All drugs should be compounded under suitable quality standards, but who should be ensuring those standards among traditional compounders and outsourcing facilities was debated at a 2018 House Energy and Commerce Subcommittee on Health hearing.
In written testimony, FDA Commissioner Scott Gottlieb, MD, cited a litany of manufacturing problems at compounding facilities, including mold contamination of the type that caused lethal fungal infections during the New England Compounding Center