Pharmacy examining board

Wis. Stat. ch. 450

in effect

Wis. Stat. § 450.01 Definitions

In this chapter: (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: (a) A practitioner or his or her authorized agent. (b) A patient or research subject at the direction of a practitioner. (c) A pharmacist. (d) In the case of an opioid antagonist, any person. (1p) “Affiliated group” has the meaning given in section 1504 of the Internal Revenue Code. (1t) “Authenticate” means to affirmatively verify, before wholesale distribution of a prescription drug occurs, that each transaction listed on a pedigree has occurred. (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: (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. (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. (1z) “Biological product” has the meaning given in 42 USC 262 (i). (2) “Board” means the pharmacy examining board. (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. (3) “Compound” means to mix, combine or put together various ingredients or drugs for the purpose of dispensing. (4) “Controlled substance” has the meaning designated in s. 961.01 (4). (5) “Deliver” or “delivery” means the actual, constructive or attempted transfer of a drug or device from one person to another. (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: (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; (b) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals; or (c) Intended to affect the structure or any function of the body of persons or other animals. (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. (8) “Distribute” means to deliver, other than by administering or dispensing. (9) “Distributor” means a person licensed by the board under s. 450.07 (2). (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: (a) The wholesale distributor or chain pharmacy warehouse takes title to, but not physical possession of, the drug. (b) The wholesale distributor invoices a pharmacy, a chain pharmacy warehouse, or a person authorized to dispense or administer the drug to a patient. (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. (10) “Drug” means: (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; (b) Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals; (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 (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. (11) “Drug product” means a specific drug or drugs in a specific dosage form and strength from a known source of manufacture. (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. (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: (a) The organizations are nonprofit and tax exempt or are a part of a larger nonprofit, tax-exempt organization. (b) The organizations are located in this state or serve residents in this state. (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. (d) The organizations provide one or more of the following services: 1. Medical care. 2. Mental health care. 3. Dental care. 4. Prescription medications. (e) The organizations use volunteer health care professionals, nonclinical volunteers, and partnerships with other health care providers to provide the services under par. (d). (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. (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. (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. (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. (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. (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. (13r) (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: 1. To a pharmacy or to a person authorized to dispense or administer a drug to a patient. 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. 3. To an authorized distributor of record, then to one other authorized distributor of record, then to an office-based practitioner. 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. 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. (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. (13v) “Opioid antagonist” means a drug, such as naloxone, that satisfies all of the following: (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. (b) The drug is not a controlled substance. (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. (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. (14m) “Pedigree” means a document or electronic file containing information that records each distribution of a prescription drug. (15) “Pharmacist” means a person licensed by the board under s. 450.03 or 450.05. (15g) “Pharmacy technician” means a person registered by the board under s. 450.068. (15m) “Pharmacy warehouse” means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales. (15t) “Practice of a pharmacy technician” means any of the following: (a) The activities specified in rules promulgated by the board under s. 450.02 (2) (b). (b) Administering vaccines or drugs as authorized under s. 450.035. (16) “Practice of pharmacy” means any of the following: (a) Interpreting prescription orders. (b) Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices. (c) Participating in drug utilization reviews. (d) Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices. (e) Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses. (f) Drug product substitution under s. 450.13. (g) Supervision of pharmacy technicians and other pharmacist supportive personnel. (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: 1. The patient’s physician. 2. The patient’s advanced practice registered nurse, if the advanced practice registered nurse may issue prescription orders under s. 441.09 (2). 3. The patient’s physician assistant. (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: 1. The patient’s personal attending physician. 3. The patient’s physician assistant. (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: 1. A physician. 2. An advanced practice registered nurse who may issue prescription orders under s. 441.09 (2). 3. A physician assistant. (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. (j) Performing any act necessary to manage a pharmacy. (k) Administering prescribed drug products and devices under s. 450.035 (1r) and vaccines. (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. (18) “Prescribed drug or device” means any drug or device prescribed by a practitioner. (19) “Prescription” means a drug or device prescribed by a practitioner. (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: (a) A drug, drug product, or drug-containing preparation that is subject to 21 USC 353 (b) or 21 CFR 201.105. (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). (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. (21c) “Remotely supervised pharmacy” means a pharmacy governed by s. 450.09 (2) (b). (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: (a) An action by a pharmacist or pharmacy technician with respect to a prescription drug that the pharmacist or pharmacy technician is dispensing. (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. (21m) “Repackager” means a person that repackages. (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. (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. (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. (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: (a) Intracompany sales of prescription drugs. (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. (c) The distribution of prescription drug samples, if the distribution is permitted under 21 USC 353 (d). (d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23. (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. (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. (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. (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. (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. (j) A transaction excluded from the definition of “wholesale distribution” under 21 CFR 203.3 (cc). (k) The donation or distribution of a prescription drug under s. 255.056 or under 21 CFR 203.39. (L) The transfer from a retail pharmacy or pharmacy warehouse of an expired, damaged, returned, or recalled prescription drug to the original manufacturer or original wholesale distributor or to a 3rd-party returns processor or reverse distributor. (m) The return of a prescription drug, if the return is authorized by the law of this state. (n) The operation or implementation of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), or the possession or delivery of a household pharmaceutical item, as defined in s. 165.65 (1) (d), within the scope of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law. (o) The possession or delivery of a prescription drug within the scope of a written authorization under s. 450.115 (3). (p) The services of a 3rd-party logistics provider or out-of-state 3rd-party logistics provider. (24) “Wholesale distributor” means a person engaged in the wholesale distribution of prescription drugs, including manufacturers, repackagers, own-label distributors, private label distributors, jobbers, brokers, warehouses, including manufacturers’ and distributors’ warehouses, manufacturers’ exclusive distributors, manufacturers’ authorized distributors of record, prescription drug wholesalers and distributors, independent wholesale prescription drug traders, retail pharmacies that conduct wholesale distribution, and chain pharmacy warehouses that conduct wholesale distribution.

Wis. Stat. § 450.02 Pharmacy examining board

(1) The department shall keep a record of the proceedings and a register of the names and places of practice or business of pharmacies, manufacturers, wholesale distributors, 3rd-party logistics providers, out-of-state 3rd-party logistics providers, and other persons licensed under this chapter, and the books, registers and records of the department shall be prima facie evidence of the matters recorded. (2) The board shall promulgate rules to do all of the following: (a) Define the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05. (b) Define the activities that constitute the practice of a pharmacy technician for purposes of the registration requirement under s. 450.068. (2g) (a) The pharmacy examining board shall, after consultation with the medical examining board and the board of nursing, promulgate rules that establish criteria for approving courses under ss. 450.035 (1r) and (2) and 450.085 (1). (b) The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in s. 450.035 (1g), by a pharmacist under s. 450.035 (1r) or by another person under s. 450.035 (1t). (2m) The board shall periodically prepare and distribute letters, bulletins or other types of notice to pharmacists that identify the courses that are approved for purposes of ss. 450.035 (1r) and (2) and 450.085 (1). (3) The board may promulgate rules: (a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs. (b) Establishing security standards for pharmacies. (c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug. (d) Necessary for the administration and enforcement of this chapter and ch. 961. (e) Establishing minimum standards for the practice of pharmacy. (f) Establishing procedures for identifying pharmacists and pharmacy technicians impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists and pharmacy technicians in obtaining treatment. (3m) (a) The board or its designee may grant a variance to a requirement of this chapter or to a rule promulgated by the board if all of the following are true: 1. The board or its designee determines that a natural or man-made disaster or emergency exists or has occurred. 2. A pharmacist has requested the variance. 3. The board or its designee determines that the variance is necessary to protect the public health, safety, or welfare. (am) If a member of the board disagrees with a decision made by a designee under par. (a) or sub. (3r), the board chairperson shall call a meeting of the board as soon as practicable to review the decision. The board may affirm or modify the designee’s decision. (b) A variance granted under par. (a) shall be for a stated term not to exceed 90 days, except that the board or its designee may extend the variance upon request by a pharmacist if it determines that an extension is necessary to protect the public health, safety, or welfare. (3r) (a) The board or its designee may authorize a pilot program, and may grant a waiver or variance in connection with the pilot program from any rule promulgated by the board, if all of the following are true: 1. The pilot program is related to the practice of pharmacy or prescription verification. 2. The board or its designee determines that the pilot program will improve the safety, quality, or efficiency of the practice of pharmacy in this state. (b) The board or its designee may not authorize a pilot program under par. (a) that lasts longer than 3 years. (4) The board may not promulgate a rule which does any of the following: (a) Limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance with all applicable state and federal laws. (b) Interprets s. 448.03 (2) (e) to expand the therapeutic alternate drug selection powers of a pharmacist beyond those specified in s. 450.01 (16) (h). (5) The board may promulgate rules governing pharmacies that are operated as remotely supervised pharmacies. Rules promulgated under this subsection may exempt pharmacies operated as remotely supervised pharmacies from requirements governing pharmacies that are not operated as remotely supervised pharmacies.

Wis. Stat. § 450.03 Pharmacist; licensure

(1) No person may engage in the practice of pharmacy or use the title “pharmacist” or sell, give away or barter drugs unless the person is licensed as a pharmacist by the board. This subsection does not apply to: (a) The offer to sell or sale of contraceptive articles, as defined under s. 450.155 (1) (a), by a registered nurse licensed under s. 441.06. (b) The sale of any nonprescription drug product, in an original unbroken package, which complies with 21 USC 301 to 392. (c) The sale of pesticides which comply with ss. 94.67 to 94.71. (d) The delivery of complimentary samples of drug products or devices to a practitioner by a manufacturer or its agent acting in the usual course of business. (e) Any person lawfully practicing within the scope of a license, permit, registration, certificate, or certification granted to practice as a pharmacy technician under s. 450.068, to provide home medical oxygen under s. 450.076, to practice professional, practical, or advanced practice registered nursing under ch. 441, to practice dentistry, dental therapy, or dental hygiene or as an expanded function dental auxiliary under ch. 447, to practice medicine and surgery under ch. 448, to practice optometry under ch. 449, to practice naturopathic medicine under ch. 466, or to practice veterinary medicine under ch. 89, or as otherwise provided by statute. (f) A person who has successfully completed his or her second year in, and is enrolled at, an accredited school of pharmacy and whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and administering vaccines or drugs as authorized under s. 450.035. (fm) A person who is enrolled at an accredited school of pharmacy and whose practice of pharmacy is limited to administering vaccines or drugs as authorized under s. 450.035. (g) A person who has applied for a license under s. 450.05 whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and administering vaccines or drugs as authorized under s. 450.035 during the period before which the board takes final action on the person’s application. (gm) A person who has applied for a registration under s. 450.068 and whose practice as a pharmacy technician is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and during the period before which the board takes final action on the person’s application. (h) The provision of services by a health care provider under s. 257.03. (i) Any person, other than a pharmacy technician, who is providing services as directed, supervised, and inspected by a pharmacist who has the power to direct, decide, and oversee the implementation of the services rendered, subject to any rules promulgated by the board and subject to s. 450.035 (2m). (j) A person who dispenses, distributes, or sells dialysate drugs or devices necessary for providing home peritoneal kidney dialysis to a patient with end-stage renal disease if all of the following apply: 1. The person is licensed under s. 450.07 or 450.071, or is an agent of a person licensed under s. 450.07 or 450.071. 2. The person lawfully holds the dialysate drugs or devices. 3. The dialysate drugs or devices are held and delivered in their original, sealed packaging from the manufacturing facility. 4. The dialysate drugs or devices are delivered only pursuant to a prescription order issued by a licensed physician and only if an order from a licensed pharmacy is transmitted to the person. 5. The dialysate drugs or devices are delivered to one of the following: a. A patient with end-stage renal disease or the patient’s designee, for the patient to self-administer the dialysis therapy. b. A health care provider or institution, for administration or delivery of the dialysis therapy to a patient with end-stage renal disease. 6. If required by federal law, the dialysate drugs or devices are approved or cleared by the federal food and drug administration. (k) A person who sells, gives away, or barters hemp, as defined in s. 94.55 (1), or takes any of the actions described in s. 450.01 (16) (a) to (k) in relation to hemp. (L) A person who is providing services as directed, supervised, and inspected by a person described in par. (e) in any of the following settings: 1. A narcotic treatment service for opiate addiction, as defined in s. 51.4224 (1) (a). 2. A free and charitable clinic. (2) Except as provided in s. 450.10, the board shall issue a license as a pharmacist to any person who does all of the following: (a) Has received a professional degree from a pharmacy program approved by the board. (b) Has completed an internship in the practice of pharmacy or has practical experience acquired in another state that is comparable to that included in an internship and that is approved and verified by the board or by the agency that is the equivalent of the board in the state in which the practical experience was acquired. (c) Passes the examination under s. 450.04. (d) Pays the fee specified in s. 440.05 (1).

