Type of Notice: General Announcement
Posting Date: 25–Jun–2021
This is an update for the New Inhalation Product Monographs: Proposed Approach for Performance Tests Employing Non-standard Apparatus Compendial Notice, posted on USP website for public comments on August 28, 2020, with the comment deadline of November 30, 2020. In accordance with the Rules and Procedures of the Council of Experts, USP is publishing the comments received from stakeholders.
Beginning in 2018, USP received comments from FDA and industry stakeholders that the inclusion of non-standard apparatus in inhalation product monographs created a potential burden for industry and was inconsistent with the agency’s inhalation product specific guidance documents. In response, USP proposed a new compendial approach intended to ensure the efficient development of new inhalation product monographs. Based on the comments received, USP is reconsidering the approach for addressing performance tests employing non-standard apparatus. The previously proposed approach was intended to address a specific set of concerns pertaining to new inhalation drug product monographs which employ non-standard apparatus in performance tests. However, comments received from FDA and other stakeholders expanded the scope of the issue to include all inhalation product monographs containing any detailed performance test (irrespective of the test apparatus), including any performance test with detailed acceptance criteria.
USP will focus future efforts on engaging with stakeholders to explore new ways of addressing these important performance quality tests for inhalation drug products within the public standard in a manner that will not impede generic development.
Should you have any questions, please contact Nicholas Garito (firstname.lastname@example.org).