— November 14, 2026 · Health Department Says It Will Not Act Against Pharmacies Compounding Six Peptides, Under Ten Conditions

Table of Contents

1. At a Glance
2. What the Department Announced
3. The Six Peptides and the Forms Covered
4. The Ten Conditions in Plain Words
5. What the Policy Does Not Do
6. How the Policy Came About
7. The Peptide Left Out, and the Others Not Covered
8. What the Research Shows So Far
9. What Happens Next
10. Reading the Headlines
11. Sources and Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

At a Glance

The forms and routes come from Appendix B of the Department’s policy. The votes are the counts read aloud “for the record” on the U.S. Food and Drug Administration’s own webcast of the Pharmacy Compounding Advisory Committee meeting of 23–24 July 2026; each peptide received the same count for its free base and its acetate form. No written minutes or transcript of the meeting had been posted as of 14 November 2026.

• 10 conditions must all be met for the Department’s non-enforcement statement to apply.
• 13 November 2026 — the last day of the two-week public comment period. The Federal Register’s record showed 289 comments received by 14 November; 115 had been posted publicly on regulations.gov.
• No end date — the policy runs, peptide by peptide, until a final rule decides whether that peptide goes on the compounding list. It names no start date either.
• 0 of 7 — the number of these peptides the U.S. Food and Drug Administration’s staff proposed adding to the list. The committee voted the other way on 6.

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What the Department Announced

The document is titled “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” It describes itself as setting out “the Secretary of the Department of Health and Human Services’ (HHS) enforcement policy regarding the use of certain peptide bulk drug substances in compounding while the list of bulk drug substances that can be used in compounding under section 503A … is developed through rulemaking.”

Three terms explain what that means:

• Compounding is the preparation of a medicine by a pharmacist or physician, usually for one patient, rather than by a drug manufacturer. Compounded drugs are not approved by the U.S. Food and Drug Administration. The policy itself says so: “Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.”
• Section 503A of the Federal Food, Drug, and Cosmetic Act sets the rules under which a state-licensed pharmacy, a federal facility or a licensed physician may compound. One rule is that the raw active ingredient — the bulk drug substance, usually a powder — must be part of an approved drug, have an official United States Pharmacopeia monograph, or appear on a list the government builds by regulation, the “503A bulks list.” None of the six peptides meets any of the three.
• Enforcement discretion means the government says it does not intend to act against conduct that falls outside the law’s requirements, in stated circumstances. The rule itself does not change.

The policy’s operative sentence reads: “Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list, HHS does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product, the subject of an applicable USP or NF monograph, or on the 503A bulks list … when all of the following circumstances are present.” Ten numbered conditions follow, then Appendix A, which the document calls the “503A Interim Access List,” naming the six peptides.

The Department gave three reasons. First, “based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding,” and that public comments “may provide additional evidence that FDA can consider in rulemaking.” Second, the Secretary “has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients,” offering “a more controlled alternative.” Third, the Secretary “has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.” The document does not identify the utilization data it mentions.

Some details of the record:

• The Federal Register lists the issuing office as the Office of the Secretary; the contact person is in the Office of the Assistant Secretary for Health, and the comment docket is HHS-OASH-2026-0496 on regulations.gov.
• The policy PDF on the Department’s website carries no date and no signature. The Federal Register notice is the only document bearing the Secretary’s name, and no signing date appears in any primary record.
• The notice was filed for public inspection at 11:15 a.m. on 28 October 2026 and published on 30 October 2026. Reports that it was “published in the Federal Register” on 28 October confuse the filing date with the publication date.
• No effective date is stated, and no press release from the Department was found.
• The Department re-posted its PDF on 6 November 2026; a sentence-by-sentence comparison with the first version found no change to the peptides, routes or conditions.