Wis. Stat. § 450.04 Examinations

(1) Examinations for licensure as a pharmacist shall be designed to determine whether an applicant is competent to engage in the practice of pharmacy. (2) Examinations shall be conducted at least semiannually. (3) Every candidate for examination for licensure as a pharmacist shall submit an application on a form provided by the department and pay the fee specified in s. 440.05 (1) at least 30 days before the date of examination.

Wis. Stat. § 450.05 Pharmacist licensed in other state; licensure

The board may, upon application and payment of the fee specified in s. 440.05 (2), license as a pharmacist any person who is licensed in another state if the person produces satisfactory evidence of having met requirements comparable to those that existed in this state at the time the person became licensed in the other state. The board may deny a license as a pharmacist under this section to any person whose license to practice pharmacy in another state has been voluntarily surrendered, limited, suspended, or revoked. The board may require an applicant under this section to pass an equivalency examination administered by the board. If the board requires an equivalency examination, any person licensed as a pharmacist in another state who is engaged in the active practice of pharmacy may only be required to pass an examination on state and federal laws, rules, and regulations.

Wis. Stat. § 450.06 Pharmacies located in this state; licensure

(1) No pharmacist or person engaged in the practice of pharmacy under s. 450.03 (1) (f), (g), or (i) may dispense at any location in this state that is not licensed as a pharmacy by the board. No person in this state may use or display the title “pharmacy,” “drugstore,” “apothecary,” or any other title, symbol, or insignia having the same or similar meanings, except for a place of practice which is licensed under this section as a pharmacy by the board. (2) The board shall issue a license to operate a pharmacy at a specific location in this state if: (a) An application is made on forms provided by the board showing all of the following: 1. The location of the pharmacy. 2. A floor plan of the pharmacy. 3. The name and address of the person holding title and ownership control of the location. 4. The name of the managing pharmacist of the pharmacy under s. 450.09 (1). (b) The location of the pharmacy is inspected in a manner approved by the board and found to meet all the requirements of this chapter. (c) The initial credential fee determined by the department under s. 440.03 (9) (a) is paid. (2m) The board may require that practice-related information be submitted on the application under sub. (2) (a). (3) No pharmacy located in this state may be opened or kept open for practice following a change of ownership or change of location unless the pharmacy is licensed for the new owner or at the new location, notwithstanding any remaining period of validity under the pharmacy’s license under the previous owner or at the previous location. (4) Any person who fails to license his or her place of practice as required under this section may be assessed a forfeiture of not less than $25 nor more than $50 for each separate offense. Each day of violation constitutes a separate offense.

Wis. Stat. § 450.07 Manufacturers; licensure

(1) Except as provided under sub. (1m), no person may engage in manufacturing in this state unless the person obtains a manufacturer’s license from the board. For the issuance of a license under this subsection, the applicant shall pay the initial credential fee determined by the department under s. 440.03 (9) (a). (1m) A license is not required under this section for a person to engage in the manufacturing of hemp, as defined in s. 94.55 (1). (4) (a) The issuance of licenses under this section is subject to rules the board adopts for the protection of the public health and safety. (b) The board shall adopt rules prescribing minimum standards for manufacturing and distributing drugs. Rules adopted under this paragraph may not impose requirements regarding the storage of a controlled substance in a safe, a steel cabinet, a vault, or any other secure storage compartment, area, room, or building unless one of the following applies: 1. The controlled substance is included in schedule I, II, III, or IV under ch. 961. 2. The controlled substance is also a controlled substance under federal law. (c) The rules adopted by the board under par. (b) shall require a manufacturer to maintain and to update at least once per month a list of the manufacturer’s authorized distributors of record.

Wis. Stat. § 450.08 Credential renewals

(1) The renewal dates for all licenses and registrations granted by the board are specified under s. 440.08 (2) (a). Except as provided under sub. (2) (a), only a holder of an unexpired license or registration may engage in his or her licensed activity. (2) (a) A pharmacist’s license may be renewed by complying with continuing education requirements under s. 450.085 and paying the applicable fee determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a). Notwithstanding s. 440.08 (3) (a), if a pharmacist fails to obtain renewal by that date, the board may suspend the pharmacist’s license, and the board may require the pharmacist to pass an examination to the satisfaction of the board to restore that license. (b) A pharmacy, pharmacy technician’s, manufacturer’s, distributor’s, or home medical oxygen provider’s license or registration may be renewed by paying the applicable fee determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).

Wis. Stat. § 450.09 Pharmacy practice

(1) Managing pharmacist. (a) Every pharmacy shall be under the control of the managing pharmacist who signed the pharmacy license application, the most recent license renewal application or the most recent amended schedule of operations. The managing pharmacist shall be responsible for the professional operations of the pharmacy. A pharmacist may be the managing pharmacist of not more than one community and one institutional pharmacy at any time and shall be engaged in the practice of pharmacy at each location he or she supervises. The board shall by rule define community pharmacy and institutional pharmacy for the purposes of this section, but a pharmacy that is operated exclusively as a remotely supervised pharmacy shall not be considered a community pharmacy or institutional pharmacy for the purposes of this paragraph. (b) If the managing pharmacist anticipates being continuously absent for a period of more than 30 days from a pharmacy he or she supervises, the managing pharmacist shall delegate the supervisory responsibility to another pharmacist for the duration of the absence by written power of attorney which shall be kept on file in the pharmacy to which the power of attorney applies. The pharmacist designated to assume the supervisory responsibility for the pharmacy during the managing pharmacist’s absence shall be engaged in the practice of pharmacy at the pharmacy to which the power of attorney applies. (2) Supervision by pharmacist. (a) No pharmaceutical service may be provided to any person unless a pharmacist is present in the pharmacy to provide or supervise the service, except as provided in par. (b). (b) If pharmaceutical services are to be provided without a pharmacist being present in the pharmacy, all of the following shall apply: 1m. The pharmacy shall be considered a remotely supervised pharmacy and shall be subject to and governed by any rules promulgated under s. 450.02 (5). 2m. A pharmacist shall remotely supervise the pharmaceutical services provided, consistent with any rules promulgated under s. 450.02 (5). (4) Condition of pharmacy. The pharmacy shall be maintained in a clean and orderly manner and the professional service area shall be equipped with proper fixtures and equipment for sanitation. (6) Medication profile record system. Every pharmacy shall maintain a medication profile record system of all drug products dispensed for a particular patient according to the minimum standards for such systems established by the board by rule. Every practitioner shall maintain a record of all drug products dispensed to each patient according to standards established by the appropriate examining board by rule. The standards established by each examining board shall require the recording of all renewal dispensing information required by federal and state law and related rules and regulations. (7) Selection of drugs. Drug products purchased for subsequent sale and dispensing at a pharmacy shall be selected for purchase by a pharmacist. (7m) State prisons. A prescription drug that is returned to a pharmacy that primarily serves patients confined in a state prison may be dispensed to any patient in any state prison, but only if all of the following are satisfied: (a) The prescription drug was never in the possession of the patient to whom it was originally prescribed. (b) The prescription drug is returned in its original container. (c) A pharmacist determines that the prescription drug has not been adulterated or misbranded. (8) Penalties. Any person who violates this section may be assessed a forfeiture of not less than $25 nor more than $50 for each separate offense. Each day of violation constitutes a separate offense.

Wis. Stat. § 450.10 Disciplinary proceedings; immunity; orders

(1) (a) In this subsection, “unprofessional conduct” includes any of the following, but does not include the dispensing of an antimicrobial drug for expedited partner therapy as described in s. 450.11 (1g) or the delivery of an opioid antagonist as described in s. 450.11 (1i): 1. Making any materially false statement or giving any materially false information in connection with an application for a license or registration or for renewal or reinstatement of a license or registration. 2. Violating this chapter or, subject to s. 961.38 (4r), ch. 961 or any federal or state statute or rule which substantially relates to the practice of the licensee or registrant. 3. Engaging in the practice of pharmacy or practicing as a pharmacy technician while the person’s ability to practice is impaired by alcohol or other drugs or physical or mental disability or disease. 4. Engaging in false, misleading or deceptive advertising. 5. Making a substantial misrepresentation in the course of practice which is relied upon by another person. 6. Engaging in conduct in the practice of the licensee or registrant that evidences a lack of knowledge or ability to apply professional principles or skills. 7. Obtaining or attempting to obtain compensation by fraud or deceit. 8. Violating any order of the board. (b) Subject to subch. II of ch. 111 and the rules adopted under s. 440.03 (1), the board may reprimand the licensee or registrant or deny, revoke, suspend, or limit the license or registration or any combination thereof of any person licensed under this chapter who has: 1. Engaged in unprofessional conduct. 2. Been adjudicated mentally incompetent by a court. 3. Been found guilty of an offense the circumstances of which substantially relate to the practice of the licensee or registrant. (2) In addition to or in lieu of a reprimand or denial, limitation, suspension, or revocation of a license or registration under sub. (1), the board may, for the violations enumerated under sub. (1), assess a forfeiture of not more than $1,000 for each separate offense. Each day of violation constitutes a separate offense. (3) (a) In this subsection, “health care professional” means any of the following: 1. A pharmacist or pharmacy technician licensed or registered under this chapter. 2. A nurse licensed under ch. 441. 3. A chiropractor licensed under ch. 446. 4. A dentist or dental therapist who is licensed under subch. I of ch. 447 or who holds a compact privilege under subch. II of ch. 447. 5. A physician, physician assistant, podiatrist, physical therapist, physical therapist assistant, occupational therapist, occupational therapy assistant, or genetic counselor licensed under ch. 448, a physical therapist or physical therapist assistant who holds a compact privilege under subch. XI of ch. 448, an occupational therapist or occupational therapy assistant who holds a compact privilege under subch. XII of ch. 448, or a physician assistant who holds a compact privilege under subch. XIII of ch. 448. 5m. A dietitian who is certified under subch. V of ch. 448 or who holds a compact privilege under subch. XIV of ch. 448. 5q. An athletic trainer licensed under subch. VI of ch. 448. 6. An optometrist licensed under ch. 449. 7. An acupuncturist certified under ch. 451. 8. A veterinarian licensed under ch. 89. 9. A psychologist who is licensed under ch. 455, who is exercising the temporary authorization to practice, as defined in s. 455.50 (2) (o), in this state, or who is practicing under the authority to practice interjurisdictional telepsychology, as defined in s. 455.50 (2) (b). 10. A social worker, marriage and family therapist, or professional counselor, as those terms are defined in subch. I of ch. 457. 11. A speech-language pathologist or audiologist who is licensed under subch. II of ch. 459 or who holds a compact privilege under subch. III of ch. 459, or a speech and language pathologist licensed by the department of public instruction. 12. A naturopathic doctor or limited-scope naturopathic doctor licensed under ch. 466. (b) Any health care professional who in good faith provides another health care professional with information concerning a violation of this chapter or ch. 961 by any person shall be immune from any civil or criminal liability that results from any act or omission in providing such information. In any administrative or court proceeding, the good faith of the health care professional providing such information shall be presumed. (4) (a) The secretary may, in case of the need for emergency action, issue general and special orders necessary to prevent or correct actions by any pharmacist under this section that would be cause for suspension or revocation of a license. (b) Special orders may direct a pharmacist to cease and desist from engaging in particular activities.

