H966- | 36C261-26-AP-0279 | PHARMACY USP 797 800 CERTIFICATION TESTING/ SERVICE
ID: 36C26126Q0173Type: Presolicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF261-NETWORK CONTRACT OFFICE 21 (36C261)MATHER, CA, 95655, USA

NAICS

Testing Laboratories and Services (541380)

PSC

OTHER QC/TEST/INSPECT- INSTRUMENTS AND LABORATORY EQUIPMENT (H966)
Timeline
    Description

    The Department of Veterans Affairs is seeking proposals for Pharmacy USP 795, 797, and 800 Certification Testing Services at the VA Central California Healthcare System. The procurement involves semi-annual certification testing of sterile compounding clean rooms, ensuring compliance with United States Pharmacopeia standards and VHA directives. This testing is critical for maintaining safety and quality in pharmacy operations, with services required to be performed by CETA certified technicians. Interested vendors must submit their proposals by January 6, 2025, at 4:00 PM Pacific Time, and can contact Contract Specialist John D. Waldrip at John.Waldrip@va.gov for further information.

    Point(s) of Contact
    John D WaldripContract Specialist
    John.Waldrip@va.gov
    Files
    Title
    Posted
    This Presolicitation Notice announces a federal contract opportunity for Pharmacy Certification Testing Services at the VA Central California Healthcare System. The Department of Veterans Affairs, Network Contracting Office 21, is seeking proposals under Solicitation Number 36C26126Q0173. The services required are for USP 797 and 800 certification testing and related services. The response deadline is January 6, 2025, at 4:00 PM Pacific Time. The contracting office is located in North Las Vegas, NV, and the point of contact is Contract Specialist John D. Waldrip. This notice provides essential details for potential bidders, including the NAICS code 541380 and Product Service Code H966.
    The VA Central California Healthcare System (VA CCHCS) requires semi-annual certification testing for its sterile compounding clean rooms, adhering to USP<795>, USP<797>, and USP<800> standards, ISO, and VHA Directives. This Performance Work Statement outlines a base year contract with four option years for these services. The scope includes comprehensive testing of clean rooms in Building 1 (excluding the out-of-service Hazardous Drug Room) and Building 24, covering airflow, HEPA filter integrity, biological safety cabinets, laminar flow units, particulate counting, differential pressure, air exchange rates, pass-through boxes, and viable particle sampling. The contractor must be CETA certified, located within a 250-mile radius of the Fresno VA, and provide preliminary reports within 24 hours, with final reports within 30 days. The period of performance is from February 1, 2026, to January 31, 2031, if all options are exercised. The contractor is responsible for quality control, safety, security, and adherence to VA standards of conduct.
    This Quality Assurance Surveillance Plan (QASP) outlines the performance objectives and thresholds for critical support services, serving as a key component in federal government RFPs. It details three main areas: inspection service frequency, report accuracy and timeliness, and the use of qualified personnel. For inspection services, certification testing intervals must have no deviations and be 100% compliant with VA directives. All reports are required to be 100% accurate, complete, and submitted on time, with no discrepancies allowed. Lastly, all personnel must meet CETA certification requirements 100% of the time. Failure to meet these stringent standards, which are subject to 100% inspection, will result in termination for default. The QASP emphasizes that these thresholds are critical to mission success and are not a substitute for the Performance Work Statement (PWS).
    The Department of Veterans Affairs (VA) is soliciting proposals for Pharmacy United States Pharmacopeia (USP) 795, 797, and 800 Certification Testing for the VA Central California Healthcare System. This Request for Proposal (RFP) outlines a base year and four option years, spanning from February 1, 2026, to January 31, 2031. The services include various tests for clean benches, biological safety cabinets, air and surface samples, and airflow studies in Buildings 1 and 24, with formal reports required annually. The acquisition is unrestricted, falling under NAICS code 541380 (Testing Laboratories and Services) with a size standard of $19 million. Offerors must submit questions by December 29, 2025, and payment will be made monthly via electronic funds transfer through the Tungsten Network. This RFP ensures the VA Central California Healthcare System meets critical pharmacy compliance and safety standards.
    This is a Pre-Solicitation Notice for Pharmacy Certification Testing Services at VA Central California Healthcare System. The notice, identified by Solicitation Number 36C26126Q0173, outlines a requirement for PHARMACY USP 795 797 800 CERTIFICATION TESTING/ SERVICE. The contracting office is located in zip code 89086, and the response date is January 6, 2025, at 4:00 PM Pacific Time. The product service code is H966, and the NAICS code is 541380. The point of contact for this solicitation is Contract Specialist John D. Waldrip, who can be reached at John.Waldrip@va.gov. This notice serves to inform potential vendors of an upcoming opportunity to provide specialized pharmacy certification testing services to the Department of Veterans Affairs.
