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
mycophenolate mofetil (Cellcept) PO [UD ⇒ UD]
Non - Antineoplastic
Pharmacy: Receiving / Storage / Preparation
Exposure Risk: minimal
• Handling/preparation PPE Requirements: do not handle while pregnant; single CX gloves
• Receiving from Distributor: Standard
• Pharmacy Storage Area: Carousel
• Packaging/Reconstitution Location: n/a
• 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: PO- Single CX gloves , tube- double CX gloves and gown , 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 open capsule, 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: BBW for embry of fetal toxicity,malignancies,and serious infections,increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special Warning: Tablets should not be crushed and capsules should not be opened or crushed. Avoid inhalation or directcontact with skin or mucous membranse of the powder contained in capsules and oral suspension. If such contact occurs,wash thoroughly with soap and water, rinse eyes with plain water
Reason for exemption of USP<800> Containment Requirements: Purchased in final dosage form; packaged as unit dose. Does not require additional manipulation for dispensing.
Enteral Drug Administration notes.
Generic (Brand)
Comments and Considerations
Recommendations for Administration with Enteral Nutrition
mycophenolate mofetil (Cellcept)
Food has no effect on AUC, but shown to decrease AUC
No dose adjustment required. Do NOT manipulate tabs/caps due to teratogenic effect. Use available suspension.
Last updated: Jan. 23, 2023
Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
The following outlines must be followed.
Receiving /
Storage /
Preparation
minimal
Storage /
Admin.
low
Spills
(Brand)
(Cellcept)