Section 9 Personal Training

Sections 1 through 8 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings are the blueprint and engineering structures with checks and balances for quality control. They also provide direct protective measures on and an introduction to the rights of the employees on our road to USP< 800> compliance. Section 9 seamlessly falls from employer labor requirements into the required training elements specifically for handling hazardous substances (drugs) at facilities.

It cannot be emphasized enough that sites must have a good training program in place to protect employees working with hazards. As discussed in Section 8, USP highlights the OSHA requirement that personnel who may be exposed to hazardous chemicals (drugs) when working must be provided information and training before the initial assignment to work with a hazardous chemical (drugs). In addition, this must be modified whenever the hazard changes, such as the addition of a newly defined hazardous drug.

Within Section 9, specific tasks are listed for minimal competencies:

  1. Overview of the entity’s list of hazardous drug list(s) and their risks
  2. Review of the entity’s standard operating procedures related to handling of HDs
  3. Proper use of personnel protective equipment
  4. Proper use of equipment and devices (rooms, hoods, CSTDs, pumps, etc.)
  5. Response to known or suspected hazardous drug exposure
  6. Spill management
  7. Disposal of hazardous drugs and trace-contaminated materials

Visante has extracted best practices for training for sites to consider as additions to the required training competencies:

  1. Vial handling for hazardous drugs: each defined job code
  2. Site specific specialized preparation for unique routes of administration: bladder instillation; intraocular; intrathecal; intraperitoneal; intraventional radiology; surgical, etc.
  3. Delivery competency
  4. Drug and supply quarantine release
  5. Linen handling for patients receiving hazardous drugs
  6. Operative use of hazardous drugs
  7. Environmental monitoring program
  8. Certification validation

In addition to what is listed in USP <800> for sterile products additionally the following must be minimally trained for an understanding of sterile compounding principles:

  1. Hand hygiene
  2. Garbing
  3. Aseptic technique
    • Media fill test
    • Glove tip test
  4. Cleaning and disinfection

In addition to what is listed in USP <797> and USP <800> incorporation of new USP <795> for non-sterile hazardous drugs:

  1. Cleaning of equipment between uses
  2. Cleaning of compounding area
  3. Component selection, handling, and transport
  4. Performing calculations
  5. Measuring and mixing
  6. Use of equipment
  7. Documentation of the compounding process (e.g., Master Formulation)
  8. Records and Compounding Records

It is in the best interest of sites to get a signed agreement on hire and on an annual basis confirming education and acknowledgment of the defined competencies.

As the NEW official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.


[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings Accessed May 10, 2017


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