Comment from Merz North America part 1 of 2

Summary: Merz North America, the authorized U.S. distributor of Asclera® (polidocanol) injection, opposes the inclusion of polidocanol on the 503B Bulk Drug Substance List. They argue that there is no demonstrated clinical need for compounded polidocanol and that compounding the substance from bulk drug material poses significant safety risks, including microbial contamination and inconsistent potency.