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Please see http://docs.legis.wisconsin.gov for the production version.
The bill requires the Pharmacy Examining Board to issue interim licenses for
third-party logistics providers and out-of-state third-party logistics providers
between the date of enactment until permanent or emergency rules take effect,
whichever is sooner, if, in the opinion of the board, the applicant is currently in
compliance with federal law relating to third-party logistics providers. An interim
license to act as a third-party logistics provider or out-of-state third-party logistics
provider expires 90 days after the date that emergency rules take effect, or 90 days
after the date that permanent rules take effect, whichever is sooner. No fee is
required for a holder of an interim license to act as a third-party logistics provider
or an out-of-state third-party logistics provider.
Finally, the bill requires third-party logistics providers, whether or not
licensed under the bill, to cooperate with inspections of their facilities and delivery
vehicles.
For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB163,1 1Section 1 . 440.08 (2) (a) 69g. of the statutes is created to read:
SB163,2,32 440.08 (2) (a) 69g. Third-party logistics provider: July 1 of each
3even-numbered year.
SB163,2 4Section 2 . 440.15 of the statutes is amended to read:
SB163,2,9 5440.15 No fingerprinting. Except as provided under ss. 440.03 (13) (c),
6441.51 (5) (a) 5., 448.980 (5) (b) 3., and 448.985 (3) (a) 4., 450.071 (3) (c) 9., and 450.075
7(3) (c) 9.,
the department or a credentialing board may not require that an applicant
8for a credential or a credential holder be fingerprinted or submit fingerprints in
9connection with the department's or the credentialing board's credentialing.
SB163,3 10Section 3 . 450.01 (11m) of the statutes is amended to read:
SB163,3,3
1450.01 (11m) “Facility" means a location where a wholesale distributor or
23rd-party logistics provider
stores, distributes, handles, repackages, or offers for
3sale
other services related to prescription drugs.
SB163,4 4Section 4 . 450.01 (13w) of the statutes is created to read:
SB163,3,105 450.01 (13w) “Out-of-state 3rd-party logistics provider” means a person
6located outside this state that contracts with a prescription drug manufacturer to
7provide or coordinate warehousing, distribution, or other services within this state
8on behalf of the manufacturer but that does not take title to the manufacturer's
9prescription drug or have general responsibility to direct the prescription drug's sale
10or disposition.
SB163,5 11Section 5 . 450.01 (21s) of the statutes is amended to read:
SB163,3,1612 450.01 (21s)Third party Third-party logistics provider" means a person that
13contracts with a prescription drug manufacturer to provide or coordinate
14warehousing, distribution, or other services on behalf of the manufacturer but that
15does not take title to the manufacturer's prescription drug or have general
16responsibility to direct the prescription drug's sale or disposition.
SB163,6 17Section 6 . 450.01 (23) (p) of the statutes is created to read:
SB163,3,1918 450.01 (23) (p) The services of a 3rd-party logistics provider or out-of-state
193rd-party logistics provider.
SB163,7 20Section 7 . 450.02 (1) of the statutes is amended to read:
SB163,4,221 450.02 (1) The department shall keep a record of the proceedings and a register
22of the names and places of practice or business of pharmacies, manufacturers,
23wholesale distributors, 3rd-party logistics providers, out-of-state 3rd-party
24logistics providers,
and other persons licensed under this chapter, and the books,

1registers and records of the department shall be prima facie evidence of the matters
2recorded.
SB163,8 3Section 8 . 450.075 of the statutes is created to read:
SB163,4,9 4450.075 Third-party logistics providers; licensure. (1) License allowed.
5A person acting as a 3rd-party logistics provider or an out-of-state 3rd-party
6logistics provider of any drug or device may apply to obtain a license from the board
7under this section. Where operations are conducted at more than one facility, a
8person acting as a 3rd-party logistics provider or out-of-state 3rd-party logistics
9provider may apply to obtain a license from the board for each such facility.
SB163,4,12 10(2) Application. An applicant for a license under this section shall submit a
11form provided by the board showing all of the following and swear or affirm the
12truthfulness of each item in the application:
SB163,4,1313 (a) The name, business address, and telephone number of the applicant.
