Back to the journal
Peptides
6 min read
Updated Oct 29, 2026.
Peptide is on serums, protein powders and half the internet. This page explains the word, then sorts 20 popular peptides by where FDA stands on each. Education only. Statuses are as of the dates shown.
What are peptides?
Peptides are short chains of amino acids, the building blocks of protein. String enough amino acids together and you get a protein. Keep the chain short and you have a peptide.
Your body makes thousands of them. Many act as signals: one cell releases a peptide, another cell reads it and changes what it does. Some hormones are peptides.
Peptides are also medicines. Insulin, first used as a drug in the 1920s, is a peptide. More than 80 peptide drugs are approved worldwide [1].
The word shows up in three very different places:
Approved drugs, made by drug companies and prescribed.
Compounded drugs, made by licensed pharmacies for one patient, with a prescription.
Products sold online as "research use only."
Same word. Each bucket has its own rules and its own quality checks.
Prescription vs research peptides
A prescription peptide comes with a prescriber and a licensed pharmacy. A clinician reviews your health history. The pharmacy is licensed and overseen by its state board. Compounded drugs are still not FDA-approved, and FDA does not check them before they are sold [2].
A research peptide is sold online, often labeled "research use only" or "not for human consumption." No prescriber, no patient-specific pharmacy, no quality checks for human use. The label means what it says.
Full breakdown: Prescription vs Research Peptides.
The FDA status key
FDA keeps lists of substances pharmacies want to use in compounding. Category 2 is the list of substances FDA says "may present significant safety risks" [3]. Most peptides below were on it. Many came off in 2024 or 2026 because the people who nominated them withdrew. Coming off Category 2 does not make a peptide approved or legal to compound [3][4]. Are peptides legal? explains why.
Status | What it means | As of |
|---|---|---|
Still Category 2 | FDA lists it as a significant safety risk today. | FDA page, Apr 22, 2026 [3] |
Panel said yes, FDA hasn't | FDA's advisory committee voted to recommend it in Jul 2026. Advisory only. FDA has not decided, and adding it needs rulemaking. | Votes, Jul 23 to 24, 2026 [5][6] |
Panel said no | The committee voted against it, or FDA proposed leaving it off. | Votes, Oct 2024 to Jul 2026 [5][7] |
Review pending | Off Category 2 in Apr 2026. Committee review expected before the end of Feb 2027. | FDA page, Apr 22, 2026 [3][6] |
Withdrawn, no review | Off Category 2 in Sept 2024. No committee review found. | FDA page, Apr 22, 2026 [3] |
None of the 20 peptides below is approved by FDA for any use. None is on the 503A bulks list, the list pharmacies use to compound substances that are not part of an approved drug [4].
The library: 20 peptides, 5 shelves
Shelf 1. Growth hormone family
Ipamorelin. Still Category 2 for outsourcing facilities. For pharmacies, FDA proposed leaving it off (Oct 2024).
CJC-1295. Panel said no (Dec 2024).
AOD-9604. Panel said no, 0 to 12 (Dec 2024).
GHRP-2. Still Category 2 for outsourcing facilities. Category 3 for pharmacies.
GHRP-6. Still Category 2 for outsourcing facilities. Category 3 for pharmacies.
Comparing growth hormone peptides? Sermorelin is a different peptide with a US approval history. See Sermorelin vs Ipamorelin.
Shelf 2. Repair and recovery
BPC-157. Panel said yes, 8 to 6, 1 abstention (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
TB-500. Panel said yes, 8 to 6, 1 abstention (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
KPV. Panel said yes, 8 to 6, 1 abstention (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
LL-37. Review pending (by end of Feb 2027).
PEG-MGF. Review pending (by end of Feb 2027).
Shelf 3. Brain and sleep
Semax. Panel said yes, 8 to 5, 1 abstention (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
Selank. Withdrawn Sept 2024, no review found.
DSIP (emideltide). Panel said no, 6 to 7, 1 abstention (Jul 2026).
Dihexa. Review pending (by end of Feb 2027).
Shelf 4. Longevity and metabolism
MOTS-c. Panel said yes, 7 to 5, 2 abstentions (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
Epitalon. Panel said yes, 7 to 4, 1 abstention (Jul 2026). FDA hasn't. In HHS's interim policy (Oct 28, 2026).
Shelf 5. Hormones, immune and skin
GHK-Cu. Split. Injectable: review pending. Topical and other non-injectable forms: back in Category 1 since May 14, 2026.
Melanotan II. Review pending (by end of Feb 2027).
Kisspeptin-10. Still Category 2. The only peptide on the pharmacy (503A) Category 2 list today.
Thymosin alpha-1. Panel said no, 4 to 17 (Dec 2024).
Track the changes
These statuses move. On Oct 28, 2026, HHS filed an interim policy saying it won't take enforcement action against licensed pharmacies, federal facilities or licensed physicians that compound six of these peptides under its conditions: BPC-157, TB-500, KPV, semax, MOTS-c and epitalon [8][9]. It is not approval, and HHS can revise it. The other 14 keep their status above, as of Oct 29, 2026. Read the full breakdown in HHS's Oct 28 peptide policy. The FDA Peptide Tracker logs every change, dated, as it happens.
FAQ
What are peptides in simple terms? Short chains of amino acids. Longer chains are proteins. Some peptides are hormones or drugs. Others are skin care ingredients.
Are peptides FDA-approved? Some peptide drugs are, like insulin. None of the 20 peptides in this library is approved by FDA for any use.
What does "removed from Category 2" mean? FDA took the peptide off its significant-safety-risk list, mostly because its nomination was withdrawn. It is still not approved, and still not on the 503A bulks list [3][4].
Are research peptides safe? Nobody can say from the label. "Research use only" products are not made or checked for people. FDA's stated concerns for these peptides include impurities and immune reactions [3].
How often is this page updated? Statuses are checked against FDA's pages before each update. The as-of date sits next to each status. For the latest change, see the FDA Peptide Tracker.
Sources
Wang L, et al. Therapeutic peptides: current applications and future directions. Signal Transduct Target Ther. 2022. https://www.nature.com/articles/s41392-022-00904-4
FDA. Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of May 14, 2026). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Bass Berry. FDA Advisory Committee Recommends Six Peptides for Compounding (Jul 31, 2026). https://bassberry.com/news/fda-advisory-committee-recommends-six-peptides-for-compounding-what-the-evaluation-criteria-tell-us-about-the-road-ahead/
FDA. July 23 to 24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
FDA. Dec 4, 2024 Pharmacy Compounding Advisory Committee, voting results. https://www.fda.gov/media/185642/download
HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). https://public-inspection.federalregister.gov/2026-22192.pdf
Hyman, Phelps and McNamara, FDA Law Blog. The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line (Oct 28, 2026). https://www.thefdalawblog.com/2026/10/the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line/
Sommar Club does not prescribe or sell any of the 20 peptides in this library. This page is for education only. FDA statuses change. Check the as-of date and the FDA Peptide Tracker before relying on any status here.
