A belated Happy New Year to readers of Out of the Gates!

With the presidential inauguration and early actions on the Affordable Care Act, 2017 has started off with a bang and certainly will keep our attention on Washington, D.C. The change in the administration will usher in new leadership for the regulatory agency that's of great interest to us: the U.S. Food and Drug Administration.

While some foresee a shift in enforcement priorities, it is clear from this recent Compounding Progress Report from the FDA itself that a "vigorous" level of oversight related to the Drug Quality and Security Act will continue. "FDA intends to build on its initial efforts to implement and enforce the compounding provisions of the law in the coming months and years," the agency states.

You can count on frequent inspections from varying authorities and agencies, and you know that they will come at inopportune times, so make sure you are ready before the vehicle with the government plates pulls up. It's vital for health care organizations -- from independent compounding pharmacies to large-scale outsourcing facilities, from retail drug chains to hospital compounding labs -- to stay on top of their quality game and remain committed to patient safety through compliance and best practices.

Best wishes.

Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA