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.
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 or has practical experience acquired in another state which is comparable to that included in an 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 Cross-reference
Cross Reference: See also ch.
Phar 4 and s.
Phar 2.03, Wis. adm. code.
450.04 Annotation
Post-examination review with applicants discussed. 68 Atty. Gen. 48.
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 Cross-reference
Cross Reference: See also chs.
Phar 2 and
5, Wis. adm. code.
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
Pharmacies located in this state; licensure. 450.06(1)(1) No pharmacist may dispense at any location in this state that is not licensed as a pharmacy by the board. No person in this state 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 under this section as a pharmacy by the board.
450.06(2)
(2) The board shall issue a license to operate a pharmacy at a specific location in this state 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 located in this state 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 Cross-reference
Cross Reference: See also ch.
Phar 6, Wis. adm. code.
450.065
450.065
Out-of-state pharmacies; licensure. 450.065(1)
(1) No pharmacy that is in another state may ship, mail, or otherwise deliver a prescribed drug or device to persons in this state unless the pharmacy is licensed under
sub. (2).
450.065(2)
(2) The board shall issue a license to a pharmacy that is located outside this state if the pharmacy does all of the following:
450.065(2)(a)
(a) Applies on a form provided by the board that shows all of the following:
450.065(2)(a)2.
2. The name and address of the person holding title and ownership control of the location.
450.065(2)(b)
(b) Submits a statement in a form prescribed by the board from the owner of the pharmacy or, if the pharmacy is not a sole proprietorship, from the managing pharmacist of the pharmacy that indicates that the owner or managing pharmacist, whichever is applicable, knows the laws relating to the practice of pharmacy in this state.
450.065(2)(c)
(c) Submits evidence satisfactory to the board that it is licensed in the state in which it is located.
450.065(3)
(3) A pharmacy that applies for a license under
sub. (2) may not be required to comply with any provision in this chapter or any rule promulgated under this chapter relating to the professional service area of a pharmacy or the minimum equipment requirements for a pharmacy.
450.065(4)(a)(a) Notwithstanding
s. 450.03, a pharmacist employed in a pharmacy licensed under this section is not required to be licensed under this chapter.
450.065(4)(b)
(b) Notwithstanding
s. 450.09, a pharmacy licensed under this section is not required to be under the control of a managing pharmacist licensed under this chapter.
450.065(5)
(5) A pharmacy licensed under this section shall provide a telephone number that allows a person in this state to contact the pharmacy during the pharmacy's regular hours of business and that is available for use by a person in this state for not less than 40 hours per week.
450.065 History
History: 2005 a. 242.
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:
450.07(3)(c)
(c) Persons who procure prescription drugs or devices for the purpose of lawful research, teaching or testing and not for resale.
450.07(3)(d)
(d) Hospitals and other institutions which procure prescription drugs or devices for administration to patients.
450.07(3)(e)
(e) Officers or employees of the federal government who are authorized to receive prescription drugs or devices in the performance of their official duties.
450.07(4)(a)(a) The issuance of licenses under this section is subject to rules the board adopts for the protection of the public health and safety.
450.07(4)(b)
(b) The board shall adopt rules prescribing minimum standards for manufacturing and distributing drugs. Rules adopted under this paragraph may not impose requirements regarding the storage of a controlled substance in a safe, a steel cabinet, a vault, or any other secure storage compartment, area, room, or building unless one of the following applies:
450.07(4)(b)1.
1. The controlled substance is included in schedule I, II, III, or IV under
ch. 961.
450.07(4)(b)2.
2. The controlled substance is also a controlled substance under federal law.
450.07 Cross-reference
Cross Reference: See also chs.
Phar 12 and
13, Wis. adm. code.
