Status · 40 published
Federal status tracker
Where each compound stands under US federal law today, with the date we checked it and the source. Below the groups, the answers to the questions people get wrong most often.
The federal timeline
· primary
FDA placed kisspeptin-10 in Category 2. That is FDA's list of substances that may present significant safety risks. It is part of FDA's interim policies, not a final rule. The same day, FDA put GHRP-2, GHRP-6 and ipamorelin acetate on the Category 2 list for outsourcing facilities.
· legal-analysis
A law firm analysis reports that FDA said it would remove twelve peptides from Category 2. The removal took effect after seven days. Removal puts a peptide in limbo: out of Category 2 and not in Category 1. That is not approval, and it does not make compounding lawful. We found no FDA page that states this date or count.
· primary
FDA announced in the Federal Register that its Pharmacy Compounding Advisory Committee would meet on 23 and 24 July 2026. The public docket is FDA-2025-N-6895.
· primary
FDA's Category 2 page is marked current as of this date. Its withdrawn list includes BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, emideltide, LL-37, dihexa acetate, PEG-MGF, Melanotan II and injectable GHK-Cu. These twelve are in limbo: out of Category 2 and not in Category 1. That is not approval, and it does not make compounding lawful.
· primary
FDA's 503A category list of this date puts GHK-Cu back in Category 1, except for injectable use. Category 1 means FDA is still evaluating it, under an interim policy with conditions for pharmacies. That is not approval. Injectable GHK-Cu stays in limbo: out of Category 2 and not in Category 1. Kisspeptin-10 is still in Category 2, an interim list, not a final rule.
· primary
FDA said it intends to ask its Pharmacy Compounding Advisory Committee about GHK-Cu. It plans to do so before the end of February 2027.
· primary
The Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026. It reviewed seven peptides, each for named uses. One was BPC-157 for ulcerative colitis. Its votes are recommendations to FDA, and they do not bind it.
· legal-analysis
A law firm analysis reports the committee recommended six of the seven: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. It did not recommend emideltide, with 6 yes and 7 no. We found no vote record posted by FDA.
· legal-analysis
The same law firm analysis reports a second committee meeting is due before the end of February 2027. It will review GHK-Cu, dihexa acetate, LL-37, PEG-MGF and Melanotan II.
· primary
The Federal Register shows no FDA proposed rule to add any of these peptides to the 503A bulks list. FDA's newest proposed rule for that list is dated 5 September 2019.
Every compound by status
fda-approved · 16
- Apomorphinefda-approvedchecked
- Bremelanotidefda-approvedchecked
- Finasteridefda-approvedchecked
- Liraglutidefda-approvedchecked
- Methylene bluefda-approvedchecked
- Minoxidilfda-approvedchecked
- Ondansetronfda-approvedchecked
- Orforglipronfda-approvedchecked
- Oxytocinfda-approvedchecked
- Semaglutidefda-approvedchecked
- Sildenafilfda-approvedchecked
- Tadalafilfda-approvedchecked
- Tesamorelinfda-approvedchecked
- Tirzepatidefda-approvedchecked
- Tretinoinfda-approvedchecked
- Vardenafilfda-approvedchecked
dietary-supplement · 0
No published compound has this status.
category-1 · 4
- GHK-Cucategory-1checked
- Glutathionecategory-1checked Advisory committee: The committee recommended adding glutathione to the 503A bulks list, against FDA's proposal to leave it off
- Melatonincategory-1checked
- NAD+category-1checked
category-2 · 2
limbo · 11
investigational · 2
- CagriSemainvestigationalchecked
- Retatrutideinvestigationalchecked
no-approved-use · 5
Questions
Is removal from Category 2 the same as Category 1 or approval?
No. Removal from Category 2 puts a peptide in limbo: off the safety-risk list and not in Category 1. FDA approval of a drug is a separate step that none of the twelve has. Limbo does not make compounding lawful.
Is a committee vote an FDA decision?
No. The Pharmacy Compounding Advisory Committee gives FDA non-binding advice. FDA decides whether a substance joins the 503A bulks list, by notice-and-comment rulemaking. FDA has proposed no such rule for these peptides.
What is the difference between Category 1, Category 2 and the 503A bulks list?
Category 1 holds substances FDA is still evaluating. FDA does not plan to act against a pharmacy that compounds with them under set conditions. Category 2 holds substances that may present significant safety risks. The 503A bulks list is the final list, set by regulation.
Does this page cover state law?
No. This page covers the US federal position only. State pharmacy rules can be stricter, and this page does not track them.
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