IGMPI India



FDA heads towards implementing compounding provisions of Drug Quality and Security Act

FDA is moving towards implementing the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), which has been recently signed into the law. FDA has issued three draft guidance and three Federal Register (FR) notices in relation to the implementation of the compounding provisions of the act.
According to the FR notices, FDA would produce listings of bulk drug substances that are used in pharmacy compounding, products that are made from those substances and products that are difficult-to-compound. Along with this, it suggests that the industry should nominate candidates for the lists and the details for submission are also provided.

The draft three guidance covered

Overarching rules for pharmacy compounding and the ways to apply enforcement for violations

A definition of a new category of compounder created by the DQSA – an outsourcing facility and the requirements for registration

Interim requirements for ongoing reporting of information to FDA by the outsourced facilities on their products and services.