FDA Tracker newsroom · Peptide reclassification (RFK-14)
Category 2 “removal” isn't authorization, reading the April 2026 change honestly.
· Last reviewed
Some are reading the April 2026 removal of peptides from compounding Category 2 as a green light. The more authoritative legal reading does not: removal is not the same as Category 1, the Bulks List, or availability. We keep the verdict dot amber until a molecule can legitimately be dispensed.
In April 2026, several peptides were removed from the FDA's compounding Category 2 list. Some have read this as authorization. The more authoritative legal reading does not support that.
Removal from Category 2 is not the same as placement in Category 1, addition to the 503A Bulks List, or clearance to compound and dispense. The honest description is limbo, pending the July PCAC review and any subsequent rulemaking.
Accordingly, our verdict dots stay amber and the regulatory pill reads “Cat 2 removed, disputed.” The dot did not move even though the pill changed; that gap is exactly the point, and we will not let the optimistic reading imply availability.
What moved, and what did not
Regulatory status (CJC-1295): Still Category 2 → Cat 2 removed, disputed.
Plain-English verdict: unchanged (amber). A recommendation is not approval, not authorization to compound, and not availability — and a rejection does not move the dot either, because none of these was available before the vote.
Molecules in this update
Primary sources
Also reported by Federal Register notice (Apr 2026).
Compounded medications are not FDA-approved. PCAC is an advisory committee: a favorable vote leads to FDA rulemaking, not authorization and not next-day availability. Nothing here is medical advice, and no peptide is offered for sale on this page.
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