503A & 503B UPDATE

Fri, 02/28/2014

February 28 2014

On behalf of our loyal customers, Fagron has responded to FDA's Request for Bulk Drug Substances Nominations - for both 503A & 503B Facilities.

Fagron was one of the first suppliers to submit comments for our complete product offering to the FDA on its Request for Bulk Drug Substances Nominations for both Sections 503A and 503B of the Federal Food, Drug and Cosmetic Act (FD&CA). Fagron is fully engaged in the FDA notice and comment process and is committed to maximizing the lists of substances accepted by FDA for use in compounding preparations in facilities operating under Sections 503A and 503B of the Act. We will continue to keep you informed of any developments with regard to the recently passed legislation known as the Drug Quality and Security Act, FD&CA §§503A and B.

Fagron offers the most extensive assortment of APIs, excipients, and bases & vehicles. If you would like to find out more about The Drug Quality and Security Act please go to our website and listen to a 60 min webinar about it hosted by IACP David Miller.  Click here, Don’t miss out on it!