Developments

Regulatory & research developments

Each development record must cite a primary source document from a government, regulatory or scientific body before it can appear here.

FDA safety communication on compounded and illegally marketed semaglutide products
U.S. Food and Drug Administration · Warning/safety communication · 2026-05-31
FDA safety information page covering medications containing semaglutide. FDA states that semaglutide salt forms are not the active ingredient used in the approved drugs, reports adverse-event counts associated with compounded semaglutide, and notes warning letters issued to companies illegally selling unapproved products containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide labelled "for research purposes" or "not for human consumption".
Primary source
BPC-157 listed in FDA Category 2: bulk drug substances for compounding that may present significant safety risks
U.S. Food and Drug Administration · Compounding-related action · 2026-04-22
FDA states that compounded drugs containing BPC-157 may pose a risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and active pharmaceutical ingredient characterisation. BPC-157 is not an FDA-approved drug.
Primary source
Thymosin beta-4 fragment (LKKTETQ), also known as TB-500, listed in FDA Category 2 for compounding
U.S. Food and Drug Administration · Compounding-related action · 2026-04-22
FDA states that compounded drugs containing thymosin beta-4 fragment (LKKTETQ) may pose a risk for immunogenicity for certain routes of administration due to potential aggregation and peptide-related impurities, and that FDA has not identified human exposure data for drug products containing this fragment. It is not an FDA-approved drug.
Primary source