450.01(10)(a)
(a) Any substance recognized as a drug in the official U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States or any supplement to either of them;
450.01(10)(b)
(b) Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals;
450.01(10)(c)
(c) Any substance other than a device or food intended to affect the structure or any function of the body of persons or other animals; or
450.01(10)(d)
(d) Any substance intended for use as a component of any article specified in
pars. (a) to
(c) but does not include gases or devices or articles intended for use or consumption in or for mechanical, industrial, manufacturing or scientific applications or purposes.
450.01(11)
(11) "Drug product" means a specific drug or drugs in a specific dosage form and strength from a known source of manufacture.
450.01(13)
(13) "Manufacturing" means making, assembling, processing or modifying devices, or mixing, producing or preparing drugs in dosage forms by encapsulating, entableting or other process, or packaging, repackaging or otherwise changing the container, wrapper or label of any package containing a drug or device in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.
450.01(13m)
(13m) "Nonprescription drug product" means any nonnarcotic drug product which may be sold without a prescription order and which is prepackaged for use by consumers and labeled in accordance with the requirements of state and federal law.
450.01(14)
(14) "Patient" means the person or other animal for whom drug products or devices are prescribed or to whom drug products or devices are dispensed or administered.
450.01(16)
(16) "Practice of pharmacy" means any of the following:
450.01(16)(b)
(b) Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices.
450.01(16)(d)
(d) Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices.
450.01(16)(e)
(e) Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses.
450.01(16)(g)
(g) Supervision of pharmacist supportive personnel.
450.01(16)(h)
(h) Making therapeutic alternate drug selections in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of a hospital and approved by the hospital's medical staff and by an individual physician for his or her patients for the period of each patient's stay within the hospital.
450.01(16)(i)
(i) Drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.
450.01(16)(j)
(j) Performing any act necessary to manage a pharmacy.
450.01(17)
(17) "Practitioner" means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.
450.01(18)
(18) "Prescribed drug or device" means any drug or device prescribed by a practitioner.
450.01(19)
(19) "Prescription" means a drug or device prescribed by a practitioner.
450.01(20)(a)
(a) Any drug, drug product or drug-containing preparation which is subject to
21 USC 353 (b) or
21 CFR 201.105.
450.01(20)(b)
(b) Any controlled substance included in schedules II to V of
ch. 961, whether by statute or rule, except substances which by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of
s. 450.11 (3),
(4) (a) and
(8) only and for violations thereof punishable under
s. 450.11 (9).
450.01(21)
(21) "Prescription order" means a written or oral order by a practitioner for a drug or device for a particular patient.
450.01 Annotation
Vitamins not intended for use in the diagnosis, cure, investigation, treatment or prevention of diseases are not drugs within the meaning of this section. 66 Atty. Gen. 137.
450.02
450.02
Pharmacy examining board. 450.02(1)
(1) The department shall keep a record of the proceedings and a register of the names and places of practice or business of pharmacies, manufacturers, distributors and other persons licensed under this chapter, and the books, registers and records of the department shall be prima facie evidence of the matters recorded.
450.02(2)
(2) The board shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under
s. 450.05.
450.02(3)(a)
(a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
450.02(3)(b)
(b) Establishing security standards for pharmacies.
450.02(3)(c)
(c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug.
450.02(3)(d)
(d) Necessary for the administration and enforcement of this chapter and
ch. 961.
450.02(3)(e)
(e) Establishing minimum standards for the practice of pharmacy.
450.02(3)(f)
(f) Establishing procedures for identifying pharmacists impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment.
450.02(4)
(4) The board may not promulgate a rule which does any of the following:
450.02(4)(a)
(a) Limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance with all applicable state and federal laws.
450.03
450.03
Pharmacist; licensure. 450.03(1)
(1) No person may engage in the practice of pharmacy or use the title "pharmacist" or sell, give away or barter drugs unless the person is licensed as a pharmacist by the board. This subsection does not apply to:
450.03(1)(b)
(b) The sale of any nonprescription drug product, in an original unbroken package, which complies with
21 USC 301 to
392.
450.03(1)(d)
(d) The delivery of complimentary samples of drug products or devices to a practitioner by a manufacturer or its agent acting in the usual course of business.
450.03(1)(e)
(e) Any person lawfully practicing within the scope of a license, permit, registration, certificate or certification granted to practice professional or practical nursing or nurse-midwifery under
ch. 441, to practice dentistry or dental hygiene under
ch. 447, to practice medicine and surgery under
ch. 448, to practice optometry under
ch. 449 or to practice veterinary medicine under
ch. 453, or as otherwise provided by statute.
