Errata Corrected in Revised General Chapter <797>

January 28, 2008

The following errata have been corrected in General Chapter <797>, as published in a Revision Bulletin on the USP Web site.

  1. The following definition of hazardous drugs is added on page 4: "HAZARDOUS DRUGS:

    Drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential for causing cancer, developmental or reproductive toxicity, or harm to organs. (see current NIOSH publication)."
  2. Usage of the term "porosity" is replaced with "nominal pore size" throughout the chapter.
  3. On Page 14, the text "The use of a CSTD is preferred because of their inherent closed system process" had been inadvertently omitted and was reinserted in the correct place.
  4. On Page 23, the word "AIR" was removed from the title of the section "Viable and Nonviable Environmental Air Sampling (ES) Testing."
  5. On Page 23, in the footnote, the correct number 2.09 replaced 2.07.
  6. On Page 50, under Hazardous Drugs as CSPs, the following changes were made:

    1. The sentence "CSTD shall be used in an ISO class 5 primary engineering control device" is replaced with "When used, a CSTD shall be used in an ISO class 5 primary engineering control device."
    2. The sentence "At least 0.01 inch water column negative pressure is required for storage and compounding of hazardous drug" is replaced with "At least 0.01 inch water column negative pressure is required for compounding of hazardous drugs."
    3. The symbol before the sentence " negative pressure buffer area" is not required for low-volume compounding operations when CSTD is used in BSC or CACI" is changed from single dagger ("shall") to double dagger ("should" ).