FDA Category 2 List in 2026: Where the Peptides Stand

FDA's current Category 2 table of bulk drug substances that "may present significant safety risks" in compounding has, by our count, 14 entries, and BPC-157 and TB-500 are not among them. Both sit on a separate FDA table of, by our count, 17 substances "nominated but withdrawn," as FDA's Category 2 page read when we captured it on October 8, 2026.

For what each February 2027 committee outcome would mean for a research store, read the peptides under PCAC review. To see which compounds FDA's letters to sellers have named, use the FDA warning letter tracker.

This guide is for founders and operators of research use only (RUO) peptide stores. Every quotation is copied from the FDA page it cites. Where the published sources do not answer a question, we say so rather than fill the gap.

Talk through your catalog and FDA exposure: book a call

What you will be able to do after reading

By the end of this guide you will be able to:

1. Explain FDA's three 503A bulk drug substance categories in FDA's words, and what changed on January 7, 2025. Delivered in What are FDA's 503A bulk drug substance categories?.

2. Read and count the current Category 2 table and the withdrawn table yourself. Delivered in Which substances are on Category 2 today? and Are BPC-157 and TB-500 on Category 2?.

3. Build one catalog row per compound with its FDA table, statute marking and date. Delivered in Which peptides are listed, with category and date?.

4. Place the advisory committee meeting in context, and say what a category placement does and does not tell a research store. Delivered in How does the Pharmacy Compounding Advisory Committee fit? and What does a category placement say about a research use only store?.

5. Set up a monthly watch of the FDA pages that can change your catalog sheet. Delivered in How do you watch for changes?.

The self check near the end tests each one.

Key Facts

• By our count, FDA's current Category 2 table lists 14 substances, as captured on October 8, 2026 (FDA Category 2 page).
• By our count, a separate FDA table lists 17 substances "nominated but withdrawn," including BPC-157 and TB-500 (FDA Category 2 page).
• Four entries on the current table are peptides by FDA's own description (GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10), and all four carry the date September 29, 2023 (FDA Category 2 page).
• Of those four, only kisspeptin-10 is marked 503A. GHRP-2, GHRP-6 and ipamorelin acetate are marked 503B on the current table (FDA Category 2 page).
• FDA's committee meeting is set for "before the end of February 2027," with five withdrawn substances on the agenda (FDA PCAC meeting notice).

What are FDA's 503A bulk drug substance categories?

This section delivers outcome 1 of 5: explain the three categories.

They are three groups under an interim policy FDA uses while it builds the 503A bulks list. Start with the rule they sit inside.

What may a 503A compounder use in the first place?

FDA's page opens with the rule. "State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that" meet one of three conditions. They must "Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding"; or they "Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist"; or they "Appear on FDA's list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product." Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503A.

The same page adds two supply chain conditions. Bulk drug substances "must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510 of the FD&C Act," and "The agency urges compounders to know your bulks supplier." Source: FDA 503A bulks page.

How is the 503A bulks list being built?

FDA says it "solicited nominations for bulk drug substances in 2015 to include on the 503A bulks list" and "is consulting with the Pharmacy Compounding Advisory Committee for and the U.S. Pharmacopeia Convention for input as it evaluates them." Source: FDA 503A bulks page.

Two rules are on record. "A final regulation was issued in February 2019," in which "FDA placed six substances on the list, identified and did not place four other substances on the list, and established the criteria to evaluate substances for inclusion on the list." Then "A proposed regulation was issued in September 2019," in which "the agency proposed to place five substances on the list and not to place 26 other substances on the list." FDA adds that it "will continue to evaluate bulk drug substances that have been nominated with sufficient supporting information and address those substances on a rolling basis through notice-and-comment rulemaking." Source: FDA 503A bulks page.

The page does not name the substances in either rule, and our ledger does not hold the rules, so this guide cannot say whether any peptide was among them.

Why does an interim policy exist at all?

Because the list is still being built. FDA says it "developed an interim policy describing conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities and licensed physicians for compounding drug products from certain bulk drug substances that cannot otherwise be used under section 503A." FDA says it "describes three categories of bulk drug substances nominated for use in compounding." Source: FDA 503A bulks page.

What is category 1, in FDA's words?

