450.11(4)(b)
(b) Paragraph (a) does not apply to complimentary samples of drug products or devices dispensed by a practitioner to his or her patients.
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(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)(a)(a) 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)(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)(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)(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.
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(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 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 and each prescription drug 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 to be disposed of were obtained without consideration.
450.115 History
History: 2013 a. 198;
2015 a. 197.
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 History
History: 1985 a. 146.
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(1)(1)
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. 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.
450.13(2)
(2) Exception. A prescriber 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. (1). 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) Renewed prescriptions. Prescriptions dispensed with a drug product equivalent may be renewed 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 (1) 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.
450.14(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.
450.145
450.145
Reporting potential causes of public health emergency.