U.S. Department of Health and Human Services Interim Policy on Compounding Six Peptides (2026)
On 30 October 2026 the Federal Register published a notice from the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) announcing a policy on compounding with six peptides. Under it, the department “does not intend to take action” against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug from one of six peptide raw ingredients — Body Protection Compound-157 (BPC-157), Epitalon, Lysine-Proline-Valine (KPV), Mitochondrial Open Reading Frame of the 12S rRNA-c (MOTS-c), Semax and Thymosin Beta-4 Fragment (TB-500) — in one named chemical form and for named routes only, when all ten of the policy’s conditions are met. The policy runs until a final rule decides, peptide by peptide, whether each one belongs on the list of ingredients that pharmacies may compound with.
The policy followed the July 2026 meeting of the U.S. Food and Drug Administration (FDA) Pharmacy Compounding Advisory Committee, which voted to recommend these six peptides for that list after the agency’s own staff had proposed that none of them be listed. It is not an approval. The Federal Register notice calls it a “draft” policy and says it “does not establish any rights for any person and is not binding on HHS or the public”; the policy document itself calls it “this interim policy.” Written comments were accepted until 13 November 2026.
This page reports what the documents say and where matters stood on 14 November 2026. The department’s website could not be reached from the server that prepared this page, so its documents were read through the Internet Archive’s copies. The background is on the page U.S. Food and Drug Administration (FDA) Review of Compounded Peptides Including BPC-157 (2026); see also the news article Six Peptides: The HHS Compounding Policy and Its Limits and the Peptides section, which has a page for each peptide.
Table of Contents
- What the Department Did
- Enforcement Discretion, 503A and the Bulks List in Plain Terms
- The Six Peptides, Forms and Routes
- The Ten Conditions
- The Stated Reasons
- How It Relates to the July 2026 Advisory Committee and the U.S. Food and Drug Administration’s Proposals
- What the Policy Does Not Do
- What Was Left Out
- Comments and Next Steps
- Dates and Status as of 14 November 2026
- How This Fits Earlier Actions
- Primary Documents
- Key Research Papers
- Connections
- Featured Videos
1. What the Department Did
- The document. “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” A four-page file holds the policy, its ten conditions and Appendix A, the list of six peptides. A sixteen-page file, named “appendix-b” but in fact the whole document, adds Appendix B: an identity sheet and justification for each peptide, and a testing standard for the ingredient’s certificate of analysis. Neither file carries a date, signature or version number.
- The office. The Federal Register notice names the issuing agency as the “Office of the Secretary, Department of Health and Human Services.” Its contact person sits in the Office of the Assistant Secretary for Health, and the public docket carries that office’s prefix: HHS-OASH-2026-0496.
- The official. The notice is signed “Robert F. Kennedy, Jr., Secretary, Department of Health and Human Services.” No signing date appears in any of the records; the Federal Register’s own data give none.
- The publication. The notice was filed for public inspection at the Office of the Federal Register at 11:15 a.m. on 28 October 2026 and published on Friday 30 October 2026 in volume 91 of the Federal Register, pages 68526–68527 (cited as 91 FR 68526; document number 2026-22192; Regulation Identifier Number 0910-ZD94). It is a “notice of availability” in the Notices section, not a rule, and regulations.gov classes its docket as “Nonrulemaking.” The policy file was already on the department’s website on 28 October, when the Internet Archive first copied it.
- No start date. Neither the policy nor the notice states an effective date, and the Federal Register’s data leave that field empty.
- Draft or interim. The notice twice calls the document a “draft” policy and once “this interim policy.” The policy document never uses the word “draft”: it calls itself “this interim policy,” heads its operative section “HHS Interim Enforcement Policy” and calls Appendix A the “503A Interim Access List.”
No press release about the policy was found on the department’s website or in the Internet Archive, and no statement about it on the U.S. Food and Drug Administration’s website. The documents give no reason why the Secretary’s office, rather than the agency, issued it; they note only that the 503A list is one the Secretary develops by regulation. One observation: the Regulation Identifier Number prefix 0910 and the notice’s billing code are those normally used for U.S. Food and Drug Administration documents.
