Enclomiphene is a component of an FDA-approved drug, clomiphene citrate, and is thus nominated for use in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. This allows it to be legally prepared by a compounding pharmacy when prescribed by a physician. If and when any updates occur to the FDA bulk drugs list, we will work with our partners and patients to update our treatment protocols and ensure continuity of care.