SB40-ASA1,1461,43 1. To a pharmacy or to a person authorized to dispense or administer a drug to
4a patient.
SB40-ASA1,1461,65 2. To an authorized distributor of record, and then to a pharmacy or to a person
6authorized to dispense or administer a drug to a patient.
SB40-ASA1,1461,87 3. To an authorized distributor of record, then to one other authorized
8distributor of record, then to an office-based practitioner.
SB40-ASA1,1461,139 (b) For purposes of this subsection, a distribution of a prescription drug to a
10warehouse or to another entity that redistributes the drug by intracompany sale to
11a pharmacy or to another person authorized to dispense or administer the drug
12constitutes a distribution to the pharmacy or to the person authorized to dispense or
13administer the drug.
SB40-ASA1, s. 3526k 14Section 3526k. 450.01 (14m) of the statutes is created to read:
SB40-ASA1,1461,1615 450.01 (14m) "Pedigree" means a document or electronic file containing
16information that records each distribution of a prescription drug.
SB40-ASA1, s. 3526L 17Section 3526L. 450.01 (21e) of the statutes is created to read:
SB40-ASA1,1461,2018 450.01 (21e) "Repackage" means to repack or otherwise change the container,
19wrapper, or label of a prescription drug, except that "repackage" does not include any
20of the following:
SB40-ASA1,1461,2221 (a) An action by a pharmacist with respect to a prescription drug that the
22pharmacist is dispensing.
SB40-ASA1,1462,223 (b) An action by a pharmacist who receives a prescription drug or device that
24the pharmacist dispensed to a patient, if, after altering the packaging or labeling of

1the prescription drug or device, the pharmacist returns the prescription drug or
2device to the patient.
SB40-ASA1, s. 3526m 3Section 3526m. 450.01 (21m) of the statutes is created to read:
SB40-ASA1,1462,44 450.01 (21m) "Repackager" means a person that repackages.
SB40-ASA1, s. 3526n 5Section 3526n. 450.01 (21s) of the statutes is created to read:
SB40-ASA1,1462,106 450.01 (21s) "Third-party logistics provider" means a person that contracts
7with a prescription drug manufacturer to provide or coordinate warehousing,
8distribution, or other services on behalf of the manufacturer but that does not take
9title to the manufacturer's prescription drug or have general responsibility to direct
10the prescription drug's sale or disposition.
SB40-ASA1, s. 3526o 11Section 3526o. 450.01 (23) of the statutes is created to read:
SB40-ASA1,1462,1412 450.01 (23) "Wholesale distribution" means distribution of a prescription drug
13to a person other than a consumer or patient, but does not include any of the
14following:
SB40-ASA1,1462,1515 (a) Intracompany sales of prescription drugs.
SB40-ASA1,1462,1816 (b) The sale, purchase, distribution, trade, or transfer of a prescription drug or
17offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency
18medical reasons.
SB40-ASA1,1462,2019 (c) The distribution of prescription drug samples, if the distribution is
20permitted under 21 CFR 353 (d).
SB40-ASA1,1462,2221 (d) Drug returns, when conducted by a hospital, health care entity, or
22charitable institution as provided in 21 CFR 203.23.
SB40-ASA1,1462,2523 (e) The sale of minimal quantities, as defined by the board in an administrative
24rule, of prescription drugs by retail pharmacies to licensed practitioners for office
25use.
SB40-ASA1,1463,2
1(f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a
2drug, or the dispensing of a drug pursuant to a prescription.
SB40-ASA1,1463,53 (g) The sale, transfer, merger, or consolidation of all or part of the business of
4a pharmacy from or with another pharmacy, whether accomplished as a purchase
5and sale of stock or business assets.
SB40-ASA1,1463,116 (h) The sale, purchase, distribution, trade, or transfer of a prescription drug
7from one authorized distributor of record to one additional authorized distributor of
8record, if the manufacturer states in writing to the receiving authorized distributor
9of record that the manufacturer is unable to supply the drug and the supplying
10authorized distributor of record states in writing that the drug has previously been
11exclusively in the normal distribution channel.
SB40-ASA1,1463,1512 (i) The delivery of, or offer to deliver, a prescription drug by a common carrier
13solely in the common carrier's usual course of business of transporting prescription
14drugs, if the common carrier does not store, warehouse, or take legal ownership of
15the drug.
SB40-ASA1,1463,1716 (j) A transaction excluded from the definition of "wholesale distribution" under
1721 CFR 203.3 (cc).
SB40-ASA1,1463,1818 (k) The donation or distribution of a prescription drug under s. 255.056.
SB40-ASA1, s. 3526p 19Section 3526p. 450.01 (24) of the statutes is created to read:
SB40-ASA1,1464,220 450.01 (24) "Wholesale distributor" means a person engaged in the wholesale
21distribution of prescription drugs, including manufacturers, repackagers, own-label
22distributors, private label distributors, jobbers, brokers, warehouses, including
23manufacturers' and distributors' warehouses, manufacturers' exclusive
24distributors, manufacturers' authorized distributors of record, prescription drug
25wholesalers and distributors, independent wholesale prescription drug traders,