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The Six Peptides and the Forms Covered

Each peptide can be made in more than one chemical form. The free base is the peptide alone; the acetate is the peptide paired with acetic acid, a salt form that is often more stable as a powder. Because they are chemically different, the U.S. Food and Drug Administration treats them as separate bulk drug substances, and its advisory committee voted on each form separately. The Department’s policy covers only one form of each peptide, and only certain routes. Condition 2 ties the conditions to these limits: the ingredient must have “the identity and limitations in route of administration described in Appendix B,” including its amino acid sequence, structure, molecular weight and formula.

• Body Protection Compound-157 (acetate) — a chain of 15 amino acids. Covered for “subcutaneous, intramuscular, oral, and topical dosage forms” — injection under the skin or into muscle, by mouth, or on the skin. It is the only peptide covered for all four.
• Thymosin Beta-4 Fragment (acetate) — seven amino acids, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln. Covered for injection under the skin or into muscle. The Department’s document calls it only “TB-500”; the name “Thymosin beta-4, fragment” is the one the U.S. Food and Drug Administration uses.
• Lysine-Proline-Valine (acetate) — three amino acids. Covered for “topical and oral dosage forms” only, not injection.
• Mitochondrial Open Reading Frame of the 12S rRNA-c (acetate) — 16 amino acids. Covered for injection under the skin or into muscle.
• Semax (free base) — seven amino acids, Met-Glu-His-Phe-Pro-Gly-Pro. Covered for “intranasal use” only. It is the one peptide covered in its free-base form.
• Epitalon (acetate) — four amino acids, Ala-Glu-Asp-Gly. Covered for injection under the skin or into muscle, in forms “dispensed in intermittent courses.”

Every route sentence in Appendix B ends with the same requirement: the medicine must be “compounded from API accompanied by a certificate of analysis (CoA) meeting the conditions of this policy” — that is, from an active ingredient that comes with a laboratory certificate showing what it is and how pure it is. A footnote to the appendix’s testing table says those quality tests are written for injectable forms, “which should be the standard route of administration (ROA) for peptides due to their low oral bioavailability,” even though oral, skin and nasal routes are covered for three of the six.

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The Ten Conditions in Plain Words

All ten must be present at once. The wording below is a plain summary; the quoted phrases are the document’s own.

1. On the list. The peptide is one of the six in Appendix A, the “503A Interim Access List.”
2. Right identity and route. The ingredient matches the identity in Appendix B — amino acid sequence, chemical structure, molecular weight and formula — and is used only by the routes listed there.
3. Tested ingredient. The ingredient comes from a facility registered with the U.S. Food and Drug Administration and with a valid certificate of analysis whose results meet the agency’s guidance-based criteria. The stated purpose is “assurance that what a compounder receives from a supplier is what it claims to be” and has been tested for identity, purity, potency, and contaminants “such as endotoxins, heavy metals, microbial contamination, and impurities.”
4. Known original maker. The original manufacturer — “not a subsequent packer, repacker, labeler, or distributor” — is registered with the agency, follows current good manufacturing practice, and has its physical address on the certificate. A registered repacker or reseller must itself have checked the manufacturer and the manufacturer’s certificate.
5. Reporting. The compounder reports serious adverse events “regardless of whether or not considered drug related,” and product-quality problems, to the U.S. Food and Drug Administration’s MedWatch program and to the states where the products are made and sent. Each report names the active ingredient and its strength, the original manufacturer with its facility identifier, and the dosage form and route. The document adds that the reporting procedure “should be detailed on the product labeling provided to the patient.”
6. Label statement. The label reads: “This is a compounded drug product. Not for resale.”
7. One peptide per product. No mixtures. The stated reason is that a single active ingredient makes it easier “to attribute adverse events or clinical outcomes to a specific substance.”
8. Proof for pills. Because “achieving adequate oral bioavailability of peptides is inherently difficult,” a compounder making a by-mouth form is expected to keep documentation that the specific formulation “achieves an adequate level of oral bioavailability in humans” — that enough of the peptide is absorbed.
9. Syringes only. The only delivery device packaged with the medicine is a syringe cleared by the U.S. Food and Drug Administration through its premarket notification (510(k)) process, because “more complex drug delivery devices introduce additional patient risk.” The document does not say how intranasal Semax is to be delivered under this condition.
10. Every other law still applies. The medicine must meet all other requirements of the Federal Food, Drug, and Cosmetic Act, including that it not be made under insanitary conditions and that section 503A’s “patient specific prescription requirement” is met — a prescription for a named patient.

