Wisconsin Legislature: 20,3530h

(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.

(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:

(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.

(b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements adopted by the board for wholesale distribution facilities.

1. The person is at least 21 years old.

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.

3. The person is employed by the applicant full time in a managerial level position.

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.

5. The person is actively involved in and aware of the daily operations of the wholesale distributor.

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.

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.

8. The person has not been convicted of a felony.

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.

(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.

(4) The board may set, by rule, continuing education requirements for designated representatives under this section.

(5) (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.

(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.

20,3530eg Section 3530eg. 450.071 (3) (a) of the statutes, as created by 2007 Wisconsin Act .... (this act), is amended to read:

450.071 (3) (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.

20,3530g Section 3530g. 450.072 of the statutes is created to read:

450.072 Wholesale distributors; restrictions on transactions. (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.

(2) (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. 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 in located that the person is licensed to receive prescription drugs.

(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:

1. The manufacturer or wholesale distributor documents the authorized agent's name and address.

2. Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent's patient.

(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.

(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.

20,3530h Section 3530h. 450.073 of the statutes is created to read:

450.073 Wholesale distributors; pedigree. (1) A wholesale distributor shall establish and maintain a pedigree for each prescription drug that leaves, or has ever left, the normal distribution channel. Before a wholesale distribution of a prescription drug leaves the normal distribution channel, a wholesale distributor shall provide a copy of the pedigree to the person receiving the drug. This section does not apply to a retail pharmacy or pharmacy intracompany warehouse unless the pharmacy or pharmacy intracompany warehouse engages in the wholesale distribution of prescription drugs.

(2) A pedigree shall contain all necessary identifying information concerning each sale in the chain of the distribution of the prescription drug from the manufacturer of the prescription drug or the manufacturers 3rd-party logistics provider, colicensed product partner, or exclusive distributor until final sale or distribution to a pharmacy or a person dispensing or distributing the prescription drug. The pedigree shall include all of the following:

(a) The name, address, telephone number, and, if available, electronic mail address of each recipient or distributor of the prescription drug in the chain of distribution, until the final sale or distribution described in sub. (2) (intro.).

(b) The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a).

(d) A certification that every recipient has authenticated the pedigree before distribution of the prescription drug to the next point in the chain of distribution.

(e) The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug.

(3) The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2010, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2011, and the board may delay the implementation date in increments if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain or is not capable of adequately protecting patient safety.

(4) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but not including the original manufacturer of the prescription drug, who possesses a pedigree for the prescription drug, and who intends to further distribute the prescription drug, shall verify that each transaction recorded on the pedigree has occurred before the person may distribute the prescription drug.

(5) (a) A pedigree shall be maintained by a person who purchases prescription drugs identified in the pedigree and by a wholesale distributor who distributes prescription drugs identified in the pedigree for not less than 3 years from the date of sale or distribution.

(b) A person maintaining a pedigree under par. (a) shall make the pedigree available for inspection or use by a law enforcement officer within 7 days after the law enforcement officer's request.

20,3530i Section 3530i. 450.074 of the statutes is created to read:

450.074 Wholesale distributors; prohibited actions, enforcement, penalties. (1) If the board finds that there is a reasonable probability that a wholesale distributor, other than a manufacturer, has done any of the following, that continued distribution of a prescription drug involved in the occurrence could cause death or serious adverse health consequences, and that additional procedures would result in an unreasonable delay, the board shall issue an order requiring that distribution of a prescription drug in this state cease immediately:

(a) Violated a provision of ss. 450.071 to 450.073.

(b) Falsified a pedigree or sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use.

(2) If the board issues an order under sub. (1), the board shall provide the person who is the subject of the order an opportunity for an informal hearing not more than 10 days after the date on which the order is issued. If, after a hearing, the board determines that the order was issued without sufficient grounds, the board shall vacate the order.

(3) Any person who knowingly does any of the following is guilty of a Class H felony:

(a) Fails to obtain a license required under s. 450.071.

(b) Purchases or otherwise receives a prescription drug from a pharmacy in violation of s. 450.072 (1).

(d) Violates s. 450.072 (2) (b).

(e) Violates s. 450.072 (2) (d).

(f) Violates s. 450.073.

(g) Provides false or fraudulent records to, or makes a false or fraudulent statement to, the board, a representative of the board, or a federal official.

(h) Obtains or attempts to obtain a prescription drug by fraud, deceit, or misrepresentation, or engages in misrepresentation or fraud in the distribution of a prescription drug.

(i) Manufactures, repackages, sells, transfers, delivers, holds, or offers for sale a prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or otherwise unfit for distribution, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.

(j) Adulterates, misbrands, or counterfeits a prescription drug, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.

(k) Receives a prescription drug that has been adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeited, or suspected of being counterfeited, and delivers or proffers such a drug.

