Peptide Science Desk

FDA Category 2 Peptide List (2026): Which Peptides Are on It Now?

Checked on fda.gov: October 28, 2026

This page lists what the FDA itself posts. Being off the list is not approval.

By the Peptide Science Desk Editorial TeamFact-checked against FDA and official sources · Not yet reviewed by a licensed clinician. How we check facts

Short answer: As of October 28, 2026, only one peptide is on the FDA’s Category 2 list for regular pharmacies: kisspeptin-10. In April 2026, BPC-157, TB-500, and 15 other items were moved off the list because the groups that asked for them took back their request. Moved off does not mean approved or safe. On October 28, 2026, HHS issued an interim policy for 6 of them.

Live tracker: is the FDA peptide policy final yet?

State health officials at a meeting with the FDA
State health officials meet with the FDA about pharmacy compounding (December 2012 photo).Photo: U.S. Food and Drug Administration, public domain

What is Category 2?

  • Some pharmacies mix (compound) medicines themselves.
  • People can ask the FDA to let pharmacies use a new ingredient. While the FDA thinks about it, it puts the ingredient in a group.
  • Category 2 is the group where the FDA saw "significant safety risks." The FDA may act against pharmacies that mix these.
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Peptides still on Category 2

  • Regular pharmacies mix medicine for one patient. The FDA calls them 503A.
  • Big "outsourcing" pharmacies make large batches. The FDA calls them 503B.
  • Source: the FDA Category 2 page, checked October 26, 2026.

Moved off in April 2026

  • The FDA says these were moved because the groups that asked for them withdrew. It is not an FDA finding that they are safe.
  • The FDA still posts its safety worries for each one on the same page.
  • None of them is FDA approved.

Covered by the October 28, 2026 HHS policy

  • Only for licensed pharmacies and doctors, with a prescription, under strict rules.
  • None of these is FDA approved. "Research use only" products are not covered.

So can pharmacies make them now?

  • For 6 of them, yes, under strict rules. On October 28, 2026, HHS said it will not take action against licensed pharmacies and doctors that make BPC-157, TB-500, KPV, MOTS-c, Semax and epitalon for a patient with a prescription.
  • This is interim (for now). It is not FDA approval, and it does not put them on the official "bulks list." A regular pharmacy still can only use an ingredient that has an official quality standard, is part of an FDA-approved drug, or is on that list, unless a policy like this one applies.
  • HHS says being put on or taken off Category 2 did not change their status for pharmacies.
  • For the other 11 that moved off (like CJC-1295, ipamorelin, Selank, DSIP and GHK-Cu shots), nothing changed. They are not on the bulks list or in the new policy.
  • In July 2026, FDA advisers voted for the same 6, and no on emideltide (DSIP). FDA staff had advised against all 7. You can read the FDA’s own July 2026 slides and briefing papers for that meeting. We link them under Sources.

GHK-Cu creams are different

GHK-Cu that is not a shot, like a cream, was put back on the FDA’s "under review" list (Category 1) in May 2026. FDA advisers plan to talk about it before the end of February 2027.

What this means for you

Off the list does not mean approved. None of these peptides is FDA approved. Talk to your doctor before using any of them.

The numbers in charts

Where the FDA's risky-ingredient list stands

Peptides the FDA reviewed for its "Category 2" list (may have serious safety risks)

"Withdrawn" does NOT mean approved or safe. It means the people who nominated them pulled the request.

Show the numbers as a table
Where the FDA's risky-ingredient list stands
FDA listStill on Category 2Nominated, then withdrawnTotal
Peptides named on the FDA page41721
The 17 withdrawn: AOD-9604, BPC-157, LL-37, CJC-1295, dihexa, DSIP, epitalon, GHK-Cu (shots), ipamorelin, KPV, PEG-MGF, melanotan II, MOTS-c, selank, semax, thymosin alpha-1 and TB-500. MK-677 (ibutamoren) is also still on Category 2, but it is not a peptide. Sources: FDA: Bulk drug substances that may present significant safety risks (content current as of 04/22/2026).

FDA peptide policy: what happened when

Official steps, news reports, and the White House meetings on the plan

  • Official record
  • News report
  • OMB meeting

  1. Official recordBy April 22, 2026The FDA page on risky compounding ingredients lists BPC-157 under "nominated but withdrawn," not in Category 2.

  2. Official recordJuly 23-24, 2026FDA advisers (the Pharmacy Compounding Advisory Committee) talked about 7 peptides, including BPC-157, TB-500 and Semax, for the pharmacy ingredient list.

  3. News reportJuly 23-24, 2026 (vote details)Reuters reported the votes. July 23: yes on BPC-157, KPV, TB-500 and MOTS-c. July 24: yes on Semax and epitalon, and no on emideltide (DSIP), 7 no, 6 yes, 1 did not vote. FDA staff had advised against all 7. The advisers are outside experts. The FDA does not have to follow them.

  4. Official recordOctober 14, 2026The White House budget office (OMB) got the FDA plan for review. It is listed as a "notice" with no legal deadline.

  5. News reportOctober 15, 2026Reuters reported that the FDA sent the plan to the White House, and that Hims & Hers has said it plans to offer peptides if the rules allow.

  6. News reportOctober 15-16, 2026The AP reported, citing 2 people who did not give their names, that the plan would let pharmacies make some popular peptides for a while, including BPC-157. This is not confirmed by the FDA.

