medical convenience kit

(B)The term “transaction” does not include— (i)intracompany distribution of any product between members of an affiliate or within a manufacturer; (ii)the distribution of a product among hospitals or other health care entities that are under common control; (iii)the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant tosection 247d of title 42, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason; (iv)the dispensing of a product pursuant to a prescription executed in accordance withsection 353(b)(1) of this title; (v)the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance withsection 353(d) of this title; (vi)the distribution of blood or blood components intended for transfusion; (vii)the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use; (viii)the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described insection 501(c)(3) of title 26to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (ix)the distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors; (x)the dispensing of a product approved undersection 360b(c) of this title; (xi)products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission undersection 2021 of title 42; (xii)a combination product that is not subject to approval underor licensure under, and that is— (I)a product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (II)2 or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or (III)2 or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a “medical convenience kit” as described in clause (xiii); (xiii)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 clause 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— (IV)in the case of a medical convenience kit that includes a product, the product is— (xiv)the distribution of an intravenous product 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); (xv)the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; (xvi)the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection; (xvii)the distribution of a medical gas (as defined insection 360ddd of this title); or (xviii)the distribution or sale of any licensed product undersection 262 of title 42that meets the definition of a device undersection 321(h) of this title.

Source

21 USC § 360eee(24)(B)


Scoping language

In this part
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