Peptide policy tracker
Where U.S. rules stand on compounding peptides, including the FDA advisory committee votes of July 2026, with each fact tied to its source. The tracker records what regulators and courts have done. It does not tell anyone what to take or where to get it.
Quick answer. As of October 20, 2026, no peptide has been added to the FDA list that lets pharmacies compound from bulk ingredients, and no new interim policy has been issued. An FDA advisory committee voted in July to recommend six of seven peptides it reviewed, against the advice of FDA staff scientists, but its votes are only advice. A draft interim policy went to the White House budget office on October 14 and has not been released. Compounded semaglutide and tirzepatide, and the retatrutide "for research" market, are covered separately by the FDA.
Where things stand
| Topic | Status | Source |
|---|---|---|
| Peptides on the 503A bulks list | None, according to a law-firm review dated October 16, 2026. | Holland & Knight law-firm alert, October 16, 2026. Secondary source |
| FDA staff view of the seven peptides reviewed in July | Recommended against adding any of them. FDA documents reviewed by outside authors said evidence of benefit and safety was not sufficient. | Holland & Knight law-firm alert, October 16, 2026. Secondary source |
| Advisory committee vote, July 23 and 24, 2026 | Recommended six of seven. Advisory only. FDA can accept, reject or delay it. | McDermott Will & Schulte law-firm client alert, July 27, 2026. Secondary source |
| Interim access policy | A draft was sent to the White House Office of Management and Budget for review on October 14, 2026. It has not been issued, and its contents are not public. | Holland & Knight law-firm alert, October 16, 2026. Secondary source |
| Formal rulemaking | No proposed or final rule has been issued. One law-firm review suggests a final rule could come in late 2027 or 2028. | Holland & Knight law-firm alert, October 16, 2026. Secondary source |
| Next committee meeting | Expected before the end of February 2027, for GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF. No date is set. | McDermott Will & Schulte law-firm client alert, July 27, 2026. Secondary source |
| Compounded semaglutide and tirzepatide | The FDA says they are not approved and are not reviewed for safety, effectiveness or quality. The shortages that allowed broad compounding ended in 2024 and 2025. | U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026 |
| Retatrutide and cagrilintide | The FDA says they cannot be used in compounding under federal law. | U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026 |
| Products sold "for research use only" | The FDA says semaglutide, tirzepatide, retatrutide, survodutide and mazdutide have been sold as "for research purposes" or "not for human consumption" while marketed for human use, and it advises against buying them. | U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026 |
| State rules | Differ by state and are not bound by federal interim policy. Ohio, for example, has said Category 2 or 3 peptides cannot be compounded. | McDermott Will & Schulte law-firm client alert, July 27, 2026. Secondary source |
The July 2026 vote
The FDA Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026 to discuss whether seven peptides should go on the 503A bulks list. That list names ingredients that state-licensed pharmacists and physicians may use when compounding for individual patients. The committee voted separately on each peptide in its free base and acetate forms.
Vote counts below come from two secondary reports that agree with each other. The FDA meeting page lists the agenda but does not show the vote results.
| Peptide | Uses the FDA listed | Yes | No | Abstain | Result |
|---|---|---|---|---|---|
| BPC-157 | Ulcerative colitis | 8 | 6 | 1 | Recommended |
| KPV | Wound healing and inflammatory conditions | 8 | 6 | 1 | Recommended |
| TB-500 | Wound healing | 8 | 6 | 1 | Recommended |
| MOTS-c | Obesity and osteoporosis | 7 | 5 | 2 | Recommended |
| Epitalon | Insomnia | 7 | 4 | 1 | Recommended |
| Semax | Cerebral ischemia, migraine, trigeminal neuralgia | 8 | 5 | 1 | Recommended |
| Emideltide (DSIP) | Opioid withdrawal, chronic insomnia, narcolepsy | 6 | 7 | 1 | Not recommended |
The "uses evaluated" column is what the FDA listed for each peptide on its agenda. It is not a statement that any of those uses has been shown to work.
What a yes vote does and does not mean
- It is advice to the FDA. It is not a rule, and it is not an approval of any peptide as a medicine.
- Being on the bulks list would let licensed pharmacies compound from that ingredient for an individual patient on a prescription. It would not mean the FDA has found the peptide safe or effective.
- Adding a substance to the list normally requires notice-and-comment rulemaking. The FDA says it will weigh the committee votes and public comments, and commentary notes it usually follows its advisory committees.
- Critics, including the authors of a Health Affairs commentary (opinion), argue that the evidence is thin, that the members who voted yes had ties to peptide businesses or clinics, and that product quality at compounding pharmacies is hard to assure. Supporters, including HHS Secretary Kennedy and some members of Congress, argue for easing access. The Atlas takes no side and notes both views.
Timeline
- 2023. The FDA places more than a dozen peptides, including BPC-157, in Category 2 of its interim bulks policy. Category 2 flags significant safety concerns. Source: Holland & Knight law-firm alert, October 16, 2026. Secondary source.
