new text begin Transaction. new text end

new text begin (a) "Transaction" means the transfer of product between persons in which a change of ownership occurs. new text end

new text begin (b) The term "transaction" does not include: new text end

new text begin (1) intracompany distribution of any product between members of an affiliate or within a manufacturer; new text end

new text begin (2) the distribution of a product among hospitals or other health care entities that are under common control; new text end

new text begin (3) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including: new text end

new text begin (i) a public health emergency declaration pursuant to United States Code, title 42, section 247d; new text end

new text begin (ii) a national security or peacetime emergency declared by the governor pursuant to section 12.31; or new text end

new text begin (iii) a situation involving an action taken by the commissioner of health pursuant to section 144.4197, 144.4198 or 151.37, subdivisions 2, paragraph (b), and 10, except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason; new text end

new text begin (4) the dispensing of a drug pursuant to a valid prescription issued by a licensed practitioner; new text end

new text begin (5) the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with United States Code, title 21, section 353(d); new text end

new text begin (6) the distribution of blood or blood components intended for transfusion; new text end

new text begin (7) the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use; new text end

new text begin (8) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in United States Code, title 26, section 501(c)(3), to a nonprofit affiliate of the organization to the extent otherwise permitted by law; new text end

new text begin (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; new text end

new text begin (10) the dispensing of a product approved under United States Code, title 21, section 360b(c); new text end

new text begin (11) transfer of products to or from any facility that is licensed by the Nuclear Regulatory Commission or by a state pursuant to an agreement with such commission under United States Code, title 42, section 2021; new text end

new text begin (12) transfer of a combination product that is not subject to approval under United States Code, title 21, section 355, or licensure under United States Code, title 42, section 262, and that is: new text end

new text begin (i) a product comprised of a device and one 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; new text end

new text begin (ii) two 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 new text end

new text begin (iii) two or more finished medical devices plus one or more drug or biological products that are packaged together in a medical convenience kit; new text end

new text begin (13) the distribution of a medical convenience kit if: new text end

new text begin (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 with United States Code, title 21, section 360(b)(2); new text end

new text begin (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, United States Code, title 21, section 801, et seq.; new text end

new text begin (iii) in the case of a medical convenience kit that includes a product, the person who manufactures the kit: new text end

new text begin (A) purchased the product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and new text end

new text begin (B) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and new text end

new text begin (iv) in the case of a medical convenience kit that includes a product, the product is: new text end

new text begin (A) an intravenous solution intended for the replenishment of fluids and electrolytes; new text end

new text begin (B) a product intended to maintain the equilibrium of water and minerals in the body; new text end

new text begin (C) a product intended for irrigation or reconstitution; new text end

new text begin (D) an anesthetic; new text end

new text begin (E) an anticoagulant; new text end

new text begin (F) a vasopressor; or new text end

new text begin (G) a sympathomimetic; new text end

new text begin (14) 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; new text end

new text begin (15) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; new text end

new text begin (16) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection; new text end

new text begin (17) the distribution of a medical gas as defined in United States Code, title 21, section 360ddd; or new text end

new text begin (18) the distribution or sale of any licensed product under United States Code, title 42, section 262, that meets the definition of a device under United States Code, title 21, section 321(h). new text end