Why this guide quotes instead of summarizing
Regulatory status is the one topic on which a raw-material supplier has the strongest incentive to paraphrase and the weakest standing to do so. A paraphrase ages silently; a quotation carries its own date. So this guide does three things only: it names the primary sources a buyer should read, it quotes the sentences from those sources that mention the six compounds on this site, and it records the date each source was read (2026-10-19) together with the page's own "content current as of" date where one is shown.
Everything quoted below sits inside a marked quotation with a link to the source. The prose around the quotations explains where to look and how to log what you find; it does not tell you what the rules mean for your organization, because that depends on where you are, what you are and what you intend to do with the material, and because Pepti is a manufacturer of research-use raw material, not a regulatory adviser. For research use only. Not for human or veterinary use.
Where regulatory status actually lives
For the United States, three public sources cover almost everything a raw-material buyer needs to read about GLP-1-family peptides.
FDA "drug alerts and statements" pages
FDA publishes topic pages that are updated in place. Two matter here: the page on unapproved GLP-1 drugs (which carries the compounding, border and "research purposes" statements quoted below) and the page on compounder policy as national supply stabilized (which carries the dated shortage determinations). Each shows a "Content current as of" date at the bottom; log that date with your quotation, because the text can change without the URL changing.
The FDA drug shortage database
The database is the record of whether a product is "in shortage" or "resolved". The statements page quoted below explains that a manufacturer-reported "available" status is not the same as an FDA resolution determination; the database is where the determination is recorded.
The Federal Register
Notices, proposed rules and agency orders are published in the Federal Register with a citation (volume FR page), a document number and a publication date. The site has a public search and a programmatic query interface; searching the exact compound name in quotation marks returns every document that mentions it. On 2026-10-19 a term search returned documents for semaglutide and tirzepatide, and none for retatrutide, cagrilintide, mazdutide or survodutide. A zero result is a search outcome on a date, not a legal conclusion, and should be logged as exactly that.
Other jurisdictions have their own primary sources (medicines agencies, official gazettes). The method is the same: find the agency's own page, quote it, date it.
What FDA says about retatrutide and cagrilintide in compounding
The FDA page on unapproved GLP-1 drugs contains a section headed with the two compounds' names. Quoted in full:
Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.
The agency has warned:
- Telehealth companies for marketing unapproved drugs such as retatrutide, including instances of direct marketing to consumers.
- Active pharmaceutical ingredient distributors for selling retatrutide and other GLP-1 drugs to compounders.
- Outsourcing facilities for repackaging retatrutide.
FDA, page on unapproved GLP-1 drugs, section "Retatrutide and cagrilintide cannot be used in compounding"; content current as of 2026-10-01; read 2026-10-19.
For a buyer of retatrutide or cagrilintide raw material, the practical reading is narrow and factual: FDA has stated that these two substances cannot be used in compounding under federal law, and has listed the kinds of organizations it has warned. What that means for your organization is for your own compliance function to decide; Pepti supplies these compounds to research organizations, laboratories and B2B buyers for research use, reviews buyer eligibility and intended use before a quote becomes an order, and does not sell to consumers.
What FDA says about "research purposes" labelling and online sales
The same page addresses products labelled for research but sold to consumers. This passage names five of the six compounds on this site, so it is quoted in full:
FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labeled “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health.
FDA, page on unapproved GLP-1 drugs, section "Versions sold falsely for research purposes or not for human consumption"; content current as of 2026-10-01; read 2026-10-19.
FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide.
FDA, same page, section "Illegal online sales of these drugs"; content current as of 2026-10-01; read 2026-10-19.
This passage is the reason the research-use boundary on this site is a working rule and not a label. FDA's concern, in its own words, is material sold directly to consumers with instructions for use while carrying a research label. A supplier that sells only to research organizations, laboratories and B2B buyers, reviews who the consignee is before quoting, and provides no instructions for use is on the other side of that description. A buyer evaluating any supplier, including Pepti, can test that claim by reading the supplier's pages: are there consumer checkout buttons, are there instructions for use, is there a stated eligibility review? The verification guide adds the rest of the checks.
