new text begin Wholesale distribution. new text end

new text begin "Wholesale distribution" means the distribution of a drug to a person other than a consumer or patient, or receipt of a drug by a person other than the consumer or patient, but does not include: new text end

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

new text begin (2) the distribution of a drug or an offer to distribute a drug 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 sections 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 minimal quantities of a drug by a licensed retail pharmacy to a licensed practitioner for office use; new text end

new text begin (6) 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; new text end

new text begin (7) 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; new text end

new text begin (8) the distribution of a drug by the manufacturer of such drug; new text end

new text begin (9) 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; new text end

new text begin (10) a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug; new text end

new text begin (11) 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 with United States Code, title 21, section 360eee-1(e); new text end

new text begin (12) salable drug returns when conducted by a dispenser; new text end

new text begin (13) 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 section as 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 that manufactures the kit: new text end

new text begin (A) purchased such 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 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; new text end

new text begin (15) the distribution of an intravenous drug 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 drug 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 medical gas, as defined in United States Code, title 21, section 360ddd; new text end

new text begin (18) facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or new text end

new text begin (19) 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 in United States Code, title 21, section 360eee(16)(B), and registered under United States Code, title 21, section 360, for 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. new text end