FDA's 503A Category 2 lists six substances; BPC-157 is not one of them
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Key findings
- FDA's 503A category list, updated May 14, 2026 and read 20 October 2026, places 49 substances in Category 1 and six in Category 2.
- Category 2 means FDA "has identified significant safety risks" with a substance in compounding, and the Category 1 no-action policy does not apply to it.
- FDA's safety-risk page lists 17 entries, BPC-157 among them, as "previously in category 2" and withdrawn by the people who nominated them.
- Leaving Category 2 by withdrawal is not a move to Category 1. A withdrawn substance sits in no 503A category, though FDA's safety-risk page still lists Ipamorelin acetate in Category 2 under the 503B interim policy.
- The FDA page that defines the categories speaks to compounders. Its main text does not contain the words "research" or "possession."
Category 2 is shorter than most people who cite it think. FDA's current 503A list, dated May 14, 2026 and read on 20 October 2026, names six substances in it.
Most of the peptides this market associates with Category 2 are not among the six. FDA now lists them on a separate page as substances that were in Category 2 until the people who nominated them withdrew. That changes what the label means, and it does not mean what a seller quoting an older list might hope.
What the three categories say
The categories sort substances that someone has asked FDA to add to the 503A bulks list. A 503A compounder may use a bulk ingredient that meets a USP or NF monograph where one exists. Otherwise it must be part of an FDA-approved drug or be on that list. FDA's page "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act" (content current as of May 14, 2026, read 20 October 2026) describes the categories as part of an "interim policy" while it evaluates each nomination.
Category 1 substances "may be eligible for inclusion on the 503A bulks list." FDA says it "does not intend to take action against a compounder" using them, as long as the conditions in its guidance are met.
Category 2 substances were nominated with enough information for FDA to evaluate them, and FDA "has identified significant safety risks relating to the use of these substances in compounding." The Category 1 policy does not extend to them. FDA "would consider taking action against a compounder" under its general enforcement policies.
Category 3 substances "were nominated with insufficient supporting information for FDA to evaluate them." They are also outside the Category 1 policy.
Put simply, only Category 1 carries a promise of no action. Categories 2 and 3 carry none, for different reasons.
Category 2 as of 20 October 2026
The list itself is a PDF titled "Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act." Every page is stamped "Updated May 14, 2026." Its Category 2 section names six entries. The dates in the second column come from FDA's page "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks" (content current as of April 22, 2026, read 20 October 2026).
| 503A Category 2 entry, as FDA writes it | Date FDA gives for its 503A Category 2 placement |
|---|---|
| Cesium Chloride | July 30, 2018 |
| Domperidone | October 27, 2015 |
| Germanium Sesquioxide | June 9, 2016 |
| Ibutamoren Mesylate | September 29, 2023 |
| Kisspeptin-10 | September 29, 2023 |
| Quinacrine Hydrochloride for intrauterine administration | June 9, 2016 |
Kisspeptin-10 is the only peptide named in 503A Category 2 today.
The 17 withdrawn entries
The safety-risk page has a second table. FDA introduces it in one line: these substances, "previously in category 2 of the interim policies were withdrawn by the nominators." It gives no withdrawal dates.
There are 17 entries. They include BPC-157, AOD-9604, CJC-1295, Cathelicidin LL-37, Dihexa acetate, Emideltide (DSIP), Epitalon, GHK-Cu (injectable), KPV, Melanotan II, MOTs-C, PEG-MGF, Selank acetate, Semax, Thymosin-alpha 1, Thymosin beta-4 fragment (TB-500) and Ipamorelin acetate. FDA keeps its summary of the safety concerns beside each one.
Here is the stake. A withdrawn nomination is not a clean bill. It does not move a substance into Category 1, and the no-action policy is written for Category 1 only. With its nomination gone, a substance sits in no 503A category, and the no-action policy does not reach it. The 503B side can differ: the safety-risk page notes that Ipamorelin acetate also appears in its Category 2 table "because it is in category 2 under the 503B interim policy."
How a substance moves
Placements change, and FDA's own documents show three ways.
- Into Category 2. FDA's 503A page says: "If FDA adds a substance to category 2, we will publish the safety information describing the risks on FDA.gov."
- Out of Category 1. A Category 1 substance stays under the interim policy until FDA decides on the bulks list, unless FDA removes it "based on, for example, information about safety risks."
- Out of any category, by withdrawal. The May 14 list records GHK-Cu (except for injectable routes) as removed from Category 1 on April 22, 2026, because its nominations were withdrawn. On May 5, 2026, one nominator said it meant to withdraw only the injectable route. The non-injectable form "will be added back to category 1."
Category 3 is not final either. FDA says those substances "can be re-nominated with sufficient supporting information." One door is closing: FDA's page says the guidance does not intend to place substances nominated on or after January 7, 2025 into these categories.
The end point is a rule, not a category. FDA's page says a February 2019 final rule placed six substances on the 503A bulks list and declined four, and a September 2019 proposed rule, which would place five more and decline 26, has not been finalized. FDA says it consults its Pharmacy Compounding Advisory Committee as it evaluates nominations, and the May 14 list says it intends to consult that committee on GHK-Cu before the end of February 2027.
What the list is not
The list is a policy about compounders. Every enforcement sentence on FDA's 503A page is addressed to compounders. The category sentences name "a compounder," and the interim-policy sentence names "state-licensed pharmacies, federal facilities and licensed physicians" that compound. The page's main text does not contain the word "research," and it does not contain "possession" or "possess" (checked 20 October 2026).
So the categories are not a ban on owning anything. They are not a ruling on research-use sales either, in either direction. A seller that says a substance is "not Category 2" has said something about pharmacy compounding policy and nothing about its own product.
How to read the list and its date
Three checks keep a reader from quoting a stale list.
- Read the stamp. The PDF carries an "Updated" date on every page. Today it reads May 14, 2026. A screenshot without that line cannot be dated.
- Read the withdrawn table too. A substance missing from Category 2 may be on the safety-risk page's withdrawn list, which is a different status from Category 1.
- Check which section. The safety-risk page marks each entry 503A, 503B or both. GHRP-2 and GHRP-6 sit in Category 3 on the 503A list and are listed in Category 2 on the 503B side. The same name can carry two placements.
Limitations
This piece reads three FDA documents as they stood on 20 October 2026. It is not legal advice. The interim guidance itself, the 2019 rules and the 503B category list were not read in full here. FDA guidance is nonbinding, and the categories describe enforcement intent, not law. The safety-risk page gives no withdrawal dates, so when each of the 17 left Category 2 is not known from these sources. State pharmacy law was not read.
FDA's most recent update to the list is dated May 14, 2026. The next update decides whether six is still the count.
Sources
All read 2026-10-20. FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, content current as of 2026-05-14. FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated 2026-05-14. FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of 2026-04-22.
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