PREP Act Glossary of Terms
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biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic or analogous product, arsphenamine or its derivative (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings.
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device includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals or intended to affect the structure or function of the body of man or other animals which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
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distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: manufacturers; repackagers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
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drug includes articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or function of the body of man or other animals.
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manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a covered countermeasure; and any or all of the parent companies, subsidiaries, affiliates, successors, and assigns of a manufacturer.
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program planner means a State or local government, including an Indian Tribe; a person employed by the State or local government; or other person (such as a private sector employer or community group) who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a countermeasure. This includes persons who establish requirements or provide policy guidance ,or who supply technical or scientific advice or assistance or who provide a facility to administer or use a “covered countermeasure” in accordance with a Declaration.
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qualified pandemic or epidemic product means a drug, biological product, or device that is:
Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic, or limit the harm such a pandemic or epidemic might otherwise cause; manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product or device; or
intended to enhance the use or effect of these drugs, biological products or devices
and
- Approved, licensed or cleared FDA;
- Authorized for emergency use by FDA;
- Permitted to be used pursuant to Federal law in conditions inconsistent with its approval, clearance, or licensing;
- Shipped and held by a government agency or someone working on that agency’s behalf for emergency use only when authorized, or
- Exempted by FDA for use as an investigational drug or device under research for possible use to diagnose, mitigate, prevent, treat, cure or limit harm of a pandemic or epidemic or life-threatening condition caused by such a drug or device.
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qualified person means:
- a licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or
- a person within a category identified as “qualified” in a Declaration, such as volunteers.
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security countermeasure is a drug, biological product, or device that the Health and Human Services Secretary determines to be a priority:
To treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or to treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;
Is determined by the HHS to be a necessary countermeasure to protect public health;
and is
- Approved or cleared by FDA;
- Licensed by FDA;
- May reasonably be determined to qualify for approval or licensing within eight years after HHS decides to purchase the countermeasure; or
- Authorized for emergency use by FDA.