The document does not mention informed consent, and it contains no ban on foreign ingredient makers as such: its test is registration with the agency and compliance with manufacturing rules.

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What the Policy Does Not Do

Much of the coverage has asked whether the six peptides are now “legal.” The documents themselves set out several limits:

• It is not an approval. None of the six is a U.S. Food and Drug Administration-approved drug, and the policy repeats that compounded drugs are not reviewed by the agency for safety, effectiveness or quality before they are sold.
• It is not a listing. The six peptides are not on the 503A bulks list. The policy applies only “while the list … is developed through rulemaking,” and the Federal Register notice says only that the agency’s “future rulemakings may propose adding some or all of these peptides to the 503A bulks list based on the available evidence.”
• It is not binding. In the notice’s words, it “does not establish any rights for any person and is not binding on HHS or the public.” Its own phrasing is that the Department “does not intend to take action” — a statement of intent, not a permission.
• It covers three kinds of compounder only. The policy names “a State-licensed pharmacy, Federal facility, or licensed physician.” Large-scale outsourcing facilities, which operate under a separate section of the law, section 503B, are not among them. The document has no sentence that excludes them in so many words; the exclusion follows from the list of who is covered.
• It keeps the prescription rule. Condition 10 keeps section 503A’s requirement of a valid prescription for an individual patient.
• It does not cover products sold “for research use only.” The Department describes the policy as a way to discourage the use of “research-use-only peptides supplied by foreign manufacturers.” Nothing in it applies to sellers who are not one of the three kinds of compounder.
• It can end early. “HHS may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises.” Otherwise it ends for each peptide when a final rule decides that peptide’s place on the list, either way.
• It covers one form and set routes. The free base of five peptides and the acetate of Semax are outside it, as are routes not named in Appendix B — for example, injected Lysine-Proline-Valine or Semax given by injection.

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How the Policy Came About

The policy is the latest step in a three-year sequence, most of it reported on this site’s page U.S. Food and Drug Administration (FDA) Review of Compounded Peptides Including BPC-157 (2026).

• September 2023 — Category 2. According to the Department’s document, the six peptides were in the U.S. Food and Drug Administration’s “Category 2” from September 2023 (29 September 2023 for four of them). Category 2 is the agency’s interim list of nominated ingredients for which it “has identified significant safety risks relating to the use of these substances in compounding.”
• April 2026 — nominations withdrawn. The nominators of the peptides for the compounding list withdrew their nominations; the withdrawal letters were posted to the agency’s nominations docket on 14 and 29 April 2026. The Category 2 page, “content current as of 04/22/2026,” moved the peptides into a table of substances “nominated but withdrawn” while keeping its safety notes for each. The Department’s document says the peptides were in Category 2 “until April 22, 2026,” and that “neither the placement nor the removal changed [their] status under section 503A.”
• 16 April 2026 — meeting called. A Federal Register notice (91 FR 20465) set a Pharmacy Compounding Advisory Committee meeting for 23–24 July 2026 on seven peptides. Although the nominations had been withdrawn, the agency’s briefing documents say it was “electing to proceed” with the review.
• May 2026 — the staff proposals. The agency’s briefing memoranda, dated May 2026, proposed for all fourteen peptide forms that each “NOT be included on the 503A Bulks List,” weighing four criteria: chemical characterization, safety, evidence of effectiveness, and historical use in compounding.
• 23–24 July 2026 — the votes. The committee voted the other way on twelve of the fourteen forms, recommending six peptides and rejecting only emideltide. An agency participant told the committee during the meeting that its recommendations “weren’t final decisions. So the final decisions would come out through rulemaking.” The agency’s calendar page describes advisory committees as making “non-binding recommendations.”
• Before the meeting — membership. The Associated Press reported that “more than a half-dozen people with connections to the peptide industry were added to the group” before the meeting, and that members from academic backgrounds mostly voted against. A spokesperson for the Department was quoted in a Reuters report as saying that “all committee members underwent the same ethics review and vetting process required of all FDA advisory committee members.”
• 28–30 October 2026 — the policy. The Department’s document cites the committee only as having “voted in favor”; for every one of the six it records that the agency’s drug-review center “recommended against listing either form.” Appendix B gives a “threefold” justification for each peptide: historical use “is now documented and quantified”; lot-by-lot certificates from registered facilities now supply test results the center “found missing/lacking”; and the center’s safety concerns were, in the Department’s words, “inferential rather than observed” or “mechanistic rather than observed.”

