Pharmacy Compounded Sterile Preparation (CSP) VISN 15

Solicitation / RFP / RFQ

This solicitation is for Hazardous and Non-Hazardous Pharmacy Compounded Sterile Preparation Services for VISN 15 Pharmacies. The contract will be a firm-fixed-price, 5-year requirements contract with annual ordering periods. The primary purpose is to serve as a contingency plan to ensure continuity of patient care during planned or unplanned downtime in VA pharmacy sterile compounding areas.

• Compounding of hazardous and non-hazardous sterile intravenous products.

• Services must be performed at an FDA 503A compliant facility.

• Adherence to USP <797>, <800>, and <795> standards, CETA standards, and delivery protocols.

• Compliance with the Drug Quality and Security Act (DQSA) and 21 U.S. Code § 353a.

• Provision of all necessary materials, supplies, equipment, and personnel.

• Compounding, labeling, delivery, and beyond-use dating based on USP 797, USP 800, DSCSA, and federal law.

• Aseptic compounding based on patient-specific orders.

• Delivery of orders by 9:00 AM CST the day following submission by 2:00 PM CST.

• Maintenance of appropriate storage conditions during shipment.

• Contingency backup plan for facility disruptions.

• Quality Assurance Surveillance Program with specific performance objectives.

• Contract Type: Firm-Fixed-Price, Requirements Contract.

• Period of Performance: 06/01/2026 – 05/31/2031 (Five (5) year contract with annual ordering periods).

• Estimated Value: Not explicitly stated, but it is a requirements contract.

• Questions Due: March 20, 2026, 1:00 PM CST (email to maria.owen2@va.gov).

• Answers to Questions: Will be provided via amendment.

• Offers Due: April 7, 2026, 1:00 PM CST (email to maria.owen2@va.gov).

• Evaluation Factors: Technical Capability, Past Performance, and Price. Technical and Past Performance combined are more important than Price.

• Proposals are to be submitted in two parts: price response and non-price response.

• The acquisition is listed as UNRESTRICTED.

• NAICS Code: 325412 (Pharmaceutical and medicine manufacturing).

• Size Standard: 1300 Employees.

• The solicitation incorporates FAR 52.212-1, 52.212-3, and 52.212-4 by reference.

• Several attachments are referenced, including D.1 Summary of Services, D.2 VHA PBM, D.3 Past Performance Contacts, and D.4 VISN 15 Wage Determination Table.

Form / Attachment / Pricing Sheet

This document is a "Past Performance Survey" questionnaire intended for use by offerors to collect past performance information from references. It is designed to gather feedback on the offeror's performance on previous contracts, specifically for Compounding Services conducted within the past three years.

• Offeror Information: Fields for Business Name, Address, Contact Person, Email, Telephone, Contract Value, Contract Number/Reference, and Contract Period of Performance Dates.
• Description of Services: A section for a brief description of the services provided under the contract.
• Performance Information: A rating scale (1-6, NA) for various aspects of performance, including:
  • Quality of Product or Service
  • Price Control
  • Timeliness/Schedule
  • Business Relationships
  • Key Personnel
• Overall Performance Rating: A selection for Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory, or Unknown.
• Specific Questions: Inquiries regarding contract termination for default and whether the contractor has received cure notices or similar actions.
• Comments: Space for evaluators to provide detailed comments, especially for non-satisfactory ratings.

Offerors must provide this form to a minimum of three current/past performance references. These references will complete the questionnaire and return it directly to the Contract Specialist, Maria Riza R. Owen, at maria.owen2@va.gov. The email subject line must include "36C25526R0023, Past Performance Questionnaire." Questionnaires are due by the Solicitation's due date/time identified on SF 1449, block 8, unless extended by amendment. Offerors should note that questionnaires submitted directly by the offeror will not be considered. This form is critical for the government's evaluation of the offeror's past performance.

Form / Attachment / Pricing Sheet

This document is the VHA PBM Assessment Guide for Compounded Sterile Preparations (CSPs) within VAMCs and Outsourced Compounding Pharmacies. It serves as a checklist to assess regulatory requirements and quality standards for both outsourced compounding pharmacies and VAMC pharmacies involved in CSPs.

