Sustaining the Stockpile
The Strategic National Stockpile (SNS) is a critical federal resource designed to provide lifesaving medicines and medical supplies during public health emergencies, particularly chemical, biological, radiological, nuclear and high-yield explosive incidents, pandemics and emerging infectious diseases. Sustainment of the SNS involves managing the full lifecycle of stockpile assets, including procuring, storing, maintaining, and transporting supplies to support the nation’s emergency response capabilities.
Medicines and Supplies Maintained in the SNS
The SNS maintains large quantities of medicines and medical supplies to support response operations during a wide range of public health emergencies. Many of these products are not commercially available. The SNS formulary includes items such as:
Antibiotics
Antivirals
Vaccines
Chemical nerve agent antidotes
Antitoxins
Radiological chelators, thyroid blockers, and anti-neutropenics
Intravenous (IV) fluids
IV ancillary and airway management supplies
Burn and blast supplies
Ventilators
Personal protective equipment
How the Stockpile is Maintained
SNS sustainment and readiness activities include:
Conducting routine quality assurance on all products
Performing an annual inventory of all products
Overseeing the shelf life of medicines to ensure the stock is rotated and kept within U.S. Food and Drug Administration (FDA) potency shelf-life limits
Inspecting environmental conditions, security measures, and package integrity
Ensuring SNS holdings are based on current scientific data and threat levels
Maintaining the capability to rapidly deploy assets during a public health emergency
Coordinating with federal, state, local, tribal, and territorial partners to support readiness planning and response operations
Conducting training, exercises, and operational assessments to strengthen preparedness capabilities
Extending the Shelf Life of SNS Assets
The SNS participates in the Federal Shelf-Life Extension Program (SLEP), which is managed by the Department of War and the FDA. As certain SNS pharmaceuticals near their labeled expiration date, they may be submitted to the FDA for shelf-life extension consideration if they meet the following criteria:
The cost savings achieved through SLEP are greater than the cost of product replacement
The product remains under federal control and is stored under approved conditions
After the FDA conducts stability testing and confirms that products remain suitable for continued use, the agency may extend the expiration date. The FDA may also grant extensions based on a review of data provided by manufacturers. Initial testing typically extends shelf life by 12 to 24 months, with additional testing potentially resulting in longer extensions. Products that fail FDA testing are removed from SNS inventory.
SNS responsibilities for participating in SLEP include:
Tracking expiration dates and manufacturer lot numbers for eligible products
Coordinating shipments to the FDA for stability testing
Receiving and monitoring FDA testing results for each product lot
Removing and replacing product lots that fail FDA testing
When shelf life is extended, these products are not relabeled with a new expiration date.
In its early years, the SNS relabeled all products that were granted extensions. However, in 2012, the SNS stopped relabeling shelf-life extended supplies based on the following:
SNS products may be subject to regulatory mechanisms that supersede other considerations for shelf-life extension.
SNS products may require regulatory mechanisms to be in place whether or not they have been relabeled.
The United States has a limited capacity for relabeling the growing inventory of shelf-life extended products.
Relabeling is a costly and time-intensive process and inventory is not deployable during that process.
New expiration dates are provided through other means, such as Dear Healthcare Provider letters or on the ASPR website.
Please visit the FDA website for more information expiration date extension.
Industry Partnerships and Contracting Opportunities
The SNS participates in the Federal Shelf-Life Extension Program (for federal stockpiles) which is managed by the Department of Defense and the FDA. Once the FDA conducts stability testing and determines that products are stable and safe for continued use, the program will extend the use-by dates of pharmaceuticals beyond their original expiration dates. Testing typically provides an added 12 to 24 months of extended shelf life. More testing can lead to even longer extensions. Products that fail FDA testing are removed from stockpile inventory.
Participation in the Shelf-Life Extension Program requires:
Tracking the expiration date and manufacturer lot numbers of eligible products
Coordinating the shipment of products to FDA for stability testing
Receiving and tracking FDA testing results for each lot of product
Disposing of and replacing product lots that have failed FDA testing
For questions or additional information about the Federal Shelf-Life Extension Program, contact FDA.
Inventory Management and Tracking System
The SNS follows Federal Acquisition Regulation (FAR) Part 5 requirements for publicizing contract opportunities related to procuring goods and services. SAM.gov is the federal government’s primary resource for information on current and upcoming contracting opportunities.
For proposals involving new products, technologies, or capabilities, please request a meeting through medicalcountermeasures.gov.
Contact Us
For further questions or information about the Strategic National Stockpile, please email us at sns.ops@hhs.gov