450.03(2)
(2) The board shall issue a license as a pharmacist to any person who files satisfactory proof of qualifications under
s. 450.04 (3), passes the examination under
s. 450.04 and pays the fee specified in
s. 440.05 (1), except as provided under
s. 450.10.
450.04(1)(1) Examinations for licensure as a pharmacist shall be designed to determine whether an applicant is competent to engage in the practice of pharmacy.
450.04(2)
(2) Examinations shall be conducted at least semiannually.
450.04(3)
(3) Every candidate for examination for licensure as a pharmacist shall submit an application on a form provided by the department and pay the fee specified in
s. 440.05 (1) at least 30 days before the date of examination. Every candidate shall also submit proof to the board that he or she:
450.04(3)(a)
(a) Has received a professional degree from a pharmacy program approved by the board; and
450.04(3)(b)
(b) Has completed an internship in the practice of pharmacy under
s. 450.045 or has practical experience acquired in another state which is comparable to that included in the internship and which is approved and verified by the board or by the agency which is the equivalent of the board in the state in which the practical experience was acquired.
450.04 History
History: 1985 a. 146;
1991 a. 39.
450.04 Annotation
Post-examination review with applicants discussed. 68 Atty. Gen. 48.
450.045(1)(1) Internships in the practice of pharmacy shall be conducted under the general supervision and according to the procedures and standards of the pharmacy internship board.
450.045(2)
(2) Internships shall consist of practical experience in the responsibilities of a pharmacist and shall be conducted under the supervision of a pharmacist approved by the pharmacy internship board.
450.045(3)
(3) The director of the pharmacy internship program shall determine when an applicant has completed an internship and shall notify the board of all applicants who have completed internships.
450.045 History
History: 1985 a. 146.
450.05
450.05
Pharmacist licensed in other state; licensure. The board may, upon application and payment of the fee specified in
s. 440.05 (2), license as a pharmacist any person who is licensed in another state if the person produces satisfactory evidence of having met requirements comparable to those that existed in this state at the time the person became licensed in the other state. The board shall not license as a pharmacist under this section any person whose license to practice pharmacy in another state has been voluntarily surrendered, limited, suspended or revoked. The board may require an applicant under this section to pass an equivalency examination administered by the board. If the board requires an equivalency examination, any person licensed as a pharmacist in another state who is engaged in the active practice of pharmacy may only be required to pass an examination on state and federal laws, rules and regulations.
450.05 History
History: 1985 a. 146.
450.05 Annotation
This chapter applies to out-of-state pharmacies that regularly and continually solicit mail orders for retail sale of prescription drugs to Wisconsin residents.
72 Atty. Gen. 121.
450.06
450.06
Pharmacy; licensure. 450.06(1)(1) No pharmacist may dispense at any location which is not licensed as a pharmacy by the board. No person may use or display the title "pharmacy", "drugstore", "apothecary" or any other title, symbol or insignia having the same or similar meanings, except for a place of practice which is licensed as a pharmacy by the board.
450.06(2)
(2) The board shall issue a license to operate a pharmacy at a specific location if:
450.06(2)(a)
(a) An application is made on forms provided by the board showing all of the following:
450.06(2)(a)3.
3. The name and address of the person holding title and ownership control of the location.
450.06(2)(b)
(b) The location of the pharmacy is inspected and found to meet all the requirements of this chapter.
450.06(2m)
(2m) The board may request, but may not require, that practice-related information be submitted on the application under
sub. (2) (a).
450.06(3)
(3) No pharmacy may be opened or kept open for practice following a change of ownership or change of location unless the pharmacy is licensed for the new owner or at the new location, notwithstanding any remaining period of validity under the pharmacy's license under the previous owner or at the previous location.
450.06(4)
(4) Any person who fails to license his or her place of practice as required under this section may be assessed a forfeiture of not less than $25 nor more than $50 for each separate offense. Each day of violation constitutes a separate offense.
450.06 History
History: 1985 a. 146;
1991 a. 39.
450.07
450.07
Manufacturers and distributors; licensure. 450.07(1)(1) No person may engage in manufacturing in this state unless the person obtains a manufacturer's license from the board. For the issuance of a license under this subsection, the applicant shall pay the fee specified in
s. 440.05 (1).
450.07(2)
(2) No person may engage in the sale or distribution at wholesale of a prescription drug or device in this state without first obtaining a distributor's license from the board. For the issuance of a license under this subsection, the applicant shall pay the fee specified in
s. 440.05 (1).
450.07(3)
(3) No manufacturer or distributor may sell or distribute a prescription drug or device at wholesale to any person other than:
