General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

The Compounding Expert Committee is proposing new General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. The purpose of the new proposed General Chapter is to provide standards to protect personnel and the environment when handling hazardous drugs (HDs). Each year, approximately 8 million U.S. healthcare workers are potentially exposed to HDs. The new proposed General Chapter defines processes intended to provide containment of HDs to as low as a limit as reasonably achievable.
The new proposed General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings addresses:
  • Standards that apply to all personnel who compound HDs preparations and all places where HDs are prepared, stored, transported, and administered
  • Receiving, storing, compounding, dispensing, administering, and disposing of both nonsterile and sterile products and preparations 
  • Altering, counting, crushing, and pouring HDs.
General Chapter <800> will be published in Pharmacopeial Forum (PF) 40(3) [May–Jun. 2014]. The General Chapter is being presented in advance of publication of PF 40(3) to allow additional time for public review and comment. To ensure that all comments are addressed, please indicate the line number(s) corresponding to your comments and submit to The General Chapter is available with line number at the link below. Comments will be accepted until July 31, 2014, the end of the comment period for PF 40(3).
Proposed General Chapter <800> applies to all personnel who are involved in handling HDs including but not limited to, healthcare practitioners and staff, occupational health and safety specialists, and human resources. An overview of the proposed General Chapter is available below:
Should you have any questions, please contact the Healthcare Quality Standards staff at
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