SB163,4,1414 (b) All trade or business names used by the applicant.
SB163,4,1715 (c) Names, addresses, and telephone numbers of contact persons for all
16facilities used by the applicant for the warehousing, distribution, or other services
17on behalf of the manufacturer of prescription drugs.
SB163,4,1818 (d) The type of ownership or operation for the applicant's business.
SB163,4,2019 (e) If the applicant's 3rd-party logistics provider business is a partnership, the
20name of each partner and the name of the partnership.
SB163,4,2321 (f) If the applicant's 3rd-party logistics provider business is a corporation, the
22name of each corporate officer and director, the name of the corporation, and the state
23of incorporation.
SB163,4,2524 (g) If the applicant's 3rd-party logistics provider business is a sole
25proprietorship, the name of the sole proprietor and the name of the business entity.
SB163,5,2
1(h) A list of all licenses and permits issued to the applicant by any other state
2that authorizes the applicant to warehouse or distribute prescription drugs.
SB163,5,33 (i) The name, address, and telephone number of a designated representative.
SB163,5,54 (j) For the person identified as the designated representative in par. (i), a
5personal information statement that contains all of the following:
SB163,5,66 1. The person's date and place of birth.
SB163,5,87 2. The person's place of residence for the 7-year period immediately preceding
8the date of the application.
SB163,5,109 3. The person's occupations, positions of employment, and offices held during
10the 7-year period immediately preceding the date of the application.
SB163,5,1211 4. The name and addresses for each business, corporation, or other entity listed
12in subd. 3.
SB163,5,1613 5. A statement indicating whether the person has been, during the 7-year
14period immediately preceding the date of the application, the subject of any
15proceeding for the revocation of any business or professional license and the
16disposition of the proceeding.
SB163,5,2117 6. A statement indicating whether the person has been, during the 7-year
18period immediately preceding the date of the application, enjoined by a court, either
19temporarily or permanently, from possessing, controlling, or distributing any
20prescription drug, and a description of the circumstances surrounding the
21injunction.
SB163,6,222 7. A description of any involvement by the person during the past 7 years with
23any business, including investments other than the ownership of stock in a publicly
24traded company or mutual fund, that manufactured, administered, prescribed,

1distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits
2in which such a business was named as a party.
SB163,6,83 8. A description of any misdemeanor or felony criminal offense of which the
4person was, as an adult, found guilty, whether adjudication of guilt was withheld or
5the person pleaded guilty or no contest. If the person is appealing a criminal
6conviction, the application shall include a copy of the notice of appeal, and the person
7shall submit a copy of the final disposition of the appeal not more than 15 days after
8a final disposition is reached.
SB163,6,109 9. A photograph of the person taken within the 12-month period immediately
10preceding the date of the application.
SB163,6,1511 (k) A statement that each facility used by the applicant for 3rd-party logistics
12provider services has been inspected in the 3-year period immediately preceding the
13date of the application by the board, a pharmacy examining board of another state,
14the National Association of Boards of Pharmacy, or another accrediting body
15recognized by the board, with the date of each such inspection.
SB163,6,18 16(3) Licensure. The board shall grant a license to an applicant to act as a
173rd-party logistics provider or an out-of-state 3rd-party logistics provider if all of
18the following apply:
SB163,6,1919 (a) The applicant pays the fee specified in s. 440.05 (1).
SB163,6,2220 (b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements
21adopted by the board for 3rd-party logistics providers or out-of-state 3rd-party
22logistics providers.
SB163,6,2423 (c) All of the following apply to each person identified by the applicant as a
24designated representative:
SB163,6,2525 1. The person is at least 21 years old.
SB163,7,3
12. The person has been employed full time for at least 3 years in a pharmacy
2or with a wholesale prescription drug distributor in a capacity related to the
3dispensing of and distribution of, and record keeping related to, prescription drugs.
SB163,7,44 3. The person is employed by the applicant full time in a managerial position.
SB163,7,105 4. The person is physically present at the 3rd-party logistics provider's or
6out-of-state 3rd-party logistics provider's facility during regular business hours
7and is involved in and aware of the daily operation of the 3rd-party logistics provider
8or the out-of-state 3rd-party logistics provider. This subdivision does not preclude
9the person from taking authorized sick leave and vacation time or from being absent
10from the facility for other authorized business or personal purposes.
