Emergency Use Authorization Toolkit

Print
EUA Toolkit banner

Strategic National Stockpile

Fact Sheet

 

Overview

The Public Health Service Act authorizes the secretary of Health and Human Services, in coordination with the secretary of Homeland Security, to maintain a stockpile of drugs, vaccines, and other medical products and supplies, known as the Strategic National Stockpile (SNS), to provide for the emergency health security of the United States and its territories.1,2

The current SNS program has its origin in the National Pharmaceutical Stockpile (NPS), which Congress required the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to create in 1999.3 The mission of the NPS was to assemble large quantities of essential medical supplies to provide to states and communities during an emergency within 12 hours of a federal decision to deploy the stockpile.3,4 In 2003, the NPS was renamed the SNS.3,4

Note: As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which reauthorization may impact a number of laws and programs described below. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. (Download a printable PDF.)

 

What the SNS Program Does

The SNS program is designed to supplement and resupply state and local inventories of medicines and supplies during emergencies severe enough to exhaust local supplies.3 Decisions about what medicines and materiel should be included in the SNS are made by the HHS Assistant Secretary of Preparedness and Response (ASPR), the HHS, the Department of Homeland Security (DHS), and the CDC, in consultation with state and local public health officials and private sector organizations and entities. In determining and reviewing the composition of SNS assets, the HHS and the CDC look at multiple factors, including the medical vulnerability of the U.S. population (and of at-risk populations such as children and other vulnerable populations), current biological/chemical threats, the availability of medicines and medical supplies, and the ease of disseminating specific medicines.4

Portions of the stockpile have been and can be deployed for events such as anthrax attacks, foodborne hepatitis A, and encephalitis.5 In response to the 2009 H1N1 influenza pandemic, drugs, vaccines, and medical supplies were deployed from the stockpile.4 During the H1N1 response, antivirals from the SNS were released in the largest quantities ever deployed from the SNS and in an accelerated timeframe.4

 

How the SNS Program Works

Deployment of the SNS

 
State governors or their designees request deployment of SNS assets when there has been an overt terrorist event that will harm the public’s health or where epidemiological, laboratory, or other surveillance systems have identified unusual patterns of disease or deaths that may indicate a terrorist event or other national emergency.3 Federal personnel work in conjunction with state and local officials to determine if and what components of the SNS are needed.3 Ultimately, however, the federal government is responsible for making the decision to deploy all or portions of the SNS.3 The SNS is not considered a first response tool, but rather as a support mechanism to state and local response efforts.

Items in the SNS can be deployed by the secretary of Homeland Security to respond to an actual or potential emergency or by the HHS secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect public health and safety. The declaration of a federal or state public health emergency is not required to deploy the stockpile, and its contents can be deployed in advance of a public health emergency.

SNS caches are strategically located in secured warehouses across the United States to ensure the timely deployment of materiel to any location in the country by land or air.3 Initial deployments from the SNS are 12-hour “Push Packages,” which are caches of medicines and medical supplies that can address a range of needs arising from what may be an ill-defined threat in the early hours of an emergency event.3 The CDC Division of SNS (DSNS) also simultaneously deploys its Stockpile Service Advance Group to coordinate with state and local officials in the receipt and distribution of SNS assets. CDC transfers authority for the SNS assets to state and local officials once the materiel has arrived at its receiving/storage site.3 State and local officials are responsible for unpacking the SNS assets for distribution to various warehouses or dispensing sites identified by state and local officials.3

If an event requires specific or additional medicines and supplies, a deployment from managed inventory (MI) supplies is delivered within 24-36 hours.3 Medicines and supplies in an MI-deployed stockpile can be modified depending on the nature of the emergency and the suspected or confirmed agent.3 Where the agent is well defined, the SNS would be immediately deployed from MI with medicines and supplies appropriate for that agent.3

The SNS may also include medicines that have been authorized under the FDA’s Emergency Use Authorization (EUA) authority, which allows for the use of unapproved medical products (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]) or the use of approved medical products in unapproved ways to diagnose, treat, or prevent diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents if criteria in the Federal Food, Drug, and Cosmetics Act are met. Medicines authorized by an EUA must be distributed and dispensed according to conditions imposed as a part of its authorization by the FDA. Conditions can include the dissemination of information (e.g., fact sheets) to healthcare providers, authorized dispensers, patients, and other consumers regarding the EUA, the product’s significant known and potential benefits and risks, and the extent to which such benefits and risks are unknown.

