CHAPTER 450
PHARMACY EXAMINING BOARD
450.02 Pharmacy examining board.
450.025 Pharmacist advisory council.
450.03 Pharmacist; licensure.
450.035 Administration of drug products and devices; vaccines.
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.
450.085 Continuing education.
450.09 Pharmacy practice.
450.10 Disciplinary proceedings; immunity; orders.
450.11 Prescription drugs and prescription devices.
450.12 Labeling of prescription drugs and prescription drug products.
450.125 Drugs for animal use.
450.13 Using drug product equivalent in dispensing prescriptions.
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.
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(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(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(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(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)(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 stores, handles, repackages, or offers for sale prescription drugs.
