§360eee. Definitions

Affiliate— The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—

Authorized— The term “authorized” means—

Dispenser— The term “dispenser”—

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.

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.

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.

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.

Illegitimate product— The term “illegitimate product” means a product for which credible evidence shows that the product—

Licensed— The term “licensed” means—

Manufacturer— The term “manufacturer” means, with respect to a product—

Prescription drug— The term “prescription drug” means a drug for human use subject to section 353(b)(1) of this title.

Product— The term “product” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.

Product identifier— The term “product identifier” means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

Quarantine— The term “quarantine” means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

Repackager— The term “repackager” means a person who owns or operates an establishment that repacks and relabels a product or package for—1

Return— The term “return” means providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

Returns processor or reverse logistics provider— The term “returns processor” or “reverse logistics provider” means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

Specific patient need— The term “specific patient need” refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.

Standardized numerical identifier— The term “standardized numerical identifier” means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

Suspect product— The term “suspect product” means a product for which there is reason to believe that such product—

Third-party logistics provider— The term “third-party logistics provider” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.1

Trading partner— The term “trading partner” means—

Transaction history— The term “transaction history” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Transaction information— The term “transaction information” means—2

Transaction statement— The “transaction statement” is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

Verification or verify— The term “verification” or “verify” means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title.

Wholesale distributor— The term “wholesale distributor” means a person (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title).