450.075 Third-party logistics providers; licensure.

738 words·~3 min read·/wi/chapter-450/450-075-2

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(1)License allowed. A person acting as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider of any drug or device may apply to obtain a license from the board under this section. If operations are conducted at more than one facility, a person acting as a 3rd-party logistics provider or out-of-state 3rd-party logistics provider may apply to obtain a license from the board for each such facility.

(2)Application. An applicant for a license under this section 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:

(a)The name, business address, and telephone number of the applicant.

(b)All trade or business names used by the applicant.

(c)Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the warehousing, distribution, or other services on behalf of the manufacturer of prescription drugs.

(d)The type of ownership or operation for the applicant’s business.

(e)If the applicant’s 3rd-party logistics provider business is a partnership, the name of each partner and the name of the partnership.

(f)If the applicant’s 3rd-party logistics provider business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation.

(g)If the applicant’s 3rd-party logistics provider business is a sole proprietorship, the name of the sole proprietor and the name of the business entity.

(h)A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to warehouse or distribute prescription drugs.

(i)The name, address, and telephone number of a designated representative.

(j)For the person identified as the designated representative in par.

(i), a personal information statement that contains all of the following:

1. The person’s date and place of birth.

2. The person’s place of residence for the 7-year period immediately preceding the date of the application.

3. The person’s occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application.

4. The name and addresses for each business, corporation, or other entity listed in subd. 3.

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.

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.

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.

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 person shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.

9. A photograph of the person taken within the 12-month period immediately preceding the date of the application.

(k)A statement that each facility used by the applicant for 3rd-party logistics provider services 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.

(3)Licensure. The board shall grant a license to an applicant to act as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider if all of the following apply:

(a)The applicant pays the fee specified in s. 440.05

(1).

(b)The inspections conducted pursuant to sub.

(k)satisfy requirements adopted by the board for 3rd-party logistics providers or out-of-state 3rd-party logistics providers.