450.01(13r)(a)(a) "Normal distribution channel" means a chain of custody for a prescription drug that runs, directly or by drop shipment, from the manufacturer of a drug, from the manufacturer to the manufacturer's colicensed partner, from the manufacturer to the manufacturer's 3rd-party logistics provider, or from the manufacturer to the manufacturer's exclusive distributor, and continues as described in any of the following:
450.01(13r)(a)1.
1. To a pharmacy or to a person authorized to dispense or administer a drug to a patient.
450.01(13r)(a)2.
2. To an authorized distributor of record, and then to a pharmacy or to a person authorized to dispense or administer a drug to a patient.
450.01(13r)(a)3.
3. To an authorized distributor of record, then to one other authorized distributor of record, then to an office-based practitioner.
450.01(13r)(a)4.
4. To a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.
450.01(13r)(a)5.
5. To an authorized distributor of record, then to a pharmacy warehouse, then to the pharmacy warehouse's intracompany pharmacy, then to a patient or to a person authorized to dispense or administer a drug to a patient.
450.01(13r)(b)
(b) For purposes of this subsection, a distribution of a prescription drug to a warehouse or to another entity that redistributes the drug by intracompany sale to a pharmacy or to another person authorized to dispense or administer the drug constitutes a distribution to the pharmacy or to the person authorized to dispense or administer the drug.
450.01(14)
(14) "Patient" means the person or other animal for whom drug products or devices are prescribed or to whom drug products or devices are dispensed or administered.
450.01(14m)
(14m) "Pedigree" means a document or electronic file containing information that records each distribution of a prescription drug.
450.01(15m)
(15m) "Pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales.
450.01(16)
(16) "Practice of pharmacy" means any of the following:
450.01(16)(b)
(b) Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices.
450.01(16)(d)
(d) Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices.
450.01(16)(e)
(e) Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses.
450.01(16)(g)
(g) Supervision of pharmacist supportive personnel.
450.01(16)(h)
(h) Making therapeutic alternate drug selections, if made in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of a hospital and approved by the hospital's medical staff and use of the therapeutic alternate drug selection has been approved for a patient during the period of the patient's stay within the hospital by any of the following:
450.01(16)(h)2.
2. The patient's advanced practice nurse prescriber, if the advanced practice nurse prescriber has entered into a written agreement to collaborate with a physician.
450.01(16)(i)
(i) Drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.
450.01(16)(j)
(j) Performing any act necessary to manage a pharmacy.
450.01(16)(k)
(k) Administering prescribed drug products and devices under
s. 450.035 (1r) and, pursuant to vaccination protocols, vaccines.
450.01(17)
(17) "Practitioner" means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.
450.01(18)
(18) "Prescribed drug or device" means any drug or device prescribed by a practitioner.
450.01(19)
(19) "Prescription" means a drug or device prescribed by a practitioner.
450.01(20)
(20) "Prescription drug" means all of the following, but does not include blood, blood components intended for transfusion, or biological products that are also medical devices:
450.01(20)(b)
(b) A controlled substance included in schedules II to V of
ch. 961, whether by statute or rule, except a substance that by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of
s. 450.11 (3),
(4) (a), and
(8) only and for violations thereof punishable under
s. 450.11 (9).
450.01(21)
(21) "Prescription order" means an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient.
450.01(21e)
(21e) "Repackage" means to repack or otherwise change the container, wrapper, or label of a prescription drug, except that "repackage" does not include any of the following:
450.01(21e)(a)
(a) An action by a pharmacist with respect to a prescription drug that the pharmacist is dispensing.
450.01(21e)(b)
(b) An action by a pharmacist who receives a prescription drug or device that the pharmacist dispensed to a patient, if, after altering the packaging or labeling of the prescription drug or device, the pharmacist returns the prescription drug or device to the patient.
450.01(21m)
(21m) "Repackager" means a person that repackages.
450.01(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)(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 CFR 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)(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(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, 3rd party logistics providers, retail pharmacies that conduct wholesale distribution, and chain pharmacy warehouses that conduct wholesale distribution.
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, distributors 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 adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under
s. 450.05.
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). Notwithstanding
s. 15.08 (5) (b), the board may promulgate rules under this paragraph only if the rules are identical to rules recommended by the pharmacist advisory council. The board may amend or repeal rules promulgated under this paragraph only upon the recommendation of the pharmacist advisory council.
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 impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment.
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)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), 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(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 Cross-reference
Cross Reference: See also
Phar, Wis. adm. code.
450.025
450.025
Pharmacist advisory council. The pharmacist advisory council shall recommend rules for promulgation by the board under
s. 450.02 (2g) (b) and may recommend the amendment or repeal of any rules promulgated under
s. 450.02 (2g) (b). A unanimous vote of the members of the pharmacist advisory council is required for the council to make a recommendation under this section.
450.025 History
History: 1997 a. 68;
1997 a. 237 s.
727m.
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)(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)(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.
