The compounding framework in plain English — because every peptide headline depends on it.
Two kinds of compounding
- 503A pharmacies compound patient-specific preparations against an individual prescription, under state-board oversight.
- 503B outsourcing facilities compound larger batches under stricter federal manufacturing rules. The October 2026 peptide policy does not reach 503B at all.
Three lists, three different meanings
- Category 2 (the “do-not-compound” list). In September 2023 the FDA placed 19 peptide substances in Category 2 — effectively barred from compounding. In April 2026, twelve were removed, in every case because their nominations were withdrawn — a procedural reason, expressly not a safety finding.
- Category 1. Substances with no significant safety concern flagged. Today only two peptides sit here: GHK-Cu in non-injectable form, and VIP.
- The 503A Bulks List (21 CFR 216.23). The actual authorization list. A substance gets here through advisory-committee review (the PCAC) plus FDA rulemaking. None of the six policy peptides is on it yet.
The sentence to remember: Category 2 removal ≠ Category 1 ≠ Bulks List ≠ FDA approval. Four different events, four different legal meanings — and most headlines collapse them into one.
Educational information only — not medical or legal advice. Status as of November 7, 2026. See Our Legal Mandate.