As used in this chapter, the term, transaction, means the transfer of product between trading partners in which a change of ownership occurs. The term does not include:

(1) Intracompany distribution of any product between members of an affiliate or within a manufacturer;

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(2) The distribution of a product among hospitals or other health systems that are under common control;

(3) The distribution of a product for emergency medical reasons, including a public health emergency declaration pursuant to state or federal law;

(4) The dispensing of a product pursuant to a prescription;

(5) The distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with state and federal law;

(6) The distribution of blood or blood components intended for transfusion;

(7) The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(8) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by state and federal law;

(9) 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;

(10) A combination product that is:

(a) A product composed of a device and one or more other regulated components, such as a drug or device, biologic or device, or drug, device or biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(b) Two or more separate products packaged together in a single package or as a unit and composed of a drug and device or a device and biological product; or

(c) Two 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 subdivision (11);

(11) 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 if:

(a) The medical convenience kit is assembled in an establishment that is registered with the United States Food and Drug Administration as a device manufacturer;

(b) The medical convenience kit does not contain a federally scheduled controlled substance;

(c) In the case of a medical convenience kit that includes a product, the person who manufactured the kit purchased the product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer, and does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

(d) In the case of a medical convenience kit that includes a product, the product is an intravenous solution intended for the replenishment of fluids and electrolytes; a product intended to maintain the equilibrium of water and minerals in the body; a product intended for irrigation or reconstitution; an anesthetic; an anticoagulant; a vasopressor; or a sympathomimetic;

(12) 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);

(13) The distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(14) The distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(15) The distribution of a medical gas; or

(16) The distribution or sale of any licensed biologic product that meets the definition of device under federal law.

Source: SL 2017, ch 174, § 3.