Clinical

The FDA signalled movement on BPC-157 and a dozen other peptides, and the market read it as permission. Removal from the do-not-compound list is not the same as approval to compound.

The FDA approved label changes removing cardiovascular, breast cancer and dementia risk statements from the boxed warning. The endometrial cancer warning stayed, and compounded products were not addressed.

Exosome and stem cell products marketed for regeneration are generally regulated as biological drugs, and none is FDA approved for those uses. The claims are usually what triggers enforcement.

The infusion is a routine medical act. The marketing is where clinics get into trouble — reversing aging, repairing DNA, treating addiction. Here is the defensible version.

Titrating per label is not microdosing. Deliberately staying sub-therapeutic and advertising it for longevity or metabolic health is a different question entirely.

Retatrutide is investigational, not approved for any indication, and has no lawful compounding pathway under 503A or 503B. What is actually in the vials being sold.

The shortages that made compounded semaglutide and tirzepatide possible are over, the grace periods expired, and FDA has moved to close the remaining route.