Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances. The following outlines must be followed.
generic (Brand) Route [Packaging: Mfg ⇒ Dispense]
NIOSH Group
leflunomide (Arava) PO [Bulk ⇒ Packager]
Non - Antineoplastic
Pharmacy: Receiving / Storage / Preparation
Exposure Risk: low
• Handling/preparation PPE Requirements: do not handle while pregnant; single CX gloves
• Receiving from Distributor: Standard
• Pharmacy Storage Area: Carousel
• Packaging/Reconstitution Location: Repacking area
• Compounding (Non-Sterile/Sterile) Location: n/a
• Omnicell Load: Yes
Transport
• Transport (dose is placed inside a plastic sealable bag): Standard
Nursing: Storage / Admin.
Exposure Risk: low
• Handling/administration PPE Requirements: Single CX gloves , wash hands after handling
• Storage of Finished dose in Nursing Area/Procedural Area: Patient Med Drawer, Omnicell
• Signage on Patient Door Required: No
• Manipulation of Dosage Form: Standard
• Special Manipulation for Administration: do not handle while pregnant
Disposal / Spills
• Disposal of Drug Waste: Full- blue bin , trace/packaging- trash
• Disposol of Used PPE: trash bin (inside plastic bag)
• Spill management: n/a
NIOSH Supplemental Information: Teratogenic in lab studies at 1/10 human dose,marked postnata lsurvival at 1/100 HD; severe liver injury reportedin patients; carcinogenicity observed at doses below HD
Reason for exemption of USP<800> Containment Requirements: Minimal manipulation for dispensing. Does not require additional manipulation for administering.
Last updated: Dec. 13, 2021
Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
The following outlines must be followed.
Receiving /
Storage /
Preparation
low
Storage /
Admin.
low
Spills