Science journalism · Not medical advice Regulatory window · PCAC review in 42 days

Regulatory Tracker

A running record of FDA and PCAC actions on peptide compounding — enforcement waves, committee reviews, Federal Register filings. No commentary on legality. Just the record, dated, with links.

  1. PCAC Peptide Compounding Review Window

    The FDA Pharmacy Compounding Advisory Committee convenes to evaluate peptide compounds for potential reclassification. The two-day window covers 503A pharmacy eligibility criteria and the substance list review process. Outcome will define the regulatory lane for compounding pharmacies dispensing GH-axis peptides.

  2. FDA Warning Letter Wave — Peptide Compounding (April 2026)

    Second enforcement wave targeting compounding pharmacies and grey-market vendors. Cited patterns: numeric dosing in marketing copy, stack recommendations, and implied prescriber endorsement. Expands the March 2026 action to telehealth platforms recommending compounded peptides.

  3. FDA Warning Letter Wave — Peptide Compounding (March 2026)

    Coordinated FDA warning letters to compounding pharmacies and peptide marketers. Enforcement focused on drug-promotion language, unhedged treatment claims, and dosing protocol publications. Defined the floor for what science-journalism coverage of peptides must avoid.

  4. FDA Federal Register Notice — 503A Bulk Substance List Review

    Federal Register notice opening the comment period for the annual review of bulk substances eligible for 503A compounding. Peptides including BPC-157, TB-500, and Ipamorelin remain on the Category 2 list (evaluation pending) — the primary regulatory lever ahead of the PCAC July window.

  5. FDA PCAC Public Meeting — Peptide Substance Nominations

    Public PCAC meeting where nominated peptide substances were formally entered into the review queue. Ipamorelin, Sermorelin, and Tesamorelin received separate nomination entries. Meeting established the procedural record that the July 2026 review will draw on.

  6. FDA Draft Guidance — Compounding from Bulk Drug Substances Under 503A

    Draft guidance clarifying which bulk drug substances 503A pharmacies may compound without a valid prescription, and the evidentiary standards required to remain on the candidate list. Relevant to most grey-market peptide formulations currently in distribution.