13rd-party logistics providers, retail pharmacies that conduct wholesale distribution,
2and chain pharmacy warehouses that conduct wholesale distribution.
SB40-ASA1, s. 3530a 3Section 3530a. 450.07 (title) of the statutes is amended to read:
SB40-ASA1,1464,4 4450.07 (title) Manufacturers and distributors; licensure.
SB40-ASA1, s. 3530b 5Section 3530b. 450.07 (2) of the statutes is repealed.
SB40-ASA1, s. 3530c 6Section 3530c. 450.07 (3) of the statutes is repealed.
SB40-ASA1, s. 3530d 7Section 3530d. 450.07 (4) (c) of the statutes is created to read:
SB40-ASA1,1464,108 450.07 (4) (c) The rules adopted by the board under par. (b) shall require a
9manufacturer to maintain and to update at least once per month a list of the
10manufacturer's authorized distributors of record.
SB40-ASA1, s. 3530e 11Section 3530e. 450.071 of the statutes is created to read:
SB40-ASA1,1464,19 12450.071 Wholesale distributors; licensure. (1) No person may engage in
13the wholesale distribution of a prescription drug in this state without obtaining a
14license from the board for each facility from which the person distributes
15prescription drugs. The board shall exempt a manufacturer that distributes
16prescription drugs or devises manufactured by the manufacturer from licensing and
17other requirements under this section to the extent the license or requirement is not
18required under federal law or regulation, unless the board determines that it is
19necessary to apply a requirement to a manufacturer.
SB40-ASA1,1464,21 20(2) An applicant shall submit a form provided by the board showing all of the
21following and swear or affirm the truthfulness of each item in the application:
SB40-ASA1,1464,2222 (a) The name, business address, and telephone number of the applicant.
SB40-ASA1,1464,2323 (b) All trade or business names used by the applicant.
SB40-ASA1,1465,3
1(c) Names, addresses, and telephone numbers of contact persons for all
2facilities used by the applicant for the storage, handling, and distribution of
3prescription drugs.
SB40-ASA1,1465,44 (d) The type of ownership or operation for the applicant's business.
SB40-ASA1,1465,65 (e) If the applicant's wholesale distribution business is a partnership, the name
6of each partner and the name of the partnership.
SB40-ASA1,1465,97 (f) If the applicant's wholesale distribution business is a corporation, the name
8of each corporate officer and director, the name of the corporation, and the state of
9incorporation.
SB40-ASA1,1465,1110 (g) If the applicant's wholesale distribution business is a sole proprietorship,
11the name of the sole proprietor and the name of the business entity.
SB40-ASA1,1465,1312 (h) A list of all licenses and permits issued to the applicant by any other state
13that authorizes the applicant to purchase or possess prescription drugs.
SB40-ASA1,1465,1414 (i) The name, address, and telephone number of a designated representative.
SB40-ASA1,1465,1615 (j) For the person listed in par. (i), a personal information statement that
16contains all of the following:
SB40-ASA1,1465,1717 1. The person's date and place of birth.
SB40-ASA1,1465,1918 2. The person's places of residence for the 7-year period immediately preceding
19the date of the application.
SB40-ASA1,1465,2120 3. The person's occupations, positions of employment, and offices held during
21the 7-year period immediately preceding the date of the application.
SB40-ASA1,1465,2322 4. The name and addresses for each business, corporation, or other entity listed
23in subd. 3.
SB40-ASA1,1466,224 5. A statement indicating whether the person has been, during the 7-year
25period immediately preceding the date of the application, the subject of any

1proceeding for the revocation of any business or professional license and the
2disposition of the proceeding.
SB40-ASA1,1466,73 6. A statement indicating whether the person has been, during the 7-year
4period immediately preceding the date of the application, enjoined by a court, either
5temporarily or permanently, from possessing, controlling, or distributing any
6prescription drug, and a description of the circumstances surrounding the
7injunction.
SB40-ASA1,1466,128 7. A description of any involvement by the person during the past 7 years with
9any business, including investments other than the ownership of stock in a publicly
10traded company or mutual fund, that manufactured, administered, prescribed,
11distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits
12in which such a business was named as a party.
SB40-ASA1,1466,1813 8. A description of any misdemeanor or felony criminal offense of which the
14person was, as an adult, found guilty, whether adjudication of guilt was withheld or
15the person pleaded guilty or no contest. If the person is appealing a criminal
16conviction, the application shall include a copy of the notice of appeal, and the
17applicant shall submit a copy of the final disposition of the appeal not more than 15
18days after a final disposition is reached.
SB40-ASA1,1466,2019 9. A photograph of the person taken within the 12-month period immediately
20preceding the date of the application.
SB40-ASA1,1467,221 (k) A statement that each facility used by the applicant for the wholesale
22distribution of prescription drugs has been inspected in the 3-year period
23immediately preceding the date of the application by the board, a pharmacy
24examining board of another state, the National Association of Boards of Pharmacy,

