Medical Device FDA Approval Process [+Timeline] Not all peptides are restricted. Here's the breakdown you actually need. The FDA's Category 2 classification affects specific compounded peptides BPC 157, TB 500, CJC 1295 Ipamorelin, AOD 9604, Epithalon, Selank, Semax. Others like Sermorelin 80+ peptides are fda approved. most people aren't using any of them. bpc 157, tb 500, ipamorelin none completed phase 3 trials. the feb 2026 reclassification to category 1 restored compounding access for 14 FDA Peptide Reclassification 2026: What It Actually Means Timeline of FDA approvals for weight loss parenteral medications. Download Scientific Diagram Sermorelin: Understanding How It Works, Its Uses, and What People Need to Know Nirvanix Health Blog