Wis. Stat. § 450.11 Prescription drugs and prescription devices

(1) Dispensing. Except as provided in sub. (1i) (b) 2., no person may dispense any prescribed drug or device except upon the prescription order of a practitioner. All prescription orders shall, except as provided in sub. (1a), specify the date of issue, the name and address of the practitioner, the name and quantity of the drug product or device prescribed, directions for the use of the drug product or device, the symptom or purpose for which the drug is being prescribed if required under sub. (4) (a) 8., and, if the order is written by the practitioner, the signature of the practitioner. Except as provided in ss. 118.2915 (3) (a), 118.2925 (3), 118.294 (2), 255.07 (2), 441.18 (2) (a) 1., 448.035 (2), 448.037 (2) (a) 1., 448.9725 (2), and 448.9727 (2) (a) 1. and except for standing orders issued under s. 441.18 (2) (a) 2., 448.037 (2) (a) 2., or 448.9727 (2) (a) 2., all prescription orders shall also specify the name and address of the patient. A prescription order issued under s. 118.2915 (3) (a), 118.2925 (3), or 118.294 (2) shall specify the name and address of the school. A prescription order issued under s. 255.07 (2) shall specify the name and address of the authorized entity or authorized individual. Any oral prescription order shall be immediately reduced to writing by the pharmacist and filed according to sub. (2). (1a) Chart orders. A prescription order entered on the chart or medical record of an inpatient or resident of a health care facility by a practitioner is not required to include the address of the practitioner. (1b) Identification card required for certain controlled substances. (a) In this subsection: 1. “Health care facility” means a facility, as defined in s. 647.01 (4); any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09; a facility under s. 45.50, 51.05, 51.06, 233.40, 233.41, 233.42, or 252.10; and any other facility identified by the board by rule. 2. “Identification card” means any of the following: a. An operator’s license issued under ch. 343 or under a comparable law of another state. b. An identification card issued under s. 343.50 or under a comparable law of another state. c. An identification card issued by a U.S. uniformed service. d. A U.S. or foreign passport. e. A tribal identification card, as defined in s. 134.695 (1) (cm). (b) Except as provided under par. (e), a controlled substance included in schedule II or III of ch. 961 may not be dispensed, and may not be delivered to a representative of the ultimate user, without an identification card belonging to the person to whom the drug is being dispensed or delivered. (bm) A pharmacist, pharmacy technician, or other person dispensing or delivering a drug shall legibly record the name on each identification card presented under par. (b) to the pharmacist, pharmacy technician, or other person, and the name of each person to whom a drug is dispensed or delivered subject to par. (e) 2., and shall maintain that record for a time established by the board by rule or, for a record that is subject to s. 961.385, until the name is delivered to the controlled substances board under s. 961.385, whichever is sooner. (c) If the person to whom a drug subject to par. (b) is being delivered is not the ultimate user of the drug, the person delivering the drug may ask the ultimate user of the drug to designate a person who is authorized to pick up the drug on behalf of the ultimate user and may inform the person to whom the drug is being delivered that his or her identification is being recorded. (d) A pharmacist or pharmacy technician is immune from any civil or criminal liability and from discipline under s. 450.10 for any act taken by the pharmacist or pharmacy technician in reliance on an identification card that the pharmacist reasonably believed was authentic and displayed the name of the person to whom the drug was being delivered if the sale was made in good faith. (e) No identification card is required under par. (b) if any of the following applies: 1. The drug is administered or dispensed directly to the ultimate user by a practitioner. 2. The pharmacist, pharmacy technician, or other person dispensing or delivering the drug has personal knowledge of the person to whom the drug is dispensed or delivered and that the person is the ultimate user or the ultimate user’s authorized representative. 3. The drug is delivered to a health care facility to be administered in the health care facility. (f) The board may, by rule, establish an exemption from the requirements under this subsection for the delivery of a drug by mail if the board determines that the exemption is necessary. (1g) Dispensing certain antimicrobial drugs for expedited partner therapy. (a) In this subsection: 1. “Antimicrobial drug” has the meaning given in s. 448.035 (1) (b). 2. “Expedited partner therapy” has the meaning given in s. 448.035 (1) (c). (b) A pharmacist may, upon the prescription order of a practitioner providing expedited partner therapy, as specified in s. 441.092, 448.035, or 448.9725, that complies with the requirements of sub. (1), dispense an antimicrobial drug as a course of therapy for treatment of chlamydial infections, gonorrhea, or trichomoniasis to the practitioner’s patient or a person with whom the patient has had sexual contact for use by the person with whom the patient has had sexual contact. The pharmacist shall provide a consultation in accordance with rules promulgated by the board for the dispensing of a prescription to the person to whom the antimicrobial drug is dispensed. A pharmacist providing a consultation under this paragraph shall ask whether the person for whom the antimicrobial drug has been prescribed is allergic to the antimicrobial drug and advise that the person for whom the antimicrobial drug has been prescribed must discontinue use of the antimicrobial drug if the person is allergic to or develops signs of an allergic reaction to the antimicrobial drug. (c) 1. Except as provided in subd. 2., a pharmacist is immune from civil liability for injury to or the death of a person who takes an antimicrobial drug dispensed for that person under this subsection in connection with expedited partner therapy if the antimicrobial drug is dispensed as provided under par. (b). 2. The immunity under subd. 1. does not extend to the distribution or dispensing of an antimicrobial drug by a pharmacist whose act or omission involves reckless, wanton, or intentional misconduct. (1i) Opioid antagonists. (a) Prescription and liability. 1. A pharmacist may, upon and in accordance with the prescription order of an advanced practice registered nurse under s. 441.18 (2) (a) 1., of a physician under s. 448.037 (2) (a) 1., or of a physician assistant under s. 448.9727 (2) (a) 1. that complies with the requirements of sub. (1), deliver an opioid antagonist to a person specified in the prescription order and may, upon and in accordance with the standing order of an advanced practice registered nurse under s. 441.18 (2) (a) 2., of a physician under s. 448.037 (2) (a) 2., or of a physician assistant under s. 448.9727 (2) (a) 2. that complies with the requirements of sub. (1), deliver an opioid antagonist to an individual in accordance with the order. The pharmacist shall provide a consultation in accordance with rules promulgated by the board for the delivery of a prescription to the person to whom the opioid antagonist is delivered. 2. A pharmacist who, acting in good faith, delivers an opioid antagonist in accordance with subd. 1., or who, acting in good faith, otherwise lawfully dispenses an opioid antagonist, shall be immune from criminal or civil liability and may not be subject to professional discipline under s. 450.10 for any outcomes resulting from delivering or dispensing the opioid antagonist. (b) Possession, dispensing, and delivery. 1. Any person may possess an opioid antagonist. 2. a. Subject to subd. 2. b. to d., any person may deliver or dispense an opioid antagonist. b. An advanced practice registered nurse may only deliver or dispense an opioid antagonist in accordance with s. 441.18 (2) or in accordance with his or her other legal authority to dispense prescription drugs. c. A physician may only deliver or dispense an opioid antagonist in accordance with s. 448.037 (2) or in accordance with his or her other legal authority to dispense prescription drugs. cm. A physician assistant may only deliver or dispense an opioid antagonist in accordance with s. 448.9727 (2) or in accordance with his or her other legal authority to dispense prescription drugs. d. A pharmacist may only deliver or dispense an opioid antagonist in accordance with par. (a) 1. or in accordance with his or her other legal authority to dispense prescription drugs. (c) Immunity. 1. In this paragraph, “opioid-related drug overdose” has the meaning given in s. 256.40 (1) (d). 2. Subject to par. (a) 2. and ss. 441.18 (3), 448.037 (3), and 448.9727 (3), any person who, acting in good faith, delivers or dispenses an opioid antagonist to another person shall be immune from civil or criminal liability for any outcomes resulting from delivering or dispensing the opioid antagonist. 3. Subject to ss. 256.40 (3) (b) and 895.48 (1g), any person who, reasonably believing another person to be undergoing an opioid-related drug overdose, administers an opioid antagonist to that person shall be immune from civil or criminal liability for any outcomes resulting from the administration of the opioid antagonist to that person. (1m) Electronic transmission. Except as provided in s. 89.068 (1) (c) 4., a practitioner may transmit a prescription order electronically only if the patient approves the transmission and the prescription order is transmitted to a pharmacy designated by the patient. (2) Prescription order file. Every prescription order shall be filed in a suitable book or file and preserved for at least 5 years. Prescription orders transmitted electronically may be filed and preserved in electronic format. (3) Preparation of prescription drugs. Except as provided in sub. (1i) (b) and ss. 118.2925 (4), 255.07 (3), and 450.076, no person other than a pharmacist or practitioner or their agents and employees as directed, supervised, and inspected by the pharmacist or practitioner, including pharmacy technicians, may prepare, compound, dispense, or prepare for delivery for a patient any prescription drug. (4) Label required. (a) Except as provided under par. (b), no prescribed drug or device may be dispensed unless there is a label attached to the container disclosing all of the following: 1. The name and address of the dispensing practitioner or licensed facility from which the prescribed drug or device was dispensed. 1m. The telephone number of the pharmacy, if the prescribed drug or device is dispensed by an out-of-state pharmacy licensed under s. 450.065. 2. The date on which the prescription was dispensed. 3. The number of the prescription order as recorded in the prescription order file of the facility from which the prescription was dispensed. 4. The name of the practitioner who prescribed the drug or device. 5. a. Except as provided in subd. 5. b. to d., the full name of the patient. b. For an antimicrobial drug dispensed under sub. (1g), the full name of the patient, if known, or the words, “expedited partner therapy” or the letters “EPT.” c. For an opioid antagonist when delivered under sub. (1i) (a), the name of the person to whom the opioid antagonist is delivered. d. For an epinephrine delivery system under s. 118.2925 (3) or 255.07 (2), the name of the school, authorized entity, authorized individual, or other person specified under s. 255.07 (3). 6. Directions for use of the prescribed drug or device as contained in the prescription order. 7. The name and strength of the prescribed drug dispensed, unless the prescribing practitioner requests omission of the name and strength of the drug dispensed. 8. The symptom or purpose for which the drug is being prescribed if the prescription order specifies the symptom or purpose under sub. (4m). (b) Paragraph (a) does not apply to complimentary samples of drug products or devices dispensed by a practitioner to his or her patients. (4g) Brand name permitted on label; drugs and drug products. (a) In this subsection: 1. “Brand name” has the meaning given in s. 450.12 (1) (a). 2. “Drug product equivalent” has the meaning given in s. 450.13 (1e). 3. “Generic name” has the meaning given in s. 450.12 (1) (b). (b) If a pharmacist, pursuant to a prescription order that specifies a drug product by its brand name, dispenses the drug product equivalent of the drug product specified in the prescription order, the label required under sub. (4) (a) may include both the generic name of the drug product equivalent and the brand name specified in the prescription order, unless the prescribing practitioner requests that the brand name be omitted from the label. (c) This subsection does not apply to a prescription order for a biological product. (4i) Brand name permitted on label; biological products. (a) In this section: 1. “Brand name” has the meaning given in s. 450.122 (1) (a). 