FDA announced the release of a 2018 Compounding Policy Priorities Plan outlining its ongoing efforts to implement key com- pounding provisions of the Drug Quality and Safety Act (DQSA), passed in 2013. The plan specifically details how FDA will: ● address manufacturing standards for outsourcing facilities ● regulate compounding from bulk drug substances ● restrict com- pounding of drugs that are essentially copies of FDA-approved drugs ● solidify the FDA’s partnership with state regulatory authorities, and ● provide guidance on other activities that compounders undertake. One goal “is to make it more feasible, and lower cost, for a larger swath of pharmacies to transition to becoming outsourcing facilities,” the announcement states. Three final guidances on compounding are provided with the announcement.
[IPQ has closely tracked the regulatory/legislative developments in the US regarding compounding since the 2012 NECC crisis. See the Pulitzer-nominated IPQ November 2012 Monthly Update to better understand the foundation of FDA’s current enforce- ment engagement with pharmacy compounding.]