An Overview of USP 800
The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. Throughout the healthcare landscape, people are asking, “What is USP 800?” Let’s start with the USP itself.
What is the USP?
The U.S. Pharmacopeia Convention (USP) is a scientific nonprofit organization made up of “independent Volunteer Experts that work together in Expert Committees with a mission “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” The Expert Committees set standards and recommendations on the safety of a wide range of medicinal practices.
What is the USP 800
The USP 800 is part of three other USP chapters with “the intent of the Expert Committee to align these standards, providing a unified approach to quality compounding.”
- 795—Pharmaceutical Compounding – Nonsterile Preparations (Last revised in 2014)
- 797—Pharmaceutical Compounding – Sterile Preparations (Last revised in 2008)
- 800—Hazardous Drugs – Handling in Healthcare Settings (Last revised on: Dec 1, 2019)
- 825—Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging (A new chapter first published on June 1, 2019)
What Are Hazardous Drugs?
The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.
USP 800 Guidelines
NIOSH notes that “about 8 million U.S. healthcare workers are potentially exposed to HDs, including pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.” To address these risks, The USP created General Chapter 800. If your healthcare facility chooses to follow and be compliant with USP 800, here are some key points about Chapter 800:
- The USP does not set or enforce regulations. However, some USP standards are enforced by the Food and Drug Administration (FDA), state pharmacy boards, and accrediting agencies such as The Joint Commission.
- All clinical pharmacists and pharmacy technicians, but also other healthcare workers who have potential to come into contact with hazardous drugs should consider reading the General Chapter 800. Such as: nurses, physicians, surgeons, physician assistants, respiratory therapists, home health aides, nurses’ aides, veterinarians, veterinary technicians, veterinary assistants; healthcare facility housekeeping, janitorial services, and environmental services.
- All personnel who handle hazardous drugs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final hazardous drugs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.
- USP 800 calls for facilities who have hazardous drugs in their formulary to create, if not already in place, a Compounding Supervisor role who will oversee hazardous drug specific areas for receipt, storage, and compounding. The Compounding Supervisor must thoroughly understand the rationale for risk-prevention policies, risks to themselves and others, risks of non-compliance that may compromise safety, and the responsibility to report potentially hazardous situations to the management team.
- A key responsibility of the Compounding Supervisor is the bi-annual environmental wipe sampling for hazardous drug surface residue.
- Antineoplastic hazardous drugs and all active pharmaceutical ingredients (APIs) must be unpacked (i.e., removed from external shipping containers) in an area that is neutral/normal or negative pressure relative to the surrounding areas. Hazardous drugs must not be unpacked from their external shipping containers in sterile compounding areas or in positive pressure areas.
- Two pairs of chemotherapy gloves are required for compounding sterile and nonsterile hazardous drugs, as well as for administering injectable antineoplastic hazardous drugs.
- Gowns shown to resist permeability by hazardous drugs are required when administering injectable antineoplastic hazardous drugs. For all other activities, the entity’s Standard Operating Procedure must describe the appropriate PPE to be worn based on its occupational safety plan and assessment of risk.
Written Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) will help the Compounding Supervisor create a USP 800 compliance checklist. USP 800 calls for the SOPs to be created and maintained for the safe handling of hazardous drugs in all situations hazardous drugs are used throughout a facility. The SOPs must be reviewed at least every 12 months by the designated person, and the review must be documented. Revisions in forms or records must be made as needed and communicated to all personnel handling hazardous drugs.
Standard Operating Procedure Checklist
The Standard Operating Procedures for handling of hazardous drugs should include the following:
- Hazard Communication Program and Occupational Safety Program
- Designation of hazardous drugs areas for Receipt, Storage, and Compounding
- Use and maintenance of proper engineering controls
- Hand hygiene and use of personal protective equipment (PPE) based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
- Deactivation, decontamination, cleaning, and disinfection
- Dispensing, Transport, and Administering
- Environmental monitoring (e.g., wipe sampling)
- Disposal and Spill Control
- Medical surveillance
Stericycle Can Help Your Healthcare Organization Become USP 800 Compliant
This overview of USP 800 is limited. Be sure to consult your state board of pharmacy and other related accrediting and regulatory bodies to see what parts of the USP chapters they have adopted. The USP 800 reinforces and heightens the awareness of existing regulations and best practices set by NIOSH/Centers for Disease Control (CDC) and the Occupational Safety and Health Administration (OSHA). For example, USP 800 calls for “personnel who transport, compound, or administer hazardous drugs to document their training according to OSHA standards (see OSHA Standard 1910.120 Hazardous Waste Operations and Emergency Response) and other applicable laws and regulations.” Stericycle can help keep your organization complaint and ensure safe and effective disposal of your facilities' pharmaceutical waste streams.