Shortage determinations for semaglutide and tirzepatide, by date
Shortage status matters to some buyers because other rules reference it. The FDA compounder-policy page is a dated log; the entries that state determinations are quoted here in date order, oldest first.
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
FDA, compounder-policy page, entry dated 10/02/2024; content current as of 2026-04-01; read 2026-10-19.
FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. Today, FDA has issued a new decision determining the tirzepatide injection shortage is resolved. FDA’s determination is based on its analysis of all the information before the agency.
FDA, same page, entry dated 12/19/2024; read 2026-10-19.
FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.
FDA, same page, entry dated 2/21/2025; read 2026-10-19.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list.
FDA, same page, entry dated 4/1/2026; read 2026-10-19.
When a status is noted as “available,” that reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.
FDA, same page, note under the shortage-status tables; read 2026-10-19.
Two reading notes. First, the page records a re-evaluation of the tirzepatide determination between 2024-10-02 and 2024-12-19; a buyer who logged only the first entry would have an incomplete record, which is why the log method below asks for the whole dated trail. Second, every determination entry on the page is followed by the sentence quoted next, which applies regardless of shortage status:
FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.
FDA, same page, sentence repeated under the dated entries; read 2026-10-19.
The bulk-substances list notices in the Federal Register
On 2026-05-01 FDA published a notice proposing not to include semaglutide, tirzepatide and liraglutide on a list of bulk substances, then extended the comment period. The published summaries are quoted as they appear in the Federal Register.
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
Federal Register, 91 FR 23431, published 2026-05-01, document 2026-08552, summary; read 2026-10-19.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA’s proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Federal Register, 91 FR 38719, published 2026-06-26, document 2026-12937, summary; read 2026-10-19.
These are proposals and a procedural extension, not final determinations, as of the read date. A buyer tracking this should search the Federal Register again for the same document numbers and for any later notice that cites them; the final notice, when it appears, will reference the May notice by date. Log the citation (volume and page), the document number and the publication date, not just the URL, because the URL slug can be truncated and the citation is what a regulator or auditor will recognize.
Border and trade actions that mention tirzepatide
Two actions touch the movement of GLP-1 material and products across the US border. The first is FDA's statement about raw materials entering the supply chain; the second is a US International Trade Commission order about finished products using a trademark. They are different instruments and are quoted separately.
The agency has established a green list import alert (66-80) to help stop GLP-1 active pharmaceutical ingredients (APIs) that have potential quality concerns from entering the U.S. supply chain. This import alert does not apply to GLP-1 API from manufacturers that, based on an FDA inspection or other FDA evaluation, appear to be in compliance with FDA’s rigorous standards for manufacturing practices.
This action will help protect consumers from receiving poor-quality compounded drugs containing foreign-made APIs (which are also called bulk drug substances) that may be manufactured without appropriate controls to assure quality. This action does not stop the legal importation into the U.S. market of GLP-1 APIs from compliant API manufacturers, nor does it create any new limits on the legal compounding of GLP-1 drugs.
FDA, page on unapproved GLP-1 drugs, section "FDA actions at the border"; content current as of 2026-10-01; read 2026-10-19.
Pepti's position relative to this statement is stated plainly on every page of this site and repeated at the end of this guide: Pepti is a manufacturer of research-use raw material and does not present itself as a drug-substance manufacturer. A buyer who needs a supplier that FDA has inspected or evaluated should ask that supplier for the evidence directly; Pepti does not claim it.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined to issue a general exclusion order (“GEO”) prohibiting the importation of products containing tirzepatide and products purporting to contain tirzepatide that infringe U.S. Trademark No. 6,809,369 or include a false designation of origin; a limited exclusion order (“LEO”) prohibiting the entry of falsely advertised products containing tirzepatide and products purporting to contain tirzepatide that are imported by or on behalf of certain defaulting respondents; and cease and desist orders (“CDOs”) directed against certain defaulting respondents. This investigation is terminated.
Federal Register, 90 FR 15720, published 2025-04-15, document 2025-06352 (US International Trade Commission), summary; read 2026-10-19.
