Chapter 450

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.

450.137(2)(d) (d) Has given written informed consent to use the investigational drug, device, or biological product. The content of the written informed consent provided by the patient shall be consistent with and at least as comprehensive as the consent used in clinical trials for the investigational drug, device, or biological product.

450.137(2)(e) (e) Is aware of the potential costs that may be associated with or otherwise result from the use of the investigational drug, device, or biological product under this section.

450.137(2)(f) (f) Possesses a written verification executed by the individual’s treating physician attesting that the individual meets the conditions under pars. (a) to (e), and that the physician is not compensated directly by the manufacturer of the investigational drug, device, or biological product for making that attestation.

450.137(3) (3) Manufacturers. A manufacturer of an investigational drug, device, or biological product may, but is not required to, make that investigational drug, device, or biological product available to an eligible patient. If the manufacturer charges an eligible patient for an investigational drug, device, or biological product, the manufacturer may not charge more than an amount that is equal to the manufacturer’s actual cost to manufacture the investigational drug, device, or biological product provided to the eligible patient.

450.137(4) (4) Limitations of liability.

450.137(4)(a) (a) A physician is immune from civil or criminal liability or from professional discipline under s. 448.02 based solely on the physician’s recommendation to an eligible patient for the use of an investigational drug, device, or biological product to treat the patient’s life-threatening disease or condition if the eligible patient gives written informed consent that satisfies sub. (2) (d) and s. 448.30.

450.137(4)(b) (b) Any manufacturer, distributor, pharmacist, practitioner, health care facility, or other person who lawfully makes available, delivers, distributes, prescribes, dispenses, or administers an investigational drug, device, or biological product to an eligible patient consistent with this section, and who in doing so exercises reasonable care, may not be held liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from any of the following:

450.137(4)(b)1. 1. The design, development, clinical testing, investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of the investigational drug, device, or biological product.

450.137(4)(b)2. 2. The lack of safety or effectiveness of the investigational drug, device, or biological product.

450.137(5) (5) Reporting. The manufacturer or sponsor of an investigational drug, device, or biological product that makes the investigational drug, device, or biological product available to a patient in this state shall submit to the federal food and drug administration an annual summary of the use of the investigational drug, device, or biological product. The summary shall include the number of doses supplied, the number of patients treated, the uses for which it was made available, and any known serious adverse events.

450.137(6) (6) State officials. No official, employee, or agent of this state may block or attempt to block an eligible patient’s access to an investigational drug, device, or biological product. Any counseling, advice, or recommendation of a practitioner that is consistent with the applicable standard of care for the practitioner is not a violation of this subsection.

450.137(7) (7) Insurance. Nothing in this section alters the obligations of an eligible patient’s insurer under the contract of insurance and applicable law.

450.137 History History: 2017 a. 165 s. 1; 2021 a. 238 s. 44.

450.14 450.14 Poisons.

450.14(1) (1) In this section, “highly toxic” has the meaning specified under 15 USC 1261 (h).

450.14(2) (2) No person may deliver any highly toxic substance unless the delivery is made on the prescription order of a practitioner or complies with pars. (a) to (d):

450.14(2)(a) (a) The container shall be plainly labeled with the name of the substance, the name and address of the person delivering the substance and, except as provided in sub. (3), the word “Poison”.

450.14(2)(b) (b) The person delivering the substance shall ascertain that the recipient is aware of the poisonous character of the substance and desires it for a lawful purpose.

450.14(2)(c) (c) Before delivery, the person delivering the substance shall record in a book kept for that purpose the name of the article or substance, the quantity, the purpose, the date, the name and address of the person for whom procured and the signature of the individual personally delivering the article or substance. The record shall be signed by the person to whom the substance is delivered. Each book containing records required under this paragraph shall be preserved by the owner of the book for at least 3 years after the date of the last entry and shall be open to inspection by authorized officers.

450.14(2)(d) (d) If the recipient is under 18 years of age, he or she must have the written order of an adult.

450.14(3) (3) A “Poison” label under sub. (2) (a) is not required for liniments, ointments or other external preparations which are plainly labeled “for external use only”.

450.14(4) (4) This section does not apply to manufacturers or distributors selling at wholesale nor to pesticides which comply with ss. 94.67 to 94.71.

450.14(5) (5) Any person who violates this section is guilty of a Class H felony.

450.14 History History: 1985 a. 146; 1997 a. 283; 2001 a. 109.

450.145 450.145 Reporting potential causes of public health emergency.

450.145(1) (1) Within 24 hours after an occurrence of any of the following, a pharmacist or pharmacy shall report the occurrence electronically, by fax machine, by telephone, or in writing to a local health department, as defined in s. 250.01 (4), or the department of health services:

450.145(1)(a) (a) An unusual increase in the number of prescriptions dispensed or nonprescription drug products sold by the pharmacist or pharmacy for the treatment of medical conditions specified by the department of health services by rule under s. 252.02 (7).

450.145(1)(b) (b) An unusual increase in the number of prescriptions dispensed by the pharmacist or pharmacy that are antibiotic drugs.

450.145(1)(c) (c) The dispensing of a prescription by the pharmacist or pharmacy for treatment of a disease that is relatively uncommon or may be associated with bioterrorism, as defined in s. 323.02 (4).