  7. Official recordOctober 18, 2026Reginfo.gov listed the first meeting: October 21, asked for by the American Academy of Peptide Medicine.

  8. News reportOctober 20, 2026Health Secretary Kennedy said on TV the goal is a "regulated marketplace" for peptides.

  9. Official recordOctober 21, 2026The list grew to 3 meetings: Hims & Hers Health (Oct 23) and the Alliance for Pharmacy Compounding (Oct 27) were added.

  10. OMB meetingMeeting: American Academy of Peptide Medicine (Lee Rosebush)Oct 21, 3:00 PM ET (Oct 21, 10:00 PM Riyadh)

  11. Official recordOctober 22, 2026The list grew to 5: the Center for Science in the Public Interest (Oct 27) and Carmen Group for Medivant Healthcare (Oct 28) were added.

  12. Official recordOctober 23, 2026A 6th meeting was added: Faegre Drinker Consulting for the Collaborative for Evidence-Based Medicines (Oct 28). No notes or handouts were posted when we checked.

  13. OMB meetingMeeting: Hims & Hers HealthOct 23, 2:00 PM ET (Oct 23, 9:00 PM Riyadh)

  14. Official recordOctober 26, 2026Still pending at OMB. Still 6 meetings listed. No Federal Register notice. No policy text.

  15. OMB meetingMeeting: Alliance for Pharmacy Compounding (Scott Brunner)Oct 27, 2:00 PM ET (Oct 27, 9:00 PM Riyadh)

  16. OMB meetingMeeting: Center for Science in the Public Interest (Quynh Nguyen)Oct 27, 2:30 PM ET (Oct 27, 9:30 PM Riyadh)

  17. Official recordOctober 28, 2026HHS issued the peptide policy. It lists 6 peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Pharmacies must use tested ingredients from FDA-registered makers, use only 1 peptide per product, and report bad side effects to the FDA. A Federal Register notice was filed the same day and published October 30.

  18. Official recordOctober 28, 2026 (meetings)Reginfo.gov now lists 4 meetings. The 2 meetings planned for October 28 are no longer on the list.

  19. News reportOctober 29, 2026 (reactions)NPR reported that the consumer group Public Citizen says the policy puts patients at risk by going around FDA approval. NPR also noted that outsourcing facilities (503B), which make larger batches, are not part of the policy, and that a Florida compounding pharmacy said it needs time to prepare before filling prescriptions.

  20. Official recordOctober 30, 2026The Federal Register printed the HHS notice (91 FR 68526). It says written comments can be sent for 2 weeks after publication on regulations.gov, Docket No. HHS-OASH-2026-0496.

  21. News reportOctober 30, 2026 (reactions)Politico reported that states are not bound by the HHS policy: many are expected to go along, but some may set stricter rules or keep blocking peptide compounding. AJMC reported that FDA career scientists had recommended against all 6 peptides, that the Partnership for Safe Medicines petitioned the FDA to block compounding of them, and that an FDA advisory committee was scheduled (as of July) to review 5 more peptides in February.

HHS issued an interim policy on Oct 28, 2026 for 6 peptides. Nothing in this timeline made any peptide FDA approved.

Last checked 2026-11-03. News reports are marked so you can tell them apart from official records. Sources: Federal Register: FR Doc. 2026-22192; Reginfo.gov: OMB review, RIN 0910-ZD94; Our FDA peptide policy tracker.

More charts: Peptides by the numbers

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FAQ

Is BPC-157 still on the FDA Category 2 list?

No. It was moved off in April 2026 because the groups that nominated it withdrew. The FDA did not say it is safe, and it is not FDA approved.

Which peptides are on Category 2 now?

For regular (503A) pharmacies: kisspeptin-10. For outsourcing (503B) pharmacies: GHRP-2, GHRP-6, and ipamorelin.

Does being off Category 2 make a peptide legal?

No. Being off the list changed nothing by itself, HHS says. Since October 28, 2026, 6 of these peptides are covered by an interim HHS policy for licensed pharmacies with a prescription. None is FDA approved.

Which peptides does the October 2026 HHS policy cover?

Six: BPC-157, TB-500, KPV, MOTS-c, Semax and epitalon. It covers them only when a licensed pharmacy or doctor makes them for a patient with a prescription, under strict rules.

What is the difference between 503A and 503B?

503A pharmacies mix medicine for one patient with a prescription. 503B "outsourcing facilities" make bigger batches and follow stricter factory rules.

What safety risks does the FDA list for compounded BPC-157, CJC-1295 and ipamorelin?

For all 3, the FDA says the body may fight them like a germ (an immune reaction), and that unwanted bits from making them are hard to check. For BPC-157, it found little or no safety data in people. For CJC-1295, it saw serious side effects, like a fast heartbeat and a whole-body reaction where blood vessels widen. For ipamorelin, it points to a published study with serious side effects, including a death, when it was given into a vein.

What are Category 2 peptides?

Peptides the FDA put in its Category 2 group of bulk drug ingredients because it saw "significant safety risks." The FDA may act against pharmacies that mix them.

Are the 6 HHS policy peptides on the 503A bulks list?

No. BPC-157, TB-500, KPV, MOTS-c, Semax, and epitalon are not on the 503A bulks list. The October 28, 2026 HHS policy is interim enforcement discretion until a final FDA decision, not approval.

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Sources

Not medical advice. Medical disclaimer.