Pharmacy OneSource Blog

Complying with USP 800 Hazardous Drug Compounding Requirements

Posted on 11/02/16

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“Poison is in everything, and no thing is without poison. The dosage either makes it a poison or a remedy” - Paracelsus

As healthcare professionals, we have generally associated medicines as inconsequential to us while handling them to make patients better and treat diseases. One of the diseases that we are  working diligently to treat is cancer. Cancerous cells generally divide more rapidly than normal cell and many antineoplastics used to treat cancers and other immune-related maladies work by interfering with rapid cellular division.

These agents are not without problems or unintended consequences however, as they indiscriminately kill all rapidly dividing cells by interfering with DNA and RNA sequences. The problem with this mechanism of action is that this targeted activity can affect all cells, especially rapidly developing fetal/embryonic cells. The National Institute of Occupational Safety and Health (NIOSH) has designated this group of drugs as hazardous, and presents both short-term and long-term risks that include reproductive toxicity and the developmental cancers.

Based on decades of scientific evidence, voluntary safe handling guidelines of hazardous drugs have shown to be ineffective, prompting the USP, in collaboration with renowned experts, to developed USP Chapter <800> for the Safe Handling of Hazardous Drugs in the Healthcare Setting. This chapter is a synthesis of decades worth of guidance from NIOSH, OSHA, ASHP, and ONS to create requirements for protecting individuals while working with these agents.

The chapter will require every facility to maintain a list of antineoplastic and other hazardous drugs it uses, including all the drugs on the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs, and update the list anytime a new dosage or agent is added. Compounding staff involved with these hazardous drugs can start preparing to meet USP 800 standards, but may feel challenged figuring out where to start assessing their cleanroom’s risk. 

Register today for a free webinar with me on November 9 to learn more about USP chapter <800> regarding the safe compounding of hazardous drugs, including a review of the chapter requirements with a focus on the new 2016 NIOSH List of Hazardous Drugs and challenging aspects of the chapters requirements. (Please note: Pharmacy OneSource is not an accredited organization so we cannot provide CE credit for the webinar at this time.)

sterile compounding  

Topics: Sterile Compounding

About the Author

Eric S. Kastango RPh, MBA, FASHP is president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee and served until April 2013.