 

State and Local Receipt and Distribution of SNS Assets

Each state has established plans to receive and distribute SNS assets to their local jurisdictions as soon as possible after receipt of the deployment.3 SNS assets are delivered to one predesignated location in the state; once authorized state personnel sign for receipt of the SNS assets, the materiel becomes the responsibility of the state. States are required to store the assets under appropriate environmental conditions and properly secure the assets, especially products that are on the U.S. Drug Enforcement Agency’s schedule of controlled substances.

State personnel are then responsible for unpacking the shipment and distributing the materiel within the state for further distribution by state and/or local officials, depending on the state’s SNS plan. SNS assets now generally come ready to dispense to individuals (“unit of use”) without further repacking required. Medicines and supplies are distributed and ultimately dispensed to according state and local SNS plans.

 

Storage, Replenishment, and Destruction of SNS Assets

The CDC DSNS is responsible for ensuring that the medicines in the SNS are routinely checked and rotated to keep within shelf-life potency limits.3 For 12-hour Push Packages, quarterly quality assurance and quality control checks are conducted, as well as annual 100 percent inventory of all Push Package items and inspections of security, overall package maintenance, and environmental conditions.3 The SNS is part of the federal Shelf Life Extension Program (SLEP) administered by the Department of Defense and the Food and Drug Administration. SLEP tests eligible medicines from the SNS to determine if, and for how long, the expiration date on the qualifying products can be extended. Extending the shelf life of SNS assets may be a cost effective alternative to replacing large quantities of medicines that have expired. (See ASTHO Fact Sheet on SLEP.) Items that are not extended or returned to the manufacturer for product rotation are destroyed.

 

State and Other Stockpiles


In addition to the SNS, most states have their own stockpiles of medicines and supplies that were purchased either with partial federal funding or with state funds. State-maintained stockpiles are not currently eligible for participation in SLEP. The Cities Readiness Initiative (CRI) was created in 2004 to focus on emergency preparedness in the largest cities and metropolitan areas in the United States, where more than 50 percent of the nation’s population resides. The CRI has enabled public health departments in states and large metropolitan areas to develop plans to respond to large-scale bioterrorist events by dispensing antibiotics to the entire population of a specified metropolitan area within 48 hours.3

 

How the SNS Program Affects States

All states are directly affected by the SNS program. All states have SNS programs and have received one or more deployments from the SNS. State and local health departments receive ongoing training about and regularly exercise SNS deployments.

Practice Notes

  • Identify the agency and offices(s) responsible for managing your state’s SNS program and other medical stockpiles.
  • Understand the procedures, protocols, and legal requirements for receiving and managing an SNS deployment.
  • Understand your state’s plan for distributing and dispensing medicines and supplies from the SNS, CRI, and state stockpiles.

Sources

  1. The Strategic National Stockpile is authorized by Public Health Service Act §319F-2; 42 U.S.C. § 247d-6b.
  2. CDC, Public Health Law Program. “Frequently Asked Questions About Federal Public Health Emergency Law.” September 2009. Available at http://www2a.cdc.gov/phlp/docs/FAQs%20Fed%20PHE%20laws%20101409.pdf. Accessed January 31, 2012.
  3. CDC. “Strategic National Stockpile (SNS)” webpage. Available at www.cdc.gov/phpr/stockpile/stockpile.htm. Accessed January 31, 2012.
  4. ASTHO. The Strategic National Stockpile: From Concept to Achievement. August 2010. Available at http://www.astho.org/Programs/Preparedness/Strategic-National-Stockpile/The-Strategic-National-Stockpile--From-Concept-to-Achievement/. Accessed January 31, 2012.
  5. Institute of Medicine (US). Forum on Medical and Public Health Preparedness for Catastrophic Events. Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model. Washington, DC. National Academies Press. 2010. Available at www.ncbi.nlm.nih.gov/books/NBK53126/pdf/TOC.pdf. Accessed January 31, 2012.
  6. FDA. “Emergency Use Authorizations Questions and Answers” webpage. At www.fda.gov/NewsEvents/PublicHealthFocus/ucm153297.htm. Accessed January 31, 2012.

Note: This document was compiled from June–December 2011 and reflects the laws and programs current then. It reflects only portions of the laws relevant to public health emergencies and is not intended to be exhaustive of all relevant legal authority. This resource is for informational purposes only and is not intended as a substitute for professional legal or other advice. The document was funded by CDC Award No. 1U38HM000454 to the Association of State and Territorial Health Officials; Subcontractor PI Elliott, Logan Circle Policy Group LLC.