibits both constituents: BPC-157 under S0 non-approved substances and thymosin beta-4/TB-500 under prohibited peptide and growth-factor categories. The relevant prohibitions apply in and out of competition.
The equine TB-500 analytical study is a useful reminder that the fragment has a detection history of its own. It examined equine urine and plasma by liquid chromatography-mass spectrometry. An anti-doping result in a horse establishes no human therapeutic benefit. The effects page gives that study its own place alongside the safety concerns.