USP General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings sets standards for every step at which a hazardous drug (HD) is handled: receipt, storage, compounding, dispensing, administration, deactivation and cleaning, spill control, and disposal. It became official on 1 December 2019 and, since the revised <795> and <797> took effect on 1 November 2023, is compendially applicable to compounding. It is enforced by state boards of pharmacy, accreditation bodies, and occupational-safety regulators. This checklist follows the chapter's own structure. It is not legal advice; verify against the current chapter and your state's rule.
1. Scope and the HD list
The chapter applies to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport or administer them. A drug is hazardous if it appears on the NIOSH List of Hazardous Drugs in Healthcare Settings, which groups drugs as antineoplastic, non-antineoplastic hazardous, and drugs with reproductive risk. Hormones (estrogens, progestins, testosterone), several anticonvulsants and antivirals, and many oncology agents are on it; a compounding pharmacy's hazardous list is usually longer than it expects.
- ✓Maintain a written list of every HD your entity handles, reviewed at least every 12 months and whenever a new agent is added, against the current NIOSH list
- ✓Record for each HD the dosage forms handled and whether it is compounded from bulk, manipulated (crushed, split, reconstituted), or dispensed intact
- ✓Make the list available to all staff who may handle the drugs
2. Assessment of risk
For antineoplastic HDs that require manipulation (compounding from bulk, crushing, reconstitution) the full containment requirements of the chapter apply without exception. For other HDs — final dosage forms that are only counted or packaged, and drugs on the non-antineoplastic and reproductive-risk groups — the entity may perform a documented assessment of risk and adopt alternative containment strategies. The assessment must cover the drug, dosage form, risk of exposure, packaging and manipulation, and must be reviewed at least every 12 months.
- ✓Identify which HDs and dosage forms are eligible for an assessment of risk and which must follow full containment
- ✓Document each assessment: drug, dosage form, exposure risk, packaging, manipulations, and the alternative strategies adopted
- ✓Review every assessment at least every 12 months and record the review
3. Designated person, training, medical surveillance
- ✓Appoint a designated person responsible for the HD programme: policies, competency, monitoring, and reporting of exposures
- ✓Train every employee who handles HDs before they do so and at least every 12 months: hazards, engineering controls, PPE, spill management, disposal; document competency
- ✓Offer medical surveillance to workers who handle HDs and document the programme, with baseline and periodic assessment per your occupational-health advice
- ✓Have a written plan for personnel of reproductive capability and for acknowledgement of risk
4. Facilities and engineering controls
HDs must be stored, compounded and manipulated in areas designed to contain them. The chapter's core requirements for compounding:
| Area | Requirement |
|---|---|
| Containment secondary engineering control (C-SEC) — the room | Externally vented; negative pressure of 0.01 to 0.03 inches of water column relative to adjacent areas; at least 12 air changes per hour (30 ACPH for a sterile buffer room); a sink and an eyewash within the C-SEC or nearby per chapter |
| Containment primary engineering control (C-PEC) — the hood | Nonsterile: Class I BSC, CVE or Class II BSC, externally vented (or redundant HEPA in series where the chapter permits). Sterile: Class II BSC or CACI, externally vented, in an ISO 7 negative-pressure buffer room (C-SEC) or a containment segregated compounding area for shorter BUDs |
| Storage | HDs stored separately from non-HDs in a negative-pressure room with at least 12 ACPH and external venting; antineoplastic HDs requiring manipulation never stored in positive-pressure areas |
| Closed-system transfer devices | Recommended for compounding; required for administration of antineoplastics where the dosage form allows |
| Certification | C-PECs and C-SECs certified at least every 6 months and after relocation or major service; pressure monitored daily or continuously and recorded |
5. Receiving and storage
- ✓Receive HDs in a designated area; unpack antineoplastic HDs in a neutral or negative-pressure area, never in a positive-pressure sterile anteroom
- ✓Have a spill kit at receiving and a written procedure for damaged packages
- ✓Store HDs in the negative-pressure storage room, segregated from non-HDs; refrigerated antineoplastic HDs in a dedicated refrigerator inside the negative-pressure area
- ✓Label storage locations and bins as hazardous; assign HD lots to hazmat locations on putaway and record who put what where
This is one of the two places software carries real weight. In Pharmacy Flow a material flagged hazardous is routed by the putaway rule to a segregated hazmat location on receipt, with the reason recorded ("Hazardous (NIOSH) → segregated hazmat room"); controlled materials go to a vault and refrigerated materials to cold storage by the same rule. The lot's location and status history then show where it has been.
6. Personal protective equipment
- ✓Two pairs of chemotherapy gloves tested to ASTM D6978 for compounding; outer gloves changed every 30 minutes or when contaminated
- ✓Disposable gowns shown to resist HD permeability, closed at the back, long sleeves, closed cuffs; changed per manufacturer data or every 2–3 hours, and after a spill
- ✓Head, hair, shoe and sleeve covers; second pair of shoe covers donned before entering the C-SEC
- ✓Eye and face protection when there is a splash risk; respiratory protection (fit-tested N95 or better, or a chemical-cartridge respirator) where required, for example for spills
- ✓Written PPE procedures per activity, and documented training on donning and doffing
7. Compounding and dispensing
- ✓Compound HDs only within the C-PEC, with a plastic-backed preparation mat changed after each preparation batch and after a spill
- ✓Use dedicated equipment for HDs where possible; decontaminate shared equipment per procedure
- ✓Label HD preparations to identify them as hazardous and to indicate special handling and disposal
- ✓Transport HDs in containers that minimise breakage and leakage; do not send antineoplastic HDs through pneumatic tubes
- ✓Counting or packaging intact final dosage forms of non-antineoplastic HDs may follow the assessment of risk; do not use automated counting machines for antineoplastic HDs
8. Deactivation, decontamination, cleaning, spills
- ✓Written procedures for each step — deactivation, decontamination, cleaning, disinfection — with agents, frequencies and PPE specified
- ✓Clean the C-PEC work surface between batches and at least daily; the C-SEC at least monthly for walls and ceilings and daily for floors, or per your procedure and manufacturer guidance
- ✓Spill kits accessible in every area where HDs are handled; a written spill procedure; spills documented and reported
- ✓Dispose of HD waste and contaminated PPE in the correct waste stream per federal, state and local regulation
9. Environmental monitoring and wipe sampling
The chapter recommends surface wipe sampling for HD residue initially as a baseline and then at least every six months, at defined locations: inside the C-PEC, the pass-through, the C-SEC floor near the C-PEC, the staging or receiving area, the dispensing area and the patient administration area. There is no regulatory limit for surface contamination; if residue is found, the entity is expected to identify the cause and re-evaluate practices. Pressure differentials, temperature and — where a sterile C-SEC — the <797> environmental programme are monitored alongside.