    Lifecycle
    Similar Opportunities
    Pharmaceutical Repackaging Services for National CMOP (770)
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is soliciting proposals for pharmaceutical repackaging services for the National Consolidated Mail Outpatient Pharmacy (CMOP) program. The contract, identified as 36C77026R0004, is a firm-fixed-price, indefinite-delivery agreement intended to support the repackaging of government-purchased oral solid pharmaceuticals into various bottle sizes for distribution to over 7 million veterans. The contract spans a five-year ordering period from February 1, 2026, to January 31, 2031, with a potential six-month extension, and has a minimum value of $20 million and a maximum value of $125 million. Interested contractors should contact Renee Kreutzer at renee.kreutzer@va.gov for further details and must submit their proposals by the specified deadlines, ensuring compliance with all relevant regulations and standards.
    Z1DA--Renovate Pharmacy for USP800 Compliance Project 540-18-102
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is seeking bids for the "Renovate Pharmacy for USP800 Compliance Project 540-18-102" at the Louis A. Johnson VA Medical Center in Clarksburg, West Virginia. This project involves comprehensive construction services to ensure the pharmacy meets USP 800 compliance standards, requiring the contractor to provide all necessary labor, materials, equipment, permits, and supervision over a performance period of 496 calendar days. The contract is set aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSB) with an estimated construction magnitude between $2,000,000 and $5,000,000. Interested parties must submit questions in writing to Contracting Officer Rebecca Besten at rebecca.besten@va.gov, and the response deadline for bids is January 7, 2026, at 3 PM Eastern Time, with the solicitation anticipated to be issued on or about January 20, 2026.
    6505--Ustekinumab Pens/Syringes or Biosimilar
    Veterans Affairs, Department Of
    The Department of Veterans Affairs (VA) is preparing to issue a Request for Proposal (RFP) for the procurement of Ustekinumab Pens/Syringes or Biosimilars, aimed at supplying various federal health entities including the Department of Defense, Bureau of Prisons, Indian Health Service, and Federal Health Care Center. The contract will be awarded for an initial period of one year, with the possibility of four additional one-year option periods, ensuring a consistent supply of these critical pharmaceutical products through the VA and DoD Pharmaceutical Prime Vendor Programs. Offerors must provide drugs with unique National Drug Code (NDC) numbers and ensure that any biosimilar products meet FDA licensing requirements, as outlined in the FDA Purple Book. The solicitation is expected to be released around January 12, 2026, with a tentative closing date of January 27, 2026; interested parties should direct inquiries to Chris Carthron at Christopher.Carthron@va.gov or (708) 786-4980.
    VA Direct to Patient supply services
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is seeking small business vendors to provide direct delivery supply services for medical and surgical items to Veteran patients through its Consolidated Mail Outpatient Pharmacy (CMOP) program. The contractor must demonstrate at least two years of experience, the capacity to process approximately 14 million prescriptions annually, and the ability to maintain compliance with federal and state regulations while ensuring a 48-hour average turnaround time for prescription fulfillment. This opportunity is critical for ensuring timely access to essential medical supplies for Veterans, with the contract structured to reimburse vendors per filled prescription at government contract prices, plus handling fees. Interested vendors must submit a capabilities statement to the primary contact, Phillip Reuwer, at Phillip.Reuwer@va.gov by January 11, 2026, with any questions directed to the same contact before January 8, 2026.
    6505--36C77026Q0061/RFI/Domestic Sources Rx_MedSurge
    Veterans Affairs, Department Of
    The Department of Veterans Affairs (VA) is seeking information from domestic pharmaceutical manufacturers through a Request for Information (RFI) designated 36C77026Q0061, aimed at supporting the Consolidated Mail Outpatient Pharmacy (CMOP) in fulfilling its Open Market (OM) purchasing needs. The RFI seeks to identify both small and large businesses capable of providing a range of pharmaceutical products and ancillary items, with a focus on those manufactured in the United States, to enhance the supply chain for approximately 450,000 prescriptions mailed daily to Veterans. Interested manufacturers are required to submit detailed company and product information, including FDA-approved NDC numbers and operational capabilities, by March 15, 2026, at 4:30 PM CT. For further inquiries, respondents can contact Michael McAlhaney at Michael.McAlhaney@va.gov or (913) 684-1976.