FDA describes category 1 this way: "These substances may be eligible for inclusion on the 503A bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list." The interim enforcement position: "FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met." Source: FDA 503A bulks page.

Category 1 is not permanent. FDA says these substances "may continue to be within the scope of the interim enforcement policy described in FDA's guidance until the agency decides on inclusion of these substances on the 503A bulks list or unless the agency removes the substances from category 1 based on, for example, information about safety risks." Source: FDA 503A bulks page.

What is category 2, in FDA's words?

"These substances were nominated with sufficient supporting information to permit FDA to evaluate them, and they may be eligible for inclusion on the 503A bulks list. However, FDA has identified significant safety risks relating to the use of these substances in compounding pending further evaluation and, therefore, does not intend to adopt the policy described for the substances in category 1." Source: FDA 503A bulks page.

FDA also says how it announces an addition: "If FDA adds a substance to category 2, we will publish the safety information describing the risks on FDA.gov and advise that the substance has been added to category 2 and is not within the scope of the policies regarding substances in category 1." The enforcement position: "FDA would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies." Source: FDA 503A bulks page.

In our reading, the words pending further evaluation make category 2 a holding position for compounders, not a final finding about a substance.

What is category 3, in FDA's words?

"These substances may be eligible for inclusion on the 503A bulks list but were nominated with insufficient supporting information for FDA to evaluate them." FDA says they can be re-nominated with sufficient supporting information through a public docket, and that "These substances are not eligible for the policy that applies to substances in category 1. FDA would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies." Source: FDA 503A bulks page.

So the enforcement sentence for category 2 and category 3 is the same. The difference is the reason: category 2 is about safety risks FDA identified, category 3 is about missing information in the nomination. Our ledger holds no list of category 3 substances, so this guide cannot say which peptides, if any, sit there.

What changed on January 7, 2025?

FDA says it "issued a guidance document to revise the application of this policy," and that this guidance "states the agency does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories." FDA also says "Compounders and other interested parties may continue to nominate substances for inclusion on the 503A bulks list." Source: FDA 503A bulks page.

In our reading, that means the category tables are close to fixed for new names. A compound nominated after that date would not be expected to appear in category 1, 2 or 3 at all. The page does not say what status such a substance has in the meantime, so we do not guess.

Who does the Category 2 list apply to?

Every enforcement statement on these pages is addressed to compounders. FDA says it "would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies." The list does not say anything about research suppliers, and a compound's place on it or off it is not a ruling on whether a research supplier may sell it. Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503A.

The page also covers two statutes, not one. Its subtitle reads "Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act," and its column header asks whether each substance is in "503A category 2, 503B category 2, or both." FDA says it "has identified potential significant safety risks when reviewing nominations for bulk drug substances proposed to be included on the sections 503A or 503B bulks lists." Source: FDA Category 2 page.

Our sources hold FDA's 503A category definitions but not its 503B interim policy text, so for entries marked 503B only we report the marking and FDA's reason, nothing more.

Which substances are on Category 2 today?

This section delivers outcome 2 of 5: read and count both tables.

As captured on October 8, 2026, FDA's current table has, by our count, 14 entries. They are: cesium chloride, chloral hydrate, diethylstilbestrol, domperidone, "Edetate disodium (except for ophthalmic use)", germanium sesquioxide, "Growth hormone releasing peptide-2 (GHRP-2) (for injectable and nasal routes of administration)", GHRP-6, ibutamoren mesylate, ipamorelin acetate, kisspeptin-10, "Neomycin sulfate (all parenteral drug products containing neomycin sulfate except when used for ophthalmic or otic use or in combination with polymyxin B sulfate for irrigation of the intact bladder)", "Quinacrine hydrochloride for intrauterine administration" and tranilast. The peptides on that table are GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10, plus ibutamoren mesylate, which is listed under both 503A and 503B. Source: FDA Category 2 page.

A note on how we grouped them. FDA's own reason text names "peptide-related impurities" or "peptide characterization" for GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10. FDA's reason text for ibutamoren mesylate does not use the word peptide. We keep it beside the four because its 503A date matches kisspeptin-10's; that grouping is our editorial choice, not FDA's (FDA Category 2 page).

How is the page built?

