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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; 2005 a. 242; 2007 a. 20, 202.
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(1) (1) A health care facility under s. 150.84 (2) or a facility identified under s. 980.065.
450.062(2) (2) The office or clinic of a practitioner.
450.062(3) (3) A county jail, rehabilitation facility under s. 59.53 (8), state prison under s. 302.01, or county house of correction under s. 303.16 (1).
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)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.
450.07 450.07 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) (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 History History: 1985 a. 146; 1991 a. 39; 2005 a. 14; 2007 a. 20.
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.
450.071(3)(c)8. 8. The person has not been convicted of a felony.
450.071(3)(c)9. 9. The person submits to the department 2 fingerprint cards, each bearing a complete set of the applicant's fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for the purposes of verifying the identity of the applicant and obtaining the applicant's criminal arrest and conviction record. This subdivision does not apply to a person accredited by the national association of boards of pharmacy's verified-accredited wholesale distributor program.
450.071(3m) (3m) Notwithstanding subs. (2) and (3), the board may grant a license to engage in the wholesale distribution of prescription drugs to a person who is domiciled in another state and is licensed to engage in the wholesale distribution of prescription drugs in another state, if the board determines that the standards for licensure in the state in which the person is licensed are at least as stringent as the standards for licensure under this section.
450.071(4) (4) The board may set, by rule, continuing education requirements for designated representatives under this section.
450.071(5) (5)
450.071(5)(a)(a) The board shall require every wholesale distributor to submit a surety bond acceptable to the board in an amount not to exceed $100,000 or other equivalent means of security acceptable to the board, except that the board shall not require submission of a bond or other security under this subsection by a chain pharmacy warehouse that is engaged only in intracompany transfers. A wholesale distributor that operates more than one facility is not required to submit a bond or other security under this paragraph for each facility.
450.071(5)(b) (b) The bond or other security under this subsection shall be used to secure payment of fees or costs that relate to the issuance of a license under this section and that have not been paid within 30 days after the fees or costs have become final. No claim may be made against a wholesale distributor's bond or other security under this subsection more than one year after the date on which the wholesale distributor's license expires.
(6) Applications for licensure under this section are not subject to inspection or copying under s. 19.35, and may not be disclosed to any person except as necessary for compliance with and enforcement of the provisions of this chapter.
450.071 History History: 2007 a. 20; 2009 a. 180.
450.072 450.072 Wholesale distributors; restrictions on transactions.
450.072(1)(1) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy, a person authorized to administer or dispense drugs, or a pharmacy's intracompany warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. A wholesale distributor that receives returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs may distribute the prescription drugs only to the original manufacturer of the products or to a 3rd party returns processor. Notwithstanding s. 450.073, returns or exchanges of saleable or nonsaleable prescription drugs, including any redistribution by a receiving wholesaler, are not subject to pedigree requirements under s. 450.073 if the returns or exchanges are exempt from the pedigree requirement under the federal food and drug administration's current guidance on the federal prescription drug marketing act. A person licensed under s. 450.071 or a pharmacy or other person authorized to administer or dispense drugs shall ensure that the person or pharmacy's return process is secure and does not permit the entry of adulterated and counterfeit products.
450.072(2) (2)
450.072(2)(a)(a) A manufacturer or wholesale distributor may not deliver prescription drugs to a person unless the person is licensed under s. 450.071 or 450.06 or by the appropriate licensing authority of another state or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1), and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale. A manufacturer or wholesale distributor may not deliver prescription drugs to a person that is not known to the manufacturer or wholesale distributor unless the manufacturer or wholesale distributor has verified with the board or with the licensing authority of the state in which the person is located that the person is licensed to receive prescription drugs or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1), and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale.
450.072(2)(b) (b) A manufacturer or wholesale distributor may distribute a prescription drug only to the premises listed on the person's license or authorization, except that a manufacturer or wholesale distributor may distribute the prescription drugs to an authorized agent of the person at the premises of the manufacturer or wholesale distributor if all of the following are true:
450.072(2)(b)1. 1. The manufacturer or wholesale distributor documents the authorized agent's name and address.
450.072(2)(b)2. 2. Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent's patient.
450.072(2)(c) (c) A manufacturer or wholesale distributor may distribute a prescription drug to a hospital pharmacy receiving area if a licensed pharmacist or another authorized recipient signs, at the time of the distribution, a receipt that shows the type and quantity of prescription drugs distributed. If there is a discrepancy between the type and quantity of prescription drugs indicated on the receipt and the type and quantity of prescription drugs received at the hospital pharmacy receiving area, the discrepancy shall be reported to the manufacturer or wholesale distributor that distributed the prescription drugs no later than the day immediately following the date on which the prescription drugs were distributed to the hospital pharmacy receiving area.
450.072(2)(d) (d) No manufacturer or wholesale distributor may accept payment for, or allow the use of, a person's credit to establish an account for the purchase of a prescription drug from any person other than the owner of record, the chief executive officer, or the chief financial officer identified on the license or authorization of a person who may receive prescription drugs. Any account established for the purchase of prescription drugs shall bear the name of the licensed or authorized person.
450.072 History History: 2007 a. 20; 2011 a. 100.
450.073 450.073 Wholesale distributors; pedigree.
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2011-12 Wisconsin Statutes updated though 2013 Wis. Act 200 and all Supreme Court Orders entered before April 18, 2014. Published and certified under s. 35.18. Changes effective after April 18, 2014 are designated by NOTES. (Published 4-18-14)