2. Enforcement Discretion, 503A and the Bulks List in Plain Terms
Compounding is the preparation of a medicine by a pharmacist or physician for an individual patient rather than by a drug manufacturer. The policy repeats the standard warning: “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 lets a licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, compound drugs for a specific patient without the drug-approval, labeling and factory-manufacturing rules — but only from eligible ingredients. A bulk drug substance is the raw active ingredient, usually a powder. It is eligible only if it has a United States Pharmacopeia or National Formulary monograph (an official quality standard), is a component of an approved drug, or appears on the 503A Bulks List in federal regulations (Title 21 of the Code of Federal Regulations, section 216.23(a)), which changes only by notice-and-comment rulemaking. The six peptides meet none of the three.
Enforcement discretion is a government agency’s stated decision not to take action against certain conduct, in certain circumstances, even though that conduct does not meet the law’s requirements. It does not change the law, it gives no one a legal right, and the agency can change or withdraw it. The policy’s own wording reflects this: “HHS does not intend to take enforcement action” and “HHS may revisit application of this interim policy (in whole or in part).” The U.S. Food and Drug Administration has used the same tool for years: under its interim policy for “Category 1” substances, nominated ingredients still awaiting a listing decision, it does not intend to act against compounders who meet that guidance’s conditions.
A free base is the peptide molecule on its own; an acetate is the same peptide paired with acetate, the salt form of acetic acid, the acid in vinegar. The U.S. Food and Drug Administration treats the two as separate bulk drug substances, and the policy covers only one form of each peptide. A certificate of analysis is the document a manufacturer issues for each batch of an ingredient, reporting the tests run on it and their results. Section 503B covers a different kind of compounder, larger “outsourcing facilities” that make compounded drugs in bulk.
3. The Six Peptides, Forms and Routes
Appendix A lists the six in this order: “1. BPC-157 2. Epitalon 3. KPV 4. MOTS-c 5. Semax 6. TB-500.” Appendix B defines each by its amino-acid sequence, chemical formula and molecular weight, and limits each to one form and to named routes. The use the U.S. Food and Drug Administration reviewed for each peptide at the July 2026 committee meeting is added for reference; the policy itself does not limit any peptide to a disease or use.
| Peptide | Form covered | Routes covered | Size | Use reviewed in July 2026 |
|---|---|---|---|---|
| Body Protection Compound-157 | Acetate | Injection under the skin or into a muscle; oral; topical (on the skin) | 15 amino acids | Ulcerative colitis |
| Thymosin Beta-4 Fragment | Acetate | Injection under the skin or into a muscle | 7 amino acids | Wound healing |
| Epitalon | Acetate | Injection under the skin or into a muscle, “dispensed in intermittent courses” | 4 amino acids | Insomnia |
| Semax | Free base | Intranasal (in the nose) | 7 amino acids | Cerebral ischemia, migraine and trigeminal neuralgia |
| Lysine-Proline-Valine | Acetate | Topical and oral | 3 amino acids | Wound healing and inflammatory conditions |
| Mitochondrial Open Reading Frame of the 12S rRNA-c | Acetate | Injection under the skin or into a muscle | 16 amino acids | Obesity and osteoporosis |
Each route sentence in Appendix B ends with the same limit: the dosage forms must be “compounded from API accompanied by a CoA meeting the conditions of this policy” — that is, from an active ingredient that comes with a certificate of analysis meeting the policy’s terms. Condition 2 then ties every compounded product to “the identity and limitations in route of administration described in Appendix B.” Semax is the only peptide covered as a free base; the other five are covered only as acetates.
Some details of the text, as written:
- Naming. The department’s document calls Thymosin Beta-4 Fragment only “TB-500,” defined by its sequence of seven amino acids; the U.S. Food and Drug Administration’s Category 2 page names it “Thymosin beta-4, fragment (LKKTETQ),” “also known as TB-500.”
- Injection as the standard. A footnote in Appendix B says injectable forms “should be the standard route of administration (ROA) for peptides due to their low oral bioavailability,” yet the policy also covers oral, topical and intranasal forms.
- Nasal delivery. Condition 9 allows only a 510(k)-cleared syringe as a device; the document does not say how intranasal Semax is to be delivered.
4. The Ten Conditions
The policy applies only “when all of the following circumstances are present.” In plain words, keeping the document’s own headings in quotation marks:
- “503A Interim Access List.” The peptide is one of the six in Appendix A.
- “Identity of the Peptide Bulk Drug Substance.” The ingredient matches the identity in Appendix B — “amino acid sequence, chemical structure, molecular weight, and molecular formula” among other things — and is used only by the routes Appendix B names.
