News topic
Regulatory News & Updates
FDA rulings, 503A/503B compounding regulations, international regulatory actions, and policy shifts that change peptide availability.
7 articles in this topic
FDA Sets July 23–24 Meeting to Review BPC-157, TB-500, and 5 More Peptides for Compounding Access
The FDA announced a formal advisory committee meeting on July 23–24 to evaluate whether seven peptides — including BPC-157, TB-500, and Semax — should be added to the 503A bulk drug substances list, restoring legal compounding access. A public comment docket is open until July 22.
RFK Jr. Announces 14 Peptides Moving Back to Category 1: What It Means
On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced that approximately 14 of the 19 peptides on the FDA Category 2 restricted list will return to Category 1 — restoring legal compounding access.
Oral Wegovy Pill Gets FDA Approval: What You Need to Know
The FDA approved oral semaglutide (Wegovy pill) for chronic weight management in December 2025 — eliminating the need for weekly injections. Here is what the clinical data shows.
FDA Category 2 Peptide Ban: The Complete Guide
Everything you need to know about the FDA's Category 2 classification of peptides — which compounds are affected, what it means for access, and the 2026 reclassification reversal.
FDA Approves Monthly Tirzepatide KwikPen for Weight Management
The new Zepbound KwikPen packs 4 weekly doses into one device — a full month of treatment. Available at $299/month for the starting dose via LillyDirect.
FDA Peptide Reclassification: March 2026 Status Update
One month after the announcement that 14 peptides would return to Category 1 compounding status, the formal FDA reclassification has not been published. Here is the latest on what is happening and what to expect.
Are Peptides Legal in 2026? The Complete Post-RFK Status Guide
The legal landscape for peptides shifted dramatically in 2026 after HHS Secretary RFK Jr. moved 14 peptides back to Category 1. Here is exactly what is legal, what is not, and what it means for patients and researchers.