Understanding the New Proposed USP Chapter <800>
June 2014 - Vol. 11 No. 6 - Page #6

Each year, approximately eight million US health care workers are potentially exposed to hazardous drugs (HDs).1 The subject of worker exposure to HDs (ie, chemotherapy, antineoplastics, cytotoxics, etc) has been discussed since the early 1970s, when chemotherapy was mixed on countertops or in horizontal laminar airflow workbenches that blew HD-contaminated air into the room, directly at compounding personnel. In 2004, the National Institute of Occupational Safety and Health (NIOSH) published the NIOSH Alert, Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 11 months after the publication of the 2004 version of USP Chapter <797>. In the 2008 revision of USP Chapter <797>, a specific section was devoted to the preparation of hazardous drugs, which defined several key requirements, including2:

  1. Appropriate primary and secondary engineering controls to ensure sterility and drug containment 
  2. The use of personal protective equipment (PPE), regardless of engineering control employed
  3. Training of compounding personnel to include at least the following: 
    • Safe aseptic manipulation practices; 
    • Negative pressure techniques when utilizing a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI); 
    • Correct use of closed system drug-transfer devices (CSTDs); 
    • Containment, cleanup, and disposal procedures for breakages and spills; and 
    • Treatment of personnel contact and inhalation exposure
  4. Training of personnel who perform routine custodial waste removal and cleaning activities in storage and preparation areas for HDs in appropriate  procedures to protect themselves and prevent contamination.

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