Peptide Compounding Docket Map: The Correct 503A and 503B Rulemaking Numbers
Verified docket numbers for FDA's peptide compounding rulemaking — including the September 2019 503A proposed rule that is still not final seven years later.
By PeptidesBeat Editorial Desk
Last reviewed
Every docket in this map was verified directly against the Federal Register API on August 23, 2026. Docket numbers are the load-bearing part of any regulatory citation — when they are wrong, every downstream claim is suspect.
The docket that matters most
FDA-2018-N-4845 is the September 5, 2019 proposed rule, “Amendments to the List of Bulk Drug Substances That Can Be Used to Compound Drug Products Under Section 503A” (Federal Register document 2019-18951). It has exactly one document — the 2019 proposal — and nothing since. Seven years after publication, it is still not final. This is the precedent that shapes every timeline assumption about peptide compounding legality.
A common citation error to be aware of
Some trackers cite FDA-2018-N-3240 for the 503A bulk substances rulemaking. That docket is actually the 503B (outsourcing facility) clinical-need list — “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B.” It is an active docket with twelve documents, the latest a comment-period extension dated June 26, 2026. It is a different statutory list than 503A. Getting this distinction right matters because the two lists have different rules, different nomination processes, and different enforcement consequences.
The verified map
| Docket | What it is | Status (verified 2026-08-23) |
|---|---|---|
| FDA-2018-N-4845 | 503A proposed rule (Sept 2019) | One document; not final — 7 years |
| FDA-2018-N-3240 | 503B clinical-need list | Active; 12 documents; latest 2026-06-26 |
| FDA-2015-D-3517 | 503A interim policy | Active; interim policy docs 2023-12, 2025-01 |
| FDA-2025-N-6895 | PCAC peptide nominations meeting | July 23–24, 2026 meeting |
| FDA-2024-N-4777 | PCAC meeting notice | Oct 2024 |
| FDA-2024-N-4188 | PCAC meeting notice | Sep 2024 |
The July 2026 PCAC vote, precisely stated
On July 23–24, 2026, the Pharmacy Compounding Advisory Committee recommended six of seven nominated peptides for the 503A bulk drug substances list: BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. Emideltide was not recommended (reported vote 6-7-1). Reported vote tallies for the others: Epitalon 7-4-1, Semax 8-5-1.
The recommendations are nonbinding. FDA must complete notice-and-comment rulemaking before any of these can legally be compounded. None of the six are legal to compound today.
What follows
- A second PCAC meeting is scheduled before the end of February 2027, with roughly five more peptides queued.
- The April 2026 removal of twelve peptides from Category 2 created a gray zone, not authorization.
- FDA is simultaneously tightening compounding enforcement: patient-specific prescription requirements, the “essentially a copy” doctrine, and the four-prescriptions-per-month framework described as a ceiling rather than a safe harbor.
This page is part of the PeptidesBeat regulatory ledger, updated as dockets move. Last verified: August 23, 2026.
Educational content, not medical advice. © 2026 PeptidesBeat.