wholesale distribution

(4)For the purposes of this subsection and subsection (d), the term “wholesale distribution” means the distribution of a drug subject to subsection (b) to a person other than a consumer or patient, or receipt of a drug subject to subsection (b) by a person other than the consumer or patient, but does not include— (A)intracompany distribution of any drug between members of an affiliate or within a manufacturer; (B)the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control; (C)the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act [42 U.S.C. 247d], except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason; (D)the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b)(1); (E)the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use; (F)the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (G)the purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity; (H)the distribution of a drug by the manufacturer of such drug; (I)the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug; (J)a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug; (K)the distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance withsection 360eee–1(e) of this title; (L)salable drug returns when conducted by a dispenser; (M)the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this subparagraph as a “medical convenience kit”) if— (i)the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance withsection 360(b)(2) of this title; (ii)the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801et seq.]; (iii)in the case of a medical convenience kit that includes a product, the person that manufacturers the kit— (I)purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and (II)does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and (iv)in the case of a medical convenience kit that includes a product, the product is— (I)an intravenous solution intended for the replenishment of fluids and electrolytes; (II)a product intended to maintain the equilibrium of water and minerals in the body; (III)a product intended for irrigation or reconstitution; (IV)an anesthetic; (V)an anticoagulant; (VI)a vasopressor; or (VII)a sympathomimetic; (N)the distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids); (O)the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; (P)the distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection; (Q)the distribution of medical gas, as defined insection 360ddd of this title; (R)facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or (S)the transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described insection 360eee(16)(B) of this titleand registered undersection 360 of this titlefor the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

Source

21 USC § 353(e)(4)


Scoping language

None: Default is title Scope
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