30 October 2019
An Overview of USP 800
The U.S. Pharmacopeia Convention (USP) will update 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. 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 (Effective Date: Dec 1, 2019)
825—Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging (A new chapter first published on June 1, 2019)
What is a Hazardous Drug (HD)?
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.
A USP 800 Summary
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:
Written Standard Operating Procedures (SOPs)
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 HDs in all situations HDs 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 HDs. The SOPs for handling of HDs should include:
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 of course the Occupational Safety and Health Administration (OSHA). For example, USP 800 calls for “personnel who transport, compound, or administer HDs 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.
Interested in Our Solutions? We Can Help
Sign up to receive Stericycle’s latest news, tips and offers to help your business remain compliant
Which solution interests you?