450.11(9)(a)(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.
450.11(9)(b) (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.
450.11(9)(bm) (bm) A violation of sub. (1b) is not punishable under par. (a) or (b).
450.11(9)(c) (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.
450.115 450.115 Drug disposal programs and authorizations.
450.115(1)(1) In this section:
450.115(1)(a) (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.
450.115(1)(am) (am) “Hospice worker” means a person who is employed by a hospice, as defined in s. 50.90 (1).
450.115(1)(b) (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.
450.115(1)(c) (c) “Trustee" means a person that holds in trust title to or power over property. “Trustee" includes an original, added, or successor trustee.
450.115(1)(d) (d) “Ward" means a person for whom a guardian has been appointed.
450.115(2) (2) Nothing in this chapter, or rules promulgated under this chapter, prohibits any of the following:
450.115(2)(a) (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).
450.115(2)(b) (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.
450.115(2)(c) (c) Subject to sub. (4), the possession of a prescription drug under a written authorization described in sub. (3).
450.115(3) (3)
450.115(3)(a)(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.
450.115(3)(b) (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.
450.115(3)(c) (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.
450.115(3)(d) (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.
450.115(4) (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:
450.115(4)(a) (a) The authorization describes with reasonable specificity each prescription drug or controlled substance that is to be disposed of.
450.115(4)(b) (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.
450.115(4)(c) (c) The authorization and each prescription drug or controlled substance to be disposed of were obtained without consideration.
450.115 History History: 2013 a. 198; 2015 a. 197; 2017 a. 99.
450.12 450.12 Labeling of prescription drugs and prescription drug products.
450.12(1) (1) In this section:
450.12(1)(a) (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.
450.12(1)(b) (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.
450.12(2) (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.
450.12(3) (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.
450.12(4) (4) This section does not apply with respect to biological products.
450.12 History History: 1985 a. 146; 2017 a. 149.
450.122 450.122 Labeling of biological products.
450.122(1) (1) In this section:
450.122(1)(a) (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.
450.122(1)(b) (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.
450.122(2) (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.
450.122(3) (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.
450.122 History History: 2017 a. 149; s. 35.17 correction in (2).
450.125 450.125 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.
450.125 History History: 1991 a. 306; 2015 a. 55.
450.13 450.13 Using drug product equivalent in dispensing prescriptions.
450.13(1e)(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.
450.13(1s) (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.
450.13(2) (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.
450.13(3) (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.
450.13(4) (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.
450.13(5) (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:
450.13(5)(a) (a) The patient's individual physician.
450.13(5)(b) (b) The patient's advanced practice nurse prescriber, if the advanced practice nurse prescriber has entered into a written agreement to collaborate with a physician.
450.13(5)(c) (c) The patient's physician assistant.
450.13(6) (6)Applicability. This section does not apply with respect to a prescription for a biological product.
450.135 450.135 Using interchangeable biological product in dispensing prescriptions.
450.135(1) (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.
450.135(2) (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.
450.135(3) (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.
450.135(4) (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.
450.135(5) (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:
450.135(5)(a) (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:
450.135(5)(a)1. 1. An interoperable electronic medical records system.
450.135(5)(a)2. 2. An electronic prescribing technology.
450.135(5)(a)3. 3. A pharmacist benefit management system.
450.135(5)(a)4. 4. A pharmacy record.
450.135(5)(b) (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:
450.135(5)(b)1. 1. There is no interchangeable biological product for the product prescribed.
450.135(5)(b)2. 2. A refill of the biological product is not changed from the product dispensed on the prior filling of the prescription.
450.135(6) (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.
450.135(7) (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:
450.135(7)(a) (a) The patient's individual physician.
450.135(7)(b) (b) The patient's advanced practice nurse prescriber, if the advanced practice nurse prescriber has entered into a written agreement to collaborate with a physician.
450.135(7)(c) (c) The patient's physician assistant.
450.135(8) (8)Applicability. This section applies only with respect to prescriptions for biological products.
450.135(9) (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.
450.135 History History: 2017 a. 149.
450.137 450.137 Access to investigational drugs, devices, and biological products for terminally ill patients.
450.137(1) (1)Definitions. In this section:
450.137(1)(a) (a) “Eligible patient" means a patient who is eligible under sub. (2).
450.137(1)(b) (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:
450.137(1)(b)1. 1. The drug, device, or biological product has successfully completed a phase one clinical trial approved by the federal food and drug administration.
450.137(1)(b)2. 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.
450.137(1)(b)3. 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).
450.137(1)(c) (c) “Life-threatening disease or condition” means a disease or condition that is life-threatening, as defined in 21 CFR 312.81 (a).
450.137(2) (2)Eligibility. An individual is an eligible patient for purposes of this section if the individual meets all of the following conditions:
450.137(2)(a) (a) Has been diagnosed with a life-threatening disease or condition.
450.137(2)(b) (b) Has exhausted approved treatment options and is unable to participate in a clinical trial involving the investigational drug, device, or biological product.
450.137(2)(c) (c) Has received a recommendation or prescription order from the individual's treating physician for an investigational drug, device, or biological product.
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2015-16 Wisconsin Statutes updated through 2017 Wis. Act 273 and all Supreme Court and Controlled Substances Board Orders effective on or before April 14, 2018. Published and certified under s. 35.18. Changes effective after April 14, 2018 are designated by NOTES. (Published 4-14-18)