Chapter 450

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; 2021 a. 238 s. 45.

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(5m) (5m) Disclosures to consumers.

450.13(5m)(a) (a) Each pharmacy shall post in a prominent place at or near the place where prescriptions are dispensed a sign that clearly describes a pharmacist’s ability under this state’s law to substitute a less expensive drug product equivalent under sub. (1s) unless the consumer or the prescribing practitioner has indicated otherwise under sub. (2).

450.13(5m)(b) (b) The pharmacy examining board shall create a list of the 100 most commonly prescribed generic drug product equivalents, including the generic and brand names of the drugs, and provide, either directly or on the department’s Internet site, the list to each pharmacy on an annual basis. Each pharmacy shall make available to the public information on how to access the list under this paragraph.

450.13(5m)(c) (c) Each pharmacy shall have available for the public a listing of the retail price, updated no less frequently than monthly, of the 100 most commonly prescribed prescription drugs, which includes brand name and generic equivalent drugs and biological products and interchangeable biological products, that are available for purchase at the pharmacy.

450.13(6) (6) Applicability. This section does not apply with respect to a prescription for a biological product.

450.13 History History: 1985 a. 146; 1991 a. 114; 1997 a. 27; 2005 a. 187; 2011 a. 161; 2017 a. 149; 2021 a. 9.

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(8m) (8m) Disclosure to consumers. Each pharmacy shall post in a prominent place at or near the place where prescriptions are dispensed a sign that clearly describes a pharmacist’s ability under this state’s law to substitute a less expensive interchangeable biological product under sub. (2) unless the consumer or the prescribing practitioner has indicated otherwise under sub. (3).

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. Each pharmacy shall make available for the public information on how to access the federal food and drug administration’s lists of all currently approved interchangeable biological products through the department’s Internet site.

450.135 History History: 2017 a. 149; 2021 a. 9.

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.