Below a short header, the first table, "Bulk drug substances under category 2 of the interim policies," has four columns: the substance, whether it is "503A category 2, 503B category 2, or both," the "Date added to category 2," and "Potential significant safety risks." The second table, "Bulk drug substances nominated but withdrawn," has only two columns: the substance and its "Potential significant safety risks." Source: FDA Category 2 page.

Our reading: the withdrawn table has no date or statute column, so a skimming reader can take its 17 names for current entries. FDA's header says otherwise: "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." Source: FDA Category 2 page.

What dates does FDA give for the 14 current entries?

From the current table, in FDA's order, with entries that carry FDA's own qualifiers copied in quotation marks (FDA Category 2 page; see also FDA 503A bulks page):

• Cesium chloride: 503A, July 30, 2018.
• Chloral hydrate: 503B, October 5, 2022.
• Diethylstilbestrol: 503B, August 21, 2023.
• Domperidone: 503A, October 27, 2015.
• Edetate disodium (except for ophthalmic use): 503B, October 12, 2022.
• Germanium sesquioxide: 503A, June 9, 2016.
• GHRP-2 (FDA limits the entry to two named routes): 503B, September 29, 2023.
• GHRP-6: 503B, September 29, 2023.
• Ibutamoren mesylate: 503A September 29, 2023; 503B December 29, 2022.
• Ipamorelin acetate: 503B, September 29, 2023.
• Kisspeptin-10: 503A, September 29, 2023.
• "Neomycin sulfate (all parenteral drug products containing neomycin sulfate except when used for ophthalmic or otic use or in combination with polymyxin B sulfate for irrigation of the intact bladder)": 503B, October 12, 2022.
• "Quinacrine hydrochloride for intrauterine administration": 503A June 9, 2016; 503B June 7, 2021.
• Tranilast: 503B, September 29, 2023.

Our count from that list: four entries carry a 503A marking alone, eight carry 503B alone, and two (ibutamoren mesylate and quinacrine hydrochloride) carry both. Six entries share the September 29, 2023 date. The newest date on the table is September 29, 2023, so on the page as captured, no substance has been added since then.

What reasons does FDA give for the peptide entries on the current table?

These are FDA's words, quoted from the "Potential significant safety risks" column. We quote the reason FDA leads with; several entries go on to cite adverse event reports or literature, which we do not repeat here. Read them on the page itself. Source for every quotation in this subsection: FDA Category 2 page.

GHRP-2: "Compounded drugs containing GHRP-2 for injectable and nasal administration may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. GHRP-2 also contains an unnatural amino acid, which adds to the complexity of peptide characterization." FDA's entry adds that causality "has not been established" for the reports it cites. Source: FDA Category 2 page.

GHRP-6: "Compounded drugs containing GHRP-6 may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has identified limited safety-related information." Source: FDA Category 2 page.

Ipamorelin acetate: "Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization." FDA also says it "has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration." Source: FDA Category 2 page.

Kisspeptin-10: "Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has no, or only limited, safety-related information for the proposed routes of administration." Source: FDA Category 2 page.

Ibutamoren mesylate: "Ibutamoren mesylate poses significant safety risks due to the potential for congestive heart failure in certain patients." Source: FDA Category 2 page.

In our reading, FDA's lead reasons for the four peptides are about the product (aggregation, impurities, characterization) and about missing information. Those are the questions a buyer asks of your lot documents, so review your certificate of analysis practice alongside this page. See batch specific versus generic lot COAs.

Are BPC-157 and TB-500 on Category 2?

They are not on the current table. FDA keeps a second table titled "Bulk drug substances nominated but withdrawn" and says: "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." By our count, that table holds 17 entries: AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide (DSIP), epitalon, "GHK-Cu (for injectable routes of administration)", ipamorelin acetate (FDA notes it "also appears in the table above because it is in category 2 under the 503B interim policy"), KPV, PEG-MGF, melanotan II, MOTs-C, selank acetate, semax, thymosin alpha 1 and TB-500, which FDA lists as "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500." Source: FDA Category 2 page.

For the full BPC-157 picture, read BPC-157 FDA status.

What does "withdrawn" mean, and what does it not mean?

