PEPTIDE THERAPEUTICS: FDA Regulatory Update & Proposed Timeline | April 2026
Yoon Hang Kim, MD, MPH | www.directintegrativecare.com KEY DISTINCTION: Removal from Category 2 does NOT equal Category 1 approval. Peptides removed from Category 2 currently occupy regulatory limbo as unapproved new drugs. Full legal compounding access requires PCAC review, a favorable recommendation, and final FDA rulemaking. Until that formal