800 Hazardous Drugs—Handling in Healthcare Settings

Based on the public comments received for the proposed 800 in PF 40(3), the USP Compounding Expert Committee has developed a revised chapter. The USP 800 chapter has been created to identify the requirements for:

• The receipt of hazardous drug materials
• The storage of hazardous drugs
• Pharmaceutical compounding
• Dispensing
• Administration of hazardous drugs and materials

USP 800 has been created to help inform and educate practitioners of the appropriate protocol and guidelines to:

• Adhere to aseptic protocols to protect patients
• Protect the healthcare personnel, cleanroom operators and pharmacists
• Ensure a particulate free environment that is conducive with the necessary cleanliness levels and safety protocol for hazardous drugs handling

There will be an upcoming revision to USP 797 – Pharmaceutical Compounding – Sterile Preparations. This new revision will entail any inconsistencies identified after the release of USP 800.  The USP 797 updates will contain some of the following details:

• Elimination of the current allowance in 797 for facilities that prepare a low volume of HDs that permits placement of a Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI) in a non-negative pressure room. All HD compounding must be done in a separate area designated for HD compounding.

• Addition of an allowance in 800 for a Containment Segregated Compounding Area (C-SCA), a separate, negative pressure room with at least 12 air changes per hour (ACPH) for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or compounding aseptic containment isolator (CACI) located in a C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours.

Below are some of the major changes from the proposal of USP 800 in PF 40(3):

• Updates in nomenclature and verbiage. New definitions and revised wording are apparent the in the new USP 800 chapter.
• Removed statement concerning no acceptable level of HDs.
• Revised section on list of HDs, to allow entities to perform an assessment of risk for non-antineoplastic drugs and final dosage forms to determine alternative containment strategies and/or work practices.
• Clarified that HDs may be unpacked in either a neutral/normal or negative pressure area.

Allowance for either external venting or redundant high-efficiency particulate air (HEPA) filtration of containment primary engineering controls (C-PECs) used for nonsterile compounding. The proposed chapter is posted online at http://www.usp.org/usp-nf/notices/general-chapterhazardous-drugs-handling-healthcare-settings with line numbers.

Please provide the line numbers corresponding to your comments when submitting comments to CompoundingSL@usp.org.