- “Characterization.” The ingredient comes from a facility registered with the U.S. Food and Drug Administration under section 510 of the Act, with a valid certificate of analysis meeting the agency’s guidance-based criteria — assurance that it “is what it claims to be and has been tested for identity, purity, potency, and the absence of harmful contaminants.”
- The original manufacturer. The company that actually made the ingredient — “not a subsequent packer, repacker, labeler, or distributor” — is registered, follows current good manufacturing practice, and has its factory address on the certificate. A registered repacker or reseller in between must itself have checked the manufacturer and its certificate.
- Reporting. Compounders report serious adverse events in people “regardless of whether or not considered drug related,” and product-quality problems, to the agency’s MedWatch program and to the states where the products are made and sent, along with each product’s ingredient, strength, original manufacturer, dosage form and route. The patient’s label is to explain how to report problems.
- “Product labeling.” The label carries the statement “This is a compounded drug product. Not for resale.”
- One active ingredient. Each product contains a single peptide from Appendix A. The stated reason: side effects and outcomes are easier to attribute to one substance, which is “essential for meaningful safety surveillance and signal detection.”
- “Route of administration.” Because “achieving adequate oral bioavailability of peptides is inherently difficult and complex,” a compounder making an oral form is expected to keep documents showing that the specific formulation “achieves an adequate level of oral bioavailability in humans” — that enough of the peptide is absorbed into the body when swallowed.
- “Drug delivery device.” The only device packaged with or containing the drug is a syringe cleared by the U.S. Food and Drug Administration through its 510(k) premarket process. “More complex drug delivery devices introduce additional patient risk.”
- Everything else in the Act still applies, “including that the drug product not be compounded under insanitary conditions” and section 503A’s “patient specific prescription requirement.”
The testing standard. Appendix B lists what the certificate of analysis is to report, including the peptide’s identity and sequence confirmed by two independent methods, its content and purity, peptide-related impurities, laboratory immunogenicity tests, nitrosamines, leftover solvents and metals, microbial counts and bacterial endotoxins (fever-causing remnants of bacteria). Immunogenicity is the ability of a substance to provoke an immune response, such as antibodies against the peptide; impurities left over from making a synthetic peptide are one recognized source of that risk.
The policy does not mention patient consent or informed consent anywhere.
5. The Stated Reasons
The policy gives three general reasons and a justification for each peptide.
- Interest and access. “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.” It adds that public comments “may provide additional evidence that FDA can consider in rulemaking,” and that the policy is meant “to expand and improve patient access while FDA reviews these substances.” The Federal Register version of the same sentence ends “given the lack of availability of approved products.”
- Products sold for “research use only.” “The Secretary of HHS 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. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative.”
- Patient choice. “Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”
The justification for each peptide. Appendix B gives each peptide a “threefold” justification: its “historical use is now documented and quantified”; its “characterization record has materially changed,” because batch certificates from registered facilities now supply the test results the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research had found missing; and that center’s safety concerns are, in the department’s words, “inferential rather than observed” (Thymosin Beta-4 Fragment), “mechanistic rather than observed” (Semax, Epitalon) or “an absence of information rather than an observed signal” (Lysine-Proline-Valine). For Mitochondrial Open Reading Frame of the 12S rRNA-c it cites “a randomized placebo-controlled trial of a MOTS-c analogue” that “reported no serious adverse events”; for Semax, an intranasal human record of “several hundred subjects with no reported adverse outcome.”
What the documents do not cite. The “data regarding utilization of peptides” are not identified, and no adverse-event dataset is named. These characterizations are the department’s and were not checked here against the center’s memoranda; the agency’s own findings are summarized on the U.S. Food and Drug Administration peptide review page and on each peptide’s page.
6. How It Relates to the July 2026 Advisory Committee and the U.S. Food and Drug Administration’s Proposals
On 23 and 24 July 2026 the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee, a panel of outside experts, considered seven peptides. The agency’s introductory briefing document proposed, for all fourteen substance-forms (a free base and an acetate of each peptide), that each “NOT be included on the 503A Bulks List.” The committee voted the other way for six peptides, both forms each, and agreed with the agency only on emideltide (delta sleep-inducing peptide, DSIP).
