Piflufolastat F-18 (Pylarify) Radiopharmaceutical Unit Doses

The National Institutes of Health Clinical Center intends to sole-source patient-ready Piflufolastat F-18 (Pylarify) unit doses and unused-dose fees for prostate cancer imaging at its Bethesda, Maryland facility.

United States of America > HEALTH AND HUMAN SERVICES, DEPARTMENT OF > NATIONAL INSTITUTES OF HEALTH > NATIONAL INSTITUTES OF HEALTH - CC


General
Open (active)
NOI-27-000004
Sep 29, 2026 02:00 PM
Sep 22, 2026 11:42 PM
1 year base + 4 × 1 year options
Sole Source
Federal
Ask AI about this solicitation
Contact
lu-chang.lu@nih.gov
6707 Democracy Boulevard, Bethesda, MD, USA
Submission Instructions
Email
Description

The National Institutes of Health Clinical Center intends to negotiate on a sole-source basis for patient-ready Piflufolastat F-18 injection (Pylarify) unit doses and unused-dose fees. The drug must be compounded, calibrated, dispensed, and delivered on demand by an authorized nuclear pharmacy because of its short radioactive half-life. The requirement supports prostate cancer imaging and related patient-care protocols and must comply with applicable U.S. Food and Drug Administration and U.S. Nuclear Regulatory Commission requirements. The notice identifies an indefinite-delivery/indefinite-quantity requirement of approximately 150 to 230 Pylarify injections and four unused-dose fees, with a 12-month base period beginning October 1, 2026, followed by four 12-month option periods. Doses must arrive at the NIH Clinical Center Nuclear Pharmacy Facility at least 30 minutes before the specified administration/calibration time. The notice is not a request for proposals; responsible sources may submit a capability statement for consideration before the stated deadline.

Classification Codes
NAICS325412Pharmaceutical Preparation Manufacturing
PSC6505Drugs and Biologicals
Smart Codes
radiopharmaceutical injectionsnuclear pharmacy compoundingpatient-ready drug delivery
Specifications
Supply & Service
No
Timeline
Sep 22, 2026 11:42 PM-Published Date
Sep 29, 2026 02:00 PM-Capability Statements Due
Oct 1, 2026-Base Period Begins
Oct 1, 2027-Option Period 1 Begins
Oct 1, 2028-Option Period 2 Begins
Oct 1, 2029-Option Period 3 Begins
Oct 1, 2030-Option Period 4 Begins
Sep 30, 2031-Base and Option Period Ends
Requirements
No
Documents
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