Comment from MedDay Pharmaceuticals
AnonymousOpposeBusiness
Summary: MedDay Pharmaceuticals opposes the inclusion of high-dose biotin (greater than 60 mcg) on the 503B Bulks List. They argue that there is no demonstrated clinical need for compounding high-dose biotin and that it presents unique safety risks and impurities compared to lower dosages.
Please see the attached comment regarding reasons that biotin in dosages greater than 60 micrograms should be excluded from the 503B bulks list.