Zdrowie i gospodarka · 11/07/2016

FDA Releases Draft Guidance on Compounded Drug Products Under Section 503A of the FD&C Act

The FDA is releasing a draft guidance on compounded drug products that are essentially copies of commercially available drugs, outlining policies for exemptions under Section 503A of the FD&C Act. The guidance clarifies terms such as 'commercially available' and 'regularly or in inordinate amounts' for licensed pharmacists and physicians who compound these products.