On the day the policy was posted, the Associated Press reported that U.S. Food and Drug Administration scientific staff “had little input on the decision and opposed the changes, according to six people familiar with its development,” and that the Department had included several safety measures suggested by agency staff, such as side-effect reporting and purity checks. These accounts come from unnamed sources and do not appear in the primary documents. No statement by the U.S. Food and Drug Administration about the policy was found on its website as of 14 November 2026.

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The Peptide Left Out, and the Others Not Covered

Emideltide, a nine-amino-acid peptide also known as delta sleep-inducing peptide, was reviewed on 24 July 2026 for opioid withdrawal, chronic insomnia and narcolepsy. The agency’s staff proposed not listing it; the committee agreed, by six votes to seven with one abstention on each form. Some coverage reported the result as “7–6,” meaning seven votes against. The briefing found only small intravenous studies from 1981 to 1998, none using the proposed under-the-skin injection. Emideltide is not in the Department’s Appendix A, so the policy does not apply to it.

The April 2026 Category 2 page lists seventeen peptides as “nominated but withdrawn.” Besides the six in the policy and emideltide, they include AOD-9604, cathelicidin LL-37, CJC-1295, dihexa acetate, copper peptide GHK-Cu (for injection), ipamorelin acetate, pegylated mechano growth factor, melanotan II, selank acetate and thymosin alpha-1. None of these was on the July agenda, and none is in the Department’s policy. The Category 2 page still carries the agency’s safety notes for them — for melanotan II, for example, it cites published case reports of serious adverse events. The agency’s own list of ingredient categories states that it intends to consult the committee “before the end of February 2027” about copper peptide GHK-Cu.

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What the Research Shows So Far

For all six peptides most of the published research is in cells and animals. The U.S. Food and Drug Administration’s briefings found no human study at all for three of them, and small or indirect studies for the rest. A 2026 review in a pharmacy-compounding journal examined the uses proposed for these peptides and the concerns raised during the committee review (Willis and Vu, 2026). The summaries below report findings, not uses.

