Regulations and Laws That May Apply During a Pandemic
During a pandemic, certain legal authoritiesExternal
Public Health Service Act
The Public Health Service (PHS) Act forms the foundation of the HHS’ legal authority for responding to public emergencies by authorizing the HHS Secretary to take key actions, such as lead all federal public health and medical response, declare a public health emergency, assist states in meeting health emergencies, maintain the Strategic National Stockpile, and control communicable diseases. The PHS Act was amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006External
Issuing Declarations
Under the Robert T. Stafford Disaster Relief and Emergency Assistance ActExternal
The HHS Secretary may, under section 319 of the PHS ActExternal
Under the Public Readiness and Emergency Preparedness Act (PREP Act)External
Visit the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) website for a comprehensive overview of the HHS legal authorities, policies and committeesExternal
Federal Food, Drug and Cosmetic Act
The Federal Food, Drug and Cosmetic (FD&C) Act is the foundation for Food and Drug Administration’s (FDA’s) authority and responsibility to protect and promote the public health by, among other things, ensuring the safety and effectiveness of human and veterinary drugs, biological products, and medical devices; and ensuring the safety and security of our nation’s food supply. Section 564 of the FD&C Act, authorizes the HHS Secretary to declare an emergency justifying the emergency use authorization (EUA)External
An EUA declaration can be made only when certain legal criteria are met and when scientific evidence is available to support the use during an emergency. For more information, please visit the following Food and Drug Administration web pages.
- FDA Medical Countermeasure (MCM) Legal, Regulatory and Policy FrameworkExternal
- FDA Emergency Use AuthoritiesExternal
- FDA PAPHRA Q&A for Public Health Preparedness and Response StakeholdersExternal
- FDA Emergency Use Authority of Medical Products and Related Authorities (April 2016)External
- FDA Emergency use of an Investigational Drug or BiologicExternal
Isolation and Quarantine
Under section 361 of the PHS Act, the HHS Secretary is authorized to take measures to prevent the entry and spread of communicable diseases from foreign countries into the US and between states. The authority for carrying out these functions on a daily basis is delegated to the Centers for Disease Control and Prevention (CDC), Division of Global Migration and Quarantine. More information about legal authorities for isolation and quarantine is available on the CDC Quarantine and Isolation web page.