FDA's header says the substances were "previously in category 2 of the interim policies" and "were withdrawn by the nominators." That is the whole of what the page says about the withdrawal. It gives no withdrawal date for any entry, no reason for the withdrawal, and no statement of which category, if any, the substances sit in now (FDA Category 2 page).

Our reading, which is judgment: withdrawn describes what the nominator did, not what FDA concluded. FDA kept the safety reasons on the page beside each withdrawn name. A store that tells buyers BPC-157 or TB-500 was removed from Category 2 is reporting the half of the page that sounds good and leaving out the reasons FDA still publishes.

What reasons does FDA give for the 17 withdrawn entries?

Again in FDA's words, the reason FDA leads with for each, from the same page. Several entries continue with information about adverse event reports or nonclinical findings, which we do not repeat. Source for every quotation below: FDA Category 2 page.

• AOD-9604: "Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• BPC-157: "Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization."
• Cathelicidin LL-37: "Compounded drugs containing cathelicidin LL-37 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• CJC-1295: "Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration," with FDA adding "Available clinical data are limited."
• Dihexa acetate: "FDA has not identified any human exposure data on drug products containing dihexa acetate."
• Emideltide (DSIP): "Compounded drugs containing emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• Epitalon: "Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities."
• GHK-Cu: FDA says it "may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities."
• Ipamorelin acetate: nearly the same text as in the current table, beginning "Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration."
• KPV: "FDA has not identified any human exposure data on drug products containing KPV."
• PEG-MGF: "Compounded drugs containing Mechano Growth Factor Pegylated (PEG-MGF) may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• Melanotan II: "Compounded drugs containing Melanotan II may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities."
• MOTs-C: "Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• Selank acetate (TP-7): "Compounded drugs containing selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities."
• Semax (heptapeptide): "Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities."
• Thymosin alpha 1 (Ta1): "Compounded drugs containing thymosin-alpha-1 (Ta1) may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization."
• TB-500: "Compounded drugs containing thymosin Beta-4, Fragment (LKKTETQ) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities."

Our count from the text above: 15 of the 17 withdrawn entries name "peptide-related impurities" in FDA's reason. The two that do not, dihexa acetate and KPV, are framed instead around the absence of human exposure data. FDA uses "significant risk" rather than "risk" for four of them: AOD-9604, PEG-MGF, MOTs-C and thymosin alpha 1 (FDA Category 2 page).

Which peptides are listed, with category and date?

This section delivers outcome 3 of 5: build your catalog rows.

This table puts the page's peptide entries in one place, using only what the page shows. The withdrawn table has no date or statute column, so those cells read "not shown." Source for every row: FDA Category 2 page. PCAC column source: FDA PCAC meeting notice.

A practical way to use this table: copy it into your own catalog sheet, add a column for whether you list the compound, and add a column for the date you last checked FDA's page. The last column is the one that goes stale.

How does the Pharmacy Compounding Advisory Committee fit?

This section delivers outcome 4 of 5: place the committee meeting in context.

The committee is the expert body FDA consults while it evaluates nominations for the 503A list. FDA's 503A page says the agency "is consulting with the Pharmacy Compounding Advisory Committee for and the U.S. Pharmacopeia Convention for input as it evaluates them." Source: FDA 503A bulks page.

What is the committee, in FDA's description?

FDA's committee page says: "The Committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act." On membership: "The Committee shall consist of a core of 12 voting members including the Chair," and "In addition to the voting members, the Committee may include one or more non-voting members who are identified with industry interests." The page shows "Content current as of: 07/29/2025." Source: FDA, Pharmacy Compounding Advisory Committee.

What does FDA say about the meeting before the end of February 2027?

FDA's advisory committee page lists five of the withdrawn substances as "being considered for inclusion on the 503A bulks list": Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II and Mechano Growth Factor, Pegylated (PEG-MGF). FDA says it "will host an advisory committee meeting before the end of February 2027," that the "meeting time and location will be scheduled in the coming months," and that "Advisory committees make non-binding recommendations to the FDA." FDA also says "the agency does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories." Sources: FDA, Meeting of the Pharmacy Compounding Advisory Committee, FDA 503A bulks page.

