Regulatory

FDA 2026 Peptide Compounding Update: What the Category Lists Say

Written by Dr. med. univ. Julian Douwes
Published 4 min read
On this page 6 sections
  1. At a Glance
  2. What Changed in 2026
  3. Why “Withdrawn” Is Not “Restored”
  4. What This Means for Patients in the US
  5. Related Articles
  6. References
FDA 2026 Peptide Compounding Update: What the Category Lists Say
TL;DR
FDA's 503A category list (updated 14 May 2026) names two peptides in category 1: vasoactive intestinal peptide and GHK-Cu for non-injectable routes. No FDA document shows a 2026 action moving around 14 peptides back to category 1. Popular peptides such as BPC-157, TB-500, thymosin alpha-1, CJC-1295 and epitalon left category 2 because their nominators withdrew them, which is not the same as being cleared for compounding.
ELI5
The FDA keeps lists of raw ingredients that compounding pharmacies may or may not use. In 2026 the list changed less than many websites claim: only a couple of peptides sit on the 'may use while we evaluate' list. Many popular peptides were taken off the 'safety concern' list because the people who nominated them withdrew the request, not because the FDA cleared them.
FDA 2026 Peptide Compounding Update: What the Category Lists Say

Key Takeaways:

  • FDA’s list of bulk drug substances nominated for 503A compounding was last updated on 14 May 2026 [1].
  • Among peptides, category 1 (“under evaluation”, which 503A pharmacies may use while FDA decides) contains vasoactive intestinal peptide and GHK-Cu for non-injectable routes [1].
  • No FDA document shows a 2026 action moving “around 14 peptides back to Category 1”. The claim circulates widely online and does not match FDA’s own list.
  • BPC-157, TB-500 (thymosin beta-4 fragment), thymosin alpha-1, CJC-1295, ipamorelin, AOD-9604, cathelicidin LL-37, epitalon, dihexa, emideltide (DSIP) and injectable GHK-Cu appear on FDA’s list of substances “previously in category 2” whose nominations “were withdrawn by the nominators” [2].
  • Leaving category 2 through withdrawal does not put a substance into category 1. FDA’s interim enforcement policy covers category 1 substances [3].

At a Glance

FactorDetail
SourceFDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated 14 May 2026)
Peptides in 503A category 1Vasoactive intestinal peptide; GHK-Cu (except injectable routes)
503A category 2 (current)Cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, quinacrine for intrauterine use
Popular peptidesListed by FDA as “nominated but withdrawn” from category 2
GHK-Cu next stepFDA intends to consult its Pharmacy Compounding Advisory Committee before the end of February 2027
Grey marketUnaffected; category lists apply only to licensed compounding

What Changed in 2026

FDA’s interim policy sorts nominated bulk drug substances into three groups [3]:

  • Category 1, under evaluation. The substance was nominated with enough supporting information and does not appear on another list. FDA does not intend to take action against a 503A compounder who uses it, provided the conditions in the guidance are met.
  • Category 2, significant safety risks. FDA has identified significant safety risks and does not extend that policy to these substances.
  • Category 3, nominated without adequate support.

The May 2026 version of the list records one change: GHK-Cu for non-injectable routes was removed from category 1 on 22 April 2026 after its nominations were withdrawn, and is being added back after one nominator clarified on 5 May 2026 that it had meant to withdraw only the injectable route [1]. Injectable GHK-Cu sits on the withdrawn list [2].

FDA’s safety-risk page keeps a separate table of substances “previously in category 2 of the interim policies” that “were withdrawn by the nominators” [2]. Most of the popular peptides are in that table, and it still carries FDA’s safety summary for each: usually immunogenicity risk, peptide-related impurities and little or no human safety data. Ipamorelin also remains in category 2 under the separate 503B (outsourcing facility) policy [2].

Why “Withdrawn” Is Not “Restored”

Several websites read the shrinking category 2 list as a reversal. FDA’s own wording does not support that. A substance whose nomination was withdrawn is no longer under evaluation. It is not in category 1, so the category 1 enforcement policy does not cover it [3]. If you are told a pharmacy can compound one of these peptides “because the FDA moved it back”, ask which list it is on and check the current FDA document yourself.

What This Means for Patients in the US

  • Check the current list, not secondary sources (including this page). FDA updates the document on a rolling basis [1].
  • Category 1 is not approval. Even vasoactive intestinal peptide and non-injectable GHK-Cu are only “under evaluation”.
  • State pharmacy boards may add their own restrictions.
  • Grey-market “research peptides” are outside all of this. They carry no guarantee of identity, purity or sterility.

For the wider picture, see Are Peptides Legal? A 2026 Regulatory Guide.

Physician-written. Written by a practicing physician at St. George Hospital. Educational content, not individual medical advice.

References

  1. U.S. Food & Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated 14 May 2026. FDA.gov
  2. U.S. Food & Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. FDA.gov
  3. U.S. Food & Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (interim policy). Content current as of 14 May 2026. FDA.gov

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