Chapter 450

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)(b) (b) The organizations are located in this state or serve residents in this state.

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)(d) (d) The organizations provide one or more of the following services:

450.01(11o)(d)1. 1. Medical care.

450.01(11o)(d)2. 2. Mental health care.

450.01(11o)(d)3. 3. Dental care.

450.01(11o)(d)4. 4. Prescription medications.

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.

450.01(13r) (13r) 

450.01(13r)(a) (a) “Normal distribution channel” means a chain of custody for a prescription drug that runs, directly or by drop shipment, from the manufacturer of a drug, from the manufacturer to the manufacturer’s colicensed partner, from the manufacturer to the manufacturer’s 3rd-party logistics provider, or from the manufacturer to the manufacturer’s exclusive distributor, and continues as described in any of the following:

450.01(13r)(a)1. 1. To a pharmacy or to a person authorized to dispense or administer a drug to a patient.

450.01(13r)(a)2. 2. To an authorized distributor of record, and then to a pharmacy or to a person authorized to dispense or administer a drug to a patient.

450.01(13r)(a)3. 3. To an authorized distributor of record, then to one other authorized distributor of record, then to an office-based practitioner.

450.01(13r)(a)4. 4. To a pharmacy warehouse to the pharmacy warehouse’s intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.

450.01(13r)(a)5. 5. To an authorized distributor of record, then to a pharmacy warehouse, then to the pharmacy warehouse’s intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.

450.01(13r)(b) (b) For purposes of this subsection, a distribution of a prescription drug to a warehouse or to another entity that redistributes the drug by intracompany sale to a pharmacy or to another person authorized to dispense or administer the drug constitutes a distribution to the pharmacy or to the person authorized to dispense or administer the drug.

450.01(13v) (13v) “Opioid antagonist” means a drug, such as naloxone, that satisfies all of the following:

450.01(13v)(a) (a) The drug binds to the opioid receptors and competes with or displaces opioid agonists at the opioid receptor site but does not activate the receptors, effectively blocking the receptor and preventing or reversing the effect of an opioid agonist.

450.01(13v)(b) (b) The drug is not a controlled substance.

450.01(13w) (13w) “Out-of-state 3rd-party logistics provider” means a person located outside this state that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services within this state on behalf of the manufacturer but that does not take title to the manufacturer’s prescription drug or have general responsibility to direct the prescription drug’s sale or disposition.

450.01(14) (14) “Patient” means the person or other animal for whom drug products or devices are prescribed or to whom drug products or devices are dispensed or administered.

450.01(14m) (14m) “Pedigree” means a document or electronic file containing information that records each distribution of a prescription drug.

450.01(15) (15) “Pharmacist” means a person licensed by the board under s. 450.03 or 450.05.

450.01(15g) (15g) “Pharmacy technician” means a person registered by the board under s. 450.068.

450.01(15m) (15m) “Pharmacy warehouse” means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales.

450.01(15t) (15t) “Practice of a pharmacy technician” means any of the following:

450.01(15t)(a) (a) The activities specified in rules promulgated by the board under s. 450.02 (2) (b).

450.01(15t)(b) (b) Administering vaccines or drugs as authorized under s. 450.035.

450.01 Note NOTE: Sub. (15t) was created as sub. (16c) by 2021 Wis. Act 100 and renumbered to sub. (15t) by the legislative reference bureau under s. 13.92 (1) (bm) 2.

450.01(16) (16) “Practice of pharmacy” means any of the following:

450.01(16)(a) (a) Interpreting prescription orders.

450.01(16)(b) (b) Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices.

450.01(16)(c) (c) Participating in drug utilization reviews.

450.01(16)(d) (d) Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices.

450.01(16)(e) (e) Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses.

450.01(16)(f) (f) Drug product substitution under s. 450.13.

450.01(16)(g) (g) Supervision of pharmacy technicians and other pharmacist supportive personnel.

450.01(16)(h) (h) Making therapeutic alternate drug selections, if made in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of a hospital and approved by the hospital’s medical staff and use of the therapeutic alternate drug selection has been approved for a patient during the period of the patient’s stay within the hospital by any of the following:

450.01(16)(h)1. 1. The patient’s physician.

450.01(16)(h)2. 2. The patient’s advanced practice nurse prescriber, if the advanced practice nurse prescriber has entered into a written agreement to collaborate with a physician.

450.01(16)(h)3. 3. The patient’s physician assistant.

