Regulatory8 min read
Compounded GLP-1s: FDA Docket Closed, 3,901 Comments
The FDA's plan to bar 503B bulk compounding of semaglutide, tirzepatide and liraglutide drew 3,901 comments before the July 30 cutoff. What survives.
Peptide Regulatory News
FDA actions, public comments, compounding rules.
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State-by-state legal guides
Are peptides legal in your state? Updated for 2026.
Regulatory News
Regulatory7 min read
FDA Maps Generic Path for Semaglutide, Tirzepatide
The FDA published 17 revised generic-peptide guidances and pulled its 2021 synthetic-peptide rule. What it changes for GLP-1 pricing and access.
Regulatory6 min read
The $2.2B Race to Sell You Prescription BPC-157
Leerink pegs compounded peptides at a $2.2B telehealth market and Hims jumped 10% on the FDA vote. What the prescription route means for price and timing.
Regulatory5 min read
FDA's Next Peptide Panel: GHK-Cu, Melanotan, Dihexa
The FDA scheduled a second peptide panel by early 2027: GHK-Cu, Melanotan II, LL-37, Dihexa, and PEG-MGF are next. What buyers should know.
Regulatory7 min read
FDA Peptide Panel: Members Sell BPC-157, TB-500
AP flagged FDA's peptide panel for members who sell BPC-157 and TB-500. Here's how the July 23-24 vote actually broke down — 6 of 7 recommended.
Regulatory5 min read
FDA Staff: No Compounding for BPC-157, TB-500, 5 More
FDA scientists recommend against adding BPC-157, TB-500, MOTS-c and 4 more to the compounding list before the July 23 vote. What it means for buyer access.
Regulatory5 min read
FDA Peptide Vote Results: What Buyers Need to Know
FDA panel backed BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon; DSIP rejected. What the results actually change for access — and what they don't.
Regulatory4 min read
FDA Hits 25 More Telehealth GLP-1 Sellers
FDA posted 25 new warning letters June 16 to telehealth firms over compounded semaglutide and tirzepatide claims. What it signals and what's still legal.
Regulatory5 min read
GLP-1s Now FDA-Approved for Fatty Liver Disease
Semaglutide and tirzepatide both FDA-approved for MASH. 63% resolution rate, fibrosis reversal in trials. What the data shows and sourcing options.
Regulatory5 min read
Ex-FDA Officials Push Back on RFK Peptide Reversal
Three former FDA officials say RFK Jr. mischaracterized their 2023 peptide-safety work. What the pushback means for buyers before the July 23 PCAC vote.
Regulatory8 min read
FDA Targets 503B GLP-1 Compounding: What Now
FDA proposed April 30 to bar 503B compounding of semaglutide, tirzepatide, and liraglutide. The comment window closed July 30. What survives the rule.
Regulatory4 min read
Orforglipron Approved: First Oral GLP-1 Pill
FDA approved orforglipron April 1 at $149/mo -- but compounded semaglutide still beats it on weight loss. Full cost and efficacy comparison inside.
Regulatory11 min read
14 Peptides Legal Again: FDA Reclassification Explained
RFK Jr. announced 14 of 19 banned peptides return to Category 1. Which ones, what it means for compounding, and 5 that stay restricted.
Regulatory8 min read
Dihexa: Off FDA Category 2, But Is It Legit?
Dihexa dropped off FDA Category 2 April 22. But the foundational research came from a company that paid $4M for misconduct. Here's the full picture.
Regulatory6 min read
GLP-1 Compounding Crackdown: Your Options Now
FDA sent 30 warning letters to telehealth GLP-1 compounders. Here's what's still legal, what changed, and where to source semaglutide and tirzepatide now.
Regulatory10 min read
Why Your Pharmacy Won't Compound CJC-1295 (But Another Will)
503A vs 503B, Category 1 vs 2, and why some pharmacies prescribe peptides others refuse. The regulatory map no one explains clearly.
Regulatory7 min read
12 Peptides Off FDA Category 2: April 22
FDA pulled 12 peptides from the Category 2 restricted list April 15 -- effective April 22. Includes GHK-Cu and Melanotan II. Full list and what it changes.
Regulatory6 min read
BPC-157 Public Comment Deadline: July 9
FDA opened a public docket today on BPC-157, TB-500, KPV, and MOTS-c. Comments before July 9 reach the committee. Here's how to submit one.