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The peptides in FDA's compounding review

On April 22, 2026 the FDA took 12 peptides off Category 2, its list of compounding safety risks, and sent them to its advisers. The July panel backed 6 of 7 for compounding; 5 wait for the next one. Here is what actually backs the doses people take of each.

Data as of . Part of the Peptide Evidence Index. License CC BY 4.0.

7 of 12

7 of the 12 peptides in FDA's compounding review have any human data, and none goes beyond limited.
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9.6%

20 of 208 dose protocols (9.6%) for the 12 peptides in FDA's compounding review trace to a study or a regulator. Guides account for 139 and community reports for 49.
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7 of 12

7 of the 12 peptides in FDA's compounding review have no study-based dose at all: BPC-157, KPV, TB-500, MOTS-c, GHK-Cu, Dihexa and PEG-MGF.
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13 of 129

The 6 peptides FDA advisers backed in July 2026 have 129 dose protocols between them, 13 from a study or regulator. BPC-157, KPV, TB-500 and MOTS-c account for 76 of them, none from a study.
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One row per peptide

A dose protocol counts as “from a study” only when every source behind it is a study or a regulator, so that column is a floor.

Peptides in FDA's compounding review, by panel: vote, human evidence and dose protocols by origin
PeptideVoteHuman evidenceAnimal onlyDose protocolsFrom a studyGuidesCommunity
July 2026 panel (7)Voted on July 23-24, 2026. Advisory only; FDA still has to write a rule.
BPC-157Backed by advisers8 to 6, 1 abstainingLimited human dataNo230203
KPVBacked by advisers8 to 6, 1 abstainingAnimal data onlyYes180180
TB-500Backed by advisers8 to 6, 1 abstainingAnimal data onlyYes190163
MOTS-cBacked by advisersAnimal data onlyYes16097
EpitalonBacked by advisersLimited human dataNo233146
SemaxBacked by advisersLimited human dataNo3010164
DSIPTurned down6 to 7, 1 abstainingLimited human dataNo202117
Next panel (5)Expected before the end of February 2027. FDA has not set a date.
GHK-CuNot voted yetLimited human dataNo110110
LL-37Not voted yetLimited human dataNo183123
DihexaNot voted yetAnimal data onlyYes8026
Melanotan IINot voted yetLimited human dataNo12255
PEG-MGFNot voted yetAnimal data onlyYes10055
Total (12 peptides)7 with human data5 animal only2082013949

Where each peptide's dose protocols come from

Dose protocols per peptide, by the weakest origin among their sources. All bars share one scale.

  • Study or regulator
  • Guides
  • Community
  1. BPC-157Backed by advisers
  2. KPVBacked by advisers
  3. TB-500Backed by advisers
  4. MOTS-cBacked by advisers
  5. EpitalonBacked by advisers
  6. SemaxBacked by advisers
  7. DSIPTurned down
  8. GHK-CuNot voted yet
  9. LL-37Not voted yet
  10. DihexaNot voted yet
  11. Melanotan IINot voted yet
  12. PEG-MGFNot voted yet

How we got here

Every date links to the source we read.

  1. FDA lists them as compounding safety risks

    FDA's 503A list update puts BPC-157, the TB-500 fragment, DSIP, injectable GHK-Cu and others in Category 2: substances that may raise significant safety risks, so pharmacies stop compounding them.

    Source: FDA

  2. FDA removes all 12 from Category 2

    Their compounding nominations were withdrawn, so FDA took them off the safety-risk list (announced April 15) and named an advisory review. Leaving the list did not make any of them legal to compound.

    Sources: FDA, Holland & Knight

  3. FDA staff advise against all seven on the July agenda

    Staff recommendations cite missing clinical data, batch-to-batch quality and immune reactions.

    Sources: Holland & Knight, ABC News

  4. July panel backs six of seven

    The Pharmacy Compounding Advisory Committee recommends BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax for the 503A bulks list and turns down DSIP. The vote is advisory; FDA still has to write a rule.

    Sources: FDA, STAT, ABC News, Holland & Knight

  5. Interim peptide policy goes to the White House

    HHS and FDA send the "Interim Access Policy for Compounding Using Certain Peptides" to the Office of Management and Budget. It has not been issued.

    Source: Holland & Knight

  6. (expected)

    Next panel expected

    GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF go to a second advisory meeting. FDA has not set a date; it is expected before the end of February 2027.

    Source: Holland & Knight

How it is counted

Which peptides: the 12 FDA took off Category 2 on April 22, 2026 and sent to its Pharmacy Compounding Advisory Committee: 7 on the July 2026 panel, 5 on the next. Vote tallies are shown only where a source we read prints them.

Human evidence is the strongest level any source shows: none, limited, some or strong human trials. “Animal only” means the evidence is animal or cell studies alone.

Dose protocols take the weakest origin among their sources. A dose cited to a trial and to a forum counts as community. Reference works count with guides, media with community.

Every number on this page is computed in code from the same records that build our peptide pages; no model writes one. Full rules on the methodology page, and the whole dataset is free to download.

Licensed CC BY 4.0. Reuse any number, including in commercial work. Credit “TruePeptideSource” and link to this page.

Cite this dataset

TruePeptideSource. (2026). The peptides in FDA's compounding review (Peptide Evidence Index, version 2026-10-24) [Data set]. https://truepeptidesource.com/data/category-2