450.11(4g)(a)1. 1. “Brand name" has the meaning given in s. 450.12 (1) (a).
450.11(4g)(a)2. 2. “Drug product equivalent" has the meaning given in s. 450.13 (1e).
450.11(4g)(a)3. 3. “Generic name" has the meaning given in s. 450.12 (1) (b).
450.11(4g)(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.
450.11(4g)(c) (c) This subsection does not apply to a prescription order for a biological product.
450.11(4i) (4i)Brand name permitted on label; biological products.
450.11(4i)(a)(a) In this section:
450.11(4i)(a)1. 1. “Brand name" has the meaning given in s. 450.122 (1) (a).
450.11(4i)(a)2. 2. “Interchangeable biological product” has the meaning given in s. 450.135 (1).
450.11(4i)(a)3. 3. “Proper name” has the meaning given in s. 450.122 (1) (b).
450.11(4i)(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.
450.11(4m) (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.
450.11(5) (5)Initial fills and refills.
450.11(5)(a) (a) Except as provided in par. (bm), 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).
450.11(5)(b)1.1. 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.
450.11(5)(b)2. 2. The authority of a pharmacist under par. (a) to dispense varying quantities of a drug does not apply with respect to controlled substances.
450.11(5)(b)3. 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.
450.11(5)(bm)1.1. 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:
450.11(5)(bm)1.a. 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.
450.11(5)(bm)1.b. 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.
450.11(5)(bm)1.c. 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.
450.11(5)(bm)1.d. 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.
450.11(5)(bm)2.a.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.
450.11(5)(bm)2.b. 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.
450.11(5)(bm)2.c. c. A pharmacist may not extend a prescription order under subd. 1. for a drug that is a controlled substance.
450.11(5)(bm)2.d. 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.
450.11(5)(bm)2.e. e. A pharmacist shall, at the earliest reasonable time after acting under subd. 1., notify the prescribing practitioner or his or her office.
450.11(5)(c) (c) An accurate record of refill dispensing shall be maintained showing the date and amount.
450.11(6) (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.
450.11(7) (7)Prohibited acts.
450.11(7)(a) (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.
450.11(7)(b) (b) Information communicated to a physician, physician assistant, or advanced practice nurse prescriber in an effort to procure unlawfully a prescription drug or the administration of a prescription drug is not a privileged communication.
450.11(7)(c) (c) No person may willfully make a false statement in any prescription order, report or record required by this section.
450.11(7)(d) (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 or practitioner.
450.11(7)(e) (e) No person may make or utter any false or forged prescription order.
450.11(7)(f) (f) No person may willfully affix any false or forged label to a package or receptacle containing prescription drugs.
450.11(7)(g) (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.
450.11(7)(h) (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.
450.11(7)(i) (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.
450.11(8) (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:
450.11(8)(a) (a) The board, insofar as this section applies to pharmacists.
450.11(8)(b) (b) The medical examining board, insofar as this section applies to physicians and physician assistants.
450.11(8)(bm) (bm) The podiatry affiliated credentialing board, insofar as this section applies to podiatrists.
450.11(8)(c) (c) The veterinary examining board, insofar as this section applies to veterinarians.
450.11(8)(d) (d) The dentistry examining board, insofar as this section applies to dentists.
450.11(8)(e) (e) The board of nursing, insofar as this section applies to advanced practice nurse prescribers.
450.11(9) (9)Penalties and enforcement proceedings.
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.
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