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21 U.S. Code § 360eee. Definitions
In this part:(1) AffiliateThe term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A)
one business entity controls, or has the power to control, the other business entity; or
(B)
a third party controls, or has the power to control, both of the business entities.
(2) AuthorizedThe term “authorized” means—
(A)
in the case of a manufacturer or repackager, having a valid registration in accordance with section 360 of this title;
(B)
in the case of a wholesale distributor, having a valid license under State law or section 360eee–2 of this title, in accordance with section 360eee–1(a)(6) of this title, and complying with the licensure reporting requirements under section 353(e) of this title;
(C)
in the case of a third-party logistics provider, having a valid license under State law or section 360eee–3(a)(1) of this title, in accordance with section 360eee–1(a)(7) of this title, and complying with the licensure reporting requirements under section 360eee–3(b) of this title; and
(D)
in the case of a dispenser, having a valid license under State law.
(3) DispenserThe term “dispenser”—
(A)
means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and
(B)
does not include a person who dispenses only products to be used in animals in accordance with section 360b(a)(5) of this title.
(4) Disposition
The term “disposition”, with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.
(5) Distribute or distribution
The term “distribute” or “distribution” means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title.
(6) Exclusive distributor
The term “exclusive distributor” means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s product to a subsequent repackager, wholesale distributor, or dispenser.
(7) Homogeneous case
The term “homogeneous case” means a sealed case containing only product that has a single National Drug Code number belonging to a single lot.
(8) Illegitimate productThe term “illegitimate product” means a product for which credible evidence shows that the product—
(A)
is counterfeit, diverted, or stolen;
(B)
is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(C)
is the subject of a fraudulent transaction; or
(D)
appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.