- February 27, 2026. HHS Secretary Robert F. Kennedy Jr. publicly backs broader peptide access. Source: Holland & Knight law-firm alert, October 16, 2026. Secondary source.
- April 15, 2026. The FDA announces it will remove 12 peptides from Category 2 after their nominations were withdrawn. This ends the safety designation but does not make them eligible for compounding. Source: Orrick, Herrington & Sutcliffe law-firm alert, April 16, 2026. Secondary source.
- May 14, 2026. The FDA bulks page, current as of this date, explains Categories 1, 2 and 3 and says the list is evaluated through rulemaking and advisory committee review. Source: U.S. Food and Drug Administration. Page content current as of May 14, 2026.
- June 29, 2026. FDA staff recommend against adding the seven peptides. The FDA announces a reconstituted advisory committee, which reports describe as having many members tied to peptide businesses or clinics. Source: Holland & Knight law-firm alert, October 16, 2026. Secondary source.
- July 23 and 24, 2026. The committee meets and votes. Six of seven peptides are recommended. Source: U.S. Food and Drug Administration meeting page. Page content current as of August 6, 2026.
- August 4, 2026. A Health Affairs commentary criticizes the vote and the committee composition. Source: Fu M, Ross JS, Nguyen NAH, Ramachandran R. Health Affairs Forefront, August 4, 2026. Opinion commentary by academic authors.
- August 24, 2026. The FDA issues five warning letters to online peptide vendors, finding that "research use only" labels did not outweigh evidence of human use, according to a law-firm review. Source: Holland & Knight law-firm alert, October 16, 2026. Secondary source.
- October 1, 2026. The FDA updates its page on unapproved GLP-1 drugs. Source: U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026.
- October 14, 2026. HHS sends a draft "interim access policy for compounding using certain peptides" to the White House budget office for review. Reports say it could let pharmacies compound some peptides while rulemaking is pending. It has not been issued. Source: STAT News, October 15, 2026. News report.
What is still pending
- Whether the White House clears the interim policy and the FDA issues it, and what it would cover.
- Whether the FDA accepts the committee votes and starts rulemaking.
- The second committee meeting on GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF.
- Possible legal challenges. A law-firm review notes that pharmaceutical trade groups have argued the FDA cannot authorize compounding through an interim policy while rulemaking is pending.
- Federal funding decisions. The FDA is funded under a temporary measure through December 11, 2026, according to the same review.
What this means for readers
- An approved medicine has been reviewed by the FDA for safety, effectiveness and quality. A compounded product has not, and a bulks-list ingredient would not change that.
- Most published research on these peptides is animal or laboratory work. The Atlas pages on the individual peptides label the evidence level.
- Rules may differ by state, by pharmacy type and by month. Ask your own clinician and pharmacist what applies to you.
Related: Compounded versus brand-name medicines | What a 503A pharmacy is | News
Questions to ask
- Is the product I am being offered an FDA-approved medicine, a compounded product, or something sold for research?
- Which pharmacy makes it, and is it licensed in my state?
- What evidence in people exists for this use?
- What happens to my plan if the rules change?
What is still unknown
- What the interim access policy says, and whether it will be issued.
- Whether the FDA will follow the committee or its own staff.
- The exact vote counts are from secondary reports. The FDA meeting page does not publish them.
- How state boards of pharmacy will respond.
Not medical or legal advice. This tracker records what regulators and courts have done. It does not say what anyone should take, where to get it, or what is legal in your state.
Sources
- Bulk drug substances used in compounding under section 503A of the FD&C Act U.S. Food and Drug Administration. Page content current as of May 14, 2026. Regulator
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee U.S. Food and Drug Administration meeting page. Page content current as of August 6, 2026. Regulator
- Bulk-list bound? PCAC backs majority of peptides in two-day public meeting McDermott Will & Schulte law-firm client alert, July 27, 2026. Secondary source. Trade press, secondary source
- FDA committee recommends looser restrictions for several peptides Healio, July 24, 2026 (page modified September 15, 2026). Trade press report. Trade press, secondary source
- Peptides at a crossroads: what wellness providers need to know about HHS and FDA actions Holland & Knight law-firm alert, October 16, 2026. Secondary source. Trade press, secondary source
- FDA announces removal of 12 peptides from Category 2 and schedules PCAC meetings Orrick, Herrington & Sutcliffe law-firm alert, April 16, 2026. Secondary source. Trade press, secondary source
- Trump administration advances plan for peptide drugs favored by RFK Jr. STAT News, October 15, 2026. News report. Trade press, secondary source
- FDA advisory committee's vote may open a drug-compounding back door for unapproved peptides Fu M, Ross JS, Nguyen NAH, Ramachandran R. Health Affairs Forefront, August 4, 2026. Opinion commentary by academic authors. Trade press, secondary source
- FDA's concerns with unapproved GLP-1 drugs used for weight loss U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026. Regulator