2. “Interchangeable biological product” has the meaning given in s. 450.135 (1). 3. “Proper name” has the meaning given in s. 450.122 (1) (b). (b) If a pharmacist, pursuant to a prescription order that specifies a biological product by its brand name, dispenses the interchangeable biological product of the biological product specified in the prescription order, the label required under sub. (4) (a) may include both the proper name of the interchangeable biological product and the brand name specified in the prescription order. (4m) Label options. If a patient indicates in writing to a practitioner who makes a prescription order for the patient that the patient wants the symptom or purpose for the prescription to be disclosed on the label, the practitioner shall specify the symptom or purpose in the prescription order. (5) Initial fills and refills. (a) Except as provided in pars. (bm) and (br), no prescription may be refilled unless the requirements of sub. (1) and, if applicable, sub. (1m) have been met and written, oral, or electronic authorization has been given by the prescribing practitioner. Unless the prescribing practitioner has specified in the prescription order that dispensing a prescribed drug in an initial amount followed by periodic refills as specified in the prescription order is medically necessary, a pharmacist may exercise his or her professional judgment to dispense varying quantities of the prescribed drug per fill up to the total number of dosage units authorized by the prescribing practitioner in the prescription order including any refills, subject to par. (b). (b) 1. The authority of a pharmacist under par. (a) to dispense varying quantities of a drug applies only with respect to the refills, if any, specified in the prescription order and does not apply with respect to the initial quantity specified in the prescription order, except that a pharmacist may dispense a varying initial quantity of a drug using that authority if such quantity of that drug was previously dispensed to the patient in the previous 2-year period under an earlier prescription. 2. The authority of a pharmacist under par. (a) to dispense varying quantities of a drug does not apply with respect to controlled substances. 3. A pharmacist may not use the authority under par. (a) to dispense varying quantities of a drug to dispense more than a 90-day supply of a drug in a single fill or refill. (bm) 1. In the event a pharmacist receives a request for a prescription to be refilled and the prescription cannot be refilled as provided in par. (a), the pharmacist may, subject to subd. 2. a. to e., extend the existing prescription order and dispense the drug to the patient, if all of the following apply: a. The pharmacist has been unsuccessful in attempting to procure a new prescription order or refill authorization for the drug after attempting to contact the prescribing practitioner or his or her office. b. The patient is on a consistent drug therapy program and the patient has previously refilled the prescription at that pharmacy or through another pharmacy in the same pharmacy chain. c. The drug is essential to the life of the patient, or the interruption of the drug therapy could result in undesirable consequences for the patient’s health. d. The pharmacist has not received and is not aware of written or oral instructions from the prescribing practitioner prohibiting further dispensing pursuant to or extension of the prescription order. 2. a. A prescribing practitioner may indicate, by writing on the face of the prescription order or, with respect to a prescription order transmitted electronically, by designating in electronic format the phrase “No extensions,” or words of similar meaning, that no extension of the prescription order may be made under subd. 1. If such indication is made, the pharmacist may not extend the prescription order under subd. 1. b. A pharmacist acting under subd. 1. may not extend a prescription order to dispense more than a 7-day supply of the prescribed drug, except that if the drug is typically packaged in a form that requires a pharmacist to dispense the drug in a quantity greater than a 7-day supply, the pharmacist may extend the prescription order as necessary to dispense the drug in the smallest quantity in which it is typically packaged. c. A pharmacist may not extend a prescription order under subd. 1. for a drug that is a controlled substance. d. A pharmacist may not extend a prescription order under subd. 1. for a particular patient if a prescription order was previously extended under subd. 1. for that patient in the previous one-year period for that drug. e. A pharmacist shall, at the earliest reasonable time after acting under subd. 1., notify the prescribing practitioner or his or her office. (br) 1. In the event a pharmacist receives a request for a prescription to be refilled and the prescription cannot be refilled as provided in par. (a), the pharmacist may, subject to subd. 2. a. to e., extend the existing prescription order and dispense the drug to the patient, if the pharmacist has not received and is not aware of written or oral instructions from the prescribing practitioner prohibiting further dispensing pursuant to or extension of the prescription order. 2. a. A prescribing practitioner may indicate, by writing on the face of the prescription order or, with respect to a prescription order transmitted electronically, by designating in electronic format the phrase “No extensions,” or words of similar meaning, that no extension of the prescription order may be made under subd. 1. If such indication is made, the pharmacist may not extend the prescription order under subd. 1. b. A pharmacist acting under subd. 1. may not extend a prescription order to dispense more than a 30-day supply of the prescribed drug, except that if the drug is typically packaged in a form that requires a pharmacist to dispense the drug in a quantity greater than a 30-day supply, the pharmacist may extend the prescription order as necessary to dispense the drug in the smallest quantity in which it is typically packaged. c. A pharmacist may not extend a prescription order under subd. 1. for a drug that is a controlled substance. d. A pharmacist may not extend a prescription order under subd. 1. for a particular patient if a prescription order was previously extended under subd. 1. for that patient during the period described in subd. 3. e. A pharmacist shall, at the earliest reasonable time after acting under subd. 1., notify the prescribing practitioner or his or her office, but is not required to attempt to procure a new prescription order or refill authorization for the drug by contacting the prescribing practitioner or his or her office prior to acting under subd. 1. After acting under subd. 1., the pharmacist may notify the patient or other individual that any further refills will require the authorization of a prescribing practitioner. 3. This paragraph applies only during the public health emergency declared on March 12, 2020, by executive order 72, and for 30 days after the conclusion of that public health emergency. During that time, this paragraph supersedes par. (bm) to the extent of any conflict. (c) An accurate record of refill dispensing shall be maintained showing the date and amount. (6) Sales of prescription drugs. In the event of any sale of prescription drugs in bankruptcy, at public auction or any other sale of prescription drugs other than in the normal course of business or practice, the seller shall give written notice of the sale to the board at least one week prior to the date of sale and shall make a complete and accurate written report of the sale to the board within 10 days after the sale, showing the name and address of all of the purchasers of prescription drugs together with an itemized inventory of the prescription drugs sold to each purchaser. This subsection does not apply to the sale of a manufacturer, distributor or pharmacy as an ongoing business or practice if the parties first notify the board of the impending sale. (7) Prohibited acts. (a) No person may obtain or attempt to obtain a prescription drug, or procure or attempt to procure the administration of a prescription drug, by fraud, deceit or willful misrepresentation or by forgery or alteration of a prescription order; or by willful concealment of a material fact; or by use of a false name or address. (b) Information communicated to a physician, physician assistant, or advanced practice registered nurse in an effort to procure unlawfully a prescription drug or the administration of a prescription drug is not a privileged communication. (c) No person may willfully make a false statement in any prescription order, report or record required by this section. (d) No person may, for the purpose of obtaining a prescription drug, falsely assume the title of, or represent himself or herself to be, a manufacturer, distributor, pharmacist, pharmacy technician, or practitioner. (e) No person may make or utter any false or forged prescription order. (f) No person may willfully affix any false or forged label to a package or receptacle containing prescription drugs. (g) Except as authorized by this chapter, no person may possess, with intent to manufacture or deliver, a prescription drug. Intent under this paragraph may be demonstrated by, without limitation because of enumeration, evidence of the quantity and monetary value of the substance possessed, the possession of manufacturing implements or paraphernalia, and the activities or statements of the person in possession of the prescription drug prior to, during and after the alleged violation. (h) Except as provided in sub. (1i) (b), no person may possess a prescription drug unless the prescription drug is obtained in compliance with this section. (i) No pharmacist, manufacturer, distributor, owner or operator of a pharmacy or agent of a pharmacist, manufacturer, distributor or such an owner or operator may give any compensation or anything of value to a practitioner for the purpose of providing, or inducing the practitioner to obtain, any equipment, computer software or access to a service that may be used for the electronic transmission of a prescription order. (8) Rule-making authority. The department of justice may promulgate rules necessary for the enforcement of this section. In addition to all law enforcement officers and agencies, the enforcement of this section is the responsibility of the department and: (a) The board, insofar as this section applies to pharmacists and pharmacy technicians. (b) The medical examining board, insofar as this section applies to physicians. (bm) The podiatry affiliated credentialing board, insofar as this section applies to podiatrists. (c) The veterinary examining board, insofar as this section applies to veterinarians. (d) The dentistry examining board, insofar as this section applies to dentists. (e) The board of nursing, insofar as this section applies to advanced practice registered nurses. (f) The physician assistant affiliated credentialing board, insofar as this section applies to physician assistants. (9) Penalties and enforcement proceedings. (a) Except as provided in par. (b), any person who violates this section may be fined not more than $500 or imprisoned not more than 6 months or both. (b) Any person who delivers, or who possesses with intent to manufacture or deliver, a prescription drug in violation of this section is guilty of a Class H felony. (bm) A violation of sub. (1b) is not punishable under par. (a) or (b). (c) In any action or proceeding brought for the enforcement of this section, it shall not be necessary to negate any exception or exemption contained in this section, and the burden of proof of any such exception or exemption shall be upon the defendant.

Wis. Stat. § 450.12 Labeling of prescription drugs and prescription drug products

(1) In this section: (a) “Brand name” means the name, other than the generic name, that the labeler of a drug or drug product places on its commercial container at the time of packaging. (b) “Generic name” means the official or established name given a drug by the U.S. department of health and human services or the U.S. adopted names council. (2) The manufacturer’s or distributor’s commercial container of every prescription drug or prescription drug product delivered to any pharmacist, practitioner, hospital or nursing home shall bear a label containing the generic name of the drug, if any, the brand name of the drug or drug product, if any, the name and address of the manufacturer of the drug or drug product and, if different from the manufacturer, the name and address of the distributor of the drug or drug product. (3) Every prescription order or medication profile record shall include the brand name, if any, or the name of the manufacturer or distributor of the drug product dispensed. (4) This section does not apply with respect to biological products.

