450.01   Definitions.
450.02   Pharmacy examining board.
450.03   Pharmacist; licensure.
450.033   Services delegated by physician.
450.035   Administration of drug products and devices; vaccines.
450.04   Examinations.
450.05   Pharmacist licensed in other state; licensure.
450.06   Pharmacies located in this state; licensure.
450.062   Remote dispensing.
450.065   Out-of-state pharmacies; licensure.
450.07   Manufacturers; licensure.
450.071   Wholesale distributors; licensure.
450.072   Wholesale distributors; restrictions on transactions.
450.073   Wholesale distributors; pedigree.
450.074   Wholesale distributors; prohibited actions, enforcement, penalties.
450.076   Home medical oxygen providers; licensure.
450.08   License renewal.
450.085   Continuing education.
450.09   Pharmacy practice.
450.095   Duty to dispense contraceptives.
450.10   Disciplinary proceedings; immunity; orders.
450.11   Prescription drugs and prescription devices.
450.115   Drug disposal programs and authorizations.
450.12   Labeling of prescription drugs and prescription drug products.
450.122   Labeling of biological products.
450.125   Drugs for animal use.
450.13   Using drug product equivalent in dispensing prescriptions.
450.135   Using interchangeable biological product in dispensing prescriptions.
450.137   Access to investigational drugs, devices, and biological products for terminally ill patients.
450.14   Poisons.
450.145   Reporting potential causes of public health emergency.
450.15   Placing prescription drugs prohibited.
450.155   Exhibition, display or advertisement of certain vending machines by use of certain material prohibited.
450.16   Sale of contraceptives prohibited in certain areas.
450.17   Violations.
450.18   Penalties.
Ch. 450 Cross-reference Cross-reference: See definitions in s. 440.01.
Ch. 450 Cross-reference Cross-reference: See also Phar, Wis. adm. code.
450.01 450.01 Definitions. In this chapter:
450.01(1) (1)“Administer" means the direct application of a vaccine or a prescribed drug or device, whether by injection, ingestion or any other means, to the body of a patient or research subject by any of the following:
450.01(1)(a) (a) A practitioner or his or her authorized agent.
450.01(1)(b) (b) A patient or research subject at the direction of a practitioner.
450.01(1)(c) (c) A pharmacist.
450.01(1)(d) (d) In the case of an opioid antagonist, any person.
450.01(1m) (1m)“Advanced practice nurse prescriber" means an advanced practice nurse who is certified under s. 441.16 (2).
450.01(1p) (1p)“Affiliated group" has the meaning given in section 1504 of the Internal Revenue Code.
450.01(1t) (1t)“Authenticate" means to affirmatively verify, before wholesale distribution of a prescription drug occurs, that each transaction listed on a pedigree has occurred.
450.01(1x) (1x)“Authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. For purposes of this subsection, an ongoing relationship exists between a wholesale distributor and a manufacturer if all of the following apply:
450.01(1x)(a) (a) The wholesale distributor, including any affiliated group of the wholesale distributor, has in effect a written agreement with the manufacturer evidencing the ongoing relationship.
450.01(1x)(b) (b) The wholesale distributor, including any affiliated group of the wholesale distributor, is included in the manufacturer's current list of authorized distributors of record.
450.01(1z) (1z)“Biological product” has the meaning given in 42 USC 262 (i).
450.01(2) (2)“Board" means the pharmacy examining board.
450.01(2m) (2m)“Colicensed" means, with respect to a partner or product, that 2 or more parties have the right to engage in marketing or manufacturing of a product consistent with the federal food and drug administration's implementation of the federal prescription drug marketing act.
450.01(3) (3)“Compound" means to mix, combine or put together various ingredients or drugs for the purpose of dispensing.
450.01(4) (4)“Controlled substance" has the meaning designated in s. 961.01 (4).
450.01(5) (5)“Deliver" or “delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another.
450.01(6) (6)“Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which does not achieve any of its principal intended purposes through chemical action within or on the body of a person or other animal, is not dependent upon being metabolized for the achievement of any of its principal intended purposes and is:
450.01(6)(a) (a) Recognized by the U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States, or any supplement to either of them;
450.01(6)(b) (b) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals; or
450.01(6)(c) (c) Intended to affect the structure or any function of the body of persons or other animals.
450.01(7) (7)“Dispense" means to deliver a prescribed drug or device to an ultimate user or research subject by or pursuant to the prescription order of a practitioner, including the compounding, packaging or labeling necessary to prepare the prescribed drug or device for delivery.
450.01(8) (8)“Distribute" means to deliver, other than by administering or dispensing.
450.01(9) (9)“Distributor" means a person licensed by the board under s. 450.07 (2).
450.01 Note NOTE: Section 450.07 (2) was repealed by 2007 Wis. Act 20.
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;
2017-18 Wisconsin Statutes updated through 2019 Wis. Act 184 and through all Supreme Court and Controlled Substances Board Orders filed before and in effect on March 28, 2020. Published and certified under s. 35.18. Changes effective after March 28, 2020, are designated by NOTES. (Published 3-28-20)