Chapter <800>: Time to Move Forward!

December 2016 : USP <800> - Vol.13 No. 12 - Page #1
Categories: Closed System Drug-Transfer Devices (CSTDs), PPE/Garb & Gloves

USP Chapter <800> was finalized and published on February 1, 2016 with an extended official implementation date of July 1, 2018 (although some states have elected to require earlier compliance). Unlike Chapter <797>’s focus on enhancing patient safety, Chapter <800> is intended primarily to protect healthcare workers and environments from exposure to hazardous drugs (HDs) in the healthcare settings where they are handled. It is important to note that many of the requirements and recommendations in Chapter <800> are not new, and a wide variety of professional sources such as the American Society of Health-System Pharmacists, American Society of Clinical Oncology, National Institute for Occupational Safety and Health, and the Oncology Nursing Society have provided similar recommendations since the 1980s.1-5 Since much of this information has long been available, we must ask why it has taken so long to commit to implementing these sensible recommendations—some of which are now requirements. While there are many reasons (and excuses) for previous delays, Chapter <800> now mandates enforcement of these regulations, which will lead to many overdue physical plant modifications and work practice alterations.

Study Results

Critical Point examined compliance with Chapter <800> as part of the 2016 USP Compliance Study. This year’s study findings establish a practice baseline for HD practices. As you review the findings on the following pages, keep in mind that the reported compliance rates are likely to be somewhat overstated. Because completion of the Chapter <800> Gap Tool (offered as part of the 2016 USP Compliance Study) is optional, those participating in the study are likely to be aware of pending regulatory requirements and be motivated to comply. It is also possible for survey respondents to interpret questions differently based on their experiences. The innate desire to view our practices—and hence ourselves—in a favorable light also is likely to cause an inflation in self-reported compliance scores, especially when contemplating compliance with regulations that serve to ensure the safety of our staff.

Here are a few thoughts on how to get on the road to Chapter <800> compliance:

  1. Designate a knowledgeable individual to be responsible for overseeing all aspects of HD handling. This person will serve as the orchestra leader; however, their success is predicated upon management providing the necessary resources to ensure they develop an expertise in effective practice strategies for compliance.
  2. Compile your organization’s list of HDs handled using the 2016 NIOSH Hazardous Drug List.4
  3. Consider performing an Assessment of Risk for those drugs (antineoplastics that only need to be packaged or counted, non-antineoplastics and reproductive only hazards) that may be eligible for alternative containment strategies and work practices. There are plenty of drugs like oxytocin or oral methotrexate that represent only situational hazards. Once identified, effective and practical containment strategies can be identified and employed.
  4. Assess the current physical plant including containment primary engineering controls (C-PEC) suitability and containment secondary engineering control (C-SEC) function. Make smart decisions about modification, get approval, and move forward. Interestingly, 26% of hospitals report that they still use the “low volume” exemption contained in Chapter <797> relative to HD compounding. Since Chapter <800> removes that exemption, at least 26% of hospitals have a significant amount of physical plant renovation to undertake. Shockingly, another 27% of hospitals report that they do not comply with the physical plant requirements of Chapter <800> and have no plans to comply!
  5. Evaluate current work practices and identify gaps between required and desired work practices and actual work practices. Revise written standard operating procedures (SOPs) accordingly. Generally speaking, there are simple changes that can be made to hazardous PPE donning and doffing practices, HD inventory receipt and handling, and organization of compounding steps, which can be made at minimal cost while dramatically improving containment of HD residues. It requires only knowledge and focus!
  6. Develop staff training based on the updated SOPs. The lowest scoring domains in the 2016 Chapter <800> Compliance Study were compliance with items within the SOP Development Domain and Personnel Training Domain. Without detailed SOPs and staff who are trained from them, achieving compliance is impossible.
  7. Establish processes to monitor for compliance with new procedures and use objective measures when possible to measure outcomes. Only 10% of hospitals report performing HD environmental wipe sampling and the vast majority of these perform it by sampling the inside of the C-PEC only. If the goal is to prevent hazardous drug residue from migrating outside of the C-SEC (or C-SCA), then it might be more important to monitor the floor directly outside of these areas.
  8. Keep seeking improvement. Focus on moving forward.


Although achieving compliance with the standards in USP Chapter <800> may appear to be a daunting undertaking, the roadmap to any operational and regulatory challenge begins with an understanding of where you are today and where you need to be at each ensuing critical step in order to achieve full compliance. Compliance is a journey, not a destination. Develop a compliance plan that is strategic and based upon your organization’s needs. Systematically evaluate the voyage traveled by HDs in your facility. Verify current containment strategies and develop new ones. Learn from the experience of others. A wealth of information is available to support your efforts. Each step you take gets you closer to your goal and more importantly, moves your organization another step closer to compliance.

Right now, that is all we can ask. Move forward. Get started. What do you have to lose?

Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the co-director of the annual USP Compliance Survey.

Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and principal of Clinical IQ, LLC, and CriticalPoint, LLC. He also serves as the co-director for the annual USP Compliance Survey.

Peter Cantor, who serves as the COO and managing partner of CriticalPoint, LLC, is the study coordinator.

Address any questions to Kate Douglass at


  1. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-93. Retrieved on November 2, 2016 from
  2. American Society of Clinical Oncology. Chemotherapy Safety Standards (2015 Update). Retrieved on November 2, 2016 from
  3. National Institute for Occupational Safety and Health. NIOSH Alert. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. September 2004. Publication 2004-165. Retrieved on November 2, 2016 from
  4. National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. September 2016. NIOSH Publication number 2016-161. Retrieved on November 2, 2016 from
  5. Oncology Nursing Society. Safe Handling of Hazardous Drugs. 2nd edition. 2011. Retrieved on November 2, 2016 from


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