The notice sets out the steps before the meeting. "FDA intends to publish a Federal Register notice and establish a docket for public comment on this meeting in the near future." "Interested persons may present data, information or views, orally or in writing, on issues pending before the committee." And "FDA intends to make meeting materials and the link to the live webcast available no later than two business days before the meeting in the Event Materials section of this webpage." The notice shows "Content current as of: 04/15/2026." Source: FDA PCAC meeting notice.

Our reading, which is judgment: the first signal that the meeting is near is the Federal Register notice and docket. The briefing material may appear as little as two business days ahead, so the window to read it before the vote is short.

For what each outcome on the five agenda substances would mean for a store, read the peptides under PCAC review before February 2027 and what the PCAC vote changes for RUO operators.

What earlier meetings does FDA's page show?

FDA's committee page links "Pharmacy Compounding Advisory Committee 2027 Meeting Materials," "Pharmacy Compounding Advisory Committee 2026 Meeting Materials," "Pharmacy Compounding Advisory Committee 2024 Meeting Materials," and "Pharmacy Compounding Advisory Committee 2022 Meeting Materials." It adds: "Meeting materials from 2021 and older are archived and can be accessed using the following hyperlinks: 2021, 2018, 2017, 2016, 2015." Source: FDA PCAC page.

Our ledger holds those link titles, not the materials behind them, so this guide cannot tell you which substances were on any earlier agenda or how the committee voted. A practical way to handle this: before you rely on a claim that the committee already voted on a compound, open the year's materials page and find the agenda item yourself.

What does a category placement say about a research use only store?

Less than most store pages imply. Here is what the sources support, what they do not, and where our judgment begins.

What do the sources actually say?

The category definitions and their enforcement positions name compounders. The interim policy names "state-licensed pharmacies, federal facilities and licensed physicians." The 503A rule names "State-licensed physicians and pharmacists that compound under section 503A." Source: FDA 503A bulks page.

When FDA wrote to two research peptide sellers in August 2026, the letters turned on drug status and intended use. FDA wrote to NuScience Peptides LLC that "evidence obtained from your website establishes that your products are intended to be drugs for human use," and noted this held "Despite statements on your product labeling marketing your products 'for laboratory, research, and analytical use' and 'not intended for human or veterinary use.'" The letter cites products that "are drugs under section 201(g)(1) of the FD&C Act" and states that introducing these "unapproved new drug products" into interstate commerce "violates sections 301(d) and 505(a) of the FD&C Act." Source: FDA warning letter to NuScience Peptides LLC.

The letter to Peptide Partners LLC uses the same structure, noting labeling that read "for research use only" and "not for human or veterinary use," and states that "evidence obtained from your website establishes that your products are intended to be drugs for human use." Source: FDA warning letter to Peptide Partners LLC.

We searched the captured text of both letters for the words "category," "503A" and "bulk." Neither letter uses any of them (our own check of FDA's published text, rechecked against the October 25, 2026 captures). The products FDA named in those letters, such as tesamorelin and PT-141 in the NuScience letter, do not appear on either table of the Category 2 page. Sources: NuScience Peptides LLC letter, FDA Category 2 page.

The intended use test those letters cite is in FDA's regulation. Intent "may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article" (21 CFR 201.128).

What do the sources not say?

They do not say a compound off Category 2 is cleared for sale by anyone. They do not say a compound on Category 2 is barred from research sale. They do not say whether FDA reads the category tables when it reviews a research seller's website. Any statement on your site that leans on the category tables in either direction goes beyond what FDA published (FDA 503A bulks page).

Our reading, which is judgment

The category tables are a compounding instrument; they cannot make a research store compliant or non compliant on their own. What reached research sellers in 2026 was the intended use question. A store that tells buyers it is not on Category 2 is making a regulatory claim on its own page, the kind of expression the intended use rule describes. Our recommendation: keep category status out of product copy and inside your internal catalog review. For the broader legal question, read is it legal to sell research peptides online and what research use only actually means.

Does a payment platform look at the category tables?

No platform entry in our ledger mentions 503A, compounding or Category 2. Stripe's prohibited and restricted businesses page names "Incorrectly labeled research chemicals" (Stripe, Prohibited and Restricted Businesses).

In our reading, Category 2 status does nothing for that line; labeling does. See the payment processor requirements tool.

