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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)1. 1. The location of the pharmacy.
450.06(2)(a)2. 2. A floor plan of the pharmacy.
450.06(2)(a)3. 3. The name and address of the person holding title and ownership control of the location.
450.06(2)(a)4. 4. The name of the managing pharmacist of the pharmacy under s. 450.09 (1).
450.06(2)(b) (b) The location of the pharmacy is inspected in a manner approved by the board and found to meet all the requirements of this chapter.
450.06(2)(c) (c) The initial credential fee determined by the department under s. 440.03 (9) (a) is paid.
450.06(2m) (2m)The board may 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)1. 1. The location of the pharmacy.
450.065(2)(a)2. 2. The name and address of the person holding title and ownership control of the location.
450.065(2)(a)3. 3. The name of the managing pharmacist of the pharmacy.
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(2)(d) (d) Pays the initial credential fee determined by the department under s. 440.03 (9) (a).
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) (4)
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; 2007 a. 20.
450.068 450.068 Pharmacy technicians; registration.
450.068(1)(1)No person may engage in the practice of a pharmacy technician or use the title “pharmacy technician” or “pharmacy tech” unless the person is registered as a pharmacy technician by the board.
450.068(2) (2)Except as provided in s. 450.10, the board shall issue a registration as a pharmacy technician to an applicant who satisfies all of the following:
450.068(2)(a) (a) The applicant submits an application for registration on a form provided by the board that specifies all of the following:
450.068(2)(a)1. 1. The applicant's home address.
450.068(2)(a)2. 2. If the applicant is employed, the name and address of the applicant's employer, and the applicant's place of employment.
450.068(2)(b) (b) The applicant satisfies one of the following:
450.068(2)(b)1. 1. The applicant is at least 18 years of age and has graduated from high school or has attained high school graduation equivalency as determined by the department of public instruction.
450.068(2)(b)2. 2. The applicant is enrolled in a youth apprenticeship program for pharmacy technicians that is on the list of youth apprenticeship programs approved by the department of workforce development under s. 106.13 (2m).
450.068(2)(d) (d) The applicant pays the fee specified in s. 440.05 (1).
450.068(3) (3)A pharmacy technician shall do all of the following:
450.068(3)(a) (a) Notwithstanding s. 440.11, if the pharmacy technician moves from the last address provided to the department, notify the department of his or her new address within 10 days of the change in writing or in accordance with other notification procedures approved by the department.
450.068(3)(b) (b) If the pharmacy technician changes his or her employer or place of employment, notify the department of his or her new employer or address of employment within 10 days of the change in writing or in accordance with other notification procedures approved by the department and, if required by the department, pay the transfer fee under s. 440.05 (7).
Effective date note NOTE: This section is created eff. 1-1-23 by 2021 Wis. Act 100.
450.068 History History: 2021 a. 100.
450.07 450.07 Manufacturers; licensure.
450.07(1)(1)Except as provided under sub. (1m), 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 initial credential fee determined by the department under s. 440.03 (9) (a).
450.07(1m) (1m)A license is not required under this section for a person to engage in the manufacturing of hemp, as defined in s. 94.55 (1).
450.07(4) (4)
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(4)(c) (c) The rules adopted by the board under par. (b) shall require a manufacturer to maintain and to update at least once per month a list of the manufacturer's authorized distributors of record.
450.07 Cross-reference Cross-reference: See also chs. Phar 12 and 13, Wis. adm. code.
450.071 450.071 Wholesale distributors; licensure.
450.071(1)(1)No person may engage in the wholesale distribution of a prescription drug in this state without obtaining a license from the board for each facility from which the person distributes prescription drugs. The board shall exempt a manufacturer that distributes prescription drugs or devices manufactured by the manufacturer from licensing and other requirements under this section to the extent the license or requirement is not required under federal law or regulation, unless the board determines that it is necessary to apply a requirement to a manufacturer.
450.071(2) (2)An applicant shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application:
450.071(2)(a) (a) The name, business address, and telephone number of the applicant.
450.071(2)(b) (b) All trade or business names used by the applicant.
450.071(2)(c) (c) Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs.
450.071(2)(d) (d) The type of ownership or operation for the applicant's business.
450.071(2)(e) (e) If the applicant's wholesale distribution business is a partnership, the name of each partner and the name of the partnership.
450.071(2)(f) (f) If the applicant's wholesale distribution business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation.
450.071(2)(g) (g) If the applicant's wholesale distribution business is a sole proprietorship, the name of the sole proprietor and the name of the business entity.
450.071(2)(h) (h) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.
450.071(2)(i) (i) The name, address, and telephone number of a designated representative.
450.071(2)(j) (j) For the person listed in par. (i), a personal information statement that contains all of the following:
450.071(2)(j)1. 1. The person's date and place of birth.
450.071(2)(j)2. 2. The person's places of residence for the 7-year period immediately preceding the date of the application.
450.071(2)(j)3. 3. The person's occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application.
450.071(2)(j)4. 4. The name and addresses for each business, corporation, or other entity listed in subd. 3.
450.071(2)(j)5. 5. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding.
450.071(2)(j)6. 6. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction.
450.071(2)(j)7. 7. A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party.
450.071(2)(j)8. 8. A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the applicant shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.
450.071(2)(j)9. 9. A photograph of the person taken within the 12-month period immediately preceding the date of the application.
450.071(2)(k) (k) A statement that each facility used by the applicant for the wholesale distribution of prescription drugs has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection.
450.071(3) (3)The board shall grant a license to the applicant to engage in the wholesale distribution of prescription drugs if all of the following apply:
450.071(3)(a) (a) The applicant pays the fee under s. 440.05 (1) (a).
450.071(3)(b) (b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements adopted by the board for wholesale distribution facilities.
450.071(3)(c) (c) All of the following apply to each person identified by the applicant as a designated representative:
450.071(3)(c)1. 1. The person is at least 21 years old.
450.071(3)(c)2. 2. The person has been employed full time for at least 3 years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing and distribution of, and record keeping related to, prescription drugs.
450.071(3)(c)3. 3. The person is employed by the applicant full time in a managerial level position.
450.071(3)(c)4. 4. The person is physically present at the wholesale prescription drug distributor's facility during regular business hours and is involved in and aware of the daily operation of the wholesale prescription drug distributor. This subdivision does not preclude the designated representative from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes.
450.071(3)(c)5. 5. The person is actively involved in and aware of the daily operations of the wholesale distributor.
450.071(3)(c)6. 6. The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one wholesale distributor is located at the facility and the wholesale distributors located at the facility are members of an affiliated group.
450.071(3)(c)7. 7. The person has not been convicted of violating any federal, state, or local law relating to wholesale or retail prescription drug distribution or distribution of a controlled substance.
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2019-20 Wisconsin Statutes updated through 2021 Wis. Act 267 and through all Supreme Court and Controlled Substances Board Orders filed before and in effect on June 29, 2022. Published and certified under s. 35.18. Changes effective after June 29, 2022, are designated by NOTES. (Published 6-29-22)