Hazardous drug handling in healthcare facilities demands meticulous compliance with USP 800 standards to protect both patients and personnel from exposure risks. Whether you’re managing a hospital inpatient pharmacy, independent compounding facility, or oncology clinic, implementing USP 800 requirements alongside daily clinical responsibilities presents real challenges.
This USP 800 compliance checklist breaks down the standard’s requirements into verifiable action items across three areas: drug assessment protocols, engineering controls, and personnel safety programs. Each section provides specific checkpoints you can use to identify gaps before your next accreditation survey, with practical items that align with Joint Commission surveys, state board inspections, and FDA oversight expectations.
What are the main requirements of USP 800?
USP 800 establishes safety standards for handling hazardous drugs in healthcare settings. The main requirements include:
Hazardous Drug Assessment: Maintain a current list of all NIOSH-designated hazardous drugs used in your facility and assess non-NIOSH drugs for hazardous characteristics.
Engineering Controls: Install and certify containment primary engineering controls (C-PECs) and containment secondary engineering controls (C-SECs) for preparation and storage areas.
Personnel Protection: Implement training programs, provide appropriate PPE, establish medical surveillance protocols, and document staff competency in hazardous drug handling procedures.
Each requirement includes specific testing, certification, and documentation standards that must be maintained for accreditation surveys.
List of NIOSH Hazardous Drugs and Assessment Protocols
Establishing Your Facility’s Hazardous Drug List
Your facility must maintain a current hazardous drug inventory based on NIOSH categorization. NIOSH divides hazardous drugs into three groups: Group 1 (antineoplastic drugs), Group 2 (non-antineoplastic reproductive risk), and Group 3 (drugs with concerning characteristics in animal studies). [1]
Update this list whenever new drugs are introduced to your formulary or when NIOSH publishes revisions. Documentation must include review dates and the designated person responsible for maintenance.
Checklist Items:
☐ Current NIOSH hazardous drug list downloaded and accessible to staff
☐ Facility-specific hazardous drug inventory compiled and categorized by NIOSH group
☐ Review schedule established (recommended annually or when formulary changes)
☐ Designated person responsible for list maintenance identified
Assessment of Non-NIOSH Listed Drugs
Drugs not on the NIOSH list may still require hazardous handling based on their characteristics. Your facility needs a written process for evaluating these medications through Safety Data Sheet (SDS) review covering reproductive toxicity, genotoxicity, carcinogenicity, organ toxicity at low doses, and structural similarity to existing hazardous drugs.
Checklist Items:
☐ Written assessment procedure for evaluating non-NIOSH drugs
☐ SDS review process established with qualified personnel
☐ Assessment documentation system implemented
☐ Communication protocol for informing staff of newly designated hazardous drugs
Required Engineering Controls for HD Handling Areas
Containment Primary Engineering Controls (C-PECs)
C-PECs—biological safety cabinets and compounding aseptic containment isolators—must be placed in designated buffer rooms or segregated compounding areas. Initial certification occurs before use, with ongoing certification following NSF/ANSI 49 standards and applicable cleanroom requirements.
Certification testing includes HEPA filter integrity, airflow velocity, containment leak testing, and protective air barrier testing. All sterile compounding C-PECs must be externally vented to outside atmosphere. Nonsterile compounding C-PECs must be either externally vented (preferred) or equipped with redundant HEPA filters in series. C-PEC certification for biological safety cabinets follows NSF/ANSI 49 standards. [2] Other C-PEC types follow applicable manufacturer and industry standards.
Checklist Items:
☐ All hazardous drug compounding performed inside certified C-PECs
☐ C-PEC certification completed per required schedule
☐ Certification documentation includes all required testing (HEPA integrity, airflow, containment)
☐ Externally vented C-PECs require verification of proper exhaust to outside atmosphere. For nonsterile compounding only, C-PECs not externally vented must have redundant HEPA filtration in series.
☐ Redundant HEPA filtration confirmed on non-externally-vented nonsterile C-PECs (if applicable)
Containment Secondary Engineering Controls (C-SECs)
C-SEC requirements vary by compounding type:
- Sterile buffer rooms: Negative pressure (minimum -0.01 inch water column) with at least 30 ACPH
- Ante-rooms: Negative or neutral pressure with at least 30 ACPH
- Nonsterile compounding areas: Negative pressure with at least 12 ACPH
Pressure differentials need monitoring through visual indicators or automated systems. Non-sterile hazardous drug handling—tablet crushing, liquid preparation—requires negative pressure containment segregated from other operations. Storage areas holding hazardous drug inventory may also need containment evaluation.