    6630--VISN 15 Automated Erythrocyte Sedimentation Rate Analyzers 36C255-26-AP-0538
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is seeking proposals for an unrestricted solicitation for Cost-Per-Test (CPT) Blanket Purchase Agreements for Automated Erythrocyte Sedimentation Rate Analyzers intended for the VISN 15 Heartland Network Veterans Affairs Medical Centers (VAMCs). This procurement aims to enhance laboratory capabilities by providing essential equipment for conducting erythrocyte sedimentation rate tests, which are critical for diagnosing various medical conditions. The solicitation is expected to be released around December 19, 2026, with a response deadline set for January 12, 2026, at 10:00 AM Central Time. Interested parties can reach out to Contract Specialist Erika Kobulnicky at Erika.Kobulnicky@va.gov or by phone at 913-946-1991 for further information.
    6505--766-26-1-400-0207 -Charleston CMOP 2 Pharmaceuticals -(VA-26-00025368)
    Veterans Affairs, Department Of
    The Department of Veterans Affairs (VA) is seeking to procure two specific pharmaceuticals, JASMIEL (J0040) 28-DAY TABLET and DROSPIRENONE 4MG (D1217), for the Consolidated Mail Outpatient Pharmacy (CMOP) in Ladson (Charleston). This procurement is critical as the products have been prescribed by VA physicians, and no substitutions are permitted due to the absence of alternative suppliers in the market. Vendors are required to submit a signed SF1449, a completed pricing schedule, a valid State Wholesale Distributor License, and a Buy American Act Certificate by January 5, 2026, at 3:00 PM CT, with deliveries staggered over a six-month period starting ten days after order receipt. Interested parties should direct their quotes to Kelley Cunningham at kelley.cunningham@va.gov.
    NATIONAL OPERATIONAL/MAILING SUPPLIES
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is seeking proposals for operational and mailing supplies through solicitation number 36C77025R0004, aimed at supporting its seven Consolidated Mail Outpatient Pharmacy (CMOP) locations. This procurement involves establishing multiple National Single Award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts for essential items such as corrugated boxes, bubble mailers, sealing tape, and child-resistant medical pouches, ensuring compliance with stringent specifications for patient safety and product integrity. The awarded contracts will facilitate timely deliveries of these supplies, which are critical for the efficient processing and shipment of prescriptions to veterans. Interested vendors must submit their proposals, including product samples and pricing schedules in Excel format, by the extended deadline of January 15, 2026, at 5:00 PM CDT. For further inquiries, contact Kelly L Mann at kelly.mann@va.gov or Kelley Cunningham at kelley.cunningham@va.gov.
    Q517--Pharmacy Emergent First Fill at the SFVAHCS
    Veterans Affairs, Department Of
    The Department of Veterans Affairs, specifically the Network Contracting Office 23, is seeking proposals for a single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract for Pharmacy Emergent First Fill Services at the Sioux Falls VA Health Care System (SFVAHCS) and its associated Community-Based Outpatient Clinics (CBOCs). The contractor will be responsible for providing an open pharmacy network that allows veterans to obtain first-fill prescriptions for a maximum of 10 days (14 days for antibiotics) from the VA's Emergent Drug List, with no refills authorized and prescriptions picked up at no charge to the patients. This service is critical for ensuring timely access to necessary medications for veterans, with the contract set to begin on January 1, 2026, and extend through December 31, 2030. Interested Service-Disabled Veteran-Owned Small Business Concerns (SDVOSBC) must submit their proposals by December 26, 2025, including required documentation and licenses, to Contract Specialist Michael Wicht at michael.wicht@va.gov or by phone at 402-996-3630.
    6505--770_Pharmaceuticals_VA CMOP National Office_36C77026Q0060
    Veterans Affairs, Department Of
    The Department of Veterans Affairs is seeking proposals for the procurement of various dosages of Duloxetine HCl capsules, intended for delivery to multiple Consolidated Mail Outpatient Pharmacy (CMOP) locations across the United States. This presolicitation notice (36C77026Q0060) outlines a requirement for monthly deliveries over a three-month period, with specific quantities and packaging details for each item, emphasizing compliance with the Drug Supply Chain Security Act (DSCSA) and adherence to strict delivery and packaging standards. Interested vendors must submit their quotes, including a signed SF1449, a price schedule in Excel format, and a state wholesale distributor license, by January 2, 2026, with an estimated award date of January 23, 2026. For further inquiries, vendors can contact Contract Specialist Michael W. McAlhaney at Michael.McAlhaney@va.gov or (913) 684-1976.