Key US decisions on consumer peptides since 2023, newest first, in plain English
By MoveWell Research TeamLast checked November 1, 2026
LatestOctober 28, 2026: HHS said it won't act against licensed pharmacies compounding BPC-157, TB-500, KPV, MOTS-c, semax or epitalon, as single-ingredient products in set routes. It is not an FDA approval.
NextAbout November 13, 2026: comments close on that policy. By end of Feb 2027: FDA's advisory committee reviews injectable GHK-Cu, LL-37, dihexa, PEG-MGF and melanotan II.
No consumer "wellness" peptide is FDA-approved. Since October 2026, six can be compounded by licensed pharmacies under an interim HHS policy. Most others have no legal compounding path, and "research use only" vials are unlawful to sell for human use.
Mounjaro, Zepbound. Shortage over; court upheld FDA in Aug 2026
Elamipretide (SS-31)
Approved drug
Forzinity, for Barth syndrome only (Sep 2025). "SS-31" sold online is unapproved
CagriSema
Under review
Filed Dec 2025; FDA decision expected Q4 2026. Not approved
Coming up
HHS · comment deadline
Comments close on the six-peptide compounding policy
The notice gives two weeks after its Oct 30 publication; the exact date is our calculation.1
FDA · approval decision
CagriSema decision
Novo Nordisk expects a decision on weekly cagrilintide + semaglutide this quarter. No date has been disclosed.2
FDA · advisory committee
Second peptide review
Injectable GHK-Cu, LL-37, dihexa, PEG-MGF and melanotan II. No date set yet.3
Eli Lilly · filing
Retatrutide submission
Lilly expects to file for obesity after completing its manufacturing data package.4
FDA · rulemaking
Formal listing of the six peptides
Adding them to the 503A bulks list takes notice-and-comment rulemaking; Holland & Knight expects a final rule in late 2027 or 2028.5
Every announcement
Newest first. Each entry says what was announced and what it means for you.
HHS · enforcement-discretion policy
Six peptides can be compounded, with strict conditions
HHS said it won't act against state-licensed pharmacies, federal facilities or physicians that compound BPC-157 (injection, oral or topical), TB-500 (injection), epitalon (injection, intermittent courses), semax (nasal), KPV (topical or oral) or MOTS-c (injection). Each product must be patient-specific and contain one peptide only, from an FDA-registered manufacturer with a certificate of analysis. Bulk outsourcing facilities and "research chemical" sellers are excluded, and the policy can be revoked.
What it means: With a prescription, these six may be available from a licensed compounding pharmacy as single-ingredient products. Blends like GLOW or Wolverine are not covered. This is not an FDA approval.
FDA warned Empower Pharmacy that its semaglutide + B12 and tirzepatide + niacinamide products are "essentially copies" of approved drugs, and that the clinical reasons on many prescriptions looked like pretext.
What it means: Compounded GLP-1s with an "added vitamin" twist are under scrutiny and may disappear.
The appeals court rejected compounders' challenge to FDA removing tirzepatide from the shortage list. The opinion notes a companion semaglutide case was decided separately.
What it means: The legal basis for mass "shortage" compounding of these drugs is closed.
"Research use only" labels don't protect peptide sellers
FDA warned five online vendors selling semaglutide, tirzepatide, retatrutide, tesamorelin, SS-31, PT-141 and others. Dosing guides, reconstitution calculators and bundled bacteriostatic water showed the products were meant for people, making them unapproved drugs.
What it means: "Research peptide" sites are an enforcement target, and their products have no quality oversight.
Panel backs six of seven peptides, against FDA staff advice
Votes to add to the compounding list: BPC-157, KPV and TB-500 8–6–1; MOTS-c 7–5–2; epitalon reported as 7–4–1 or 7–5–1 (FDA minutes not yet posted); semax 8–5–1. DSIP was rejected 6–7–1. FDA staff had recommended against all seven. The votes are advice only.
What it means: Nothing became legal that day; the votes set up the October HHS policy and future rulemaking.
After a nominator clarified on May 5 that it had withdrawn only the injectable route, FDA put non-injectable GHK-Cu back in Category 1. Injectable GHK-Cu stays out.
What it means: Prescription topical GHK-Cu can be compounded under FDA's interim policy. Injectable can't.
FDA proposes keeping GLP-1s off the outsourcing list
FDA found no clinical need for large outsourcing facilities to compound semaglutide, tirzepatide or liraglutide from bulk. Comments closed Jul 30; no final decision yet.
What it means: Large-scale compounded GLP-1 supply would stay closed outside a shortage.
12 peptides removed from the "safety risk" list, sent to review
After nominators withdrew them, FDA removed BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, DSIP, injectable GHK-Cu, LL-37, dihexa, PEG-MGF and melanotan II from Category 2, and scheduled advisory reviews.
What it means: Despite headlines, nothing became legal to compound on Apr 22. It started a review.
FDA stopped sorting new nominations into categories. Existing Category 1 substances keep enforcement discretion; new ones must wait for the final list.
What it means: This is why 2026 needed advisory votes and a special HHS policy.
FDA moved BPC-157, TB-500 and others into Category 2, citing immune reactions, impurities and thin human data. GHK-Cu was split: topical in Category 1, injectable in Category 2.
What it means: Pharmacies stopped compounding them, pushing demand to unregulated sellers.
Category 1 and Category 2 are buckets in FDA's interim list of raw ingredients pharmacies may compound from. Category 1 meant FDA generally wouldn't object while it reviewed a substance; Category 2 flagged safety risks and effectively blocked it. Leaving Category 2 doesn't make a peptide legal. Only the final list, or an explicit policy like HHS's October 2026 one, does that.
Compounding means a licensed pharmacy makes a drug for a specific patient's prescription. It is not FDA approval: compounded drugs aren't tested for safety or effectiveness the way approved drugs are.
"Research use only" products are sold as lab chemicals. FDA treats them as unapproved drugs when they're clearly meant for people.
Sources
Key sources for upcoming dates
Federal Register public inspection 2026-22192. PDF