Checklist Items:
☐ Buffer room maintaining negative pressure (minimum -0.01 inch water column differential)
☐ Ante room maintaining negative or neutral pressure relative to adjacent areas
☐ Pressure differentials monitored with visual indicators or continuous monitoring systems
☐ Air changes per hour verified during certification testing
☐ Non-sterile compounding areas (tablet crushing, liquid preparation) properly contained and ventilated
☐ Hazardous drug storage areas evaluated for containment requirements
☐ Environmental controls certification completed within required timeframes
☐ Environmental wipe sampling performed at least every 6 months to verify containment
Personnel Training and Medical Surveillance Requirements
Initial and Ongoing Training Programs
Every person who handles hazardous drugs must complete comprehensive safety training before any contact with these medications. Training content must cover risks of hazardous drug exposure, proper handling techniques, PPE selection and use, spill management, and waste disposal.
Training records require the date, topics covered, trainer identification, and employee signature. Annual retraining and competency assessment verify that training translates to proper technique through written tests, observation, or demonstration.
Checklist Items:
☐ Written training program covering all required USP 800 topics
☐ Initial training completed and documented for all personnel before HD handling
☐ Annual retraining schedule established and current
☐ Training records include date, topics covered, trainer identification, and employee signature
☐ Competency assessment method defined (written test, observation, demonstration)
☐ Role-specific training provided (compounding vs. administration vs. cleaning)
☐ Training updates documented when procedures change or incidents occur
Medical Surveillance and Reproductive Warnings
Medical surveillance programs focus on at-risk employees who regularly handle hazardous drugs. Baseline health assessments occur before hazardous drug handling begins, with periodic follow-up assessments focusing on exposure-related concerns.
All personnel of reproductive capability must receive reproductive health counseling and warnings, with documented employee acknowledgment. Participation remains voluntary with confidential health records maintained separately from personnel files.
Checklist Items:
☐ Medical surveillance program established with occupational health provider
☐ At-risk employees identified based on handling frequency and HD categories
☐ Baseline health assessments completed before HD handling begins
☐ Reproductive risk warnings provided to all personnel of reproductive capability
☐ Employee acknowledgment of reproductive risk notification documented
☐ Confidential health records maintained separately from personnel files
☐ Process for employees to report potential exposure incidents established
Personal Protective Equipment (PPE) Requirements
Minimum PPE standards require chemotherapy-rated gloves meeting ASTM D6978 and disposable gowns shown to resist permeability by HDs, plus eye and face protection for splash risk activities. [3] Compounding sterile and nonsterile HDs requires double gloving with glove changes every 30 minutes or immediately if contaminated or torn.
Checklist Items:
☐ Chemotherapy-rated gloves meeting ASTM D6978 standard available and used
☐ Disposable gowns shown to resist permeability by HDs with closed front and cuffs available
☐ Eye and face protection available for splash risk activities
☐ Glove change procedures established (every 30 minutes during compounding, immediately if contaminated or torn)
☐ Double gloving protocol implemented for all HD compounding (sterile and nonsterile)
☐ PPE disposal procedures following hazardous waste protocols
Ready for Your Next Survey?
Your C-PECs and C-SECs require ongoing certification —not when the survey notice arrives. Allometrics provides ISO 17025 accredited testing for containment primary and secondary engineering controls with pharmacy-specific scheduling that works around your chemotherapy days and patient care demands. Our technicians understand that you can’t shut down compounding when oncology patients need medications tomorrow.
Call (281) 474-3329 to schedule your USP 800 certification before your deadline.
Your USP 800 Compliance Questions Answered
USP 800 establishes three fundamental components for safe hazardous drug handling in healthcare facilities. Facilities must maintain current inventories of all hazardous drugs based on NIOSH classification, install and certify appropriate containment engineering controls in preparation areas, and develop comprehensive personnel protection programs that include initial and ongoing training, proper PPE protocols, and medical surveillance for at-risk employees.
While all USP 800 requirements work together as an integrated safety system, proper engineering controls combined with trained personnel form the foundation of hazardous drug safety. Facilities need certified containment primary engineering controls where compounding occurs, properly ventilated buffer rooms maintaining negative pressure to prevent contamination spread, and personnel trained in correct procedures while using chemotherapy-rated protective equipment meeting ASTM D6978 standards.
Risk assessment represents a mandatory component of USP 800 compliance. Healthcare facilities must maintain current hazardous drug inventories categorized according to NIOSH groups and establish documented procedures for evaluating drugs not included on the NIOSH list. This assessment process examines Safety Data Sheets for reproductive toxicity, genotoxicity, carcinogenicity, organ toxicity at low doses, and structural similarity to known hazardous drugs.
Resources
- https://archive.cdc.gov/#/details?q=https://www.cdc.gov/niosh/docs/2016-161/default.html&start=0&rows=10&url=https://www.cdc.gov/niosh/docs/2016-161/default.html
- https://www.nsf.org/knowledge-library/improving-lab-safety-accredited-biosafety-cabinetry-field-certifiers
- https://store.astm.org/d6978-05r19.html