450.01(16)(hm) (hm) Making therapeutic alternate drug selections in accordance with written guidelines or procedures previously established by a quality assessment and assurance committee of a nursing facility under s. 49.498 (2) (a) 3. or by a committee established for a nursing home under s. 50.045 (2), if the use of the therapeutic alternate drug selection has been approved for a patient during the period of the patient’s stay within the nursing facility or nursing home by any of the following:

450.01(16)(hm)1. 1. The patient’s personal attending physician.

450.01(16)(hm)3. 3. The patient’s physician assistant.

450.01(16)(hr) (hr) Making therapeutic alternate drug selections in accordance with written guidelines or procedures previously established in rules promulgated by the corrections system formulary board under s. 301.103, if the use of the therapeutic alternate drug selection has been approved for a prisoner, as defined in s. 301.01 (2), during his or her period of confinement in a state correctional institution, as defined in s. 301.01 (4), by any of the following:

450.01(16)(hr)1. 1. A physician.

450.01(16)(hr)2. 2. An advanced practice nurse prescriber.

450.01(16)(hr)3. 3. A physician assistant.

450.01(16)(i) (i) Drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.

450.01(16)(j) (j) Performing any act necessary to manage a pharmacy.

450.01(16)(k) (k) Administering prescribed drug products and devices under s. 450.035 (1r) and vaccines.

450.01(17) (17) “Practitioner” means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.

450.01(18) (18) “Prescribed drug or device” means any drug or device prescribed by a practitioner.

450.01(19) (19) “Prescription” means a drug or device prescribed by a practitioner.

450.01(20) (20) “Prescription drug” means all of the following, but does not include blood, blood components intended for transfusion, or biological products that are also medical devices:

450.01(20)(a) (a) A drug, drug product, or drug-containing preparation that is subject to 21 USC 353 (b) or 21 CFR 201.105.

450.01(20)(b) (b) A controlled substance included in schedules II to V of ch. 961, whether by statute or rule, except a substance that by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of s. 450.11 (3), (4) (a), and (8) only and for violations thereof punishable under s. 450.11 (9).

450.01(21) (21) “Prescription order” means an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient and also includes a standing order issued under s. 441.18 (2) (a) 2. or 448.037 (2) (a) 2.

450.01(21c) (21c) “Remote dispensing site” means a pharmacy governed by s. 450.09 (2) (b) 2.

450.01(21e) (21e) “Repackage” means to repack or otherwise change the container, wrapper, or label of a prescription drug, except that “repackage” does not include any of the following:

450.01(21e)(a) (a) An action by a pharmacist or pharmacy technician with respect to a prescription drug that the pharmacist or pharmacy technician is dispensing.

450.01(21e)(b) (b) An action by a pharmacist who receives a prescription drug or device that the pharmacist dispensed to a patient, if, after altering the packaging or labeling of the prescription drug or device, the pharmacist returns the prescription drug or device to the patient.

450.01(21m) (21m) “Repackager” means a person that repackages.

450.01(21p) (21p) “Standing order” means an order transmitted electronically or in writing by a practitioner for a drug or device for multiple patients or for one or more groups of patients.

450.01(21s) (21s) “Third-party logistics provider” means a person that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer but that does not take title to the manufacturer’s prescription drug or have general responsibility to direct the prescription drug’s sale or disposition.

450.01(22) (22) “Vaccination protocol” means a written protocol agreed to by a physician, as defined in s. 448.01 (5), and a pharmacist that establishes procedures and record-keeping and reporting requirements for the administration of a vaccine by a pharmacist for a period specified in the protocol that may not exceed 2 years.

450.01(23) (23) “Wholesale distribution” means distribution of a prescription drug to a person other than a consumer or patient, but does not include any of the following:

450.01(23)(a) (a) Intracompany sales of prescription drugs.

450.01(23)(b) (b) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.

450.01(23)(c) (c) The distribution of prescription drug samples, if the distribution is permitted under 21 USC 353 (d).

450.01(23)(d) (d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23.

450.01(23)(e) (e) The sale of minimal quantities, as defined by the board in an administrative rule, of prescription drugs by retail pharmacies to licensed practitioners for office use.

450.01(23)(f) (f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

450.01(23)(g) (g) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets.

450.01(23)(h) (h) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer states in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the drug and the supplying authorized distributor of record states in writing that the drug has previously been exclusively in the normal distribution channel.

450.01(23)(i) (i) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier’s usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the drug.

450.01(23)(j) (j) A transaction excluded from the definition of “wholesale distribution” under 21 CFR 203.3 (cc).

450.01(23)(k) (k) The donation or distribution of a prescription drug under s. 255.056 or under 21 CFR 203.39.