Chapter 450

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

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

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

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

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

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

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

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

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

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

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

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

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

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

450.01(23)(L) (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.

450.01(23)(m) (m) The return of a prescription drug, if the return is authorized by the law of this state.

450.01(23)(n) (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.

450.01(23)(o) (o) The possession or delivery of a prescription drug within the scope of a written authorization under s. 450.115 (3).

450.01(23)(p) (p) The services of a 3rd-party logistics provider or out-of-state 3rd-party logistics provider.

450.01(24) (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.

450.01 History History: 1985 a. 146; 1987 a. 65; 1991 a. 114; 1995 a. 448; 1997 a. 27, 68; 1997 a. 237 s. 727m; 2005 a. 187; 2007 a. 20; 2009 a. 142; 2011 a. 161, 260; 2013 a. 198, 200, 294; 2015 a. 40, 115; 2017 a. 149, 328; 2019 a. 24; 2021 a. 23, 25, 100, 101.

450.01 Annotation Vitamins not intended for use in the diagnosis, cure, investigation, treatment, or prevention of diseases are not drugs under this section. 66 Atty. Gen. 137.

450.02 450.02 Pharmacy examining board.

450.02(1) (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.

450.02(2) (2) The board shall promulgate rules to do all of the following:

450.02(2)(a) (a) Define the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05.

450.02(2)(b) (b) Define the activities that constitute the practice of a pharmacy technician for purposes of the registration requirement under s. 450.068.

450.02(2g) (2g) 

450.02(2g)(a) (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).

450.02(2g)(b) (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).

450.02(2m) (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).

450.02(3) (3) The board may promulgate rules:

450.02(3)(a) (a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.

450.02(3)(b) (b) Establishing security standards for pharmacies.

450.02(3)(c) (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.

450.02(3)(d) (d) Necessary for the administration and enforcement of this chapter and ch. 961.

450.02(3)(e) (e) Establishing minimum standards for the practice of pharmacy.

450.02(3)(f) (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.

450.02(3m) (3m) 

450.02(3m)(a) (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:

450.02(3m)(a)1. 1. The board or its designee determines that a natural or man-made disaster or emergency exists or has occurred.

450.02(3m)(a)2. 2. A pharmacist has requested the variance.

450.02(3m)(a)3. 3. The board or its designee determines that the variance is necessary to protect the public health, safety, or welfare.

450.02(3m)(am) (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.

450.02(3m)(b) (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.

450.02(3r) (3r) 

450.02(3r)(a) (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:

450.02(3r)(a)1. 1. The pilot program is related to the practice of pharmacy or prescription verification.

450.02(3r)(a)2. 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.

450.02(3r)(b) (b) The board or its designee may not authorize a pilot program under par. (a) that lasts longer than 3 years.

450.02(4) (4) The board may not promulgate a rule which does any of the following:

450.02(4)(a) (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.

450.02(4)(b) (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).

450.02(5) (5) The board may promulgate rules governing pharmacies that are operated as remote dispensing sites. Rules promulgated under this subsection may exempt pharmacies operated as remote dispensing sites from requirements governing pharmacies that are not operated as remote dispensing sites.

450.02 History History: 1985 a. 146; 1987 a. 65; 1995 a. 448; 1997 a. 68; 1997 a. 237 s. 727m; 2005 a. 270; 2015 a. 55, 290, 313; 2021 a. 25, 100, 101.

450.02 Cross-reference Cross-reference: See also Phar, Wis. adm. code.

450.03 450.03 Pharmacist; licensure.

450.03(1) (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:

450.03(1)(a) (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.

450.03(1)(b) (b) The sale of any nonprescription drug product, in an original unbroken package, which complies with 21 USC 301 to 392.

450.03(1)(c) (c) The sale of pesticides which comply with ss. 94.67 to 94.71.

450.03(1)(d) (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.

450.03(1)(e) (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 or practical nursing or nurse-midwifery 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.

450.03(1)(f) (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.

450.03(1)(fm) (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.

450.03(1)(g) (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.

450.03(1)(gm) (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.

450.03(1)(h) (h) The provision of services by a health care provider under s. 257.03.

450.03(1)(i) (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).

450.03(1)(j) (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:

450.03(1)(j)1. 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.

450.03(1)(j)2. 2. The person lawfully holds the dialysate drugs or devices.

450.03(1)(j)3. 3. The dialysate drugs or devices are held and delivered in their original, sealed packaging from the manufacturing facility.

450.03(1)(j)4. 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.

450.03(1)(j)5. 5. The dialysate drugs or devices are delivered to one of the following:

450.03(1)(j)5.a. a. A patient with end-stage renal disease or the patient’s designee, for the patient to self-administer the dialysis therapy.

450.03(1)(j)5.b. b. A health care provider or institution, for administration or delivery of the dialysis therapy to a patient with end-stage renal disease.

450.03(1)(j)6. 6. If required by federal law, the dialysate drugs or devices are approved or cleared by the federal food and drug administration.

450.03(1)(k) (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.

450.03(1)(L) (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:

450.03(1)(L)1. 1. A narcotic treatment service for opiate addiction, as defined in s. 51.4224 (1) (a).

450.03(1)(L)2. 2. A free and charitable clinic.

450.03(2) (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:

450.03(2)(a) (a) Has received a professional degree from a pharmacy program approved by the board.

450.03(2)(b) (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.

450.03(2)(c) (c) Passes the examination under s. 450.04.

450.03(2)(d) (d) Pays the fee specified in s. 440.05 (1).

450.03 History History: 1985 a. 146; 1987 a. 264; 1991 a. 39; 2001 a. 16; 2005 a. 96; 2009 a. 42; 2013 a. 114 ss. 25, 27, 28; 2015 a. 3, 55; 2017 a. 293, 366; 2019 a. 13, 68; 2021 a. 3, 100, 101, 130; 2021 a. 238 s. 45; 2021 a. 254; 2023 a. 87.

450.03 Cross-reference Cross-reference: See also chs. Phar 2 and 17, Wis. adm. code.