FDA: Agency Actively Working on 503B Compounding List, Declines To Comment On Alleged APA Violations

FDA officials tell Inside Health Policy they dispute allegations that the agency's decision to put certain compounding regulations on the most recent regulatory agenda's inactive list means the agency is no longer working to implement portions of the Drug Quality and Security Act. Agency officials underscored that FDA and Commissioner Scott Gottlieb's commitment to DQSA implementation is “simply unwavering,” and said that the agency is working on developing the 503B list, though they could not specify a timeline for...