10.3 Hazardous Drugs & USP <800>

Hazardous Drugs & USP <800>

The NABP blueprint lists training, possession, handling, storage and disposal of hazardous drugs as a distinct competency within pharmacy operations. It sits apart from compounding because USP <800> applies whether or not anything is compounded — a community pharmacy that merely counts tablets of a hazardous drug is in scope.

---

Scope

USP General Chapter <800>, Hazardous Drugs — Handling in Healthcare Settings, applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport or administer hazardous drugs. It covers the whole lifecycle: receipt, storage, compounding, dispensing, administration and disposal.

The reference list is the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, which groups drugs into:

1. antineoplastic drugs;
2. non-antineoplastic drugs that meet one or more NIOSH hazard criteria; and
3. drugs that primarily pose a reproductive risk to men or women who are actively trying to conceive, are pregnant, or are breastfeeding.

---

Assessment of Risk

An entity must handle every hazardous drug in accordance with the full containment requirements unless it performs an Assessment of Risk (AoR) for a specific dosage form of a specific drug. The AoR is not available for antineoplastic drugs that require manipulation other than counting or repackaging of final dosage forms, and it is not a way to opt out of <800> generally.

An AoR must consider the type of hazardous drug, its dosage form, the risk of exposure, the packaging, and the manipulation required, and must document alternative containment strategies and work practices. It is reviewed at least every 12 months and the review is documented.

[!IMPORTANT] An assessment of risk is a documented decision, not an absence of one. A pharmacy that dispenses intact tablets of a NIOSH-listed non-antineoplastic drug may reasonably conclude that counting them in a dedicated tray with gloves is adequate — but it must write that conclusion down, justify it, and review it annually. Doing nothing is non-compliance.

---

Facilities and Containment

---

Personnel

• The entity must designate a qualified and trained individual responsible for developing and implementing the hazardous drug programme, and for monitoring compliance.
• Personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs.
• Training precedes handling. Competence is assessed initially and at least every 12 months, and retraining follows any change in the drugs handled or the equipment used.
• Personal protective equipment appropriate to the activity — chemotherapy-tested gloves, gowns, eye and face protection, and respiratory protection where indicated — must be available and used.

---

Spills and Disposal

• Spill kits must be available wherever hazardous drugs are handled, and personnel must be trained in spill management for the volumes they might realistically encounter.
• Disposal follows hazardous waste rules, not ordinary pharmaceutical waste routes. Hazardous drug waste is segregated from general and from controlled substance waste streams. Where a hazardous drug is also a controlled substance, both regimes apply, and the controlled substance accountability requirements are not displaced.

---

The Massachusetts Interface

Massachusetts does not run a separate hazardous drug chapter; it enforces <800> through the compounding chapters and the Board's inspection process:

• Draft 247 CMR 18.05 would require a pharmacy compounding non-sterile hazardous drugs to adhere to USP <800> and to run a pressure-differential monitoring system on the C-SEC, reviewed and documented at least once daily before compounding begins — the state expression of the <800> containment principle. It is a Board draft; what binds today is USP <800> itself through 247 CMR 9.01(3).
• Draft 247 CMR 17.00 addresses sterile compounding, where hazardous sterile preparations require containment primary and secondary engineering controls; the promulgated hooks are the licence requirements in 247 CMR 6.00 and the USP duty in 247 CMR 9.01(3).
• 247 CMR 20.06 requires reporting of above-action-level environmental monitoring results and failure of certification of a primary or secondary engineering control — the two events most likely to reveal a containment failure.

---

Worked Traps

• A community pharmacy counts tablets of a NIOSH-listed drug on the general counting tray and has no documentation. Non-compliant. Either handle under full containment or perform, document and annually review an assessment of risk.
• Hazardous drug cartons are unpacked at the general receiving bench next to the clean room. Wrong — receipt and unpacking must occur in a neutral or negative-pressure area, never adjacent to a positive-pressure sterile area.
• A pharmacy assumes an assessment of risk lets it prepare an antineoplastic infusion on the open bench. Wrong — the AoR route is not available for antineoplastic drugs requiring manipulation beyond counting or repackaging final dosage forms.
• A containment hood fails its semi-annual certification and the pharmacy schedules a repair without telling anyone. In Massachusetts, failure of certification of a primary or secondary engineering control is reportable to the Board under 247 CMR 20.06.