FDA's 503A Bulks List and Interim Categories Explained, and Where BPC-157 Stands in 2026

Published 2026-10-16 · Peptide Science Desk Editorial Team

Pending medical review. This article has not yet been reviewed by a licensed clinician. It summarizes regulatory documents and does not provide dosing or treatment guidance. See our Editorial Policy.

Pharmacies that compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are limited in which bulk drug substances they can use. This explainer summarizes what FDA itself has published. Every claim below links to an FDA document.

The three routes for a 503A bulk drug substance

According to FDA’s 503A bulk drug substances page, state-licensed physicians and pharmacists compounding under 503A may only use bulk drug substances that:

comply with an applicable USP or NF monograph, if one exists, and the USP chapter on pharmacy compounding;
are components of FDA-approved drug products, if no applicable monograph exists; or
appear on FDA’s 503A bulks list, if no monograph exists and the substance is not a component of an FDA-approved drug.

FDA also states that bulk substances must come with a valid certificate of analysis and be made by an establishment registered with FDA under section 510.

How the 503A bulks list is built

FDA solicited nominations in 2015 and consults the Pharmacy Compounding Advisory Committee (PCAC) and USP as it evaluates them. A final rule in February 2019 placed six substances on the list and declined four. A September 2019 proposed rule would add five and decline 26. FDA says it adds substances through notice-and-comment rulemaking.

Interim categories 1, 2 and 3

While nominations are under review, FDA uses an interim policy with three categories:

Category 1: nominated with enough supporting information and possibly eligible. FDA does not intend to take action against compounding with these substances if the guidance’s conditions are met.
Category 2: nominated with enough information, but FDA has identified significant safety risks. FDA says it would consider taking action under its general enforcement policies.
Category 3: nominated with insufficient supporting information. These are not covered by the category 1 policy.

FDA says that under revised guidance it does not intend to place substances nominated on or after January 7, 2025 into these categories.

Peptides on FDA’s safety-risk page

FDA’s category 2 safety-risk page lists peptides including GHRP-2, GHRP-6 and ipamorelin acetate (503B, added September 29, 2023) and kisspeptin-10 (503A, September 29, 2023). The same page lists substances “previously in category 2” whose nominations were withdrawn. These include BPC-157, AOD-9604, CJC-1295, GHK-Cu (injectable), KPV, Melanotan II, MOTs-C, Selank, Semax, TB-500, Thymosin-alpha 1, epitalon and emideltide (DSIP).

For BPC-157, FDA wrote that compounded drugs containing it “may pose risk for immunogenicity for certain routes of administration” and that FDA “lacks sufficient information to know whether the drug would cause harm when administered to humans.”

The July 2026 PCAC meeting

FDA’s presentation slides for the July 23-24, 2026 PCAC meeting list BPC-157, KPV, TB-500 and MOTS-c for July 23. FDA’s slides say:

the BPC-157 nominations were withdrawn and FDA is evaluating the substances at its discretion;
the nominations were evaluated for ulcerative colitis;
FDA concluded that BPC-157 acetate and BPC-157 free base are “not well-characterized”;
FDA “found no studies that administered BPC-157 to humans via the proposed oral, SC, nasal, or transdermal” routes;
BPC-157 “is not a component of an approved product in any country”;
FDA is proposing that BPC-157 (free base) and BPC-157 acetate NOT be included on the 503A Bulks List.

FDA’s briefing document says FDA “does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.”

What we have not yet confirmed

We have not yet confirmed the committee’s vote against FDA’s official meeting minutes, and we have found no final FDA rule on BPC-157. We will update this page when FDA publishes minutes or Federal Register action.

Limits of this summary

This page describes regulatory status only. It does not judge whether BPC-157 is safe or effective, and it does not give dosing or sourcing information.