| Peptide (each form) | Yes | No | Abstain | Committee result | In the October policy |
|---|---|---|---|---|---|
| Body Protection Compound-157 | 8 | 6 | 1 | Recommended | Yes (acetate) |
| Lysine-Proline-Valine | 8 | 6 | 1 | Recommended | Yes (acetate) |
| Thymosin Beta-4 Fragment | 8 | 6 | 1 | Recommended | Yes (acetate) |
| Mitochondrial Open Reading Frame of the 12S rRNA-c | 7 | 5 | 2 | Recommended | Yes (acetate) |
| Emideltide | 6 | 7 | 1 | Not recommended | No |
| Epitalon | 7 | 4 | 1 | Recommended | Yes (acetate) |
| Semax | 8 | 5 | 1 | Recommended | Yes (free base) |
Where the counts come from. No written minutes or transcript had been posted by 14 November 2026. The agency’s Designated Federal Officer read each count aloud “for the record” on the U.S. Food and Drug Administration’s own webcast, listed in its webcast information document; the totals match the eligible voters on the agency’s final roster, and with twelve eligible voters the 7–5–1 Epitalon count printed in some news reports is impossible. The department’s policy gives no counts: it says only that the Center for Drug Evaluation and Research “recommended against listing either form” and that the committee “voted in favor.”
What the agency said. Its advisory-committee page says such committees “make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.” At the meeting an agency participant said: “those weren’t final decisions. So the final decisions would come out through rulemaking,” and another: “we don’t have a deadline for entering into that rule making.” No post-meeting agency statement on the votes was found.
How the policy relates to both. The policy follows the committee rather than the agency staff on six peptides, and it leaves out emideltide, the one peptide both rejected. It does not wait for the rulemaking the agency described; it states what the department will not enforce in the meantime. The committee voted to recommend both forms of each peptide; the policy covers one form of each, and only for named routes.
As reported by the Associated Press on 28 October 2026 (not stated in any primary document): 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 agency officials “warned that the agency’s scientific staffers had major safety concerns.” The report said the department included several safety measures suggested by agency staff, such as collecting side-effect reports and verifying purity, and quoted a department spokesperson saying the department was “confronting the risks of black-market peptides” with “a more controlled alternative through licensed U.S. compounders.”
7. What the Policy Does Not Do
- It is not an approval. None of the six peptides is an approved drug, and the policy states that compounded drugs “are not FDA-approved.” Nothing in it says the peptides are safe or effective for any condition.
- It does not put any peptide on the 503A Bulks List. The list changes only by rulemaking. 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 and creates no rights. The notice says it “does not establish any rights for any person and is not binding on HHS or the public.” The policy’s wording is “does not intend to take action,” a statement about enforcement, not a grant of permission.
- It can end. For each peptide it ends when a final rule decides whether that peptide is listed or not. It can also end earlier: the department “may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises.” It names no calendar end date.
- It keeps the prescription requirement. A compounded peptide still requires a valid prescription for an individual patient, and the rule against compounding under insanitary conditions still applies.
- It does not cover outsourcing facilities, mixtures or other devices. It names only “a State-licensed pharmacy, Federal facility, or licensed physician”; each product may hold one peptide; the only device allowed is a 510(k)-cleared syringe.
- It does not change the U.S. Food and Drug Administration’s pages. On 14 November 2026 the agency’s Category 2 page still listed all six, with its safety notes, as “nominated but withdrawn,” and its Category 1 list included none of them.
8. What Was Left Out
Emideltide. The seventh peptide reviewed in July, emideltide, was considered for opioid withdrawal, chronic insomnia and narcolepsy. The committee voted against listing it, 6 yes, 7 no and 1 abstention for each form, in line with the agency’s proposal, and it is not in Appendix A.
The other form of each peptide. The committee recommended both the free base and the acetate of each of the six. The policy covers the acetate of five peptides and the free base of Semax, so the free base of five peptides and Semax acetate fall outside it.
Other routes. Routes not named in Appendix B are outside the policy. For example, the nominations for Body Protection Compound-157 that the agency reviewed had included nasal spray and rectal suppository forms; the policy covers that peptide only by injection under the skin or into a muscle, by mouth and on the skin.
The other withdrawn peptides. The U.S. Food and Drug Administration’s Category 2 page lists seventeen substances “nominated but withdrawn.” Ten of them were neither on the July agenda nor in the policy: AOD-9604; cathelicidin LL-37; CJC-1295; dihexa acetate; the copper peptide glycyl-histidyl-lysine (GHK-Cu, for injectable routes); ipamorelin acetate; mechano growth factor, pegylated (PEG-MGF); melanotan II; selank acetate; and thymosin alpha-1. The agency’s categories list states it intends to consult the committee “before the end of February 2027” about glycyl-histidyl-lysine copper.