How do you watch for changes?

This section delivers outcome 5 of 5: set up your monthly watch.

None of the four pages states an update schedule. What each does show is a "Content current as of" date on each one, and statements about what it will post and when. Build your watch on those.

Which pages, and what dates do they show now?

As captured on October 8, 2026 and checked again on October 25, 2026 (our own capture record):

• Significant safety risks page: "Content current as of: 04/22/2026" (FDA Category 2 page).
• 503A bulk drug substances page: "Content current as of: 05/14/2026" (FDA 503A bulks page).
• PCAC meeting notice: "Content current as of: 04/15/2026" (FDA PCAC meeting notice).
• PCAC committee page: "Content current as of: 07/29/2025" (FDA PCAC page).

What has FDA said it will publish?

Three statements tell you what a change will look like. For additions: FDA "will publish the safety information describing the risks on FDA.gov and advise that the substance has been added to category 2" (FDA 503A bulks page). For the meeting: a "Federal Register notice" and a "docket for public comment," then meeting materials "no later than two business days before the meeting" (FDA PCAC meeting notice). For the list itself: rulemaking "on a rolling basis" (FDA 503A bulks page).

What cadence should you use?

Our recommendation, which is judgment and not an FDA timeline: check all four pages on the first business day of each month, and weekly once the Federal Register notice for the meeting appears. On each check, record three things: the "Content current as of" date, the count of rows in each table on the safety risks page, and the time and location line on the meeting notice. If any of the three changed, read the page in full that day.

Also keep the FDA warning letter tracker in the same routine. In our reading, the letters, not the category tables, are where FDA addressed research sellers directly in 2026.

Run your Category 2 review: an operator checklist

Work through this for every compound you list or plan to list. Each item can be checked against a page cited above.

1. Is the compound on the current table, the withdrawn table, or neither? Search FDA's page by the exact name FDA uses, including any route qualifier FDA attaches to the entry (FDA Category 2 page).

2. If it is on the current table, which statute marking does it carry, and what date? Write both down. A 503B marking is not a 503A marking (FDA Category 2 page).

3. Have you read FDA's full reason text for it, not only the first sentence? Save a dated copy of the text.

4. Is it one of the five agenda substances for the meeting before the end of February 2027? If so, add the meeting notice to your weekly checks (FDA PCAC meeting notice).

5. Does any product page, FAQ, email or ad mention Category 2, the PCAC or FDA status? Our recommendation is to remove those mentions. They turn an internal review into a public claim.

6. Does your product copy, linked content or bundling say anything about use in people? That is what FDA's letters quoted. Compare your pages with the passages FDA cited (NuScience Peptides LLC letter, Peptide Partners LLC letter).

7. Is the compound named in any FDA warning letter to a research seller? Check the FDA warning letter tracker.

8. Have you recorded the "Content current as of" date on each of the four FDA pages? Put it in your catalog sheet beside today's date.

9. Who owns the monthly check, and where is the log? Name one person.

10. Has counsel reviewed your catalog decision for compounds on either table? The FDA pages speak to compounders. Applying them to your business is a legal question for your own advisor.

Self check

Answer each question before reading its answer. If you miss one, reread the section named after it.

1. How many entries does the current Category 2 table hold, by our count of the October 8, 2026 capture?

14. See Which substances are on Category 2 today?.

2. Which four current entries are peptides by FDA's own description, and what date do they share?

GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10, all dated September 29, 2023. See What dates does FDA give for the 14 current entries?.

3. Which of those four is marked 503A?

Only kisspeptin-10. The other three are marked 503B. See Which peptides are listed, with category and date?.

4. Are BPC-157 and TB-500 on the current table?

No. Both sit on the withdrawn table, which holds 17 substances by our count. See Are BPC-157 and TB-500 on Category 2?.

5. When is the committee meeting, and how many withdrawn substances are on its agenda?

Before the end of February 2027, with five withdrawn substances on the agenda. See What does FDA say about the meeting before the end of February 2027?.

6. Do any of your product pages, FAQs or ads make a category or committee claim?

If yes, remove it and run the operator checklist again. See Run your Category 2 review: an operator checklist.