1or another accrediting body recognized by the board, with the date of each such
2inspection.
SB40-ASA1,1467,4 3(3) The board shall grant a license to the applicant to engage in the wholesale
4distribution of prescription drugs if all of the following apply:
SB40-ASA1,1467,65 (a) The applicant pays the fee under s. 440.05 (1) (a), except that before June
61, 2010, the amount of the initial fee is $350.
SB40-ASA1,1467,87 (b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements
8adopted by the board for wholesale distribution facilities.
SB40-ASA1,1467,109 (c) All of the following apply to each person identified by the applicant as a
10designated representative:
SB40-ASA1,1467,1111 1. The person is at least 21 years old.
SB40-ASA1,1467,1412 2. The person has been employed full time for at least 3 years in a pharmacy
13or with a wholesale prescription drug distributor in a capacity related to the
14dispensing and distribution of, and record keeping related to, prescription drugs.
SB40-ASA1,1467,1615 3. The person is employed by the applicant full time in a managerial level
16position.
SB40-ASA1,1467,2217 4. The person is physically present at the wholesale prescription drug
18distributor's facility during regular business hours and is involved in and aware of
19the daily operation of the wholesale prescription drug distributor. This subdivision
20does not preclude the designated representative from taking authorized sick leave
21and vacation time or from being absent from the facility for other authorized
22business or personal purposes.
SB40-ASA1,1467,2423 5. The person is actively involved in and aware of the daily operations of the
24wholesale distributor.
SB40-ASA1,1468,4
16. The person is a designated representative for only one applicant at any given
2time. This subdivision does not apply if more than one wholesale distributor is
3located at the facility and the wholesale distributors located at the facility are
4members of an affiliated group.
SB40-ASA1,1468,75 7. The person has not been convicted of violating any federal, state, or local law
6relating to wholesale or retail prescription drug distribution or distribution of a
7controlled substance.
SB40-ASA1,1468,88 8. The person has not been convicted of a felony.
SB40-ASA1,1468,159 9. The person submits to the department 2 fingerprint cards, each bearing a
10complete set of the applicant's fingerprints. The department of justice shall provide
11for the submission of the fingerprint cards to the federal bureau of investigation for
12the purposes of verifying the identity of the applicant and obtaining the applicant's
13criminal arrest and conviction record. This subdivision does not apply to a person
14accredited by the national association of boards of pharmacy's verified-accredited
15wholesale distributor program.
SB40-ASA1,1468,21 16(3m) Notwithstanding subs. (2) and (3), the board may grant a license to
17engage in the wholesale distribution of prescription drugs to a person who is
18domiciled in another state and is licensed to engage in the wholesale distribution of
19prescription drugs in another state, if the board determines that the standards for
20licensure in the state in which the person is licensed are at least as stringent as the
21standards for licensure under this section.
SB40-ASA1,1468,23 22(4) The board may set, by rule, continuing education requirements for
23designated representatives under this section.
SB40-ASA1,1469,5 24(5) (a) The board shall require every wholesale distributor to submit a surety
25bond acceptable to the board in an amount not to exceed $100,000 or other equivalent

1means of security acceptable to the board, except that the board shall not require
2submission of a bond or other security under this subsection by a chain pharmacy
3warehouse that is engaged only in intracompany transfers. A wholesale distributor
4that operates more than one facility is not required to submit a bond or other security
5under this paragraph for each facility.
SB40-ASA1,1469,116 (b) The bond or other security under this subsection shall be used to secure
7payment of fees or costs that relate to the issuance of a license under this section and
8that have not been paid within 30 days after the fees or costs have become final. No
9claim may be made against a wholesale distributor's bond or other security under
10this subsection more than one year after the date on which the wholesale
11distributor's license expires.
SB40-ASA1,1469,1412 (6) Applications for licensure under this section are not subject to inspection
13or copying under s. 19.35, and may not be disclosed to any person except as necessary
14for compliance with and enforcement of the provisions of this chapter.
SB40-ASA1, s. 3530g 15Section 3530g. 450.072 of the statutes is created to read:
SB40-ASA1,1470,7 16450.072 Wholesale distributors; restrictions on transactions. (1) A
17wholesale distributor shall receive prescription drug returns or exchanges from a
18pharmacy, a person authorized to administer or dispense drugs, or a pharmacy's
19intracompany warehouse pursuant to the terms and conditions of the agreement
20between the wholesale distributor and the pharmacy or chain pharmacy warehouse.
21A wholesale distributor that receives returns of expired, damaged, recalled, or
22otherwise nonsaleable prescription drugs may distribute the prescription drugs only
23to the original manufacturer of the products or to a 3rd party returns processor.
24Notwithstanding s. 450.073, returns or exchanges of saleable or nonsaleable
25prescription drugs, including any redistribution by a receiving wholesaler, are not

