The Federal Drug Administration (FDA) plans to release new draft guidance for physician offices engaged in sterile drug manipulations. Previous guidance released in 2016 required these offices to meet a number of onerous requirements, such as requiring such drug preparations to take place in ISO class 5 clean rooms. Over the past year, the California Medical Association (CMA) and the American Medical Association (AMA) have expressed physicians' concerns about this regulatory burden. There is no specific target date for the new guidance. To learn about the FDA 2018 plan, go to