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, if made 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 use of the therapeutic alternate drug selection has been approved for a patient during the period of the patient's stay within the hospital by any of the following:
450.01(16)(h)2.
2. The patient's advanced practice nurse prescriber, if the advanced practice nurse prescriber has entered into a written agreement to collaborate with a physician.
450.01(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(16)(k)
(k) Administering prescribed drug products and devices under
s. 450.035 (1r) and, pursuant to vaccination protocols, vaccines.
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)(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 an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient.
450.01(22)
(22) "Vaccination protocol" means a written protocol agreed to by a physician, as defined in
s. 448.01 (5), and a pharmacist that establishes procedures and record-keeping and reporting requirements for the administration of a vaccine by a pharmacist for a period specified in the protocol that may not exceed 2 years.
450.01 Annotation
Vitamins not intended for use in the diagnosis, cure, investigation, treatment, or prevention of diseases are not drugs under 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(2g)(a)(a) The pharmacy examining board shall, after consultation with the medical examining board and the board of nursing, promulgate rules that establish criteria for approving courses under
ss. 450.035 (1r) and
(2) and
450.085 (1).
450.02(2g)(b)
(b) The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in
s. 450.035 (1g), by a pharmacist under
s. 450.035 (1r). Notwithstanding
s. 15.08 (5) (b), the board may promulgate rules under this paragraph only if the rules are identical to rules recommended by the pharmacist advisory council. The board may amend or repeal rules promulgated under this paragraph only upon the recommendation of the pharmacist advisory council.
450.02(2m)
(2m) The board shall periodically prepare and distribute letters, bulletins or other types of notice to pharmacists that identify the courses that are approved for purposes of
ss. 450.035 (1r) and
(2) and
450.085 (1).
450.02(3)
(3) The board may promulgate rules:
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(3m)(a)(a) The board or its designee may grant a variance to a requirement of this chapter or to a rule promulgated by the board if all of the following are true:
450.02(3m)(a)1.
1. The board or its designee determines that a natural or man-made disaster or emergency exists or has occurred.
450.02(3m)(a)3.
3. The board or its designee determines that the variance is necessary to protect the public health, safety, or welfare.
450.02(3m)(am)
(am) If a member of the board disagrees with a decision made by a designee under
par. (a), the board chairperson shall call a meeting of the board as soon as practicable to review the decision. The board may affirm or modify the designee's decision.
450.02(3m)(b)
(b) A variance granted under
par. (a) shall be for a stated term not to exceed 90 days, except that the board or its designee may extend the variance upon request by a pharmacist if it determines that an extension is necessary to protect the public health, safety, or welfare.
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.
450.02 Cross-reference
Cross Reference: See also
Phar, Wis. adm. code.
450.025
450.025
Pharmacist advisory council. The pharmacist advisory council shall recommend rules for promulgation by the board under
s. 450.02 (2g) (b) and may recommend the amendment or repeal of any rules promulgated under
s. 450.02 (2g) (b). A unanimous vote of the members of the pharmacist advisory council is required for the council to make a recommendation under this section.
450.025 History
History: 1997 a. 68;
1997 a. 237 s.
727m.
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(1)(f)
(f) A person who has successfully completed his or her second year in, and is enrolled at, an accredited school of pharmacy and whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board.
450.03(1)(g)
(g) A person who has applied for a license under
s. 450.05 whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and during the period before which the board takes final action on the person's application.
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.
450.03 Cross-reference
Cross Reference: See also chs.
Phar 2 and
17, Wis. adm. code.
450.035
450.035
Administration of drug products and devices; vaccines. 450.035(1g)(1g) In this section, "drug product or device" does not include a vaccine.
450.035(1r)
(1r) A pharmacist may not administer by injection a prescribed drug product or device unless he or she has successfully completed a course of study and training in injection technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board. A pharmacist may administer a prescribed drug product or device under this subsection only in the course of teaching self-administration techniques to a patient. A pharmacist who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under
s. 450.02 (2g) (b).
450.035(1t)
(1t) A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board. A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may administer a prescribed drug product or device under this subsection only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board, and only in the course of teaching self-administration techniques to a patient. A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under
s. 450.02 (2g) (b).
450.035(2)
(2) A pharmacist may not administer a vaccine unless he or she has successfully completed 12 hours in a course of study and training, approved by the American Council on Pharmaceutical Education or the board, in vaccination storage, protocols, administration technique, emergency procedures and record keeping and has satisfied the requirements specified in
sub. (2t). A pharmacist may not administer a vaccine under this subsection to a person who is under the age of 18.
450.035(2g)
(2g) A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a vaccine unless he or she acts under the direct supervision of a pharmacist and he or she and the supervising pharmacist have successfully completed 12 hours in a course of study and training, approved by the American Council on Pharmaceutical Education or the board, in vaccination storage, protocols, administration technique, emergency procedures and record keeping and the supervising pharmacist has satisfied the requirements specified in
sub. (2t). A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a vaccine under this subsection to a person who is under the age of 18.
450.035(2m)
(2m) Except as provided in
sub. (1t) or
(2g), a pharmacist may not delegate to any person any administration of a prescribed drug product or device or vaccine under
sub. (1r) or
(2).
450.035(2t)
(2t) A pharmacist may not administer a vaccine under
sub. (2) or supervise a person administering a vaccine under
sub. (2g) unless the pharmacist satisfies each of the following:
450.035(2t)(a)
(a) The pharmacist has in effect liability insurance that covers the pharmacist and a person who administers a vaccine under
sub. (2g) against loss, expense and liability resulting from errors, omissions or neglect in the administration of vaccines in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year.
450.035(2t)(b)
(b) The pharmacist maintains proof that he or she satisfies the requirement specified in
par. (a) and, upon request, provides copies of such proof to the department or the board.
450.035(3)
(3) A pharmacist or a person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) who successfully completes a course of study and training specified in
sub. (1r),
(1t),
(2), or
(2g) shall maintain proof of completion and, upon request, provide copies of such proof to the department or the board.
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.
