FormWeb • mycophenolic acid

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REMS FDA Documents #1^FDA Documents #2

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mycophenolic acid

mycophenolic acid

REMS FDA Documents #1
REMS FDA Documents #2

Brand names: Myfortic

Form	Strength
DELAYED RELEASE TABLET, ORAL	180 mg

Display Immunosuppressive Agents Class: 924400

Medication comments:

USP <800> Hazardous Drug Assessment of Risk (AOR)
Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances. The following outlines must be followed.
generic (Brand) Route [Packaging: Manufacturer ⇒ Dispense]	Activities
mycophenolic acid (Myfortic) PO [Bulk ⇒ Packager]	180 mg delayed release tablet	Stock @ IDBH? N NIOSH Table 2^↑
Pharmacy: Receiving / Storage / Preparation Exposure Risk: low	• Handling/preparation PPE Requirements: Single CX glove Wash hands after handling
	• Receiving from Distributor: Standard
	• Pharmacy Storage Area: Carousel
	• Packaging/Reconstitution Location: Repackaging area
	• Compounding (Non-Sterile/Sterile) Location: n/a
	• Omnicell Load: No
Transport	• Transport (dose is placed inside a plastic sealable bag): Standard
Nursing: Storage / Administration Exposure Risk: low	• Handling/administration PPE Requirements: Single pair of CX approved gloves Wash hands after handling
	• Storage of Finished dose in Nursing Area/Procedural Area: Patient Med Drawer
	• Signage on Patient Door Required: No
	• Manipulation of Dosage Form: Standard
	• Special Manipulation for Administration: n/a
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 first trimester pregnancy loss and increased risk of congenital malformations, BBW for lymphomas and other malignancies; genotoxic in vitro and in vivo
Reason for exemption of USP<800> Containment Requirements: Minimal manipulation for dispensing. Does not require additional manipulation for administering.

Last updated: Jun. 11, 2025

Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
Black Box Warnings Embryofetal Toxicity, Malignancies, and Serious Infections

UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

This site is intended for the staff of Iredell Health System. While others may view accessible pages, Iredell Health System makes no warranty, express or implied, as to the use of this information outside of Iredell Health System. The content of this policy and procedure document serves as guidance to the delivery of quality patient care. Care providers are expected to exercise critical thinking and situational awareness skills, and in specific situations to take such action as is necessary for the delivery of quality patient care.