FDA Definition of Wholesaler
The Food and Drug Administration definition of a wholesaler is subject to exemptions and restrictions based on a variety of factors. The type of industry involved and how they handle goods are both factors in how the FDA regulates and defines what constitutes a wholesaler.
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Basic Definition
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According the FDA, a wholesaler is defined as any person that distributes a product from the place it is manufactured to the individual that makes the final delivery or sale of a device to the consumer. This definition is contained within Section 510(g) of Act 21 U.S.C. 360(g). This act defines and regulates domestic distributor registration and device listing.
Exclusions
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The FDA definition of wholesaler was expanded to exclude certain groups from the definition of wholesaler in 1998. These groups, covered under the FDA definition of initial importers, include individuals who transport goods from a foreign manufacturer to a wholesaler without altering the goods being transported.
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FDA Regulation
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The definition of wholesale distributor is designed to define groups of individuals who are subject to FDA registration rules. One of the primary purposes of the FDA definition of a wholesaler is to exclude them from the requirement for establishment registration and device listing.
Further Definitions
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The manufacturers mentioned in the basic definition of a wholesaler are explicitly defined by the FDA. Under their regulatory definition, a manufacturer includes the production by chemical, physical, biological or other means of any item that meets the FDA definition of a device.
Definitions of Definitions
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The FDA also defines what constitutes a person. This definition impacts the definition of wholesaler by determining what types of entities fall under FDA regulations for wholesalers. The FDA definition of a person includes: individuals, partnerships, corporations, associations, scientific or academic government agencies, and their organizational units or other legal entities.
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References
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