USP <800> Compliance: Tips To Mitigate Risks Related to the Enforceable Standard

Brian Williams, MHA, MBA
drugs in a compounding pharmacy

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. 

Now is the time to review your standard operating procedures (SOPs) and processes for the identification and management of hazardous drugs to ensure they are consistent with USP <800> and National Institute for Occupational Safety and Health (NIOSH). 


Get USP <800> compliance details, checklists, and templates in this downloadable guide.

What Is USP <800>?

The United States Pharmacopeia (USP)  <800> General Chapter for Hazardous Drugs Handling in Healthcare Settings focuses on the safe handling of hazardous drugs to protect healthcare workers, patients, and the environment from potential risks associated with these substances. It applies to all personnel who receive, handle, compound, administer, dispose, or otherwise come into contact with hazardous drugs, and all the environments in which they are present. These facilities include:

  • Hospitals
  • Oncology locations
  • Pharmacies (especially compounding pharmacies)
  • Long-term care facilities
  • Critical access hospitals
  • Some urgent care locations
  • Home health and hospice (who administer HDs)

Hazardous drugs included under USP <800> can include certain chemotherapy agents, immunosuppressants, hormones, and other substances with toxic or harmful properties. 

Enforceable by State Boards of Pharmacy and OSHA to follow USP <800> compliance, facilities should establish safe handling practices such as proper use of personal protective equipment (PPE), appropriate ventilation systems, designated storage areas, and precise procedures for compounding and administering hazardous drugs. 

A Brief History of USP <800>

USP <800> was originally published in 2016 to protect healthcare workers from potential exposure to drugs recognized for carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, or organ toxicity — even at low doses. The 2016 edition of USP <800> provided comprehensive guidance on handling and administering drugs. However, enforcement of these guidelines was delayed until the publication of an associated chapter, USP <797>, which covered sterile compounding practices.

In 2019, just prior to USP <800> becoming an enforceable standard, an appeal was filed regarding major revisions to General Chapters <795> and <797>, which were intended to minimize the risk of patient harm in the areas of nonsterile and sterile compounding. The main points of contention among stakeholders was Beyond Use Dates (BUDs), reinstatement of alternative technologies in USP <797>, and the applicability of USP <795> and <797> to veterinary practitioners.

The USP organization gained consensus on all of the standards which were connected to the enforceability of USP <800> and resolved the appeal on November 1, 2022. Implementation of USP <800> are effective as of November 1, 2023, and include, but are not limited to, the following:

  • A comprehensive resolution of Beyond Use Dates
  • The concepts of water activity (expanded in USP <795>)
  • A revision to the NIOSH table of HDs with the clarification of the term “antineoplastic” which now only include those listed in Table 1. It’s important to note that other hazardous characteristics may exist which requires a more thorough assessment of risk.
  • The responsibility of organizations to determine if drugs are hazardous which have not been evaluated by NIOSH or the FDA for hazardous properties.

Following the release of revised guidelines, USP announced that USP <800> would be officially enforceable beginning on November 1, 2023. This means healthcare facilities — including pharmacies, hospitals, and clinics — are now required to comply with the guidelines to ensure the safe handling of hazardous drugs, and to protect the health and safety of their staff.

What’s Needed for USP <800> Compliance?

If your facility receives hazardous drugs — as defined by the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs Used in Healthcare Settings — you’ll need to review and comply with USP <800> health and safety standards. These include, at a minimum:

  • A list of hazardous drugs with dosage form and whether the drug requires manipulation
  • Facility and engineering controls (C-PECs, C-SECs, and CSTDs)
  • Competent personnel (evidenced by training and demonstrated knowledge)
  • Safe work practices (evidenced by documented standard operating procedures)
  • Access and proper use of appropriate Personal Protective Equipment (PPE)
  • Policies for HD waste segregation and disposal

Beginning in 2023, State Boards of Pharmacy and OSHA will require proof of compliance with USP <800> during facility audits. It’s vital for organizations to have demonstrable evidence of compliance and documentation to prove alignment with all required standards. 

