NCPA recently submitted comments to the Food and Drug Administration (FDA) regarding draft guidance on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act. NCPA’s comments reiterated our position that compounded products intended for office use should continue to be regulated by individual State Boards of Pharmacy. We also commented on circumstances that may warrant compounding of drug products that are copies of commercially available products as well as circumstances surrounding a bulk drug substances list and a list of drug products that preset demonstrable difficulties for compounding. Lastly, NCPA provided our thoughts related to a standard Memorandum of Understanding (MOU) for use between FDA and the states. This MOU will address the “interstate distribution of inordinate amounts of compounded drug products.” NCPA believes that assigning a specific percentage limit that is applicable to all states is an extremely difficult task, given varying degrees of compounding activity in each state. Ideally, each individual Board of Pharmacy should determine what constitutes an “inordinate amount.” NCPA is committed to working with the FDA and other stakeholders to ensure that a workable framework for the regulation of compounding is established and is operational, to ensure enhanced patient safety and quality control.
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