The compounding of “sterile” products has made headlines in the news in the United States over the last several years, due the lack of sterile conditions in a compounding pharmacy causing an outbreak of fungal meningitis. Although USP Chapter <797> was released in 2008 and outlines in detail procedures needed to keep pharmacies sterile, these lapses in sterility still occurred. However, the state governments were primary responsible for enforcing these procedures until recently. In 2013, the Unites States Congress broadened laws by passing the Drug Quality and Security Act of 2013, which gave the federal government the power to enforce USP Chapter <797> for compounding pharmacies. In addition, USP Chapter <797> is undergoing updates, and all practitioners in the field should be aware of the changes that are coming in the future. The field of parenteral nutrition has changed over the last few years as well, giving options such as premixed bags with multiple chambers.
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