Hazardous Drugs — Handling in Healthcare Settings
Requirements for handling hazardous drugs across receipt, storage, compounding, transport, administration and disposal, to protect personnel, patients and the environment. Official 1 December 2019, and applicable to any entity handling drugs on the NIOSH hazardous-drug list.
All healthcare and compounding settings handling hazardous drugs — not only those that compound them. The chapter reaches receipt and storage, so a site that merely stocks a hazardous drug is in scope.
- 01Designated person responsible for the hazardous-drug programme
- 02List of hazardous drugs handled, based on the current NIOSH list
- 03Containment engineering controls appropriate to the activity
- 04Documented assessment of risk where full containment is not applied
- 05Personnel training, PPE and documented competency
- 06Surface-wipe sampling with defined response actions
USP <800>: frequently asked questions
Quick answers to common questions about USP <800>.
What is USP <800>?
USP <800> — Hazardous Drugs — Handling in Healthcare Settings — is a standard issued by the United States Pharmacopeia (United States / International). Requirements for handling hazardous drugs across receipt, storage, compounding, transport, administration and disposal, to protect personnel, patients and the environment. Official 1 December 2019, and applicable to any entity handling drugs on the NIOSH hazardous-drug list.
Who does USP <800> apply to?
All healthcare and compounding settings handling hazardous drugs — not only those that compound them. The chapter reaches receipt and storage, so a site that merely stocks a hazardous drug is in scope.
What are the key requirements of USP <800>?
USP <800> requires, among other things: Designated person responsible for the hazardous-drug programme; List of hazardous drugs handled, based on the current NIOSH list; Containment engineering controls appropriate to the activity; Documented assessment of risk where full containment is not applied.
When was USP <800> last updated?
The current version of USP <800> dates from December 2019.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When USP <800> — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.