Regulatory Review
Reviewed by PeptidePrescriber Editorial Team.
Last reviewed: April 15, 2026Source review date: April 15, 2026
Primary sources
As of April 19, 2026, the cleanest way to describe these substances is that FDA issued notice they will be removed from category 2 after seven calendar days because the nominations were withdrawn. That is different from saying they are already on the 503A bulks list.
Substances named in the April 2026 removal notice
- BPC-157
- Cathelicidin LL-37
- Dihexa acetate
- Emideltide (DSIP)
- Epitalon
- GHK-Cu (injectable)
- KPV
- PEG-MGF
- Melanotan II
- MOTs-C
- Semax
- TB-500
Meeting timing already announced by FDA
- July 23, 2026: BPC-157-related, KPV-related, TB-500-related, and MOTs-C-related bulk drug substances.
- July 24, 2026: Emideltide (DSIP)-related, Semax-related, and Epitalon-related bulk drug substances.
- Before the end of February 2027: LL-37, Dihexa acetate, injectable GHK-Cu, PEG-MGF, and Melanotan II.
Operational takeaway
This page should be used as a dated operational reference. It helps staff explain the current FDA signal without overstating final regulatory status or skipping the distinction between a removal notice and final bulks-list inclusion.
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