Wis. Stat. § 450.13 Using drug product equivalent in dispensing prescriptions

(1e) Definition. In this section, “drug product equivalent” means a drug product that is designated the therapeutic equivalent of another drug product by the federal food and drug administration as set forth in the latest edition of or supplement to the federal food and drug administration’s Approved Drug Products with Therapeutic Equivalence Evaluations. (1s) Drug product or equivalent to be used. Except as provided in sub. (2), a pharmacist shall dispense every prescription using either the drug product prescribed or its drug product equivalent, if its drug product equivalent is lower in price to the consumer than the drug product prescribed, and shall inform the consumer of the options available in dispensing the prescription. (2) Exception. A prescribing practitioner may indicate, by writing on the face of the prescription order or, with respect to a prescription order transmitted electronically, by designating in electronic format the phrase “No substitutions” or words of similar meaning or the initials “N.S.”, that no substitution of the drug product prescribed may be made under sub. (1s). If such indication is made, the pharmacist shall dispense the prescription with the specific drug product prescribed. No preprinted statement regarding drug product substitution may appear on the face of the prescription order. (3) Refilled prescriptions. Prescriptions dispensed with a drug product equivalent may be refilled with a different drug product equivalent only if the pharmacist informs the consumer of the change. (4) Limitation on liability. A pharmacist who dispenses a prescription with a drug product equivalent under this section assumes no greater liability than would be incurred had the pharmacist dispensed the prescription with the drug product prescribed. (5) Use of drug product equivalent in hospitals. Subsections (1s) to (4) do not apply to a pharmacist who dispenses a drug product equivalent that is prescribed for a patient in a hospital if the pharmacist dispenses the drug product equivalent in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of the hospital and approved by the hospital’s medical staff and use of the drug product equivalent has been approved for a patient during the period of the patient’s stay within the hospital by any of the following: (a) The patient’s individual physician. (b) The patient’s advanced practice registered nurse, if the advanced practice registered nurse may issue prescription orders under s. 441.09 (2). (c) The patient’s physician assistant. (5m) Disclosures to consumers. (a) Each pharmacy shall post in a prominent place at or near the place where prescriptions are dispensed a sign that clearly describes a pharmacist’s ability under this state’s law to substitute a less expensive drug product equivalent under sub. (1s) unless the consumer or the prescribing practitioner has indicated otherwise under sub. (2). (b) The pharmacy examining board shall create a list of the 100 most commonly prescribed generic drug product equivalents, including the generic and brand names of the drugs, and provide, either directly or on the department’s Internet site, the list to each pharmacy on an annual basis. Each pharmacy shall make available to the public information on how to access the list under this paragraph. (c) Each pharmacy shall have available for the public a listing of the retail price, updated no less frequently than monthly, of the 100 most commonly prescribed prescription drugs, which includes brand name and generic equivalent drugs and biological products and interchangeable biological products, that are available for purchase at the pharmacy. (6) Applicability. This section does not apply with respect to a prescription for a biological product.

Wis. Stat. § 450.14 Poisons

(1) In this section, “highly toxic” has the meaning specified under 15 USC 1261 (h). (2) No person may deliver any highly toxic substance unless the delivery is made on the prescription order of a practitioner or complies with pars. (a) to (d): (a) The container shall be plainly labeled with the name of the substance, the name and address of the person delivering the substance and, except as provided in sub. (3), the word “Poison”. (b) The person delivering the substance shall ascertain that the recipient is aware of the poisonous character of the substance and desires it for a lawful purpose. (c) Before delivery, the person delivering the substance shall record in a book kept for that purpose the name of the article or substance, the quantity, the purpose, the date, the name and address of the person for whom procured and the signature of the individual personally delivering the article or substance. The record shall be signed by the person to whom the substance is delivered. Each book containing records required under this paragraph shall be preserved by the owner of the book for at least 3 years after the date of the last entry and shall be open to inspection by authorized officers. (d) If the recipient is under 18 years of age, he or she must have the written order of an adult. (3) A “Poison” label under sub. (2) (a) is not required for liniments, ointments or other external preparations which are plainly labeled “for external use only”. (4) This section does not apply to manufacturers or distributors selling at wholesale nor to pesticides which comply with ss. 94.67 to 94.71. (5) Any person who violates this section is guilty of a Class H felony.

Wis. Stat. § 450.15 Placing prescription drugs prohibited

(1) Except as otherwise provided by law, no person may put, or cause to be put, any prescription drug in any public place, or upon any private premises without the consent of the owner or occupant. (2) Any person who violates this section is guilty of a Class H felony.

Wis. Stat. § 450.16 Sale of contraceptives prohibited in certain areas

(1) In this section, “vending machine” has the meaning given under s. 450.155 (1) (L). (2) No person may have in the person’s possession or under the person’s control, any vending machine that is located in a public school, as specified under s. 115.01 (1). (3) Any person violating this section may be fined not more than $10,000 or imprisoned for not more than 9 months or both.

Wis. Stat. § 450.17 Violations

Each member of the board shall investigate and institute actions for violations of this chapter by any person and for violation of ch. 961 by pharmacists or pharmacy technicians. The district attorney of the proper county shall promptly prosecute any such violation upon notice from any source.

Wis. Stat. § 450.18 Penalties

Except as otherwise provided in this chapter, any person who violates this chapter or any rule promulgated under the authority of this chapter may be fined not less than $50 nor more than $100 or imprisoned not less than 30 days nor more than 90 days or both.

Wis. Stat. § 450.033 Services delegated by physician

A pharmacist may perform any patient care service delegated to the pharmacist by a physician, as defined in s. 448.01 (5).

Wis. Stat. § 450.035 Administration of drug products and devices; vaccines

(1g) In this section, “drug product or device” does not include a vaccine. (1r) A pharmacist may not administer by injection a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A pharmacist who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under s. 450.02 (2g) (b). The pharmacist or his or her agent shall also, after the pharmacist administers a prescribed drug product or device under this subsection, notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner. (1t) A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) may not administer a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) may administer a prescribed drug product or device under this subsection only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under s. 450.02 (2g) (b). The person or his or her agent shall also, after the person administers a prescribed drug product or device under this subsection, notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner. (2) A pharmacist may not administer a vaccine unless he or she has successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in vaccination storage, protocols, administration technique, emergency procedures, and record keeping and has satisfied the requirements specified in sub. (2t). Except as provided under sub. (2c), a pharmacist may not administer a vaccine under this subsection to a person who is under the age of 6. (2c) A pharmacist may administer a vaccine under sub. (2) to a person who is under the age of 6 if all of the following apply: (a) The vaccine is administered pursuant to a prescription order issued within the 29 days immediately preceding the day on which the vaccine is administered. (b) The pharmacist has successfully completed a course of instruction approved by the Accreditation Council for Pharmacy Education or the board that includes the administration of vaccines to children under the age of 6. (2g) (a) A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine unless he or she acts under the direct supervision of a health care provider authorized to administer vaccines and he or she has successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in vaccination storage, protocols, administration technique, emergency procedures, and record keeping. If the supervising health care provider under this paragraph is a pharmacist, a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine unless the supervising pharmacist has successfully completed a course of study and training specified in sub. (2) and has satisfied the requirements specified in sub. (2t). (b) A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine under this subsection to a person who is under the age of 6. (2h) (a) A pharmacy technician may not administer a vaccine unless all of the following are satisfied: 1. The pharmacy technician has successfully completed at least 2 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in hands-on injection technique and the recognition and treatment of emergency reactions to vaccines. 2. The pharmacy technician acts under the direct supervision of a pharmacist and the supervising pharmacist has successfully completed a course of study and training specified in sub. (2) and has satisfied the requirements specified in sub. (2t). 3. The pharmacy technician holds a current certification in basic life support or cardiopulmonary resuscitation. 4. The pharmacy technician holds a certified pharmacy technician certification from either the Pharmacy Technician Certification Board, or its successor organization, or the National Healthcareer Association, or its successor organization. (b) A pharmacy technician may not administer a vaccine under this subsection to a person who is under the age of 6. (2i) (a) Subject to subs. (2), (2g), and (2h), a pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may administer without a prescription order any vaccine listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention. (b) Subject to subs. (2), (2g), and (2h), a pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may initiate and administer any vaccine not listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention if the vaccine is administered pursuant to a prescription order, vaccination protocol, or standing order. (2k) A person authorized to administer a vaccine under this section may administer by injection epinephrine and diphenhydramine to a person experiencing an adverse reaction to a vaccine. (2m) Except as provided in sub. (1t), (2g), (2h), or (2k), a pharmacist may not delegate to any person any administration of a prescribed drug product or device or vaccine under sub. (1r) or (2). (2t) A pharmacist may not administer a vaccine under sub. (2) or supervise a person administering a vaccine under sub. (2g) or (2h) unless the pharmacist satisfies each of the following: (a) The pharmacist has in effect liability insurance that covers the pharmacist and a person who administers a vaccine under sub. (2g) or (2h) against loss, expense and liability resulting from errors, omissions or neglect in the administration of vaccines in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year. (b) The pharmacist maintains proof that he or she satisfies the requirement specified in par. (a) and, upon request, provides copies of such proof to the department or the board. (3) A pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who successfully completes a course of study and training specified in sub. (1r), (1t), (2), (2g), or (2h), or holds a certification under sub. (2h), shall maintain proof of completion or holding the certification and, upon request, provide copies of such proof to the department or the board. (4) A pharmacist, pharmacy technician, or person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who administers a vaccine to a person under this section shall update, or cause a pharmacy to update, the Wisconsin Immunization Registry established by the department of health services within 7 days of administering the vaccine.

Wis. Stat. § 450.065 Out-of-state pharmacies; licensure

(1) No pharmacy that is in another state may ship, mail, or otherwise deliver a prescribed drug or device to persons in this state unless the pharmacy is licensed under sub. (2). (2) The board shall issue a license to a pharmacy that is located outside this state if the pharmacy does all of the following: (a) Applies on a form provided by the board that shows all of the following: 1. The location of the pharmacy. 2. The name and address of the person holding title and ownership control of the location. 3. The name of the managing pharmacist of the pharmacy. (b) Submits a statement in a form prescribed by the board from the owner of the pharmacy or, if the pharmacy is not a sole proprietorship, from the managing pharmacist of the pharmacy that indicates that the owner or managing pharmacist, whichever is applicable, knows the laws relating to the practice of pharmacy in this state. (c) Submits evidence satisfactory to the board that it is licensed in the state in which it is located. (d) Pays the initial credential fee determined by the department under s. 440.03 (9) (a). (3) A pharmacy that applies for a license under sub. (2) may not be required to comply with any provision in this chapter or any rule promulgated under this chapter relating to the professional service area of a pharmacy or the minimum equipment requirements for a pharmacy. (4) (a) Notwithstanding s. 450.03, a pharmacist employed in a pharmacy licensed under this section is not required to be licensed under this chapter. (b) Notwithstanding s. 450.09, a pharmacy licensed under this section is not required to be under the control of a managing pharmacist licensed under this chapter. (5) A pharmacy licensed under this section shall provide a telephone number that allows a person in this state to contact the pharmacy during the pharmacy’s regular hours of business and that is available for use by a person in this state for not less than 40 hours per week.

