hypogonadism; kisspeptin10; compounding; fda 503a

I. INTRODUCTION Kisspeptin-10 was nominated for inclusion on the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 Kisspeptin-10 was evaluated for the treatment of secondary hypogonadism in men.2,3...