• Regulatory Requirements: Covers compliance with HIPAA, EPA regulations, FDA/DEA registration for API sourcing, state pharmacy licensure, pharmacist-to-technician ratios, DEA registration for controlled substances, and staff licensing/certification.
• CSP Pharmaceutical Quality Standards: Addresses documentation of CSP preparation, adverse reaction reporting, tracking and visual inspection of CSPs, and sterility/stability documentation.
• VAMC Specific Quality and Safety Measures: Outlines requirements for product preparation, ingredient selection, and handling of high-risk medications.
• CSP Microbial Contamination Risk Levels: Details compliance with USP <797> Standards for low-risk, medium-risk, and high-risk CSPs, including environmental controls, personnel garbing, and cleaning procedures.
• Personnel Training and Competency: Specifies requirements for training, media-fill testing, and competency evaluations for compounding personnel.
• Quality Assurance Program: Requires a formal QA program to monitor, evaluate, and improve activities and processes.
• Vendor Information: Includes fields for vendor name, contact information, and representative signatures.

This guide is crucial for any vendor seeking to provide compounded sterile products to the VAMC. It outlines the specific standards, regulations, and quality control measures that must be met. Bidders should use this document to ensure their facilities, processes, and personnel comply with VHA requirements for CSPs, which will likely be a key factor in any related procurement.

Form / Attachment / Pricing Sheet

This document, "D.1 Summary of Services.xlsx", provides a detailed breakdown of yearly requirements for various pharmaceutical products and ancillary medical supplies across multiple facility locations. It serves as a pricing sheet or a detailed list of anticipated quantities for these items.

• Pharmaceutical Products: Lists specific drugs by name and NDC/product code, with quantities required at each facility (Eastern Kansas, Kansas City, Marion, Poplar Bluff, St. Louis, Wichita) and a total for all facilities.
• Ancillary Products: Details various medical supplies such as bag adapters, empty bags, connectors, dispensing fees, extension sets, home pumps, injection sets, and different types of sodium chloride solutions, along with their required quantities per facility and in total.
• Totals: Provides subtotals for pharmaceutical products and ancillary products, as well as a "Potential Contract Totals" row summarizing the overall estimated quantities across all categories and locations.

This document is crucial for bidders as it outlines the specific products and estimated quantities the government anticipates procuring. It directly informs pricing strategies, inventory management, and the overall capacity required to fulfill potential contract obligations. Bidders should carefully review the quantities and locations to assess their ability to meet these demands and to prepare accurate and competitive proposals.

Solicitation / RFP / RFQ

This is a pre-solicitation notice for an unrestricted procurement of a single-award, VISN-wide Indefinite Delivery/Requirements Contract. The contract will cover the provision of hazardous and non-hazardous compounded intravenous products and associated supplies. This notice is not a request for proposal, quotation, or bid.

• Provision of hazardous and non-hazardous compounded intravenous products and associated supplies (medications, diluents, fluids, IV tubing, closed system drug transfer devices, etc.).

• Aseptic compounding of sterile products based on patient-specific orders.

• Compliance with USP 797, USP 800, Drug Supply Chain Security Act (DSCSA), and all applicable federal, state, and local regulations.

• Proper delivery, handling, and storage conditions during shipment, including segregation and labeling for hazardous versus non-hazardous compounds.

• Annual update of the VHA Pharmacy Benefits Management (PBM) Assessment Guide for Compounded Sterile Preparations.

• Contract Type: Indefinite Delivery/Requirements Contract

• Award Type: Single Award

• Scope: VISN-wide

• The solicitation will be issued electronically via www.sam.gov.

• No phone, fax, or email inquiries will be taken for this Pre-Solicitation Notice.

• The solicitation will be publicized on or about February 6, 2026.

• Response Date/Time/Zone: 01-29-2026 1pm CENTRAL TIME, CHICAGO, USA

• Unrestricted procurement.

• Potential vendors MUST be registered and active in SAM.

• NAICS Code: 325412 Pharmaceutical Preparation Manufacturing (Size Standard: 1300 employees).

• Product Service Code: Q517 Pharmacy Services.

• Contracting Office ZIP Code: 66048.

• Contact: Maria Riza Owen, Contract Specialist, maria.owen2@va.gov.