• Body Protection Compound-157. First described in 1993, it was reviewed for ulcerative colitis. The agency found one meeting abstract of a two-week trial in 53 people given the peptide as an enema, which it judged “inadequate to support the efficacy and safety” of that use, and three reports in its adverse event reporting system, all with injected products, where it was unclear whether the peptide was the cause. A 2025 systematic review of its use in sports medicine found 36 studies, 35 of them preclinical; the one human study was a retrospective report in which 7 of 12 people with knee pain reported relief for more than six months after an injection, and the authors found no clinical safety data (Vasireddi and colleagues, 2025). A 2025 review notes that it has not been approved by regulators “due to the absence of sufficient and comprehensive clinical studies” (Józwiak and colleagues, 2025).
• Thymosin Beta-4 Fragment. A seven-amino-acid piece (positions 17 to 23) of thymosin beta-4, a 43-amino-acid protein found in the body. The agency found no study of the fragment in humans and no reports in its adverse event system. Much of the wound-healing research concerns the whole protein: in a 1999 rat study, thymosin beta-4 applied to the wound or injected into the abdominal cavity sped the closing of full-thickness wounds (Malinda and colleagues, 1999). The Department’s document notes that “the fragment is rapidly truncated in human serum.”
• Lysine-Proline-Valine. A three-amino-acid fragment of alpha-melanocyte-stimulating hormone, reviewed for wound healing and inflammatory conditions. The agency found no human data by any route. In a 2008 study in human cell lines and in mice, it reduced inflammatory signalling, and given in drinking water it reduced chemically induced colitis in mice (Dalmasso and colleagues, 2008).
• Mitochondrial Open Reading Frame of the 12S rRNA-c. A 16-amino-acid peptide encoded in the DNA of mitochondria, the cell’s energy-producing structures, first reported in 2015; in mice it prevented diet-induced obesity and insulin resistance (Lee and colleagues, 2015). It was reviewed for obesity and osteoporosis, and the agency found no human safety or effectiveness information. The Department’s document cites “a randomized placebo-controlled trial of a MOTS-c analogue” — a related molecule, not the peptide itself — that “reported no serious adverse events”; it does not identify the trial.
• Semax. A seven-amino-acid synthetic analogue of a fragment of adrenocorticotropic hormone (positions 4 to 10), studied mainly in Russia, where the briefing notes a nasal product is registered, and reviewed for reduced blood flow to the brain, migraine and trigeminal neuralgia. The agency’s briefing relied on one meeting abstract and one small uncontrolled study; it set aside Russian-language stroke trials because no English versions were available, and found one report in its adverse event system. One such trial, published in Russian in 2018, followed 110 people after ischemic stroke and reported higher blood levels of brain-derived neurotrophic factor, a nerve-growth protein, and better daily-function scores in the groups given Semax; the abstract does not describe the groups as randomized (Gusev and colleagues, 2018). The Department’s document states that the human record the agency compiled for nasal use “covers several hundred subjects with no reported adverse outcome.”
• Epitalon. A synthetic four-amino-acid peptide based on epithalamin, an extract of the pineal gland, reviewed for insomnia. The agency’s briefing cited one human study, of the peptide given under the tongue to women working night shifts, which did not measure sleep. A 2026 review concluded that human evidence “is limited to small physiological or biomarker studies,” that “no adequately powered randomized trial has established therapeutic efficacy,” and that the peptide is “biologically active but clinically unproven” (Jain and colleagues, 2026).

For each of the six, the agency’s briefing listed a lack of evidence of effectiveness for the use it reviewed among its reasons for proposing not to list the peptide. Some of its adverse event searches ran more than a year before the May 2026 memoranda were written (through March 2024 for emideltide and March 2025 for Thymosin Beta-4 Fragment).

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What Happens Next

The comment period closed at 11:59 p.m. Eastern Time on 13 November 2026; the Federal Register notice said only that comments could be sent “until 2 weeks after date of publication,” and regulations.gov shows the closing time. Late comments were not accepted. The Associated Press reported that the Department would take comments for two weeks “before finalizing the measure.” As of 14 November 2026 no final version had been published.

The longer process belongs to the U.S. Food and Drug Administration. Placing a peptide on the 503A bulks list, or deciding against it, is done by notice-and-comment rulemaking: a proposed rule in the Federal Register, public comment, then a final rule. During the July meeting an agency participant said: “we don’t have a deadline for entering into that rule making.” Predictions of a rule in 2027, or within a stated number of months, come from secondary sources and are not in any agency document.

