Peptide Regulation News

Safety

FDA Staff Made a Safety Case Against Compounding BPC-157 and TB-500. Here Is What It Says.

BPC-157 safety, as FDA staff set it out for the July 2026 compounding advisory meeting: quality, immunogenicity and missing human data. No final decision.

Sep 28, 2026

Legality

FDA Tells Five 'Research Use Only' Peptide Sellers Their Products Are Unapproved Drugs

Research use only peptides are unapproved drugs when sold for human use, five FDA warning letters posted 1 September 2026 tell online peptide sellers.

Sep 28, 2026

GLP-1

FDA Warning Letter Calls Empower Pharmacy's Vitamin-Added GLP-1 Compounds 'Essentially Copies'

Compounded GLP-1 vitamin combinations from Empower Pharmacy appear to be essentially copies of approved drugs, an 18 September 2026 FDA warning letter says

Sep 28, 2026

GLP-1

FDA Has Proposed Keeping Semaglutide and Tirzepatide Off the 503B Bulks List

The FDA proposed keeping semaglutide and tirzepatide off the 503B Bulks List. What that means for compounded GLP-1s, and what happens next.

Sep 4, 2026

Reference

Compounding Is Not FDA Approval — What the Difference Actually Means

A compounded drug is not an FDA-approved drug. The distinction decides what is legal, what is tested, and what recourse you have.

Reference

Are Peptides Legal in the US?

Legality depends on the compound, the seller, and the purpose. Here is how those three interact under US law.