Jun 17, 2024· Comment from Association for Accessible Medicines (AAM)· FDA-2023-N-0061-0018
FDA, Please find attached comments from The Association for Accessible Medicines (AAM) regarding Docket No. FDA–2023-N-0061, "Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule" Thanks, Scott Kuzner, Ph.D., Senior Director, Sciences and Regulatory Affairs, AAM