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) Except as provided in
s. 450.062, 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.
Effective date note
NOTE: Par. (c) is amended eff. 7-1-09 by
2007 Wis. Act 20 to read:
Effective date text
(c) The initial credential fee determined by the department under s. 440.03 (9) (a) is paid.
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.
450.062
450.062
Remote dispensing. Pursuant to rules promulgated by the board, a pharmacist may dispense at the following locations:
450.062(2)
(2) The office or clinic of a practitioner.
450.062(4)
(4) A juvenile correctional facility under
s. 938.02 (10p), juvenile detention facility under
s. 938.02 (10r), residential care center for children and youth under
s. 938.02 (15d), secured residential care center for children and youth under
s. 938.02 (15g), type 1 juvenile correctional facility under
s. 938.02 (19), type 2 residential care center for children and youth under
s. 938.02 (19r), or type 2 juvenile correctional facility under
s. 938.02 (20).
450.062 History
History: 2007 a. 202.
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.
Effective date note
NOTE: Par. (d) is amended eff. 7-1-09 by
2007 Wis. Act 20 to read:
Effective date text
(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)(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.
450.07
450.07
Manufacturers; 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 initial credential fee determined by the department under
s. 440.03 (9) (a).
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 devises [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 Note
NOTE: The correct word is shown in brackets. Corrective legislation is pending.
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)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), except that before June 1, 2010, the amount of the initial fee is $350.
Effective date note
NOTE: Par. (a) is amended eff. 7-1-09 by
2007 Wis. Act 20 to read:
Effective date text
(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)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.
