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)(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.
450.11 History
History: 1985 a. 146;
1997 a. 27,
175,
283;
2001 a. 109;
2005 a. 187,
195,
196,
242;
2007 a. 97;
2009 a. 113,
280;
2011 a. 159,
161;
2013 a. 199,
200,
239;
2015 a. 3,
35,
55,
115,
291;
2017 a. 18,
19,
133,
149,
226,
364;
2019 a. 185.
450.115
450.115
Drug disposal programs and authorizations. 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)(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)(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)(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.
450.12
450.12
Labeling of prescription drugs and prescription drug products. 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)(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)(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(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)(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)(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(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.
