USP releases new and revised chapters

USP releases new and revised chapters

The U.S. Pharmacopeia (USP) has published new and revised USP Compounding General Chapters and made them available for free download. The chapters published include: <795> Pharmaceutical Compounding – Nonsterile Preparations; <797> Pharmaceutical Compounding – Sterile Preparations; and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The new and revised standards, in addition to General Chapter <800> published in February 2016, go into effect Dec. 1. They provide a comprehensive set of standards for health care workers to help ensure quality compounded preparations and the safe handling of hazardous drugs. The revisions reflect advancements in science and clinical practice and clarify topics that were frequently misconstrued.

AHA comments on co-location guidance

The American Hospital Association (AHA) submitted comments to the Centers for Medicare & Medicaid Services draft Guidance for Hospital Co-Location with Other Hospitals and Healthcare Facilities, urging the agency to consider a series of revisions to enable successful implementation of the policy and promote safer, higher-quality care. “The option and ultimate decision to co-locate is only as meaningful as the benefits both patients and the providers who treat them receive as part of a more streamlined and coordinated process,” the AHA wrote. “Failure to provide critical flexibility for these co-located entities significantly hampers the benefits of such arrangements, diminishing the value of co-location, and likely leading to far less utilization of the option to co-locate.”

CDC responds to Ebola outbreak

The Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) to support the interagency response to the current Ebola outbreak in eastern Democratic Republic of the Congo (DRC). The DRC outbreak is the second largest outbreak of Ebola ever recorded and the largest outbreak in DRC’s history. As part of the administration’s whole-of-government effort, CDC subject matter experts are working with the USAID Disaster Assistance Response Team (DART) on the ground in the DRC and the American Embassy in Kinshasa to support the Congolese and international response. The risk of global spread of Ebola remains low. Activation of the CDC EOC does not mean that the threat of Ebola to the United States has increased or that changes are being made to CDC’s outbreak-related guidance.

FCC approves new telehealth pilot program

The Federal Communications Commission (FCC) voted unanimously to approve a notice of proposed rulemaking to establish a new $100 million Connected Care Pilot Program to support telehealth for low-income Americans, including veterans and those living in rural areas. The American Hospital Association has said the program is a critical next step toward delivering affordable telehealth services to those Americans who need it the most, and in September shared comments and recommendations with the FCC on its notice of inquiry about the program. Among other areas, the FCC’s proposed rule seeks comments on who should participate in the pilot, including eligible health care providers and broadband service providers; the goals of the pilot; and the project application submission and evaluation. FCC Chairman Ajit Pai says, “The future of health care is connected care, and this is the future I want the FCC to support.”