Outsourcing facilities. Section 503B outsourcing facilities are not among the three kinds of compounder the policy names. The document never mentions section 503B and has no sentence excluding them; the exclusion follows from its list of who is covered.
9. Comments and Next Steps
The comment period. The Federal Register notice gives no calendar date: “Written comments can be submitted until 2 weeks after date of publication.” On regulations.gov the docket HHS-OASH-2026-0496 closed at 11:59 p.m. Eastern Time on 13 November 2026, with late comments not accepted. On 14 November 2026 the Federal Register’s data counted 289 comments for the docket, while regulations.gov showed 115 public submissions posted; the difference is presumably between comments received and comments posted, but that was not confirmed.
The current version. The notice directs readers to the department’s website “to find the most current version of the policy.” The sixteen-page file there was re-issued on 6 November 2026; a sentence-by-sentence comparison with the 28 October version found no change in substance — routes, conditions and identities are identical — only file encoding and one reference in the testing table (“<761>, <1761>” became “<761>, <761>,” an apparent typing error). An intermediate archived version was not read.
What comes next, by the documents. The Associated Press reported on 28 October that the department “will take comments for two weeks before finalizing the measure.” No final version had been published by 14 November 2026. The policy itself is tied to the U.S. Food and Drug Administration’s rulemaking on the 503A Bulks List, for which the agency said in July it had no deadline; the policy notes that the Secretary “convened and consulted the PCAC as required by statute” and that the agency “must also consult with USP,” the United States Pharmacopeia, before such a rule. A proposed rule would be published in the Federal Register with its own comment period.
10. Dates and Status as of 14 November 2026
- September 2023: the six peptides placed in the U.S. Food and Drug Administration’s Category 2, the significant-safety-risk category (the department’s document gives “September 2023” for Body Protection Compound-157 and Lysine-Proline-Valine and “September 29, 2023” for the other four).
- 16 April 2026: the agency’s notice of the advisory committee meeting published, 91 FR 20465, docket FDA-2025-N-6895.
- 22 April 2026: the peptides removed from Category 2 after their nominations were withdrawn, according to the department’s document.
- 23–24 July 2026: the Pharmacy Compounding Advisory Committee met and voted to recommend six of the seven peptides, against the agency’s written proposals.
- 27 October 2026: the policy files created, according to their file data (not an official date).
- 28 October 2026: the notice filed for public inspection at 11:15 a.m.; the policy already on the department’s website.
- 30 October 2026: the notice published, 91 FR 68526–68527; comment period opened.
- 6 November 2026: the policy file re-issued on the department’s website with no change in substance.
- 13 November 2026: comment period closed at 11:59 p.m. Eastern Time.
Status: interim, not final. On 14 November 2026 the comment period had closed and no final version had been published. No effective date has been stated. The U.S. Food and Drug Administration had published no proposed or final rule adding these peptides to, or excluding them from, the 503A Bulks List; its Category 2 page (“content current as of 04/22/2026”) and categories list (“Updated May 14, 2026”) were unchanged, and its meeting page held no minutes or transcript.
11. How This Fits Earlier Actions
The U.S. Food and Drug Administration began collecting nominations for the 503A Bulks List in 2015 and set its four listing criteria in a 2019 final rule. Nominated substances wait in Categories 1, 2 or 3; for Category 1 the agency itself uses enforcement discretion. The six peptides entered Category 2 in September 2023; the department’s document says “neither the placement nor the removal changed” their status under section 503A. In 2026 the nominations were withdrawn, the agency took seven peptides to its committee with proposals not to list them, the committee voted for six, and the department issued this policy — told in full on the U.S. Food and Drug Administration peptide review page. On 24 August 2026 the agency dated five warning letters to online sellers of injectable products labeled “research use only,” calling the listed products “unapproved new drugs”; none names any of the six peptides. What is new in October 2026 is the source and form of the step: enforcement discretion from the Secretary’s office, for peptides the agency’s staff had proposed not to list, before any rulemaking. A 2026 outsourcing-facility action is on the page about the agency’s proposal on compounded semaglutide and tirzepatide.