450.145(1m) (1m) Except as provided in sub. (2), a pharmacist or pharmacy may not report personally identifying information concerning an individual who is dispensed a prescription or who purchases a nonprescription drug product as specified in sub. (1) (a), (b), or (c).

450.145(2) (2) In submitting a report under sub. (1), a pharmacist or pharmacy shall include personally identifying information other than a social security number concerning an individual who is dispensed a prescription or who purchases a nonprescription drug product as specified in sub. (1) (a), (b), or (c).

450.145 History History: 2005 a. 198 ss. 18 to 21; 2007 a. 20 s. 9121 (6) (a); 2007 a. 97 s. 183; 2009 a. 42.

450.15 450.15 Placing prescription drugs prohibited.

450.15(1) (1) Except as otherwise provided by law, no person may put, or cause to be put, any prescription drug in any public place, or upon any private premises without the consent of the owner or occupant.

450.15(2) (2) Any person who violates this section is guilty of a Class H felony.

450.15 History History: 1985 a. 146; 1997 a. 283; 2001 a. 109.

450.15 Annotation As applied to the defendant, s. 450.09 [now this section] was not unconstitutionally overbroad or vague. Butala v. State, 71 Wis. 2d 569, 239 N.W.2d 32 (1976).

450.155 450.155 Exhibition, display or advertisement of certain vending machines by use of certain material prohibited.

450.155(1) (1) Definitions. In this section:

450.155(1)(a) (a) “Contraceptive article” means any drug, medicine, mixture, preparation, instrument, article or device of any nature used or intended or represented to be used to prevent a pregnancy.

450.155(1)(b) (b) “Material” means any visual representation, image, printed matter however reproduced or sound recording.

450.155(1)(c) (c) “Harmful to minors” means that quality of any description or representation, in whatever form, of nudity, sexual conduct, sexual excitement, or sadomasochistic abuse, when it does all of the following:

450.155(1)(c)1. 1. Predominantly appeals to the prurient, shameful or morbid interest of minors.

450.155(1)(c)2. 2. Is patently offensive to prevailing standards in the adult community as a whole with respect to what is suitable material for minors.

450.155(1)(c)3. 3. Lacks serious literary, artistic, political or scientific value, if taken as a whole, for minors.

450.155(1)(d) (d) “Knowledge of the minor’s age” means knowledge or information that the person is a minor.

450.155(1)(e) (e) “Knowledge of the nature of the material” means any of the following:

450.155(1)(e)1. 1. Knowledge of the character and content of any material described herein.

450.155(1)(e)2. 2. Knowledge or information that the material described herein has been adjudged to be harmful to minors in a proceeding instituted under sub. (2), or is the subject of a pending proceeding instituted under sub. (2).

450.155(1)(f) (f) “Minor” means any person under the age of 18 years.

450.155(1)(g) (g) “Nudity” means the showing of the human male or female genitals, pubic area or buttocks with less than a full opaque covering, or the showing of the female breast with less than a fully opaque covering of any portion thereof below the top of the nipple, or the depiction of covered male genitals in a discernibly turgid state.

450.155(1)(h) (h) “Person” means any individual, partnership, firm, association, corporation or other legal entity.

450.155(1)(i) (i) “Sadomasochistic abuse” means the infliction of force, pain or violence upon a person for the purpose of sexual arousal or gratification.

450.155(1)(j) (j) “Sexual conduct” means acts of masturbation, homosexuality, sexual intercourse or physical contact with a person’s clothed or unclothed genitals, pubic area, buttocks or, if such person is a female, breast.

450.155(1)(k) (k) “Sexual excitement” means the condition of human male or female genitals when in a state of sexual stimulation or arousal.

450.155(1)(L) (L) “Vending machine” means any mechanical device which automatically dispenses contraceptive articles upon the deposit in it of specified coins in payment for the contraceptive articles.

450.155(2) (2) Exhibition, display or advertisement of certain vending machines by use of material harmful to minors.

450.155(2)(a) (a) No person with knowledge of the nature of the material and with knowledge of a minor’s age, may, for commercial purposes, exhibit, display or advertise by use of any material which is harmful to minors a vending machine that dispenses contraceptive articles.

450.155(2)(b) (b) Whoever violates par. (a) may be fined not more than $10,000 or imprisoned for not more than 9 months or both.

450.155 History History: 1985 a. 146.

450.16 450.16 Sale of contraceptives prohibited in certain areas.

450.16(1) (1) In this section, “vending machine” has the meaning given under s. 450.155 (1) (L).

450.16(2) (2) No person may have in the person’s possession or under the person’s control, any vending machine that is located in a public school, as specified under s. 115.01 (1).

450.16(3) (3) Any person violating this section may be fined not more than $10,000 or imprisoned for not more than 9 months or both.

450.16 History History: 1985 a. 146; 2017 a. 366.

450.17 450.17 Violations. Each member of the board shall investigate and institute actions for violations of this chapter by any person and for violation of ch. 961 by pharmacists or pharmacy technicians. The district attorney of the proper county shall promptly prosecute any such violation upon notice from any source.

450.17 History History: 1985 a. 146; 1995 a. 448; 2021 a. 100.

450.18 450.18 Penalties. Except as otherwise provided in this chapter, any person who violates this chapter or any rule promulgated under the authority of this chapter may be fined not less than $50 nor more than $100 or imprisoned not less than 30 days nor more than 90 days or both.

450.18 History History: 1985 a. 146.