Wis. Stat. § 450.068 Pharmacy technicians; registration

(1) No person may engage in the practice of a pharmacy technician or use the title “pharmacy technician” or “pharmacy tech” unless the person is registered as a pharmacy technician by the board. (2) Except as provided in s. 450.10, the board shall issue a registration as a pharmacy technician to an applicant who satisfies all of the following: (a) The applicant submits an application for registration on a form provided by the board that specifies all of the following: 1. The applicant’s home address. 2. If the applicant is employed, the name and address of the applicant’s employer, and the applicant’s place of employment. (b) The applicant satisfies one of the following: 1. The applicant is at least 18 years of age and has graduated from high school or has attained high school graduation equivalency as determined by the department of public instruction. 2. The applicant is enrolled in a youth apprenticeship program for pharmacy technicians that is on the list of youth apprenticeship programs approved by the department of workforce development under s. 106.13 (2m). (d) The applicant pays the fee specified in s. 440.05 (1). (3) A pharmacy technician shall do all of the following: (a) Notwithstanding s. 440.11, if the pharmacy technician moves from the last address provided to the department, notify the department of his or her new address within 10 days of the change in writing or in accordance with other notification procedures approved by the department. (b) If the pharmacy technician changes his or her employer or place of employment, notify the department of his or her new employer or address of employment within 10 days of the change in writing or in accordance with other notification procedures approved by the department and, if required by the department, pay the transfer fee under s. 440.05 (7).

Wis. Stat. § 450.071 Wholesale distributors; licensure

(1) No person may engage in the wholesale distribution of a prescription drug in this state without obtaining a license from the board for each facility from which the person distributes prescription drugs. The board shall exempt a manufacturer that distributes prescription drugs or devices manufactured by the manufacturer from licensing and other requirements under this section to the extent the license or requirement is not required under federal law or regulation, unless the board determines that it is necessary to apply a requirement to a manufacturer. (2) An applicant shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application: (a) The name, business address, and telephone number of the applicant. (b) All trade or business names used by the applicant. (c) Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs. (d) The type of ownership or operation for the applicant’s business. (e) If the applicant’s wholesale distribution business is a partnership, the name of each partner and the name of the partnership. (f) If the applicant’s wholesale distribution business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation. (g) If the applicant’s wholesale distribution business is a sole proprietorship, the name of the sole proprietor and the name of the business entity. (h) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs. (i) The name, address, and telephone number of a designated representative. (j) For the person listed in par. (i), a personal information statement that contains all of the following: 1. The person’s date and place of birth. 2. The person’s places of residence for the 7-year period immediately preceding the date of the application. 3. The person’s occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application. 4. The name and addresses for each business, corporation, or other entity listed in subd. 3. 5. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding. 6. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction. 7. A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party. 8. A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the applicant shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached. 9. A photograph of the person taken within the 12-month period immediately preceding the date of the application. (k) A statement that each facility used by the applicant for the wholesale distribution of prescription drugs has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection. (3) The board shall grant a license to the applicant to engage in the wholesale distribution of prescription drugs if all of the following apply: (a) The applicant pays the fee under s. 440.05 (1) (a). (b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements adopted by the board for wholesale distribution facilities. (c) All of the following apply to each person identified by the applicant as a designated representative: 1. The person is at least 21 years old. 2. The person has been employed full time for at least 3 years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing and distribution of, and record keeping related to, prescription drugs. 3. The person is employed by the applicant full time in a managerial level position. 4. The person is physically present at the wholesale prescription drug distributor’s facility during regular business hours and is involved in and aware of the daily operation of the wholesale prescription drug distributor. This subdivision does not preclude the designated representative from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes. 5. The person is actively involved in and aware of the daily operations of the wholesale distributor. 6. The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one wholesale distributor is located at the facility and the wholesale distributors located at the facility are members of an affiliated group. 7. The person has not been convicted of violating any federal, state, or local law relating to wholesale or retail prescription drug distribution or distribution of a controlled substance. 8. The person has not been convicted of a felony. 9. The person submits to the department 2 fingerprint cards, each bearing a complete set of the applicant’s fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for the purposes of verifying the identity of the applicant and obtaining the applicant’s criminal arrest and conviction record. This subdivision does not apply to a person accredited by the national association of boards of pharmacy’s verified-accredited wholesale distributor program. (3m) Notwithstanding subs. (2) and (3), the board may grant a license to engage in the wholesale distribution of prescription drugs to a person who is domiciled in another state and is licensed to engage in the wholesale distribution of prescription drugs in another state, if the board determines that the standards for licensure in the state in which the person is licensed are at least as stringent as the standards for licensure under this section. (4) The board may set, by rule, continuing education requirements for designated representatives under this section. (5) (a) The board shall require every wholesale distributor to submit a surety bond acceptable to the board in an amount not to exceed $100,000 or other equivalent means of security acceptable to the board, except that the board shall not require submission of a bond or other security under this subsection by a chain pharmacy warehouse that is engaged only in intracompany transfers. A wholesale distributor that operates more than one facility is not required to submit a bond or other security under this paragraph for each facility. (b) The bond or other security under this subsection shall be used to secure payment of fees or costs that relate to the issuance of a license under this section and that have not been paid within 30 days after the fees or costs have become final. No claim may be made against a wholesale distributor’s bond or other security under this subsection more than one year after the date on which the wholesale distributor’s license expires.

Wis. Stat. § 450.072 Wholesale distributors; restrictions on transactions

(1) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy, a person authorized to administer or dispense drugs, or a pharmacy’s intracompany warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. A wholesale distributor that receives returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs may distribute the prescription drugs only to the original manufacturer of the products or to a 3rd party returns processor. Notwithstanding s. 450.073, returns or exchanges of saleable or nonsaleable prescription drugs, including any redistribution by a receiving wholesaler, are not subject to pedigree requirements under s. 450.073 if the returns or exchanges are exempt from the pedigree requirement under the federal food and drug administration’s current guidance on the federal prescription drug marketing act. A person licensed under s. 450.071 or a pharmacy or other person authorized to administer or dispense drugs shall ensure that the person or pharmacy’s return process is secure and does not permit the entry of adulterated and counterfeit products. (2) (a) A manufacturer or wholesale distributor may not deliver prescription drugs to a person unless the person is licensed under s. 450.071 or 450.06 or by the appropriate licensing authority of another state or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1), and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale. A manufacturer or wholesale distributor may not deliver prescription drugs to a person that is not known to the manufacturer or wholesale distributor unless the manufacturer or wholesale distributor has verified with the board or with the licensing authority of the state in which the person is located that the person is licensed to receive prescription drugs or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1), and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale. (b) A manufacturer or wholesale distributor may distribute a prescription drug only to the premises listed on the person’s license or authorization, except that a manufacturer or wholesale distributor may distribute the prescription drugs to an authorized agent of the person at the premises of the manufacturer or wholesale distributor if all of the following are true: 1. The manufacturer or wholesale distributor documents the authorized agent’s name and address. 2. Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent’s patient. (c) A manufacturer or wholesale distributor may distribute a prescription drug to a hospital pharmacy receiving area if a licensed pharmacist or another authorized recipient signs, at the time of the distribution, a receipt that shows the type and quantity of prescription drugs distributed. If there is a discrepancy between the type and quantity of prescription drugs indicated on the receipt and the type and quantity of prescription drugs received at the hospital pharmacy receiving area, the discrepancy shall be reported to the manufacturer or wholesale distributor that distributed the prescription drugs no later than the day immediately following the date on which the prescription drugs were distributed to the hospital pharmacy receiving area. (d) No manufacturer or wholesale distributor may accept payment for, or allow the use of, a person’s credit to establish an account for the purchase of a prescription drug from any person other than the owner of record, the chief executive officer, or the chief financial officer identified on the license or authorization of a person who may receive prescription drugs. Any account established for the purchase of prescription drugs shall bear the name of the licensed or authorized person.

Wis. Stat. § 450.073 Wholesale distributors; pedigree

(1) A wholesale distributor shall establish and maintain a pedigree for each prescription drug that leaves, or has ever left, the normal distribution channel. Before a wholesale distribution of a prescription drug leaves the normal distribution channel, a wholesale distributor shall provide a copy of the pedigree to the person receiving the drug. This section does not apply to a retail pharmacy or pharmacy intracompany warehouse unless the pharmacy or pharmacy intracompany warehouse engages in the wholesale distribution of prescription drugs. (2) A pedigree shall contain all necessary identifying information concerning each sale in the chain of the distribution of the prescription drug from the manufacturer of the prescription drug or the manufacturers 3rd-party logistics provider, colicensed product partner, or exclusive distributor until final sale or distribution to a pharmacy or a person dispensing or distributing the prescription drug. The pedigree shall include all of the following: (a) The name, address, telephone number, and, if available, electronic mail address of each recipient or distributor of the prescription drug in the chain of distribution, until the final sale or distribution described in sub. (2) (intro.). (b) The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a). (c) The date of each distribution. (d) A certification that every recipient has authenticated the pedigree before distribution of the prescription drug to the next point in the chain of distribution. (e) The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug. (3) The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2010, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2011, and the board may delay the implementation date in increments if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain or is not capable of adequately protecting patient safety. (4) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but not including the original manufacturer of the prescription drug, who possesses a pedigree for the prescription drug, and who intends to further distribute the prescription drug, shall verify that each transaction recorded on the pedigree has occurred before the person may distribute the prescription drug. (5) (a) A pedigree shall be maintained by a person who purchases prescription drugs identified in the pedigree and by a wholesale distributor who distributes prescription drugs identified in the pedigree for not less than 3 years from the date of sale or distribution. (b) A person maintaining a pedigree under par. (a) shall make the pedigree available for inspection or use by a law enforcement officer within 7 days after the law enforcement officer’s request.

Wis. Stat. § 450.074 Wholesale distributors; prohibited actions, enforcement, penalties

(1) If the board finds that there is a reasonable probability that a wholesale distributor, other than a manufacturer, has done any of the following, that continued distribution of a prescription drug involved in the occurrence could cause death or serious adverse health consequences, and that additional procedures would result in an unreasonable delay, the board shall issue an order requiring that distribution of a prescription drug in this state cease immediately: (a) Violated a provision of ss. 450.071 to 450.073. (b) Falsified a pedigree or sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use. (2) If the board issues an order under sub. (1), the board shall provide the person who is the subject of the order an opportunity for an informal hearing not more than 10 days after the date on which the order is issued. If, after a hearing, the board determines that the order was issued without sufficient grounds, the board shall vacate the order. (3) Any person who knowingly does any of the following is guilty of a Class H felony: (a) Fails to obtain a license required under s. 450.071. (b) Purchases or otherwise receives a prescription drug from a pharmacy in violation of s. 450.072 (1). (c) Violates s. 450.072 (2) (a), if the person is required to obtain a license under s. 450.071. (d) Violates s. 450.072 (2) (b). (e) Violates s. 450.072 (2) (d). (f) Violates s. 450.073. (g) Provides false or fraudulent records to, or makes a false or fraudulent statement to, the board, a representative of the board, or a federal official. (h) Obtains or attempts to obtain a prescription drug by fraud, deceit, or misrepresentation, or engages in misrepresentation or fraud in the distribution of a prescription drug. (i) Manufactures, repackages, sells, transfers, delivers, holds, or offers for sale a prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or otherwise unfit for distribution, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration. (j) Adulterates, misbrands, or counterfeits a prescription drug, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration. (k) Receives a prescription drug that has been adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeited, or suspected of being counterfeited, and delivers or proffers such a drug. (L) Alters, mutilates, destroys, obliterates, or removes any part of the labeling of a prescription drug or commits another act that results in the misbranding of a prescription drug. (4) Subsection (3) does not apply to a prescription drug manufacturer or an agent of a prescription drug manufacturer, if the manufacturer or agent is obtaining or attempting to obtain a prescription drug for the sole purpose of testing the authenticity of the prescription drug.