Status as of 14 November 2026, from the public record:

• No proposed or final rule adding any of the seven July peptides to the 503A bulks list, or excluding them, has been published in the Federal Register.
• The U.S. Food and Drug Administration’s Category 2 page is unchanged since April 2026 (“content current as of 04/22/2026”) and does not mention the July meeting or the policy. None of the seven peptides is in Category 1.
• The agency’s page for the July meeting lists no minutes, summary or transcript; the vote counts exist only in its recorded webcast.
• On 24 August 2026 the agency’s drug center issued five warning letters to online peptide sellers. The letters state that “despite statements on your product labeling marketing your products for ‘research use only’ … evidence obtained from your website establishes that your products are intended to be drugs for human use.” None of the five names any of the seven peptides discussed here.
• The policy itself can be revisited “if, among other things, a safety signal or product quality issue arises,” and the reports compounders must send to MedWatch under condition 5 are the stated way such signals would be found.

The six peptides’ pages and the page U.S. Department of Health and Human Services Interim Policy on Compounding Six Peptides (2026) will be updated if a final policy or a proposed rule is published.

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Reading the Headlines

Headlines and videos since late October have asked whether peptides are “legal now.” The documents answer in narrower terms. Three different things are often run together:

• Legal status under section 503A. This has not changed. A compounder may use a bulk drug substance that is part of an approved drug, has an official monograph, or is on the 503A bulks list; none of the six is in any of those groups. Only a final rule changes that.
• Enforcement discretion. This is what changed. The Department says it does not intend to act against three kinds of compounder who meet all ten conditions, for the forms and routes in Appendix B, while the rulemaking continues. It is not binding and can be revisited.
• Approval. None of the six peptides is approved by the U.S. Food and Drug Administration for any use, and the agency’s staff found the evidence of effectiveness and safety in humans lacking for every use it reviewed. A committee vote and an enforcement policy are not approvals.

Other points of fact that headlines have varied on: the committee’s epitalon vote was 7–4–1, not 7–5–1 as some outlets printed — only twelve members were eligible to vote on that peptide under the agency’s roster, and every tally adds up to the eligible number; the “8–6, with one abstention” result applies to Body Protection Compound-157, Thymosin Beta-4 Fragment and Lysine-Proline-Valine only; and the Federal Register publication date is 30 October 2026, not 28 October.

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Sources and Primary Documents

The policy documents were read in full, including through Internet Archive copies where the Department’s site could not be reached. The committee vote counts were taken from the U.S. Food and Drug Administration’s own webcast of the meeting, whose addresses are given in the agency’s webcast information document; each count was checked against the meeting roster. Press reports are cited only where the article says “reported.”

1. U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendix A (503A Interim Access List) and Appendix B (Peptide Identities and Justifications). — Full policy with appendices (PDF, hhs.gov); four-page policy (PDF, hhs.gov); archived copy, 11 November 2026
2. Office of the Secretary, U.S. Department of Health and Human Services (30 October 2026). Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. Federal Register 91:68526-68527, FR Doc. 2026-22192. — Federal Register notice; official PDF (govinfo.gov)
3. Public comment docket HHS-OASH-2026-0496. — regulations.gov docket
4. U.S. Food and Drug Administration (16 April 2026). Pharmacy Compounding Advisory Committee; Notice of Meeting. Federal Register 91:20465, FR Doc. 2026-07361, Docket No. FDA-2025-N-6895. — Federal Register notice
5. U.S. Food and Drug Administration. July 23–24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (calendar page with event materials). — fda.gov meeting page
6. U.S. Food and Drug Administration. Briefing Document, Introduction, Pharmacy Compounding Advisory Committee, 23–24 July 2026. — fda.gov/media/193342
7. U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Questions (fourteen votes). — fda.gov/media/193711
8. U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Final Meeting Roster. — fda.gov/media/193772
9. U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee, 23–24 July 2026: Webcast Information (the record of the meeting and its votes). — fda.gov/media/193710
10. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 page), content current as of 22 April 2026. — fda.gov Category 2 page
11. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, content current as of 14 May 2026. — fda.gov 503A bulks page
12. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letters dated 24 August 2026 to online peptide sellers, MARCS-CMS 733652, 734884, 735063, 735067 and 735127. — fda.gov warning letters database
13. Associated Press (28 October 2026). Report on the U.S. Food and Drug Administration staff’s role in the peptide policy, by Matthew Perrone (reprint). — Associated Press report

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Key Research Papers

Each entry was checked against PubMed before it was written down; the findings quoted above come from these abstracts.

