6505--Streamlined Domestic Nonavailability Waiver Determination - Pharmaceuticals

Description

DEPARTMENT OF VETERANS AFFAIRS Streamlined Domestic Nonavailability Waiver Determination - Pharmaceuticals AGENCY: Department of Veterans Affairs. ACTION: Special Notice. This is a Special Notice for� commercial pharmaceutical products� as supplemented with additional information included in this notice. This announcement constitutes a notice only; proposals or quotes are NOT being requested at this time. Information provided in response to this Special Notice will not commit or bind the Department of Veterans Affairs (VA) to any requirements. SUMMARY: The Department of Veterans Affairs invites comments on a Buy American domestic nonavailability waiver determination for pharmaceuticals, written in accordance with Federal Acquisition Regulation (FAR) 25.103(b). DATES: Comments must be received by February 4, 2026. FOR FURTHER INFORMATION CONTACT: VA Risk Management and Compliance Service, acquisitionrmcs@va.gov. Additional information regarding the domestic nonavailability waiver determination may be obtained from the Office of Management and Budget Made in America Office website at https://www.madeinamerica.gov/waivers/nonavailability/695f8d355bee86c5fba364d8. SUPPLEMENTARY INFORMATION: The Department of Veterans Affairs (VA) is committed to Federal procurement actions that maximize the use of pharmaceuticals that are manufactured in the United States, and whenever possible, VA procures pharmaceuticals from sources that support American businesses and industries. Pharmaceutical acquisitions have undergone thorough market research which has highlighted that many of the pharmaceuticals procured by the VA Network Contracting Office 15 are not domestically produced. Market research was conducted to locate capable domestic manufacturers for pharmaceuticals, and the results of the market research concluded that, for the 10 pharmaceuticals listed below, domestic manufacturers are not available. Pharmaceuticals: Fenofibrate Camphor Menthol Methyl Salicylate Patches Sevelamer Carbonate Acamprosate Zolpidem Tartrate Sumatriptan Adapalene Mesalamine Clindamycin Clomiphene Citrate VA must procure foreign-made pharmaceuticals to meet patient care needs. Specifically, during periods of drug shortages of contracted pharmaceuticals, at times when a specific pharmaceutical is not on an established contract, or a domestically manufactured pharmaceutical is not otherwise available, it becomes necessary for VA to procure foreign-made end products to fulfill prescriptions. Timely procurement of pharmaceuticals is essential to avoid directly and negatively impacting Veteran care and compromising VA's mission to provide exceptional health care. Delays in receiving pharmaceuticals can interrupt prescription fulfillment for Veterans requiring treatment. To promote accountable and transparent procurements, VA ensures that nonavailability waiver determinations for foreign-made pharmaceuticals are approved internally and submitted to the OMB MIAO website at www.MadeInAmerica.gov. To streamline the process and create efficiencies for both VA and OMB MIAO, VA plans to use a single "streamlined nonavailability waiver determination" for fiscal year 2026 procurements of the 10 specified pharmaceutical products awarded by VA Network Contracting Office 15. The streamlined nonavailability waiver determination will be advantageous by reducing the volume of individual waiver determinations, preventing bottlenecks in the contract award process, and increasing procurement efficiencies thus leading to improved Veteran care. The use of the Buy American streamlined nonavailability waiver determination will preclude the need for repetitive individual nonavailability waiver determinations for the same foreign-made pharmaceuticals while still fulfilling the requirements of the FAR at 25.103(b) and OMB MIAO requirements for waiver transparency. The VA Chief Acquisition Officer has issued a single determination for fiscal year 2026, documenting that the specifically listed pharmaceuticals are not available in sufficient and reasonably available commercial quantities of satisfactory quality within the U.S. Any information regarding VA s streamlined nonavailability waiver determination or domestic manufacturing of the 10 pharmaceuticals should be submitted using the point of contact information provided above.