450.01(9m)(9m) “Drop shipment” means a sale of a prescription drug to a wholesale distributor by the manufacturer of the drug, by the manufacturer’s colicensed product partner, by the manufacturer’s 3rd party logistics provider, or by the manufacturer’s exclusive distributor, to which all of the following apply:

450.01(9m)(a)(a) The wholesale distributor or chain pharmacy warehouse takes title to, but not physical possession of, the drug.

450.01(9m)(b)(b) The wholesale distributor invoices a pharmacy, a chain pharmacy warehouse, or a person authorized to dispense or administer the drug to a patient.

450.01(9m)(c)(c) The pharmacy, chain pharmacy warehouse, or person authorized to dispense or administer the drug receives delivery of the drug directly from the manufacturer, the manufacturer’s 3rd party logistics provider, or the manufacturer’s exclusive distributor.

450.01(10)(10) “Drug” means:

450.01(10)(a)(a) Any substance recognized as a drug in the official U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States or any supplement to either of them;

450.01(10)(b)(b) Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals;

450.01(10)(c)(c) Any substance other than a device or food intended to affect the structure or any function of the body of persons or other animals; or

450.01(10)(d)(d) Any substance intended for use as a component of any article specified in pars. (a) to (c) but does not include gases or devices or articles intended for use or consumption in or for mechanical, industrial, manufacturing or scientific applications or purposes.

450.01(11)(11) “Drug product” means a specific drug or drugs in a specific dosage form and strength from a known source of manufacture.

450.01(11m)(11m) “Facility” means a location where a wholesale distributor or 3rd-party logistics provider stores, distributes, handles, repackages, or offers other services related to prescription drugs.

450.01(11o)(11o) “Free and charitable clinics” means health care organizations that use a volunteer and staff model to provide health services to uninsured, underinsured, underserved, economically and socially disadvantaged, and vulnerable populations and that meet all of the following criteria:

450.01(11o)(a)(a) The organizations are nonprofit and tax exempt or are a part of a larger nonprofit, tax-exempt organization.

450.01(11o)(c)(c) The organizations restrict eligibility to receive services to individuals who are uninsured, underinsured, or have limited or no access to primary, specialty, or prescription care.

450.01(11o)(e)(e) The organizations use volunteer health care professionals, nonclinical volunteers, and partnerships with other health care providers to provide the services under par. (d).

450.01(11o)(f)(f) The organizations are not federally qualified health centers as defined in 42 USC 1396d (l) (2) and do not receive reimbursement from the federal centers for medicare and medicaid services under a federally qualified health center payment methodology.

450.01(11r)(11r) “Intracompany sales” means any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity or any transaction or transfer between colicensees of a colicensed product.

450.01(12)(12) “Manufacturer” means a person licensed or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of “manufacturer” under the federal food and drug administration’s regulations and interpreted guidances implementing the federal prescription drug marketing act.

450.01(12m)(12m) “Manufacturer’s exclusive distributor” means a person that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer and who takes title to the manufacturer’s prescription drug but who does not have general responsibility to direct the sale or disposition of the drug.

450.01(13)(13) “Manufacturing” means making, assembling, processing or modifying devices, or mixing, producing or preparing drugs in dosage forms by encapsulating, entableting or other process, or packaging, repackaging or otherwise changing the container, wrapper or label of any package containing a drug or device in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.

450.01(13m)(13m) “Nonprescription drug product” means any nonnarcotic drug product which may be sold without a prescription order and which is prepackaged for use by consumers and labeled in accordance with the requirements of state and federal law.