(L) Alters, mutilates, destroys, obliterates, or removes any part of the labeling of a prescription drug or commits another act that results in the misbranding of a prescription drug.

(4) Subsection (3) does not apply to a prescription drug manufacturer or an agent of a prescription drug manufacturer, if the manufacturer or agent is obtaining or attempting to obtain a prescription drug for the sole purpose of testing the authenticity of the prescription drug.

20,3531 Section 3531. 450.08 (2) (a) of the statutes is amended to read:

450.08 (2) (a) A pharmacist's license may be renewed by complying with continuing education requirements under s. 450.085 and paying the applicable fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a). Failure to obtain renewal within the time period specified under this paragraph terminates the right of the person to be licensed as a pharmacist, and such right can only be acquired by passing an examination to the satisfaction of the board.

20,3532 Section 3532. 450.08 (2) (b) of the statutes is amended to read:

450.08 (2) (b) A pharmacy, manufacturer's or distributor's license may be renewed by paying the applicable fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).

20,3533 Section 3533. 451.04 (4) of the statutes is amended to read:

451.04 (4) Expiration and renewal. Renewal applications shall be submitted to the department on a form provided by the department on or before the applicable renewal date specified under s. 440.08 (2) (a) and shall include the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a).

20,3534 Section 3534. 452.025 (1) (c) of the statutes is amended to read:

452.025 (1) (c) Each application for registration as a time-share salesperson shall be accompanied by an initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a) or the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a), whichever is appropriate.

20,3535 Section 3535. 452.025 (5) (b) of the statutes is amended to read:

452.025 (5) (b) An application to renew a certificate of registration granted under this section shall be submitted with the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).

20,3536 Section 3536. 452.10 (3) of the statutes is amended to read:

452.10 (3) The fees for examinations and licenses granted or renewed under this chapter are specified under ss. s. 440.05, and 440.08 the renewal fee for such licenses is determined by the department under s. 440.03 (9) (a).

20,3537 Section 3537. 452.12 (2) (c) of the statutes is amended to read:

452.12 (2) (c) Application for a business entity license shall be made on forms prescribed by the department, listing the names and addresses of all business representatives, and shall be accompanied by the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a). If there is a change in any of the business representatives, the change shall be reported to the department, on the same form, within 30 days after the effective date of the change.

20,3538 Section 3538. 452.12 (5) (a) of the statutes is amended to read:

452.12 (5) (a) Renewal applications for all licenses shall be submitted with the applicable renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a).

20,3539 Section 3539. 452.12 (6) (e) 1. of the statutes is amended to read:

452.12 (6) (e) 1. If a person has registered as an inactive licensee before November 1, 1990, the department shall reinstate the person's original license if that person applies to the department for reinstatement of his or her original license, pays the fees fee specified under s. 440.05 (1) (a) and (b), passes an examination under s. 452.09 (3) and completes the education requirements established by the department under par. (f).

20,3540 Section 3540. 452.12 (6) (e) 2. of the statutes is amended to read:

452.12 (6) (e) 2. If a person has registered as an inactive licensee on or after November 1, 1990, the department shall reinstate the person's original license if that person applies to the department for reinstatement of his or her original license, pays the renewal fee specified under s. 440.08 (2) (a) determined by the department under s. 440.03 (9) (a) for the original license and completes 12 hours of continuing education as established by the department under par. (f). A person who is eligible for reinstatement of his or her original license under this subdivision shall complete the requirements for reinstatement under this subdivision before January 1, 1996, or within 5 years after the date on which the person registered as an inactive licensee, whichever is later.

20,3541 Section 3541. 453.062 (1) of the statutes is amended to read:

453.062 (1) Renewal. The renewal dates and renewal fees for veterinary licenses and veterinary technician certifications are specified under s. 440.08 (2) (a), and the renewal fees for such licenses and certifications are determined by the department under s. 440.03 (9) (a).

20,3542 Section 3542. 454.06 (1) (a) of the statutes is amended to read:

454.06 (1) (a) The applicant pays the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a), except as provided in s. 454.13 (1).

20,3543 Section 3543. 454.06 (8) of the statutes is amended to read:

454.06 (8) Expiration and renewal. The renewal date and renewal fee for licenses issued under subs. (2) to (6) are is specified under s. 440.08 (2) (a), and the renewal fees for such licenses are determined by the department under s. 440.03 (9) (a).

20,3544 Section 3544. 454.08 (3) of the statutes is amended to read:

454.08 (3) The examining board shall issue an establishment license to any person who pays the initial credential fee specified in s. 440.05 (1) determined by the department under s. 440.03 (9) (a) and who satisfies the requirements established by the examining board by rule, including proof of ownership of the business. Any change of ownership shall be reported to the examining board by the new owner within 5 days after the change of ownership.

20,3545 Section 3545. 454.08 (9) of the statutes is amended to read: