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Plain answer first. For many research-peptide names people ask about, FDA status is not one checkbox. You usually need two FDA sources read together:
Citing only one of those sources is how myths start.
FDA publishes an interim Category 1 / 2 / 3 PDF for bulk substances nominated for compounding review under §503A.
| Category | Plain meaning (interim policy) |
|---|---|
| Category 1 | Nominated with enough info to evaluate; FDA has not put it in Cat 2 for significant safety risks; interim policy may apply if guidance conditions are met |
| Category 2 | Nominated with enough info; FDA identified significant safety risks for compounding pending further evaluation — Cat 1–style interim policy is not adopted for these |
| Category 3 | Nominated without adequate support for evaluation |
Primary: https://www.fda.gov/media/94155/download — Updated May 14, 2026 on pack fetch.
Related guidance context: Interim Policy guidance (Jan 2025) — https://www.fda.gov/media/174456/download
FDA’s SSR page discusses bulk drug substances that may present significant safety risks for compounding. On the pack fetch, the page structure included:
Primary: FDA Significant Safety Risks page — content current as of 04/22/2026 on pack fetch.
Plain answer: The nominator pulled the nomination. FDA’s SSR page still lists some of those substances in a withdrawn / formerly Category 2 table, with safety-risk language themes.
What it does not mean:
Some lifestyle or law-firm blogs say BPC-157, TB-500, or KPV were “withdrawn from Category 1.” That framing is wrong for those three on our verified May 14, 2026 Category PDF fetch.
Correct dual-cite pattern:
So: absent from the live Cat PDF + withdrawn-former-Cat-2 on SSR — not a “Cat 1 withdrawal” story.
(GHK-Cu has a different route-split story: non-injectable GHK-Cu is Category 1 on that PDF; injectable GHK-Cu appears on the SSR withdrawn table. Do not copy the BPC/TB/KPV myth onto GHK.)
Use this as a pattern, not as a shopping note and not as outcome advice.
What FDA documents say (dual-cite required):
How to say research evidence without outcome claims: FDA staff evaluated BPC-157 free base and acetate for possible placement on the 503A Bulks List (rung: regulator review — not drug approval). Separately, BPC-157 has been studied in animals for soft-tissue healing models (rung: preclinical). That is status and study-framing literacy — not a personal recommendation.
PCAC = Pharmacy Compounding Advisory Committee.
What it is: An FDA advisory committee that provides advice and recommendations.
What it isn’t:
FDA’s charter and meeting boilerplate: the committee advises; FDA retains full regulatory decision-making authority; recommendations are non-binding.
Primaries: Charter · Meeting page · 2026 materials index · Briefing intro · Questions PDF · FR notice
When you talk about Category lists, withdrawn nominations, or Significant Safety Risks for compounds like BPC-157, TB-500, KPV, injectable GHK-Cu, CJC-1295, or similar topics:
Because the Category PDF and the Significant Safety Risks page answer different questions. For withdrawn / Cat topics, using only one page is how “Cat 1 withdrawal” myths spread.
No. Nomination withdrawal is not approval, not Bulks List inclusion, and not clearance for human use.
No. That is a myth for those three. On the May 14, 2026 Category PDF they are not on Cat 1/2/3. On the SSR page they appear under nominated-but-withdrawn (previously Category 2). Always dual-cite both FDA URLs.
No. PCAC advises. FDA decides. A recommendation is not a final Bulks List rule.
Official certified tallies / minutes were not found on the FDA meeting page or 2026 materials index as of the 2026-09-15 pack fetch → [CITATION NEEDED]. Do not use blog numbers as primary.
Related: /lanes · /what-are-peptides · /bpc-157 · /peptide-101