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Provider Notice issued 07/28/2023

 

Date: July 28, 2023
​To: Enrolled Pharmacies
​Re: Importation of Non-FDA Approved CISplatin Due to Extreme Shortage 

This notice informs providers that the Department of Healthcare and Family Services (HFS) has been notified of an extreme shortage of CISplatin, which has been determined to constitute a medical emergency for those patients in need. In accordance with the actions by the Food and Drug Administration (FDA), a non-FDA approved CISplatin, manufactured by Qilu Pharmaceutical Company in conjunction with Apotex Corporation, can be distributed into and within the State of Illinois and will be reimbursable for Illinois Medicaid enrolled providers.  

Effective immediately and during this temporary period, Apotex Corporation will distribute the following presentation of CISplatin Injection to address the critical shortage:

Product Name

Quantity

Description

U.S. NDC Number

Lot Number

Expiration Date

CISplatin Injection (50 mg/50 mL)

1 vial per carton

Colorless to yellowish clear liquid. Each 1 mL contains 1 mg of CISplatin and 9 mg of Sodium Chloride in water for injection

60505-6277-0

 

The linear barcode on the imported product label may not register accurately on the U.S. scanning systems. See Appendix 1 in the linked document below for the scannable linear barcode.

3E001C88

05/02/2025

3E002C88

05/02/2025

3E003C88

05/02/2025

3E004C88

05/03/2025

Additional information can be found via this link:

DHCP Letter: Temporary Importation of CISplatin Injection with non-U.S. Labeling (fda.gov)

Questions regarding this notice may be directed to a pharmacy consultant in the Bureau of Professional and Ancillary Services at 877-782-5565 for fee-for-service claims, or the appropriate managed care plan.

 

Kelly Cunningham, Administrator
Division of Medical Programs