What you should have when you finish

• A catalog sheet with one row per compound: which FDA table it is on, its statute marking and date, whether it is on the PCAC agenda, and the date you last checked.
• A dated, saved copy of FDA's reason text for every listed compound you sell that appears on either table.
• A log of the four FDA pages with their "Content current as of" dates and the row counts of both tables.
• Product pages, FAQs and ads with no category or PCAC claims in them.
• A named owner for the monthly check, with a trigger to go weekly when the Federal Register notice for the meeting appears.
• A written note from counsel, or a booked review, on any compound you list that FDA's page names.

Frequently Asked Questions

How many substances are on FDA's Category 2 list in 2026?

By our count, the current table on FDA's significant safety risks page lists 14 substances, as captured on October 8, 2026. A second table lists, by our count, 17 substances "nominated but withdrawn." Source: FDA Category 2 page.

Which peptides are on the current Category 2 table?

GHRP-2, GHRP-6 and ipamorelin acetate, all marked 503B and dated September 29, 2023, and kisspeptin-10, marked 503A with the same date. Ibutamoren mesylate is also on the table, under both 503A and 503B. Source: FDA Category 2 page.

Is BPC-157 on Category 2?

Not on the current table. FDA lists it on the "Bulk drug substances nominated but withdrawn" table, which it describes as substances "previously in category 2 of the interim policies" that "were withdrawn by the nominators." FDA still publishes its safety reasons beside the name. Source: FDA Category 2 page.

What is the difference between category 1, 2 and 3?

Category 1 substances were nominated with sufficient information and FDA "does not intend to take action against a compounder" using them, if conditions are met. Category 2 substances have significant safety risks FDA identified. Category 3 substances were nominated with insufficient information. For categories 2 and 3, FDA "would consider taking action against a compounder." Source: FDA 503A bulks page.

Does Category 2 apply to research use only stores?

FDA's category statements are addressed to compounders, and the pages say nothing about research suppliers. FDA's 2026 letters to research sellers rested on intended use and drug status, and neither letter uses the words "category" or "503A" (our own search of the published text). Sources: FDA 503A bulks page, NuScience Peptides LLC letter, Peptide Partners LLC letter.

When is the PCAC meeting, and which peptides are on the agenda?

FDA says it "will host an advisory committee meeting before the end of February 2027" and that time and location "will be scheduled in the coming months." The agenda lists cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II and PEG-MGF. Source: FDA PCAC meeting notice.

How often does FDA update the Category 2 page?

None of the pages we captured states an update schedule. The page shows "Content current as of: 04/22/2026," and its newest table date is September 29, 2023. Our recommendation is a monthly check, going weekly once the meeting's Federal Register notice appears. Source: FDA Category 2 page.

Related guides

• BPC-157 FDA Status: Is It on the Category 2 List?
• Peptides Under PCAC Review Before the End of February 2027: What Each Outcome Means
• What the PCAC Vote Changes for Your Peptide Store: The Correct Answer
• Is It Legal to Sell Research Peptides Online?
• Preclinical vs Human Evidence in Peptide Research: BPC-157

Sources

• U.S. Food and Drug Administration, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 04/22/2026. Read October 8, 2026; rechecked October 25, 2026.
• U.S. Food and Drug Administration, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 05/14/2026. Read October 8, 2026; rechecked October 25, 2026.
• U.S. Food and Drug Administration, Meeting of the Pharmacy Compounding Advisory Committee. Content current as of 04/15/2026. Read October 8, 2026; rechecked October 25, 2026.
• U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee. Content current as of 07/29/2025. Read October 8, 2026; rechecked October 25, 2026.
• U.S. Food and Drug Administration, Warning Letter 733652 to NuScience Peptides LLC, August 24, 2026. Read October 8, 2026.
• U.S. Food and Drug Administration, Warning Letter 735063 to Peptide Partners LLC, August 24, 2026. Read October 8, 2026.
• U.S. Electronic Code of Federal Regulations, 21 CFR 201.128, Meaning of "intended uses". Read October 8, 2026.
• Stripe, Prohibited and Restricted Businesses. Read October 8, 2026.

This guide reports what FDA, Stripe, PayPal and Braintree published, as captured on October 8, 2026. It is not legal advice for your business.