Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

Merz North America is submitting a formal request for the inclusion of several bulk drug substances (Fentanyl Citrate, Oxytocin, Vancomycin Hydrochloride, Hydromorphone Hydrochloride, Morphine Sulfate Pentahydrate, Midazolam Hydrochloride, and Norepinephrine Bitartrate) for use in compounding. They argue that using bulk APIs is clinically necessary to ensure potency, sterility, and safety, while also meeting specific prescriber requirements for varying concentrations and volumes.

Cantrell Drug Company argues that the use of bulk active pharmaceutical ingredients (APIs) should be permitted for 503B outsourcing facilities. They contend that using bulk APIs is safer than compounding from commercial products because it requires fewer aseptic manipulations, helps mitigate drug shortages, and is necessary for creating specific strengths and configurations required by patients.