Wis. Stat. § 450.075 Third-party logistics providers; licensure

(1) License allowed. A person acting as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider of any drug or device may apply to obtain a license from the board under this section. If operations are conducted at more than one facility, a person acting as a 3rd-party logistics provider or out-of-state 3rd-party logistics provider may apply to obtain a license from the board for each such facility. (2) Application. An applicant for a license under this section shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application: (a) The name, business address, and telephone number of the applicant. (b) All trade or business names used by the applicant. (c) Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the warehousing, distribution, or other services on behalf of the manufacturer of prescription drugs. (d) The type of ownership or operation for the applicant’s business. (e) If the applicant’s 3rd-party logistics provider business is a partnership, the name of each partner and the name of the partnership. (f) If the applicant’s 3rd-party logistics provider business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation. (g) If the applicant’s 3rd-party logistics provider business is a sole proprietorship, the name of the sole proprietor and the name of the business entity. (h) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to warehouse or distribute prescription drugs. (i) The name, address, and telephone number of a designated representative. (j) For the person identified as the designated representative in par. (i), a personal information statement that contains all of the following: 1. The person’s date and place of birth. 2. The person’s place of residence for the 7-year period immediately preceding the date of the application. 3. The person’s occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application. 4. The name and addresses for each business, corporation, or other entity listed in subd. 3. 5. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding. 6. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction. 7. A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party. 8. A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the person shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached. 9. A photograph of the person taken within the 12-month period immediately preceding the date of the application. (k) A statement that each facility used by the applicant for 3rd-party logistics provider services has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection. (3) Licensure. The board shall grant a license to an applicant to act as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider if all of the following apply: (a) The applicant pays the fee specified in s. 440.05 (1). (b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements adopted by the board for 3rd-party logistics providers or out-of-state 3rd-party logistics providers. (c) All of the following apply to each person identified by the applicant as a designated representative: 1. The person is at least 21 years old. 2. The person has been employed full time for at least 3 years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing of and distribution of, and record keeping related to, prescription drugs. 3. The person is employed by the applicant full time in a managerial position. 4. The person is physically present at the 3rd-party logistics provider’s or out-of-state 3rd-party logistics provider’s facility during regular business hours and is involved in and aware of the daily operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider. This subdivision does not preclude the person from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes. 5. The person is actively involved in and aware of the daily operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider. 6. The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one 3rd-party logistics provider or out-of-state 3rd-party logistics provider is located at the facility and the 3rd-party logistics providers or out-of-state 3rd-party logistics providers located at the facility are members of an affiliated group. 7. The person has not been convicted of violating any federal, state, or local law relating to distribution of a controlled substance. 8. The person has not been convicted of a felony. 9. The person submits to the department 2 fingerprint cards, each bearing a complete set of the applicant’s fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for purposes of verifying the identity of the person and obtaining the person’s criminal arrest and conviction record. (d) The applicant satisfies any other requirements established by the board by rule. (4) Rules. The board shall promulgate rules implementing this section. The rules shall ensure compliance with the federal drug supply chain security act, 21 USC 360eee, et seq. The board may not promulgate rules that impose requirements more strict than the federal drug supply chain security act or any regulations passed under the federal drug supply chain security act. The board may not promulgate rules that require a license under this section. (5) Access to records. Applications for licensure under this section are not subject to inspection or copying under s. 19.35, and may not be disclosed to any person except as necessary for compliance with and enforcement of the provisions of this chapter. (6) Inspections. A 3rd-party logistics provider or an out-of-state 3rd-party logistics provider shall allow the board and authorized federal, state, and local law enforcement officials to enter and inspect its facilities and delivery vehicles, to audit its records and written operating procedures, and to confiscate prescription drugs and records to the extent authorized by law, rule, or regulation. (7) Applicability. (a) If the federal government establishes a licensing program for 3rd-party logistics providers, the board shall evaluate the federal licensing program to determine whether licensing by this state of resident 3rd-party logistics providers is required for a resident 3rd-party logistics provider to provide 3rd-party logistics provider services in another state. If the board determines under this subsection that licensing by this state is not required, this section does not apply. (b) By April 17, 2023, and biennially thereafter, the board shall evaluate whether continued licensing by this state of resident 3rd-party logistics providers is required for a resident 3rd-party logistics provider to provide 3rd-party logistics provider services in another state and, if the board determines licensing in this state is required, submit to the legislative reference bureau for publication in the Wisconsin Administrative Register a notice continuing the licensing under this section. This section does not apply unless the board submits the notice under this paragraph.

Wis. Stat. § 450.076 Home medical oxygen providers; licensure

(1) Definitions. In this section: (a) “Home medical oxygen provider” means a person that provides medical oxygen directly to a consumer or patient in this state for that consumer’s or patient’s own use. (b) “Licensed provider” means a home medical oxygen provider licensed under this section. (c) “Medical oxygen” means oxygen that is a prescription drug. (2) License required. (a) Except as provided in par. (b), no person may operate as a home medical oxygen provider, use the title “home medical oxygen provider” or any similar title, or hold itself out as a home medical oxygen provider unless the person is a licensed provider. (b) No license under this section is required for any of the following: 1. A person that holds a current credential, as defined in s. 440.01 (2) (a), and is acting within the scope of that credential. 2. A hospital, excluding any home medical oxygen provider that is owned or operated by a hospital. 3. An employee or agent of a licensed provider acting within the scope of his or her employment or agency. (3) Licensure. The board may grant a license to act as a home medical oxygen provider to a person that does all of the following: (a) Submits an application for licensure on a form provided by the board. (b) Pays the fee specified in s. 440.05 (1). (c) Satisfies any other requirements established by the board by rule. (4) Rules. The board shall promulgate rules implementing this section. The rules shall include rules governing the professional conduct of licensed providers and their employees and agents.

Wis. Stat. § 450.085 Continuing education

(1) An applicant for renewal of a license under s. 450.08 (2) (a) shall submit proof that he or she has completed, within the 2-year period immediately preceding the date of his or her application, 30 hours of continuing education in courses conducted by a provider that is approved by the Accreditation Council for Pharmacy Education or in courses approved by the board. Courses specified in s. 450.035 (1r) and (2) are courses in continuing education for purposes of this subsection. This subsection does not apply to an applicant for renewal of a license that expires on the first renewal date after the date on which the board initially granted the license. (2) The board may waive all or part of any requirement in sub. (1) if it finds that exceptional circumstances such as prolonged illness, disability or other similar circumstances have prevented a pharmacist from meeting the requirement.

Wis. Stat. § 450.095 Duty to dispense contraceptives

(1) In this section: (a) “Contraceptive drug or device” means any drug or device approved by the federal food and drug administration that is used to prevent pregnancy, including a contraceptive drug or device restricted to distribution by a pharmacy. (b) “Without delay” means within the usual and customary time frame reasonably expected at a pharmacy for dispensing or distributing a prescription that is not a contraceptive drug or device. (2) Unless one or more of the following applies, a pharmacy shall dispense lawfully prescribed contraceptive drugs and devices and shall deliver contraceptive drugs and devices restricted to distribution by a pharmacy to a patient without delay: (a) The prescription contains an obvious or known error or contains inadequate instructions. (b) The prescription is contraindicated for the patient, is incompatible with another drug or device prescribed for the patient, or is prohibited by state or federal law. (c) The prescription is potentially fraudulent. (3) Any person who violates this section may be required to forfeit not less than $250 nor more than $2,500 for each violation. (4) Nothing in this section may be construed to abrogate a pharmacist’s legal and ethical obligations to comply with the laws of this state.

Wis. Stat. § 450.115 Drug disposal programs and authorizations

(1) In this section: (a) “Guardian” means the person named by the court under ch. 880, 2003 stats., or ch. 48 or 54 that has the duty and authority of guardianship. (am) “Hospice worker” means a person who is employed by a hospice, as defined in s. 50.90 (1). (b) “Personal representative” means an executor, administrator, or special administrator of a decedent’s estate, a person legally authorized to perform substantially the same functions, or a successor to any of those persons. (c) “Trustee” means a person that holds in trust title to or power over property. “Trustee” includes an original, added, or successor trustee. (d) “Ward” means a person for whom a guardian has been appointed. (2) Nothing in this chapter, or rules promulgated under this chapter, prohibits any of the following: (a) The direct operation or implementation of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a). (b) The transfer of a prescription drug by a person that lawfully possesses the prescription drug to a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), and that accepts the prescription drug. (c) Subject to sub. (4), the possession of a prescription drug under a written authorization described in sub. (3). (3) (a) A guardian may grant written authorization to an adult who is related to the guardian’s ward by blood, marriage, or adoption within the 3rd degree of kinship as computed under s. 990.001 (16), or to a domestic partner of the ward under ch. 770, for the disposal of a prescription drug that belongs to the ward. (b) A personal representative or a trustee may grant written authorization to an adult beneficiary, as defined in s. 701.1102 (1m), of the estate or trust for the disposal of a prescription drug that belongs to the estate or trust. (c) A person who is a competent adult may grant written authorization to that person’s domestic partner under ch. 770 or to another adult who is related to that person by blood, marriage, or adoption within the 3rd degree of kinship as computed under s. 990.001 (16), for the disposal of a prescription drug that lawfully belongs to that person. (d) A personal representative, trustee, or an adult beneficiary, as defined in s. 701.1102 (1m), of an estate or trust may grant written authorization to a hospice worker for the disposal of a controlled substance that belongs to the estate or trust. (4) A written authorization under sub. (3) is valid only to the extent permitted under federal law and only if all of the following conditions are satisfied: (a) The authorization describes with reasonable specificity each prescription drug or controlled substance that is to be disposed of. (b) The authorization is in the physical possession of the person authorized to dispose of the prescription drug or controlled substance and each prescription drug or controlled substance described in the authorization is, within 24 hours after the authorization is signed by the person granting the authorization, transferred to a drug disposal program under s. 165.65 or otherwise lawfully disposed of. (c) The authorization and each prescription drug or controlled substance to be disposed of were obtained without consideration.

Wis. Stat. § 450.122 Labeling of biological products

(1) In this section: (a) “Brand name” means the name, other than the proper name, that the labeler of a biological product places on its commercial container at the time of packaging. (b) “Proper name” means the nonproprietary name for a biological product designated by the federal food and drug administration licensure for use upon each package of the product. (2) The manufacturer’s or distributor’s commercial container of every biological product delivered to any pharmacist, practitioner, hospital, or nursing home shall bear a label containing the proper name of the biological product, the brand name of the biological product, if any, the name and address of the manufacturer of the biological product, and, if different from the manufacturer, the name and address of the distributor of the biological product. (3) Every prescription order or medication profile record for a biological product shall include the brand name, if any, and the name of the manufacturer of the biological product.