The Commission's order, in its own words, concerns products that infringe a trademark or carry a false designation of origin. The relevance to a raw-material buyer is about labelling honesty: a supplier that ships neutral labels carrying the compound name, lot alias and research-use line, with no brand names and no claim of origin other than its own stated site, is describing its goods truthfully. Pepti's tirzepatide ships that way, and its origin is the Guangzhou address on the about page.
Salt forms: a statement worth reading before you specify
One more passage from the FDA page concerns the chemical form of semaglutide. It is quoted because it bears on how a buyer writes a specification and reads a certificate, not because it decides anything about research-use supply.
The agency is aware that some semaglutide products sold by compounders may be the salt forms. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.
FDA, page on unapproved GLP-1 drugs, section "Salt forms should not be used to compound semaglutide"; content current as of 2026-10-01; read 2026-10-19.
For a research-use buyer the actionable point is analytical: know what form you are specifying and what form the certificate reports. The semaglutide page says that the salt or counter-ion form after purification is reported on the batch certificate where tested and that a buyer whose method depends on it should state the requirement on the RFQ. The COA reading guide covers the counter-ion line and what to do when it is absent.
Compounds with no Federal Register record on the read date
Searching the Federal Register for the exact terms "retatrutide", "cagrilintide", "mazdutide" and "survodutide" on 2026-10-19 returned no documents. That is worth logging, with the date, for two reasons. First, it tells you that the FDA statements quoted above (which do name retatrutide, cagrilintide, mazdutide and survodutide) are, on that date, the primary US sources that mention them, so those pages are the ones to re-read on a schedule. Second, a future search that returns a document is a change event; your log will show when the silence ended.
Silence in one register is not status. The absence of a Federal Register document says nothing about a compound's standing under any rule; it says only that no notice mentioning the name had been published. Treat it as a search result and nothing more. The same discipline applies to PubChem and the WHO INN lists, which record chemistry and naming, not regulatory standing; the identifiers on the mazdutide and survodutide pages come from those sources and are labelled as such.
Keeping your own verification log
A regulatory log for a raw material is a short table that your compliance function can audit without re-doing the research. Pepti keeps one for this site (the dates in it are the ones shown on this page); a buyer should keep one per supplier and per compound. Suggested columns:
| Column | What goes in it | Example from this guide |
|---|---|---|
| Source | Agency and page or notice title, in the source's own words | FDA compounder-policy page |
| Locator | URL and, for the Federal Register, the citation and document number | 91 FR 23431, document 2026-08552 |
| Source date | "Content current as of" date, entry date or publication date as printed on the source | content current as of 2026-04-01; entry dated 2025-02-21 |
| Quotation | The exact sentences, not a paraphrase | as in the blocks above |
| Read on | The date you read it, and by whom | 2026-10-19, QA |
| Next check | When to re-read; sooner for pages updated in place | re-read FDA pages before each production order |
Two habits make the log useful. Re-read pages that update in place before every production-size order, because their URL does not change when their text does. And when a supplier (again, including Pepti) tells you what a rule says, add a row for the supplier's statement and a row for the primary source, so the two can be compared later.
Where Pepti stands
If a buyer's compliance function needs something Pepti cannot provide, a filed master file, an agency inspection record, a determination of status, the honest answer is that Pepti does not have it and will not imply otherwise. What Pepti can provide is on the quality page: a certificate per lot, public batch records, and a verifiable independent report on one sample.
Sources and verification
- FDA, page on unapproved GLP-1 drugs (drug alerts and statements) — content current as of 2026-10-01; read 2026-10-19
- FDA, page on compounder policy as national GLP-1 supply stabilized — content current as of 2026-04-01; read 2026-10-19
- Federal Register, 91 FR 23431 (document 2026-08552) — published 2026-05-01; read 2026-10-19
- Federal Register, 91 FR 38719 (document 2026-12937) — published 2026-06-26; read 2026-10-19
- Federal Register, 90 FR 15720 (document 2025-06352) — published 2025-04-15; read 2026-10-19
- Federal Register document search (exact-term search) — searches for retatrutide, cagrilintide, mazdutide, survodutide returned no documents on 2026-10-19