5 Tips To Maintain USP <800> Compliance

While USP <800> compliance sounds straightforward, you might be surprised to find your organization is not practicing appropriate procedures. 

1. Perform an assessment of risk

This initial assessment will help you to see if your facility is actually following the standard — and even your organization’s policies. The risk assessment looks at documentation of all hazardous drugs by type and dosage, and analysis of how they’re packaged, stored, manipulated, and moved at every stage of distribution. It should also include a list of all staff members who may come into contact with hazardous drugs while performing their job duties. 

By performing a risk assessment, organizations can determine what needs improving, and make the necessary policy and facility adjustments for each drug. Assessments provide a roadmap to compliance, helping to ensure that organizations have implemented new standard operating procedures clearly aligned to USP <800> requirements prior to November 1, 2023. The process for performing the assessment of risk should be contemplated for all new HDs going forward, which requires significant communication and coordination between clinicians and pharmacy staff

2. Provide training for staff

USP <800> clearly states that everyone who handles hazardous drugs must understand the requirements. This goes beyond those responsible for compounding or administering them; it also encompasses non-medical staff, such as shipping and receiving personnel, and housekeeping. 

In addition to education on the new standards, each person must be trained on how to properly perform their job function. For instance, in the event that an HD is spilled or contaminates a surface, staff that are responsible for containing and cleaning up the spill must be trained, deemed competent, and have access to an appropriate spill kit or designated service provider. The level of competency across the organization should be assessed every 12 months, as well as when a new hazardous drug is introduced to the facility.

Using a healthcare specific learning management system, such as MedTrainer, ensures your team has access to many courses specifically designed to facilitate knowledgeability among staff. These courses could include:

  • Healthcare Professionals and Patient Safety
  • Receiving, Storing, Dispensing and Administering (Internal)
  • Overview of USP <800> for Healthcare Professionals and Support Staff
  • Spill Management and Disposal for Healthcare Facilities

3. Develop and implement policies and procedures

Standard Operating Procedures (SOPs) for the management of sterile and non-sterile hazardous drugs need to be in place for every required organization, but they may be different if you’re a compounding organization versus a non-compounding one. Generally, your SOPs should include procedures for the following:

  • Identification of HDs
  • Safe work/handling practices for HDs
  • Facility and engineering controls
  • Hazard communication program and training

These procedures and your policies related to HDs, should always be available to staff in case they have questions. Using an online compliance platform makes it easy for employees to access this information from anywhere. See how easy it is to store documents and policies in an all-in-one compliance platform. 

4. Develop an incident report template for HD near misses and exposures

In the same vein as standardized policies and procedures, it’s also important to develop an incident reporting template for hazardous drug interactions. Make sure the report template meets all requirements for documenting the nature of the incident. Using online incident reporting software to make it easier for employees to report and escalate serious issues before they snowball. Since many online incident reporting systems include automated escalation, it also means leadership can resolve the issue more quickly.

5. Appoint an experienced compliance leader to oversee

USP <800> mandates that organizations designate a person who is responsible for the oversight of monitoring the facility and maintaining accurate reports of all testing/sampling performed. They might be a pharmacist, practice manager, or member of the administration. This individual should be knowledgeable in regulatory compliance, including the OSHA’s hazardous communication standard and the NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, USP 800 standards, and the applicable state board of pharmacy requirements. They should also have clinical knowledge of how hazardous drugs are received, stored, administered, and disposed of. This person should have the skill set needed to collaborate with others, including pharmaceutical suppliers, to maintain open lines of communication and leadership commitment.

How MedTrainer Streamlines USP <800> Compliance

USP <800> compliance represents a serious step forward in controlled drug handling, and it’s designed to create airtight accountability across the chain of custody. MedTrainer is here to make sure your compliance tracking and reporting is as equally airtight. 

MedTrainer offers both sides of USP <800> compliance: educational courses for employees and document centralization for incident reports, SOPs, and more. With bite-sized learning and customizable templates for SOPs and safety plans, MedTrainer simplifies USP <800> compliance standards to give organizations peace of mind. 

Schedule a demo today to see how MedTrainer simplifies USP <800> compliance.