Wednesday, August 13, 2014

What are the proposals of the new USP 800 chapter,

 
What are the proposals of the new USP <800> chapter,
“Hazardous Drugs – Handling in Healthcare Settings?”

Introduction
The United States Pharmacopeial Convention (USP) is developing a chapter for the National Formulary (USP-NF) that will establish safety standards for handling hazardous drugs (HDs).1 Although guidelines on hazardous drug handling are available from other organizations, USP has yet to include a specific chapter on this in the USP-NF.2-7 The current USP <797> (Pharmaceutical compounding - sterile preparations) and <795> (Pharmaceutical compounding – nonsterile preparations) chapters include brief sections on HDs, but the proposed <800> chapter provides more detail on hazardous drug storage, transportation, and handling, as well as compounding, administration, and disposal.1,8,9 The proposed <800> chapter emphasizes HD containment in order to protect personnel and the environment when handling both sterile and nonsterile HDs. This chapter will be a resource for healthcare practitioners and staff, occupational health and safety specialists, and human resources. The current language in the proposed chapter includes the word “shall,” meaning required, and “should,” meaning strongly recommended. The chapter will be useful in addressing the following in relation to HDs:
  • Design of clean rooms
  • Logistics of transportation
  • Prevention of worker and environmental exposure
  • Clean-up and disposal
  • Unpacking
  • Storage
  • Compounding
  • Dispensing
  • Administration
  • Use of personal protective equipment
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