FDA sorts nominated compounding substances into categories, and the labels get quoted everywhere. This page reads the primary pages as of 30 October 2026: 17 substances sit in the "nominated but withdrawn" table, 14 in Category 2, and a new HHS enforcement policy is not an approval.
Whitepill finding
On 30 October 2026, FDA's safety-risks page, current to 22 April 2026, listed 17 substances in its "nominated but withdrawn" table and 14 in Category 2, including ibutamoren mesylate (sold as MK-677). The same day, HHS published a draft, non-binding policy holding off enforcement on compounding certain peptides, which is neither an approval nor the 503A list.
The short version
They sayCategory 2 means it is proven dangerous.
Category 2 holds substances where FDA says it identified significant safety risks. It is a sorting label under a temporary policy. See the receipt
They sayWithdrawn means it was cleared.
Withdrawn means the nominators pulled the nomination. Nothing on that table approves a substance. See the receipt
They sayThe HHS notice made peptides legal.
It is a draft, non-binding enforcement discretion policy for certain compounding. It is not an FDA approval and not the 503A list. See the receipt
Under its interim policy, FDA sorts bulk drug substances nominated for compounding into categories, defined on its 503A bulks page (content current as of 14 May 2026). Category 1 holds substances that may be eligible for the list, Category 2 ones where FDA has identified significant safety risks, and Category 3 ones nominated with too little supporting information. A separate safety-risks page carries the Category 2 details and a table of substances "nominated but withdrawn".
The labels describe how FDA sorted a nomination under a temporary policy. None of them is an approval.
FDA's page, read in full on 30 October 2026 and parsed from its two tables, lists 17 substances as "nominated but withdrawn", including BPC-157, CJC-1295, Epitalon, GHK-Cu (injectable routes), Melanotan II, Selank, Semax and TB-500. These were in Category 2 until the nominators withdrew them. Listing a name here is not a recommendation or a safety finding.
Category 2 itself lists 14 substances. Here are some of them, with the routes FDA lists them for.
| Substance | Listed for | Note |
|---|---|---|
| Ibutamoren mesylate (sold as MK-677) | 503A; 503B | FDA cites a potential for congestive heart failure in certain patients |
| Ipamorelin acetate | 503B | Also appears in the withdrawn table |
| Growth hormone releasing peptides 2 and 6 | 503B | See FDA's table for the full entry |
| Kisspeptin-10 | 503A | See FDA's table for the full entry |
Many blogs still call the withdrawn peptides "Category 2, do not compound"; those predate the April 2026 change, which a law-firm alert (secondary) also reported. For the one that matters most to this scene, see BPC-157: status, trials and harms.
On 30 October 2026 HHS published a Federal Register notice (91 FR 68526) announcing a draft policy under which it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding with a listed peptide. It applies while FDA develops the 503A bulks list through rulemaking. The notice says the draft is not binding on HHS or the public.
No. The committee voted 8 to 6, with one abstention, on 23 July 2026 in favor of adding BPC-157 to the 503A list, according to ABC News (secondary), and Time (secondary) reported that the committee went against FDA staff advice. A vote advises FDA, and the agency decides through its own process.
Leaving Category 2 does not by itself make a substance eligible for compounding, as a JD Supra summary (secondary) notes.
Not in FDA's view, according to a law-firm summary. Arnall Golden Gregory reported (secondary) that FDA sent warning letters to five online peptide sellers on 24 August 2026 after reviewing their websites. It also reported that, according to those letters, FDA treats the whole presentation of a product, including disease claims, dosing guidance and reconstitution tools, as evidence of intended drug use.
We have not confirmed from FDA's own database which products each letter named, so this rests on one law firm's summary. It is one reason Whitepill publishes no dosing or sourcing information.
1. Find the substance on FDA's own pages, not a blog. 2. Note which table it is in, and the "current as of" date. 3. "Withdrawn" and "Category 2" mean different things; a page that mixes them up is out of date. 4. An advisory vote is advice, and an HHS enforcement policy is not an approval. Wait for FDA's action on the list. 5. "Research use only" on a label does not settle anything by itself. FDA looks at the whole presentation.
FDA's two pages were fetched and read in full on 30 October 2026, and table membership comes from parsing the pages' two real tables, with the raw pages stored as dated, hashed snapshots. The HHS notice was read through the Federal Register's API and text, and its appendices could not be opened.
News and law-firm reports are labelled as secondary where they appear and may be wrong or out of date. This page explains labels; it does not give legal or medical advice, and it contains no dosing, protocol or sourcing information.
Under FDA's interim policy, Category 2 holds bulk drug substances nominated for compounding where FDA has identified significant safety risks. It is a sorting label under a temporary policy, not an approval and not a final ruling.
Not on FDA's safety-risks page as of its content date of 22 April 2026, which we read on 30 October 2026. It sits in the table of substances nominated but withdrawn. Many older blogs still call it Category 2.
It is FDA's table for substances that were in Category 2 under the interim policy until the nominators withdrew their nominations. It is not an approval, and FDA's own text for BPC-157 still says it has identified no, or only limited, safety information.
A draft policy HHS announced in a Federal Register notice on 30 October 2026. It says HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding with listed peptides while FDA develops the 503A list. It is not binding, not an approval and not the list itself.
No. An advisory committee voted 8 to 6, with one abstention, on 23 July 2026 in favor of adding it to the list, according to ABC News and Time. That vote is advice to FDA, and we found no final FDA action when we read on the date above.
According to a law-firm summary of FDA warning letters sent on 24 August 2026, FDA looks at the whole presentation of a product, and dosing guidance or reconstitution tools on a seller's site are treated as evidence of intended drug use. We have not confirmed that from FDA's own records, and we do not give legal advice.
A category is a sorting label, a vote is advice, an enforcement policy is not an approval, and a label on a vial is a claim. Read the table, the date and the primary page yourself, and take any decision about your own health to a licensed clinician.