CPC Comments on FDA’s Draft Guidance on Flow Restrictors for Oral Liquid Drug Products

On May 18, 2020, CPC filed comments on FDA’s “Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry.” In addition to certain specific comments, CPC asked that FDA further clarify the designation of restricted delivery systems, including whether they are considered as medical devices, as part of the drug container closure system/package or combination products. In addition, we noted that the Draft Guidance should lay out considerations and recommendations for use of restricted delivery systems, but should not outline requirements for their use. As such, we asked that the Draft Guidance be updated to provide considerations for manufacturers to address during their risk-based development activities and revise the sections which appear to be defining requirements.