P01 - Salient Characteristics.docx

36C26221 P000S

This government is seeking a vendor able provide the manufacturing and delivery of compounded chemotherapy drugs from an FDA 503A compliant facility for the treatment of patients receiving services at the VA Long Beach Healthcare System.

1. Salient Characteristics

1.1. The Vendor must be able to compound and provide the hazardous medications, including supportive medications, for the VA Long Beach Pharmacy; approximately thirty patients on any given day throughout the performance period. The medications required are included in, but not limited to, the list below.

1.2. All medications must be delivered with no less than 12 hours remaining on the Beyond-Use-Date (BUD) and no sooner than 6pm PST/PDT on the date of delivery to allow adequate time for administration to clinic patients during their regularly scheduled appointments.

1.3. Vendor must have a certified 503A pharmacy(s) with an active board of pharmacy license that are licensed to ship into/within the State of California.

1.4. The vendor must complete and meet all requirements for national VA Pharmacy Benefits Management (PBM) Compounded Sterile Products Assessment guidelines.

1.5. The vendor must be able to provide documentation of compliance with the standards outlined in the current version of USP 797.

1.6. The vendor must provide any current or past survey or inspection results and responses from the Joint Commission, Board of Pharmacy, FDA, or any other governing body.

1.7. The vendor must be able to provide stability data for all medications upon request.

1.8. Medications shall not be delivered until ordered by the government.

1.9. Vendor shall notify the government of any anticipated shortages, recalls or discontinuation of the medications.

1.10. Vendor must be able to ensure and provide documentation that medications are handled appropriately per the manufacturer’s specifications prior to the receipt of the medication by VA Long Beach.

1.11. Medications must meet technical specifications stated in the FDA approved package.

1.12. Medication must be stored and used in according with directions on the labeling. If deviating from the FDA approved package insert, vendor must submit supporting evidence of practice and must be approved by the government before implementing.