We hope you found our first installment of this series helpful as you make your path to full compliance with USP 800. We know there are many challenges along the way, and we welcome questions for this blog!
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Section 2 of USP 800 addresses the necessary documentation of hazardous drugs according to the NIOSH list. Here’s our summary of what you need to know in this Section.
United States Pharmacopeia 800: Hazardous Drugs – Handling in Healthcare Settings
Section 2 List of Hazardous Drugs
The approval of USP 800 requires sites to “maintain a list of hazardous drugs, which must include any items on the current NIOSH list that the entity handles. The entity’s list must be reviewed at least every 12 months”. Section 2 of the chapter references the National Institute for Occupational Safety and Health (NIOSH) document “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings”, as the resource and starting point for facilities. The latest version of the NIOSH list was published in 2016 and will be updated approximately every 2 years. 
In the 2016 list, NIOSH presented a new process for sub-classifying hazardous drugs according to their risks:
- Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance;
- Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance;
- Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.
Of note, USP added an additional classification to the list provided by NIOSH, any investigational or new drug with insufficient safety information should be considered hazardous until more information is available.
Drugs listed in Group 1 must comply with all containment and handling standards noted throughout the chapter. They are considered the highest risks of the groups. If the final dosage formulation does not require any manipulation other than repackaging or counting you do not need to follow full containment requirements.
Drugs listed in Group 2 and Group 3 represent drugs that may have risks associated with the specific formulations of the drug and specific risks to individuals who have conditions that are sensitive to the drugs (i.e., pregnant individual handling oxytocin).
The new classification should assist sites with a better understanding of the risks and assist with developing a strategy for how these drugs should be handled at their site. Table 5 of the NIOSH 2016 Hazardous Drug list provides sites with recommended personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings. This table is key for understanding the proper process and equipment necessary for safety and will make compliance with USP 800 easier to understand.
Sites can self assess the risk of each drug taking into account the type of hazardous drugs from the Groups, dosage formulations, risks for exposure, manufacturer packaging and any manipulations required to get the product into the most ready-to-administer formulation. The steps of the assessment must be documented and should be educated to the personnel who handle the hazardous drugs. For additional information, please refer to the Visante Newsletter from October 2016 where we describe an eight-step process for developing a hazardous drug list for your facility.
As the official implementation date of July 1, 2018 for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.
You’re not alone! Visante offers a full line of consulting services to clients just starting down the road to compliance, as well as to practice sites already on the journey and wanting to go beyond minimal practice standards.
 USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings
http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed March 10, 2017
 NIOSH . NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed March 10, 2017.
 NIOSH . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf Accessed March 10, 2017.
Fred Massoomi, PharmD, FASHP ; 5618 Nicholas St. Omaha, NE 68132 (402) 415-4194 firstname.lastname@example.org