FDA proposes excluding semaglutide and tirzepatide from the 503B bulks list
The FDA proposed not adding semaglutide, tirzepatide, and liraglutide to the 503B bulk substances list. A public comment period is open, closing on or around June 29, 2026.
Peptide research, quality, and regulatory news.
The FDA proposed not adding semaglutide, tirzepatide, and liraglutide to the 503B bulk substances list. A public comment period is open, closing on or around June 29, 2026.
BPC-157 came off the 503A Category 2 safety-risk list in April 2026 but is not yet on an approved bulks list, leaving its compounding status unresolved ahead of the July PCAC review.
Third-party analyses report a substantial share of online research peptides miss stated purity, and note that endotoxin can matter even at ~99% purity — reinforcing why COAs are worth reading.
An oral semaglutide 25 mg became available in January 2026, and ADA 2026 featured next-generation “beyond GLP-1” approaches and new mechanism findings.