450.072(2)(b)2.2. Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent’s patient.
450.072(2)(c)(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.
450.072(2)(d)(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.
450.072 HistoryHistory: 2007 a. 20; 2011 a. 100.
450.073450.073Wholesale distributors; pedigree.
450.073(1)(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.
450.073(2)(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:
450.073(2)(a)(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.).
450.073(2)(b)(b) The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a).
450.073(2)(c)(c) The date of each distribution.
450.073(2)(d)(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.
450.073(2)(e)(e) The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug.
450.073(3)(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.
450.073(4)(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.
450.073(5)(5)
450.073(5)(a)(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.
450.073(5)(b)(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.
450.073 HistoryHistory: 2007 a. 20.
450.074450.074Wholesale distributors; prohibited actions, enforcement, penalties.
450.074(1)(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:
450.074(1)(a)(a) Violated a provision of ss. 450.071 to 450.073.
450.074(1)(b)(b) Falsified a pedigree or sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use.
450.074(2)(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.
450.074(3)(3)Any person who knowingly does any of the following is guilty of a Class H felony:
450.074(3)(a)(a) Fails to obtain a license required under s. 450.071.
450.074(3)(b)(b) Purchases or otherwise receives a prescription drug from a pharmacy in violation of s. 450.072 (1).
450.074(3)(c)(c) Violates s. 450.072 (2) (a), if the person is required to obtain a license under s. 450.071.
450.074(3)(d)(d) Violates s. 450.072 (2) (b).
450.074(3)(e)(e) Violates s. 450.072 (2) (d).