12. Primary Documents
- U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B (16 pages; re-issued 6 November 2026) — hhs.gov policy with Appendix B. Read for this page through the Internet Archive copies of 28 October 2026 (first posted version) and 11 November 2026 (the 6 November version).
- U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (4 pages: policy, ten conditions and Appendix A) — hhs.gov policy (read through the Internet Archive copy of 6 November 2026)
- Office of the Secretary, U.S. Department of Health and Human Services (2026). Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Federal Register 91:68526–68527, 30 October 2026. Document number 2026-22192; Regulation Identifier Number 0910-ZD94 — federalregister.gov notice 2026-22192 (official PDF, govinfo.gov)
- Public docket HHS-OASH-2026-0496 (comments on the policy) — regulations.gov HHS-OASH-2026-0496
- Food and Drug Administration, U.S. Department of Health and Human Services (2026). Pharmacy Compounding Advisory Committee; Notice of Meeting. Federal Register 91:20465–20467, 16 April 2026. Docket FDA-2025-N-6895 — federalregister.gov notice 2026-07361
- U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (advisory committee calendar page, content current as of 6 August 2026) — fda.gov meeting page
- U.S. Food and Drug Administration Briefing Document, Introduction, Pharmacy Compounding Advisory Committee, 23–24 July 2026 — fda.gov/media/193342
- Pharmacy Compounding Advisory Committee, 23–24 July 2026: Webcast Information (links to the agency’s broadcasts of both days, in which each vote count was read for the record) — fda.gov/media/193710; Final Meeting Roster — fda.gov/media/193772; Questions — fda.gov/media/193711
- 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
- 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; categories list, updated 14 May 2026 — fda.gov/media/94155
The Associated Press report cited in section 6 was published on 28 October 2026. The five warning letters of 24 August 2026 are in the U.S. Food and Drug Administration’s warning-letter database under reference numbers 733652, 734884, 735063, 735067 and 735127.
Key Research Papers
- De Groot AS, Roberts BJ, Mattei A, Lelias S, Boyle C, Martin WD (2023). Immunogenicity risk assessment of synthetic peptide drugs and their impurities. Drug Discovery Today 28(10):103714 — PubMed PMID: 37467878
- Mattei AE, Roberts BJ, Lelias S, Miah S, Howard KE, Weaver JL, et al. (2025). Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products. Frontiers in Immunology 16:1730346 — PubMed PMID: 41445733
- Zizzari AT, Pliatsika D, Gall FM, Fischer T, Riedl R (2021). New perspectives in oral peptide delivery. Drug Discovery Today 26(4):1097-1105 — PubMed PMID: 33497830
- 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
- Moiz A, O’Keefe EL, O’Keefe JH (2026). Dangers of Injectable Peptides and Other Unregulated “Biohacking” Drugs. Missouri Medicine 123(4):337-343 — PubMed PMID: 42757290
- Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM (2025). Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal 21(4):485-495 — PubMed PMID: 40756949
- Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Rick Hatch GF, et al. (2026). Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. American Journal of Sports Medicine 54(1):223-229 — PubMed PMID: 41476424
- 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
These papers are background reading; none is cited in the policy or the notice. The first two describe how impurities from peptide manufacture can raise immune-reaction risk, the concern behind the testing standard; the third reviews why swallowed peptides are poorly absorbed, the concern behind condition 8. The systematic review of Body Protection Compound-157 found 35 laboratory or animal studies, one human study and no clinical safety data; the last paper is the 2015 laboratory and animal study that first described Mitochondrial Open Reading Frame of the 12S rRNA-c.
PubMed Topic Searches
Connections
- U.S. Food and Drug Administration (FDA) Actions in 2026
- U.S. Food and Drug Administration (FDA) and Regulation
- U.S. Food and Drug Administration (FDA) Review of Compounded Peptides Including BPC-157 (2026)
- Six Peptides: The HHS Compounding Policy and Its Limits
- Peptides
- Body Protection Compound-157 (BPC-157)
- Thymosin Beta-4 Fragment (TB-500)
- Lysine-Proline-Valine (KPV)
- Mitochondrial Open Reading Frame of the 12S rRNA-c (MOTS-c)
- Semax
- Epitalon
- U.S. Food and Drug Administration (FDA) Proposal on Compounded Semaglutide and Tirzepatide (2026)
- Drugs
- Dangerous Supplements: Hidden Drugs, Contamination and Overdose Risks
- Ulcerative Colitis
- Obesity
- Insomnia