- ✓Define wipe-sampling locations and frequency (at least every 6 months) in a written procedure and record every result
- ✓Record pressure differentials for the C-SEC and storage room daily or continuously, and act on out-of-range readings
- ✓Investigate any detected residue or pressure excursion as a deviation with a documented cause and corrective action
In Pharmacy Flow environmental readings are recorded per room and ISO class with the action limit on each reading, and the status — Pass, Alert within 10% of the limit, Action over it — is derived from the numbers rather than chosen. Action readings link to the environmental deviation category, so the investigation opens against the reading. Wipe-sample results can be recorded as readings with your action level; the sampling itself and the laboratory analysis are yours.
10. Documentation: the records that prove it
On inspection, <800> is largely a records question. Have these ready:
| Record | Reviewed | Where it lives |
|---|---|---|
| HD list and assessments of risk | Every 12 months | Controlled document with version and signed approval |
| Designated person appointment and programme SOPs | On change | Document control |
| Training and competency per employee | Every 12 months | Your training records; document control for the curriculum |
| Medical surveillance programme | Per occupational-health advice | Occupational health / HR, referenced from SOP |
| C-PEC/C-SEC certification reports | Every 6 months | Document control; deviation if overdue |
| Pressure, temperature readings | Daily or continuous | Environmental monitoring readings with derived status |
| Wipe sampling results | Every 6 months | Environmental monitoring readings; deviation if residue found |
| Spill and exposure reports | Per event | Deviation with category and CAPA |
| Cleaning and deactivation logs | Per schedule | Your logs; document control for the procedure |
| HD lot storage and movement | Continuous | Lot status and location history |
Tag one hazardous material and watch where it goes
We will flag a material as hazardous, receive a lot, watch the putaway rule send it to hazmat, record a pressure excursion and see the deviation open — on live software.
Where software helps, and where it does not
Most of <800> is physical: rooms, hoods, gloves, gowns, cleaning. No software makes a pharmacy compliant, and any vendor who says otherwise has not read the chapter. What software does is close the documentation gap that turns a good programme into a finding. In Pharmacy Flow: materials carry a hazardous flag that drives putaway to segregated locations; a hazardous (segregated) packout option carries the segregation through fulfilment; environmental readings derive their status from action limits and link to deviations; deviations, CAPAs, change controls and controlled documents carry Part 11 signatures that require re-authentication and are stored append-only; and every lot has a location and status history. That is the record set in section 10, produced as the work happens. The security and compliance page describes the enforcement; the Part 11 explainer covers the signatures; the sterile compounding page covers <797> alongside <800>.
Related reading: hormone therapy software (hormone APIs are on the NIOSH list), veterinary compounding (chemotherapy agents for animals), 503B software, 503A software, inventory management for the putaway rules, and the resources index.
Frequently asked questions
Is USP <800> mandatory?+
It is a USP standard that becomes enforceable through state boards of pharmacy, accreditation bodies and occupational-safety regulators. Since November 2023 it is referenced by the revised <795> and <797>, so compounding HDs is expected to follow it. States vary in adoption and some add requirements; confirm your board's current rule.
Does software make a pharmacy USP <800> compliant?+
No. <800> is mostly facilities, engineering controls, PPE and practice. Software reduces the documentation and monitoring burden — segregated putaway, environmental readings with derived status, deviations and signed procedures — and lets you prove the programme is followed.
Which drugs count as hazardous?+
Those on the NIOSH List of Hazardous Drugs in Healthcare Settings: antineoplastics, non-antineoplastic hazardous drugs, and drugs with reproductive risk. Estrogens, progestins and testosterone are on it, so many hormone compounders are HD handlers.
What is an assessment of risk?+
A documented evaluation, permitted for non-antineoplastic HDs and for antineoplastic final dosage forms that are not manipulated, that lets an entity adopt alternative containment strategies instead of full containment. It must cover drug, dosage form, exposure risk, packaging and manipulation, and be reviewed at least every 12 months. Antineoplastics requiring manipulation are not eligible.
How often must the hood and room be certified?+
At least every six months and after relocation or major service, per the chapter. Pressure differentials are monitored daily or continuously.
How often should we wipe-sample?+
The chapter recommends a baseline and then at least every six months, at defined locations including inside the C-PEC, the pass-through, the C-SEC floor, staging and receiving, dispensing and administration areas. There is no regulatory limit; detected residue triggers investigation.
Do we need a negative-pressure room to store hazardous drugs?+
For antineoplastic HDs requiring manipulation, yes: a separate, externally vented, negative-pressure room with at least 12 ACPH. For other HDs an assessment of risk may permit alternative strategies. Check the chapter's storage section and your state's rule.
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