Wis. Stat. § 450.125 Drugs for animal use

In addition to complying with the other requirements in this chapter for distributing and dispensing, a pharmacist who distributes or dispenses a drug for animal use shall comply with s. 89.068.

Wis. Stat. § 450.135 Using interchangeable biological product in dispensing prescriptions

(1) Definition. In this section, “interchangeable biological product” means a biological product that the federal food and drug administration has licensed and has determined meets the standards for interchangeability pursuant to 42 USC 262 (k) (4) or has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal food and drug administration’s Approved Drug Products with Therapeutic Equivalence Evaluations. (2) Biological product or interchangeable biological product to be used. Except as provided in sub. (3), a pharmacist shall dispense every prescription using either the biological product prescribed or an interchangeable biological product, if the interchangeable biological product is lower in price to the consumer than the biological product prescribed, and shall inform the consumer of the options available in dispensing the prescription. (3) Exception. A prescribing practitioner may indicate, by writing on the face of the prescription order or, with respect to a prescription order transmitted electronically, by designating in electronic format the phrase “No substitutions” or words of similar meaning or the initials “N.S.,” that no substitution of the biological product prescribed may be made under sub. (2). If such indication is made, the pharmacist shall dispense the prescription with the specific biological product prescribed. No preprinted statement regarding biological product substitution may appear on the face of the prescription order. (4) Refilled prescriptions. Prescriptions dispensed with an interchangeable biological product may be refilled with a different interchangeable biological product only if the pharmacist informs the consumer of the change. (5) Communication of biological product dispensed. Within 5 business days after the dispensing of a biological product, the dispensing pharmacist or the pharmacist’s designee shall do one of the following: (a) Make an entry of the specific product provided to the patient, including the name of the product and the manufacturer. Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescribing practitioner. The communication shall be conveyed by making an entry that is electronically accessible to the prescribing practitioner through one of the following: 1. An interoperable electronic medical records system. 2. An electronic prescribing technology. 3. A pharmacist benefit management system. 4. A pharmacy record. (b) If a pharmacist is unable to make an entry as provided in par. (a), communicate the biological product dispensed to the prescribing practitioner using facsimile, telephone, electronic transmission, or another prevailing means, except that communication under this paragraph is not required if any of the following applies: 1. There is no interchangeable biological product for the product prescribed. 2. A refill of the biological product is not changed from the product dispensed on the prior filling of the prescription. (6) Limitation of liability. A pharmacist who dispenses a prescription with an interchangeable biological product under this section assumes no greater liability than would be incurred had the pharmacist dispensed the prescription with the biological product prescribed. (7) Use of interchangeable biological product in hospitals. Subsections (2) to (6) do not apply to a pharmacist who dispenses an interchangeable biological product that is prescribed for a patient in a hospital if the pharmacist dispenses the interchangeable biological product in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of the hospital and approved by the hospital’s medical staff and use of the interchangeable biological product has been approved for a patient during the period of the patient’s stay within the hospital by any of the following: (a) The patient’s individual physician. (b) The patient’s advanced practice registered nurse, if the advanced practice registered nurse may issue prescription orders under s. 441.09 (2). (c) The patient’s physician assistant. (8) Applicability. This section applies only with respect to prescriptions for biological products. (8m) Disclosure to consumers. Each pharmacy shall post in a prominent place at or near the place where prescriptions are dispensed a sign that clearly describes a pharmacist’s ability under this state’s law to substitute a less expensive interchangeable biological product under sub. (2) unless the consumer or the prescribing practitioner has indicated otherwise under sub. (3). (9) Links to be maintained by board. The board shall maintain links on the department’s Internet site to the federal food and drug administration’s lists of all currently approved interchangeable biological products. Each pharmacy shall make available for the public information on how to access the federal food and drug administration’s lists of all currently approved interchangeable biological products through the department’s Internet site.

Wis. Stat. § 450.137 Access to investigational drugs, devices, and biological products for terminally ill patients

(1) Definitions. In this section: (a) “Eligible patient” means a patient who is eligible under sub. (2). (b) “Investigational drug, device, or biological product” means a drug, device, or biological product that has not been approved or licensed for use by the federal food and drug administration and meets all of the following conditions: 1. The drug, device, or biological product has successfully completed a phase one clinical trial approved by the federal food and drug administration. 2. The drug, device, or biological product remains under investigation in a phase 2 or 3 clinical trial approved by the federal food and drug administration or has completed a phase 3 clinical trial and is pending approval or licensure by the federal food and drug administration. 3. The active development or production of the drug, device, or biological product is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under 21 USC 355 (i). (c) “Life-threatening disease or condition” means a disease or condition that is life-threatening, as defined in 21 CFR 312.81 (a). (2) Eligibility. An individual is an eligible patient for purposes of this section if the individual meets all of the following conditions: (a) Has been diagnosed with a life-threatening disease or condition. (b) Has exhausted approved treatment options and is unable to participate in a clinical trial involving the investigational drug, device, or biological product. (c) Has received a recommendation or prescription order from the individual’s treating physician for an investigational drug, device, or biological product. (d) Has given written informed consent to use the investigational drug, device, or biological product. The content of the written informed consent provided by the patient shall be consistent with and at least as comprehensive as the consent used in clinical trials for the investigational drug, device, or biological product. (e) Is aware of the potential costs that may be associated with or otherwise result from the use of the investigational drug, device, or biological product under this section. (f) Possesses a written verification executed by the individual’s treating physician attesting that the individual meets the conditions under pars. (a) to (e), and that the physician is not compensated directly by the manufacturer of the investigational drug, device, or biological product for making that attestation. (3) Manufacturers. A manufacturer of an investigational drug, device, or biological product may, but is not required to, make that investigational drug, device, or biological product available to an eligible patient. If the manufacturer charges an eligible patient for an investigational drug, device, or biological product, the manufacturer may not charge more than an amount that is equal to the manufacturer’s actual cost to manufacture the investigational drug, device, or biological product provided to the eligible patient. (4) Limitations of liability. (a) A physician is immune from civil or criminal liability or from professional discipline under s. 448.02 based solely on the physician’s recommendation to an eligible patient for the use of an investigational drug, device, or biological product to treat the patient’s life-threatening disease or condition if the eligible patient gives written informed consent that satisfies sub. (2) (d) and s. 448.30. (b) Any manufacturer, distributor, pharmacist, practitioner, health care facility, or other person who lawfully makes available, delivers, distributes, prescribes, dispenses, or administers an investigational drug, device, or biological product to an eligible patient consistent with this section, and who in doing so exercises reasonable care, may not be held liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from any of the following: 1. The design, development, clinical testing, investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of the investigational drug, device, or biological product. 2. The lack of safety or effectiveness of the investigational drug, device, or biological product. (5) Reporting. The manufacturer or sponsor of an investigational drug, device, or biological product that makes the investigational drug, device, or biological product available to a patient in this state shall submit to the federal food and drug administration an annual summary of the use of the investigational drug, device, or biological product. The summary shall include the number of doses supplied, the number of patients treated, the uses for which it was made available, and any known serious adverse events. (6) State officials. No official, employee, or agent of this state may block or attempt to block an eligible patient’s access to an investigational drug, device, or biological product. Any counseling, advice, or recommendation of a practitioner that is consistent with the applicable standard of care for the practitioner is not a violation of this subsection. (7) Insurance. Nothing in this section alters the obligations of an eligible patient’s insurer under the contract of insurance and applicable law.

Wis. Stat. § 450.145 Reporting potential causes of public health emergency

(1) Within 24 hours after an occurrence of any of the following, a pharmacist or pharmacy shall report the occurrence electronically, by fax machine, by telephone, or in writing to a local health department, as defined in s. 250.01 (4), or the department of health services: (a) An unusual increase in the number of prescriptions dispensed or nonprescription drug products sold by the pharmacist or pharmacy for the treatment of medical conditions specified by the department of health services by rule under s. 252.02 (7). (b) An unusual increase in the number of prescriptions dispensed by the pharmacist or pharmacy that are antibiotic drugs. (c) The dispensing of a prescription by the pharmacist or pharmacy for treatment of a disease that is relatively uncommon or may be associated with bioterrorism, as defined in s. 323.02 (4). (1m) Except as provided in sub. (2), a pharmacist or pharmacy may not report personally identifying information concerning an individual who is dispensed a prescription or who purchases a nonprescription drug product as specified in sub. (1) (a), (b), or (c). (2) In submitting a report under sub. (1), a pharmacist or pharmacy shall include personally identifying information other than a social security number concerning an individual who is dispensed a prescription or who purchases a nonprescription drug product as specified in sub. (1) (a), (b), or (c).

Wis. Stat. § 450.155 Exhibition, display or advertisement of certain vending machines by use of certain material prohibited

(1) Definitions. In this section: (a) “Contraceptive article” means any drug, medicine, mixture, preparation, instrument, article or device of any nature used or intended or represented to be used to prevent a pregnancy. (b) “Material” means any visual representation, image, printed matter however reproduced or sound recording. (c) “Harmful to minors” means that quality of any description or representation, in whatever form, of nudity, sexual conduct, sexual excitement, or sadomasochistic abuse, when it does all of the following: 1. Predominantly appeals to the prurient, shameful or morbid interest of minors. 2. Is patently offensive to prevailing standards in the adult community as a whole with respect to what is suitable material for minors. 3. Lacks serious literary, artistic, political or scientific value, if taken as a whole, for minors. (d) “Knowledge of the minor’s age” means knowledge or information that the person is a minor. (e) “Knowledge of the nature of the material” means any of the following: 1. Knowledge of the character and content of any material described herein. 2. Knowledge or information that the material described herein has been adjudged to be harmful to minors in a proceeding instituted under sub. (2), or is the subject of a pending proceeding instituted under sub. (2). (f) “Minor” means any person under the age of 18 years. (g) “Nudity” means the showing of the human male or female genitals, pubic area or buttocks with less than a full opaque covering, or the showing of the female breast with less than a fully opaque covering of any portion thereof below the top of the nipple, or the depiction of covered male genitals in a discernibly turgid state. (h) “Person” means any individual, partnership, firm, association, corporation or other legal entity. (i) “Sadomasochistic abuse” means the infliction of force, pain or violence upon a person for the purpose of sexual arousal or gratification. (j) “Sexual conduct” means acts of masturbation, homosexuality, sexual intercourse or physical contact with a person’s clothed or unclothed genitals, pubic area, buttocks or, if such person is a female, breast. (k) “Sexual excitement” means the condition of human male or female genitals when in a state of sexual stimulation or arousal. (L) “Vending machine” means any mechanical device which automatically dispenses contraceptive articles upon the deposit in it of specified coins in payment for the contraceptive articles. (2) Exhibition, display or advertisement of certain vending machines by use of material harmful to minors. (a) No person with knowledge of the nature of the material and with knowledge of a minor’s age, may, for commercial purposes, exhibit, display or advertise by use of any material which is harmful to minors a vending machine that dispenses contraceptive articles. (b) Whoever violates par. (a) may be fined not more than $10,000 or imprisoned for not more than 9 months or both.

Source: WI Statutes (Official Site)URL: https://docs.legis.wisconsin.gov/statutes/statutes/450Fetched: 10/7/2026