SB163,7,1211 5. The person is actively involved in and aware of the daily operation of the
123rd-party logistics provider or the out-of-state 3rd-party logistics provider.
SB163,7,1713 6. The person is a designated representative for only one applicant at any given
14time. This subdivision does not apply if more than one 3rd-party logistics provider
15or out-of-state 3rd-party logistics provider is located at the facility and the
163rd-party logistics providers or out-of-state 3rd-party logistics providers located at
17the facility are members of an affiliated group.
SB163,7,1918 7. The person has not been convicted of violating any federal, state, or local law
19relating to distribution of a controlled substance.
SB163,7,2020 8. The person has not been convicted of a felony.
SB163,7,2521 9. The person submits to the department 2 fingerprint cards, each bearing a
22complete set of the applicant's fingerprints. The department of justice shall provide
23for the submission of the fingerprint cards to the federal bureau of investigation for
24purposes of verifying the identity of the person and obtaining the person's criminal
25arrest and conviction record.
SB163,8,2
1(d) The applicant satisfies any other requirements established by the board by
2rule.
SB163,8,8 3(4) Rules. The board shall promulgate rules implementing this section. The
4rules shall ensure compliance with the federal drug supply chain security act, 21
5USC 360eee
, et seq. The board may not promulgate rules that impose requirements
6more strict than the federal drug supply chain security act, or any regulations passed
7under the federal drug supply chain security act. The board may not promulgate
8rules that require a license under this section.
SB163,8,12 9(5) Access to records. Applications for licensure under this section are not
10subject to inspection or copying under s. 19.35, and may not be disclosed to any
11person except as necessary for compliance with and enforcement of the provisions of
12this chapter.
SB163,8,17 13(6) Inspections. A 3rd-party logistics provider or an out-of-state 3rd-party
14logistics provider shall allow the board and authorized federal, state, and local law
15enforcement officials to enter and inspect its facilities and delivery vehicles, to audit
16its records and written operating procedures, and to confiscate prescription drugs
17and records to the extent authorized by law, rule, or regulation.
SB163,8,22 18(7) Applicability. This section does not apply if the board determines that the
19federal food and drug administration has established a licensing program for
203rd-party logistics providers under 21 USC 360eee-3 and that licensing by this state
21of resident 3rd-party logistics providers is not required for a resident 3rd-party
22logistics provider to provide 3rd-party logistics provider services in another state.
SB163,9 23Section 9 . Nonstatutory provisions.
SB163,9,724 (1) Emergency rules related to 3rd-party logistics providers. The pharmacy
25examining board may promulgate emergency rules under s. 227.24 implementing s.

1450.075. Notwithstanding s. 227.24 (1) (c) and (2), emergency rules promulgated
2under this subsection remain in effect until June 30, 2023, or the date on which
3permanent rules take effect, whichever is sooner. Notwithstanding s. 227.24 (1) (a)
4and (3), the board is not required to provide evidence that promulgating a rule under
5this subsection as an emergency rule is necessary for the preservation of the public
6peace, health, safety, or welfare and is not required to provide a finding of emergency
7for a rule promulgated under this subsection.
SB163,9,88 (2) Interim licensure of 3rd-party logistics providers.
SB163,9,99 (a) In this subsection, the definitions under s. 450.01 apply.
SB163,9,2010 (b) The board shall grant an interim license to an applicant to act as a 3rd-party
11logistics provider or an out-of-state 3rd-party logistics provider if, in the opinion of
12the board, the applicant is currently in compliance with federal law relating to
133rd-party logistics providers. The holder of an interim license under this subsection
14shall apply for a license under s. 450.075 on or after the date that emergency rules
15take effect under sub. (1), or the date on which permanent rules take effect,
16whichever is sooner. An interim license granted under this subsection expires 90
17days after the date that emergency rules take effect under sub. (1), or 90 days after
18the date on which permanent rules take effect, whichever is sooner.
19Notwithstanding s. 440.05, no fee is required for an interim license issued under this
20subsection.
SB163,9,2121 (End)
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