The Section 503A bulks list defines what bulk drug substances compounding pharmacies can legally use to make non-FDA-approved drugs for individual patients. After HHS Secretary Robert F. Kennedy Jr.'s February 27 announcement that ~14 of the 19 peptides on Category 2 ("do not compound") would be moved back, the FDA's April 22 action removed twelve peptide bulk drug substances from Category 2 effective April 23.
The seven peptides going to the Pharmacy Compounding Advisory Committee for the July 23-24 vote: BPC-157, TB-500 (Thymosin Beta-4 fragment), KPV, MOTS-c, Semax, Epitalon, and Emideltide (DSIP). PCAC public docket FDA-2025-N-6895 is open; written comments close July 9, oral presentation requests close June 30. A second PCAC meeting scheduled before the end of February 2027 will review five additional peptides — GHK-Cu (injectable), Melanotan II, LL-37, Dihexa acetate, and PEG-MGF.
Reclassification to Category 1 lets compounders use the substance; it does not equal FDA approval. See [[pcac]], [[bpc-157]], [[tb-500]], [[503b-bulks-list]], and [[compounding]].
A June 9 Pharmacy Times analysis broke down what HHS Secretary Robert F. Kennedy Jr.'s February 27 announcement of Category 2 to Category 1 reclassification actually means for licensed compounding pharmacies. The piece emphasized that reclassification does not mean FDA approval and that BPC-157, Thymosin Alpha-1, TB-500, CJC-1295, Ipamorelin, AOD-9604, GHK-Cu, Selank, Semax, KPV, and MOTS-C still need PCAC review on July 23-24 before formal addition to the 503A bulks list. Google search volume for 'peptides' rose from 1.3 million per month in 2024 to roughly 8 million per month in 2026.
Pharmacy Times hosted a CME-eligible virtual symposium May 19 (1:00-2:30 PM EDT) framing the post-RFK Jr. peptide moment for hospital and retail pharmacists. The agenda crossed the wellness-clinic side (BPC-157, TB-500, CJC-1295, GHK-Cu after the April 22 503A Category-2 removal) with the FDA-approved peptide side (semaglutide, tirzepatide, liraglutide, navepegritide, paltusotine) and walked attendees through the July 23-24 PCAC vote calculus and patient counseling around compounded GLP-1 risk.
The FDA updated its Section 503A bulks drug substances list on May 14, 2026, continuing the rolling-status changes leading into the July 23-24 PCAC meeting that will evaluate seven peptides (BPC-157, KPV, TB-500, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2) for potential 503A-bulks-list inclusion. The April 30 503B bulks-list proposal (closing June 29) is moving in parallel toward effectively ending large-scale 503B compounding of semaglutide, tirzepatide, and liraglutide. The combined regulatory cycle through July 24 will reshape the compounding-pharmacy economy for the next 2-3 years and determine which research peptides remain accessible through licensed channels.
The FDA's PCAC public docket FDA-2025-N-6895 is now accepting written comments on the proposed addition of seven peptides to the Section 503A bulk drug substances list ahead of the July 23–24 advisory committee meeting at White Oak. Day 1 will cover BPC-157, KPV, TB-500, and MOTs-C; Day 2 will cover Emideltide (DSIP), Semax, and Epitalon. Comments received by July 9 are guaranteed to be presented to the committee, and the docket closes July 22. The window gives compounders, prescribers, and patient advocates roughly twelve weeks to formally submit clinical evidence, pharmacovigilance data, and access arguments.