Protecting the public by preventing harm from tainted sterile products is of paramount importance and is a fundamental step in providing patient- centered pharmacy services. This article will provide a brief overview of the USP, review the highlights of, describe differences between USP and USP, and describe the impact that will have on sterile compounding programs in health systems. The goal of this article is to provide a primer to pharmacy directors and others on new requirements and updates to hazardous drug handling as designated by USP. Pharmacy directors must be proactive in understanding the impact that USP will have on their processes for preparing sterile products. The official date of chapter publication has not been determined, but it is highly anticipated by stakeholders because this chapter requires key operational changes in the preparation of intravenous medications. The second round of public comments on the revised chapter opened on Decemand closed on May 31, 2015. The first round of public comments ended on Jthese comments were incorporated by the USP Compounding Expert Committee into a revised chapter. On March 28, 2014, The United States Pharmacopeia and The National Formulary (USP-NF) published USP General Chapter Hazardous Drugs–Handling in Healthcare Setting, as open for public comment in the USP Pharmacopeial Forum (PF) 40(3), the free online-only journal in which USP publishes revisions to USP-NF. As a result, a 2014 National Survey of standards in hospitals showed increases in compliance with both sterile preparation and hazardous drug requirements – but there was room for significant improvement. ![]() The authority of the US Food and Drug Administration (FDA) in regulating sterile compounding was reviewed, and accrediting organizations took a firm stand on institutions implementing the standards of USP General Chapter. A call to action was generated by many professional organizations and groups to take the recommendations for compounding as set forth by The United States Pharmacopeia (USP) seriously. 1 As the analysis of the tragedy unfolded, it was obvious that many of the deaths and disabilities could have been prevented if the center had adhered to fundamental guidelines of preparing sterile intravenous preparations. The 2012 New England Compounding Center tragedy is well known 678 confirmed cases of contaminated intravenous preparations resulted in over 60 deaths. Although complying with USP may seem to be a daunting task, it can be manageable if approached in a systematic organized way. Until the standard becomes official, it is important for pharmacists to become familiarized with the latest draft to identify potential barriers to compliance and to strategize a plan to overcome barriers. Pharmacy leaders at every level will play a key role in assisting an organization to achieve timely compliance with USP standards. Even if one is compounding in the most compliant USP cleanroom, improper technique can negate all the benefits of the physical structures. This point should be emphasized with all compounding personnel. ![]() ![]() Regardless of all of the requirements listed in USP, there is no substitute for disciplined, consistent work practices regarding proper sterile technique. USP describes hazardous drug handling related to the receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile products and preparations. USP serves as a new standard to guide the handling of hazardous drugs in order to protect patients, health care personnel, and the environment. USP General Chapter pertains to the compounding of both hazardous and nonhazardous drugs. On March 28, 2014, The United States Pharmacopeia and The National Formulary (USP-NF) published USP General Chapter Hazardous Drugs–Handling in Healthcare Settings, as open for public comment in the USP Pharmacopeial Forum (PF) 40(3).
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