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Peptides with an FDA advisory vote, no FDA decision

An FDA advisory committee has voted on these 7 compounds for the 503A bulks list. A vote is a recommendation. None of them is FDA-approved, and FDA has not proposed adding any of them.

7 compounds · statuses as of October 4, 2026

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Where each compound stands

  1. Committee vote

    Done

    FDA's Pharmacy Compounding Advisory Committee has voted on each compound below.

  2. Proposed rule

    No proposed rule

    FDA would propose adding a compound to the 503A bulks list in a published rule.

  3. Comment period

    No comment period

    The public can comment on a proposed rule before FDA decides.

  4. Final rule

    No final rule

    FDA adds the compound to the list in a final rule. FDA can also decline to add it.

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Not FDA-approved · advisory vote, no FDA decision
CompoundCommittee vote 503A listAs of
BPC-157
8-6-1FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)
Epitalon
7-4-1FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)
KPV
8-6-1FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)
Methylcobalamin injection (methyl B12)
9-5FDA staff recommended against adding it		Category 1 on FDA's interim 503A list
MOTS-c
7-5-2FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)
Semax
8-5-1FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)
TB-500 (thymosin beta-4 fragment LKKTETQ)
8-6-1FDA staff recommended against adding it		No category since April 22, 2026 (nomination withdrawn)

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What this means for you

A committee vote is a recommendation to FDA, not a decision. The next step would be a proposed rule. FDA has not published one for any of these compounds.

FDA's own staff recommended against adding each of these compounds.