1subject to pedigree requirements under s. 450.073 if the returns or exchanges are
2exempt from the pedigree requirement under the federal food and drug
3administration's current guidance on the federal prescription drug marketing act.
4A person licensed under s. 450.071 or a pharmacy or other person authorized to
5administer or dispense drugs shall ensure that the person or pharmacy's return
6process is secure and does not permit the entry of adulterated and counterfeit
7products.
SB40-ASA1,1470,14 8(2) (a) A manufacturer or wholesale distributor may not deliver prescription
9drugs to a person unless the person is licensed under s. 450.071, s. 450.06, or by the
10appropriate licensing authority of another state. A manufacturer or wholesale
11distributor may not deliver prescription drugs to a person that is not known to the
12manufacturer or wholesale distributor unless the manufacturer or wholesale
13distributor has verified with the board or with the licensing authority of the state in
14which the person in located that the person is licensed to receive prescription drugs.
SB40-ASA1,1470,1915 (b) A manufacturer or wholesale distributor may distribute a prescription drug
16only to the premises listed on the person's license or authorization, except that a
17manufacturer or wholesale distributor may distribute the prescription drugs to an
18authorized agent of the person at the premises of the manufacturer or wholesale
19distributor if all of the following are true:
SB40-ASA1,1470,2120 1. The manufacturer or wholesale distributor documents the authorized
21agent's name and address.
SB40-ASA1,1470,2322 2. Distribution to an authorized agent is necessary to promote or protect the
23immediate health or safety of the authorized agent's patient.
SB40-ASA1,1471,824 (c) A manufacturer or wholesale distributor may distribute a prescription drug
25to a hospital pharmacy receiving area if a licensed pharmacist or another authorized

1recipient signs, at the time of the distribution, a receipt that shows the type and
2quantity of prescription drugs distributed. If there is a discrepancy between the type
3and quantity of prescription drugs indicated on the receipt and the type and quantity
4of prescription drugs received at the hospital pharmacy receiving area, the
5discrepancy shall be reported to the manufacturer or wholesale distributor that
6distributed the prescription drugs no later than the day immediately following the
7date on which the prescription drugs were distributed to the hospital pharmacy
8receiving area.
SB40-ASA1,1471,149 (d) No manufacturer or wholesale distributor may accept payment for, or allow
10the use of, a person's credit to establish an account for the purchase of a prescription
11drug from any person other than the owner of record, the chief executive officer, or
12the chief financial officer identified on the license or authorization of a person who
13may receive prescription drugs. Any account established for the purchase of
14prescription drugs shall bear the name of the licensed or authorized person.
SB40-ASA1, s. 3530h 15Section 3530h. 450.073 of the statutes is created to read:
SB40-ASA1,1471,23 16450.073 Wholesale distributors; pedigree. (1) A wholesale distributor
17shall establish and maintain a pedigree for each prescription drug that leaves, or has
18ever left, the normal distribution channel. Before a wholesale distribution of a
19prescription drug leaves the normal distribution channel, a wholesale distributor
20shall provide a copy of the pedigree to the person receiving the drug. This section
21does not apply to a retail pharmacy or pharmacy intracompany warehouse unless the
22pharmacy or pharmacy intracompany warehouse engages in the wholesale
23distribution of prescription drugs.
SB40-ASA1,1472,4 24(2) A pedigree shall contain all necessary identifying information concerning
25each sale in the chain of the distribution of the prescription drug from the

1manufacturer of the prescription drug or the manufacturers 3rd-party logistics
2provider, colicensed product partner, or exclusive distributor until final sale or
3distribution to a pharmacy or a person dispensing or distributing the prescription
4drug. The pedigree shall include all of the following:
SB40-ASA1,1472,75 (a) The name, address, telephone number, and, if available, electronic mail
6address of each recipient or distributor of the prescription drug in the chain of
7distribution, until the final sale or distribution described in sub. (2) (intro.).
SB40-ASA1,1472,98 (b) The name and address of each facility from which the prescription drug was
9distributed, if different from the address provided in par. (a).
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