FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Cold Kits

FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Cold Kits
Dwight David Eisenhower Army Medical Center (DDEAMC), Fort Eisenhower, GA

DISCLAIMER

This is a Pre-solicitation Notice (Synopsis of Proposed Contract Action) to identify potential sources possessing the capabilities described herein. This Pre-solicitation Notice is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offer will be considered in response to this Pre-solicitation Notice. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract.

Responders are solely responsible for all expenses associated with responding to this NOTICE or any follow-up information request. All information received in response to this NOTICE that is marked "Proprietary" will be handled accordingly. Responses to the NOTICE will not be returned. At this time, questions concerning the composition and requirements for a future solicitation will not be entertained.

NOTE: At this time, no solicitation exists. Therefore, please do not request a copy of a solicitation. NO PHONE CALLS WILL BE ACCEPTED. It is the responsibility of any potential Offeror to monitor the SAM.gov site for the release of any subsequent solicitation.

1. NOTICE TITLE

FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Compounding Cold Kits for Dwight David Eisenhower Army Medical Center (DDEAMC).

2. PLACE OF PERFORMANCE (LOCATION)

Dwight David Eisenhower Army Medical Center (DDEAMC)
300 Hospital Road, Fort Eisenhower, Georgia 30905-5650

3. BACKGROUND

The Nuclear Medicine Section at DDEAMC requires a continuous, and reliable supply of Federal Drug Administration (FDA) approved active radiopharmaceuticals "hot doses" and non-radioactive compounding "cold kits."

Currently, these requirements are satisfied under separate contracts. The Government intends to combine the active/hot doses, and the cold kit supplies, into a single, consolidated firm-fixed-price commercial contract.

4. DESCRIPTION & CLASSIFICATION

The Contractor shall provide all necessary compounding facilities, certified personnel, USP-compliant cleanrooms, quality control testing, transportation, DOT-compliant vehicles, shielding, and related delivery accessories to fulfill routine and emergency nuclear medicine orders.

A copy of the Draft Performance Work Statement (PWS) detailing the complete itemized workload and consolidated performance standards is attached to this NOTICE. Industry is highly encouraged to review the PWS and provide feedback or capability questions as part of their response.

• NAICS Code: 325412 – Pharmaceutical Preparation Manufacturing
• Size Standard: 1,250 Employees (SBA Manufacturing Standard)
• Product Service Code (PSC): 6505 – Drugs and Biologicals

5. CRITICAL LOGISTICAL REQUIREMENTS (NON-NEGOTIABLE)

Due to the physics of isotopic decay and the critical nature of patient-care delivery timelines, the following logistical parameters are strict, non-negotiable, and must be met for a contractor to be deemed capable:

• The contractor’s nuclear compounding pharmacy facility must be physically located within a 90-minute driving radius of DDEAMC (Fort Eisenhower, GA). This is an absolute safety and technical threshold to prevent isotopic decay prior to delivery.
• Compounded active doses must be packaged and delivered directly to the DDEAMC Nuclear Medicine Service no later than 30 minutes prior to scheduled patient calibration times on an as-needed, 24-hour delivery window.
• The contractor must possess a dedicated 24/7/365 emergency compounding and transport network capable of delivering emergency "hot doses" directly to the DDEAMC Nuclear Medicine department within 2 hours of order acceptance.

6. NOTICE SUBMISSION INSTRUCTIONS

Interested parties possessing the capability to fulfill this consolidated requirement are invited to submit a written capability statement. Submissions shall adhere to the following formatting and outline instructions:

• Submissions must be limited to 5 pages, be sent electronically in Adobe PDF format and must include:
• Company Name, Address, and Point of Contact (Name, Title, Phone, and Email).
• CAGE Code and Unique Entity Identifier (UEI) registered in SAM.gov.
• Business Size Status under NAICS 325412 (e.g., Large Business, Small Business, SDVOSB, WOSB, HUBZone).

• Capability Statement Outline:
   

1. Provide a detailed description of your facility's capability to compound and supply both active radiopharmaceuticals ("hot doses") and non-radioactive cold kits simultaneously as outlined in standard clinical nuclear pharmacy models.
2. Explicitly demonstrate and verify how your facility will comply with the non-negotiable 90-minute compounding driving radius and the 2-hour emergency delivery timeline on a 24/7/365 basis. Specify the physical address of the compounding pharmacy that would support this contract.
3. Confirm your facility’s active licensing and compliance with FDA, Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), USP <797>, and USP <825> sterile compounding standards.
4. Identify any current federal contract vehicles (e.g., GSA Schedules, VA FSS, or DoD enterprise-wide contracts) under which you currently offer these supplies.
5. State whether your firm currently provides these identical compounding and delivery services to the general public or local commercial hospital systems under similar terms and conditions.

7. SUBMISSION DEADLINE AND POCs

Responses to this NOTICE must be submitted no later than August 14, 2026, at 5:00 PM Eastern Daylight Time (EDT).

Submissions shall be emailed directly to the following Contracting Points of Contact:

• Sherina Ross (Contract Specialist): sherina.l.ross.civ@health.mil
• Michael Heaney (Contract Specialist: michael.s.heaney2.civ@health.mil
• Lenore Paseda (Contracting Officer): lenore.y.paseda.civ@health.mil