1. Willis J, Vu N (2026). Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards. International Journal of Pharmaceutical Compounding 30(4):329-336. — PubMed PMID: 42752426
2. Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, et al. (2025). Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal 21(4):485-495. — PubMed PMID: 40756949
3. Józwiak M, Bauer M, Kamysz W, Kleczkowska P (2025). Multifunctionality and Possible Medical Application of the BPC 157 Peptide—Literature and Patent Review. Pharmaceuticals (Basel) 18(2):185. — PubMed PMID: 40005999
4. Malinda KM, Sidhu GS, Mani H, Banaudha K, Maheshwari RK, Goldstein AL, et al. (1999). Thymosin beta4 accelerates wound healing. Journal of Investigative Dermatology 113(3):364-368. — PubMed PMID: 10469335
5. Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin D (2008). PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation. Gastroenterology 134(1):166-178. — PubMed PMID: 18061177
6. Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, et al. (2015). The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metabolism 21(3):443-454. — PubMed PMID: 25738459
7. Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN (2018). The efficacy of semax in the treatment of patients at different stages of ischemic stroke [article in Russian]. Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova 118(3 Vyp. 2):61-68. — PubMed PMID: 29798983
8. Jain A, Gallacher DM, Issa MA, Deer TR, Yong RJ, Diwan S, et al. (2026). Epitalon and Epithalamin: A Narrative Review of Mechanistic, Preclinical, and Clinical Evidence. International Journal of Molecular Sciences 27(19):8922. — PubMed PMID: 42884164
9. Graf MV, Kastin AJ (1984). Delta-sleep-inducing peptide (DSIP): a review. Neuroscience and Biobehavioral Reviews 8(1):83-93. — PubMed PMID: 6145137

PubMed Topic Searches

1. PubMed: Peptides in pharmacy compounding
2. PubMed: Body Protection Compound-157
3. PubMed: Mitochondrial-derived peptides
4. PubMed: Peptide immunogenicity and impurities

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Connections

• News Archive
• Peptides — the hub for the six peptides in the policy
• Body Protection Compound-157
• Thymosin Beta-4 Fragment
• Lysine-Proline-Valine
• Mitochondrial Open Reading Frame of the 12S rRNA-c
• Semax
• Epitalon
• U.S. Department of Health and Human Services Interim Policy on Compounding Six Peptides (2026) — the policy in full
• U.S. Food and Drug Administration Review of Compounded Peptides (2026) — Category 2, the July meeting and the agency’s review
• U.S. Food and Drug Administration Actions in 2026
• U.S. Food and Drug Administration Proposal on Compounded Semaglutide and Tirzepatide (2026) — another 2026 compounding action
• U.S. Food and Drug Administration Ends the Semaglutide Shortage and Compounded Copies (2025) — how compounding rules changed for another peptide drug
• Drugs — the site’s drug pages
• Ulcerative Colitis — the use reviewed for Body Protection Compound-157
• Wound Healing: What Actually Speeds Repair — the use reviewed for Thymosin Beta-4 Fragment and Lysine-Proline-Valine
• Obesity and Osteoporosis — the uses reviewed for Mitochondrial Open Reading Frame of the 12S rRNA-c
• Insomnia — the use reviewed for Epitalon and emideltide
• Telomeres: Why Cells Grow Old — the cell biology behind Epitalon research
• U.S. Food and Drug Administration and Regulation — the site’s section on regulatory actions

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