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 came off the FDA's compounding Category 2 list — and the mechanism matters more than the fact. The NOMINATORS WITHDREW the nominations. FDA did not re-evaluate the substances, and it preserved every safety-risk description verbatim on its withdrawn-nominations table: BPC-157's entry still reads that it "may pose risk for immunogenicity for certain routes of administration" and that "the agency lacks sufficient information to know whether the drug would cause harm when administered to humans." Nor was there any rulemaking: a Federal Register query for all FDA compounding documents published in 2026 returns exactly three, none of them effecting this change. It was a website table update — no notice-and-comment record, no codification, and reversible the same way it was made.
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. It is worse than Category 2 in one specific way that is rarely reported: a withdrawn substance sits in NO category at all, and is therefore outside EVERY FDA enforcement-discretion policy. A widely-cited law-firm analysis infers from the removals that FDA is "reconsidering the validity of respective safety concerns." FDA's verbatim preservation of those concerns on the same page contradicts that reading, and we will say so. We are not naming the firm: the reader needs the correction, not the target.
Accordingly, the verdict dots did not move and the regulatory pill for the affected molecules now names the actual mechanism — for CJC-1295, “Nomination withdrawn · in no FDA category.” 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Regulatory status (CJC-1295): Category 2, not under current review → Nomination withdrawn · in no FDA category.
Plain-English verdict: unchanged (red). 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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