SB40-ASA1,1468,7 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.

SB40-ASA1,1468,8 8. The person has not been convicted of a felony.

SB40-ASA1,1468,15 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.

SB40-ASA1,1468,21 (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.

SB40-ASA1,1468,23 (4) The board may set, by rule, continuing education requirements for designated representatives under this section.

SB40-ASA1,1469,5 (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.

SB40-ASA1,1469,11 (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.

SB40-ASA1,1469,14 (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.

SB40-ASA1, s. 3530g Section 3530g. 450.072 of the statutes is created to read:

SB40-ASA1,1470,7 450.072 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.

SB40-ASA1,1470,14 (2) (a) A manufacturer or wholesale distributor may not deliver prescription drugs to a person unless the person is licensed under s. 450.071, s. 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.

SB40-ASA1,1470,19 (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:

SB40-ASA1,1470,21 1. The manufacturer or wholesale distributor documents the authorized agent's name and address.

SB40-ASA1,1470,23 2. Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent's patient.

SB40-ASA1,1471,8 (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.

SB40-ASA1,1471,14 (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.

SB40-ASA1, s. 3530h Section 3530h. 450.073 of the statutes is created to read:

SB40-ASA1,1471,23 450.073 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.

SB40-ASA1,1472,4 (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:

SB40-ASA1,1472,7 (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.).

SB40-ASA1,1472,9 (b) The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a).

SB40-ASA1,1472,10 (c) The date of each distribution.

SB40-ASA1,1472,12 (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.

SB40-ASA1,1472,14 (e) The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug.

SB40-ASA1,1472,20 (3) The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2009, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2010, and the board may delay the implementation date by one or more periods of one year if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain.

SB40-ASA1,1473,2 (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.

SB40-ASA1,1473,6 (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.

SB40-ASA1,1473,9 (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.

SB40-ASA1, s. 3530i Section 3530i. 450.074 of the statutes is created to read: