Peptavo is Accredited for 20 CME hours.Peptavo is Jointly Accredited for 20 CME hours. Learn more about accreditation
Peptavo is Accredited for 20 CME hours.Peptavo is Jointly Accredited for 20 CME hours. Learn more about accreditation
Get volume discounts if you are getting 3 or more clinicians certified
Book a Call
The month's peptide regulation news for prescribers, checked against the Federal Register and FDA's own pages. October 2026 brought an HHS enforcement discretion policy for six compounded peptides, with ten conditions, no FDA approval, and comments open until November 13.
The biggest peptide regulation FDA news today comes from HHS: on October 30, 2026, it published a draft policy saying it will not take enforcement action against 503A pharmacies and physicians that compound six peptides under ten conditions while FDA works through rulemaking. None of the six is FDA-approved or on the 503A Bulks List, the policy binds no state board, and public comments close on November 13.
This page is one running record of what changed for compounded and prescribed peptides, updated every month from primary sources. The latest month comes first, then where every peptide stands today, then the log of earlier changes.
Updated November 6, 2026. Covers changes through November 6. The next update follows the close of the HHS comment period in mid-November.
The notice in the Federal Register (91 FR 68526, filed October 28 and published October 30) announces the "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." It came from the Office of the Secretary and is signed by Secretary Robert F. Kennedy Jr. FDA did not issue it, and FDA's own staff had recommended against adding any of these peptides to the Bulks List in July.
The operative sentence reads: HHS "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A." The policy lasts until FDA rulemaking addresses each peptide, and HHS says it may revisit it "if, among other things, a safety signal or product quality issue arises." The notice calls the document a draft, takes comments on docket HHS-OASH-2026-0496 until 11:59 p.m. Eastern on November 13, and points to the for the current version.
Appendix B limits each peptide to one form and specific routes.
| Peptide | Form | Routes within the policy |
|---|---|---|
| BPC-157 | Acetate | Subcutaneous, intramuscular, oral, topical |
| TB-500 | Acetate | Subcutaneous, intramuscular |
| Epitalon | Acetate | Subcutaneous, intramuscular, dispensed in intermittent courses |
| MOTS-c | Acetate | Subcutaneous, intramuscular |
| KPV | Acetate | Topical, oral |
| Semax | Free base | Intranasal |
These are the six families the Pharmacy Compounding Advisory Committee recommended in July. Emideltide, the seventh peptide the committee reviewed and voted against, is not covered.
Enforcement discretion applies only when every condition holds, as summarized in analyses of the policy text by McDermott and Arnold & Porter:
The policy grants no FDA approval and adds nothing to the 503A Bulks List at 21 CFR 216.23. It covers 503A pharmacies, federal facilities, and physicians only, so a 503B outsourcing facility cannot rely on it, and because section 503A requires a prescription for an identified patient, office stock falls outside it. A vial labeled "research use only" gains nothing: HHS framed the policy as a way to move patients away from those products, and FDA sent five more warning letters to their sellers as recently as August.
State law sits on top of all of it. The policy binds no state board of pharmacy or medicine, so a state can keep stricter rules and act against a pharmacy or prescriber that federal regulators leave alone. The policy itself sends adverse event and quality reports to the states. States can also move the other way: Louisiana's Act 374, in force since August 1, bars its licensing boards from stopping 503A-compliant compounding of peptides that are off FDA's Category 2 and prohibited lists. Check your own board of pharmacy and board of medicine before you treat the federal policy as permission in your state. And because enforcement discretion is a policy, HHS can narrow or withdraw it without notice and comment, so a prescription written under it is written on terms that can change.
In the week of October 23, the Partnership for Safe Medicines filed a citizen petition asking FDA to block compounding of these peptides, RAPS reported, arguing that it is unlawful and unsafe. The same group argues that the reconstituted advisory committee was formed in breach of federal conflict of interest rules, AJMC reported. FDA has not announced a response. Earlier in the month, on October 14, HHS and FDA sent a draft titled "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget for review, Holland & Knight reported, and four outside groups met with reviewers before the notice was filed.
For the six peptides, the conditions double as a diligence checklist. Before you send a prescription, ask the pharmacy for the certificate of analysis and check that it names a registered manufacturer and that manufacturer's location. Confirm the product is a single ingredient in the listed form and route: a BPC-157 and TB-500 blend, an injectable KPV, or a semax injection falls outside the policy. For an oral form, ask to see the bioavailability documentation the policy requires. Our guides to reading a certificate of analysis and vetting a compounding pharmacy walk through those questions.
Then document. Record the peptide, form, route, pharmacy, certificate lot, and the regulatory basis you relied on, with the date, and report serious adverse events through MedWatch yourself as well as through the pharmacy. The consent discussion should say plainly that the product is compounded, unapproved, and supported by limited human evidence. The peptide consent form carries that disclosure.
| Status | Peptides | What a prescriber can rely on |
|---|---|---|
| FDA-approved drugs | Semaglutide, tirzepatide, tesamorelin, bremelanotide, and the other approved peptide drugs | Prescribe the approved product; compounded copies are narrow once a shortage ends |
| HHS enforcement discretion | BPC-157, TB-500, epitalon, MOTS-c, KPV, semax, in the forms and routes above | Compounding by a 503A pharmacy that meets all ten conditions, subject to state law |
| 503A Category 1 | Vasoactive intestinal peptide, GHK-Cu for non-injectable routes, and others | Compounding under FDA's January 2025 interim policy conditions |
| 503A Category 2 | Kisspeptin-10 | FDA has identified significant safety risks; enforcement risk |
| Awaiting a second committee review | Injectable GHK-Cu, LL-37, dihexa, melanotan II, PEG-MGF | No interim protection; FDA plans a meeting before the end of February 2027 |
| Rejected by the committee | Emideltide | No interim protection and no recommendation |
| Research use only vials | Any peptide | Illegal to sell for human use; no protection under any policy |
Our category guide explains how Categories 1, 2, and 3 work and how to check a substance against FDA's current document. The US legality guide covers approved drugs, supplements, and the state rules in Florida, California, and Texas.
The comment period closes on November 13, and HHS may revise the policy after reading the comments, so check the version date on the HHS document before relying on it. The larger step is an FDA proposed rule adding any of the six to the Bulks List, which would open its own comment period; past Bulks List rules have taken years from committee vote to final rule. FDA's second advisory committee meeting on the remaining five peptides is due before the end of February 2027, with no date set on the committee calendar. State boards are the third thing to watch, since their guidance decides what the federal policy means in practice for each license.
| Date | What changed | What it meant |
|---|---|---|
| August and September 2026 | CDC counted more than 25 illnesses in Texas, Washington, Florida, and New York after glutathione injections, and at least three Texas pharmacies recalled compounded glutathione for high endotoxin | An FDA alert of August 27 traced the cases to dietary supplement grade glutathione and told compounders never to use it in injectables. Confirm every injectable ingredient is made for injection |
| August 1, 2026 | Louisiana's Act 374 took effect, barring state licensing boards from stopping pharmacists who compound peptides in compliance with section 503A and USP chapters, or prescribers who order them from compliant 503A or 503B sources | Applies only to peptides absent from FDA's Category 2 and prohibited lists. The Board of Pharmacy bulletin summarizes it |
| August 24, 2026 | FDA sent five warning letters to online peptide sellers | Labels saying "research use only" did not outweigh evidence the products were sold for human use |
| July 23 and 24, 2026 | The advisory committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax for the Bulks List, and against emideltide | An advisory vote, against FDA staff's recommendation. Our meeting takeaways cover each vote |
| June 29, 2026 | FDA posted staff briefing documents recommending against all seven peptides and announced a reconstituted committee | Set up the July votes |
| May 14, 2026 | FDA's category document restored non-injectable GHK-Cu to Category 1 | Injectable GHK-Cu stayed outside every category |
| April 15 to 22, 2026 | FDA removed twelve peptides from Category 2 after their nominations were withdrawn | Removal gave them no interim protection, until the October policy covered six of them |
| March 31, 2026 | FDA issued a warning letter to Gram Peptides, a California seller of retatrutide and tirzepatide labeled for research use | FDA cited unapproved new drugs under section 505(a), because the seller's website showed the products were meant for human use |
| February 27, 2026 | Secretary Kennedy said he expected FDA to widen lawful access to about fourteen peptides | A statement, with no change to the rules |
Every entry is checked against the primary source before it goes in: the Federal Register, FDA's 503A category document and its revision date, FDA's warning letter database, the advisory committee calendar, and regulations.gov dockets. Law firm and trade press coverage helps us find changes, and we cite it only where the primary text is not public. When a status changes, we update this page and the guides that depend on it.
Keeping up with these rules is part of practicing with peptides. Peptavo's course teaches the regulatory pathways, sourcing, consent, and monitoring with accredited CME, and the tracker is where we record what changes after you finish it.
The latest federal action came from HHS: on October 30, 2026, HHS published an enforcement discretion policy for six compounded peptides under ten conditions. FDA has not published a proposed rule adding any peptide to the 503A Bulks List, and its second advisory committee meeting on five more peptides is due before the end of February 2027.
No. The HHS policy is a statement that HHS will not take enforcement action under set conditions. It approves no drug, makes no finding of safety or effectiveness, and adds nothing to the Bulks List.
Six: BPC-157, TB-500, epitalon, MOTS-c, KPV, and semax, each limited to one form and specific routes. Emideltide, GHK-Cu, and every other peptide fall outside it.
No. The policy covers state-licensed pharmacies, federal facilities, and licensed physicians compounding under section 503A, which requires a prescription for an identified patient.
No. The policy binds no state board of pharmacy or medicine, and each state can keep rules stricter than the federal position. Check your state's rules before prescribing.
Comments are due by 11:59 p.m. Eastern on November 13, 2026, on regulations.gov under docket HHS-OASH-2026-0496.
No. Vials sold for research use only are not lawful for human use, and no part of the HHS policy covers them. Only a compounded product from a qualifying pharmacy, or an approved drug, gives a prescriber a lawful source.
